Clinical trial NCT00279201: The DURABLE Trial: Evaluating the Durability of Starter Insulin Regimens in Patients With Type 2 Diabetes (IOOV)
Official title: The Durability of Twice-Daily Insulin Lispro Low Mixture Compared to Once-Daily Insulin Glargine When Added to Existing Oral Therapy in Patients With Type 2 Diabetes and Inadequate Glycemic Control
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diabetes Mellitus, Type 2
Keywords: diabetes
type 2
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2006-01-19
Enrollment: 2091
Sex: ALL
Minimum age (years): 30
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will compare insulin lispro low mixture \[LM\] and insulin glargine both in combination with the patient's oral diabetes medicines, for their ability to control blood sugar in patients with type 2 diabetes and compare insulin lispro LM to insulin glargine with regard to the length of time that the overall blood sugar can be controlled.

This study will also determine whether the safety of insulin lispro LM and any side effects that might be associated with it are different from those observed with insulin glargine, both in combination with the patient's oral diabetes medications.

The addendum study (Intensification Addendum) will compare how different insulin treatments work to control blood sugar in patients whose diabetes could not be controlled by either insulin lispro LM or insulin glargine.


Eligibility criteria: Inclusion Criteria:

* Must have type 2 diabetes.
* Must be at least 30 and less than 80 years of age at the time of Visit 1.
* Must be on at least two oral antidiabetes medications for at least 90 days.
* Must have an HbA1c 1.2 to 2.0 times the upper limit of normal reference range at the local lab.

Exclusion Criteria:

* Must not have used insulin on a regular basis in the last 12 months.
* Must not have had more than one episode of severe hypoglycemia in the last 24 weeks.
* Must not have a body mass index (BMI) of greater than 45 (morbid obesity).
* Must not have clinically significant hematologic, oncologic, renal, cardiac, hepatic, or gastrointestinal disease.
* Must not be pregnant or intend to get pregnant during course of the study.

Primary outcomes:
measure: INITIATION: 24-Week Endpoint Glycosylated Hemoglobin (HbA1c)
timeFrame: Endpoint (Initiation: Week 24)
measure: MAINTENANCE: Duration of Time HbA1c Maintained at Goal by Initiation Regimen (Insulin Glargine or Lispro Low Mix)
timeFrame: Endpoint (Last Observation Carried Forward [LOCF]) (Maintenance: up to 2.5 years)
measure: ADDENDUM: 24-Week Endpoint HbA1c
timeFrame: Endpoint (Addendum) (24 weeks: Week 48)
Secondary outcomes:
measure: INITIATION: Change in HbA1c From Baseline to 24 Weeks
timeFrame: Baseline (Initiation) to Endpoint (LOCF, Week 24)
measure: INITIATION: Percentage of Participants With HbA1c < or = 7.0%, HbA1c <7.0%, and HbA1c < or = 6.5% at Endpoint
timeFrame: Endpoint (Initiation: Week 24)
measure: INITIATION: HbA1c
timeFrame: Baseline (Initiation), Week 12, Week 24, Endpoint (LOCF)
measure: INITIATION: 7-point Self-monitored Plasma Glucose (SMPG) Profiles and Postprandial Excursions
timeFrame: Endpoint (LOCF) (Initiation: Week 24)
measure: INITIATION: Change From Baseline to Endpoint in 1,5 Anhydroglucitol (1,5 AG)
timeFrame: Baseline (Initiation), Endpoint (Week 24)
measure: INITIATION: Incremental Change From Baseline in Body Weight
timeFrame: Baseline (Initiation), Weeks 6, 12, 18, 24, Endpoint (LOCF)
measure: INITIATION: Body Weight
timeFrame: Baseline (Initiation), Weeks 6, 12, 18, 24, Endpoint (LOCF)
measure: INITIATION: Percentage of Participants With Self-reported Hypoglycemic Episodes
timeFrame: Baseline (Initiation), Endpoint (Week 24), Overall (sum of frequencies of hypoglycemic episodes after baseline ([Week 0]).
measure: INITIATION: Rate of Self-reported Hypoglycemic Episodes
timeFrame: Endpoint (Initiation: Week 24), Overall (incidence of hypoglycemic episodes after baseline [Week 0])
measure: INITIATION: Insulin Dose
timeFrame: Weeks 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, Endpoint (LOCF)
measure: INITIATION: Participant Demographics of Participants Who Did Versus Did Not Achieve HbA1c Goal at Week 24 - Age
timeFrame: Endpoint (Initiation: Week 24)
measure: INITIATION: Participant Demographics of Participants Who Did Versus Did Not Achieve HbA1c Goal at Week 24 - Origin
timeFrame: Endpoint (Initiation: Week 24)
measure: INITIATION: Participant Demographics of Participants Who Did Versus Did Not Achieve HbA1c Goal at Week 24 - Homeostasis Model Assessment of Insulin Resistance (HOMA-IR)
timeFrame: Endpoint (Initiation: Week 24)
measure: INITIATION: Participant Demographics of Participants Who Did Versus Did Not Achieve HbA1c Goal at Week 24 - HbA1c
timeFrame: Endpoint (Initiation: Week 24)
measure: INITIATION: Participant Demographics of Participants Who Did Versus Did Not Achieve HbA1c Goal at Week 24 - Baseline HbA1c Percentage Group
timeFrame: Endpoint (Initiation: Week 24)
measure: INITIATION: Participant Demographics of Participants Who Did Versus Did Not Achieve HbA1c Goal at Week 24 - 1,5 AG
timeFrame: Endpoint (Initiation: Week 24)
measure: INITIATION: Participant Demographics of Participants Who Did Versus Did Not Achieve HbA1c Goal at Week 24 - Pre Meals Blood Glucose, Post Meals Blood Glucose, Average of All Blood Glucose, and Fasting Blood Glucose
timeFrame: Endpoint (Initiation: Week 24)
measure: INITIATION: Participant Demographics of Participants Who Did Versus Did Not Achieve HbA1c Goal - Oral Diabetes Medication at Baseline
timeFrame: Endpoint (Initiation: Week 24)
measure: MAINTENANCE: HbA1c at Specified Visits and Endpoint
timeFrame: Baseline (Week 0), Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, Endpoint (LOCF) (up to 2.5 years)
measure: MAINTENANCE: 7-point SMPG Profiles and Postprandial Excursions
timeFrame: Baseline (Maintenance: Week 24), Endpoint (LOCF) (up to 2.5 years)
measure: MAINTENANCE: Rate of Increase in HbA1c
timeFrame: Endpoint (LOCF) (Maintenance: up to 2.5 years)
measure: MAINTENANCE: Percentage of Participants With HbA1c < or = 7.0%, HbA1c <7.0, and HbA1c < or = 6.5%
timeFrame: Endpoint (LOCF) (Maintenance: up to 2.5 years)
measure: MAINTENANCE: Incremental Change From Baseline in Body Weight
timeFrame: Baseline (Week 0), Weeks 24, 36, 48, 60, 72, 84, 96, 108, 120, Endpoint (LOCF) (Maintenance) (up to 2.5 years)
measure: MAINTENANCE: Body Weight
timeFrame: Baseline (Week 0), Weeks 24, 36, 48, 60, 72, 84, 96, 108, 120, Endpoint (LOCF) (Maintenance) (up to 2.5 years)
measure: MAINTENANCE: Insulin Dose
timeFrame: Weeks 24, 36, 48, 60, 72, 84, 96, 108, 120, Endpoint (LOCF) (Maintenance) (up to 2.5 years)
measure: MAINTENANCE: Percentage of Participants With Self-reported Hypoglycemic Episodes
timeFrame: Endpoint (LOCF) (Maintenance) (up to 2.5 years), Overall (incidence of hypoglycemic episodes after baseline (Week 0)
measure: MAINTENANCE: Rate of Self-reported Hypoglycemic Episodes
timeFrame: Endpoint (LOCF) (Maintenance) (up to 2.5 years), Overall (incidence of hypoglycemic episodes after baseline [Week 0])
measure: MAINTENANCE: Change From Baseline in 1,5-Anhydroglucitol
timeFrame: Baseline (Maintenance: Week 24), Endpoint (LOCF) (up to 2.5 years)
measure: MAINTENANCE: Change From Baseline to Endpoint in HbA1c
timeFrame: Baseline (Week 0), Week 24, Endpoint (LOCF) (Maintenance) (up to 2.5 years)
measure: MAINTENANCE: Participant Demographics of Insulin Glargine Participants Who Did Versus Did Not Maintain HbA1c Goal - Duration of Diabetes
timeFrame: Endpoint (LOCF) (Maintenance) (up to 2.5 years)
measure: MAINTENANCE: Participant Demographics of Lispro LM Participants Who Did Versus Did Not Maintain HbA1c Goal - Duration of Diabetes
timeFrame: Endpoint (LOCF) (Maintenance) (up to 2.5 years)
measure: MAINTENANCE: Participant Demographics of Insulin Glargine Participants Who Did Versus Did Not Maintain HbA1c Goal - Duration of Diabetes Group
timeFrame: Endpoint (LOCF) (Maintenance) (up to 2.5 years)
measure: MAINTENANCE: Participant Demographics of Lispro LM Participants Who Did Versus Did Not Maintain HbA1c Goal - Duration of Diabetes Group
timeFrame: Endpoint (LOCF) (Maintenance) (up to 2.5 years)
measure: MAINTENANCE: Participant Demographics of Insulin Glargine Participants Who Did Versus Did Not Maintain HbA1c Goal - Baseline HbA1c
timeFrame: Endpoint (LOCF) (Maintenance) (up to 2.5 years)
measure: MAINTENANCE: Participant Demographics of Lispro LM Participants Who Did Versus Did Not Maintain HbA1c Goal - Baseline HbA1c
timeFrame: Endpoint (LOCF) (Maintenance) (up to 2.5 years)
measure: MAINTENANCE: Participant Demographics of Insulin Glargine Participants Who Did Versus Did Not Maintain HbA1c Goal - Baseline HbA1c Group
timeFrame: Endpoint (LOCF) (Maintenance) (up to 2.5 years)
measure: MAINTENANCE: Participant Demographics of Lispro LM Participants Who Did Versus Did Not Maintain HbA1c Goal - Baseline HbA1c Group
timeFrame: Endpoint (LOCF) (Maintenance) (up to 2.5 years)
measure: MAINTENANCE: Participant Demographics of Insulin Glargine Participants Who Did Versus Did Not Maintain HbA1c Goal - Oral Diabetes Medicine at Baseline
timeFrame: Endpoint (LOCF) (Maintenance) (up to 2.5 years)
measure: MAINTENANCE: Participant Demographics of Lispro LM Participants Who Did Versus Did Not Maintain HbA1c Goal - Oral Diabetes Medicine at Baseline
timeFrame: Endpoint (LOCF) (Maintenance) (up to 2.5 years)
measure: MAINTENANCE: Participant Demographics of Insulin Glargine Participants Who Did Versus Did Not Maintain HbA1c Goal - 1,5 AG
timeFrame: Endpoint (LOCF) (Maintenance) (up to 2.5 years)
measure: MAINTENANCE: Participant Demographics of Lispro LM Participants Who Did Versus Did Not Maintain HbA1c Goal - 1,5 AG
timeFrame: Endpoint (LOCF) (Maintenance) (up to 2.5 years)
measure: MAINTENANCE: Participant Demographics of Insulin Glargine Participants Who Did Versus Did Not Maintain HbA1c Goal - Mean of Post Meals Blood Glucose and Average of All Blood Glucose
timeFrame: Endpoint (LOCF) (Maintenance) (up to 2.5 years)
measure: MAINTENANCE: Participant Demographics of Lispro LM Participants Who Did Versus Did Not Maintain HbA1c Goal - Mean of Post Meals Blood Glucose and Average of All Blood Glucose
timeFrame: Endpoint (LOCF) (Maintenance) (up to 2.5 years)
measure: ADDENDUM: Change in HbA1c From Point of Second Randomization (Addendum Baseline) to Endpoint
timeFrame: Baseline (Addendum: Week 24), Endpoint (24 weeks [Week 48])
measure: ADDENDUM: Percentage of Participants With HbA1c < or = 7.0%, HbA1c < 7.0%, and < or = 6.5%
timeFrame: Endpoint (Addendum: 24 weeks [Week 48])
measure: ADDENDUM: 7-point SMPG Profiles
timeFrame: Endpoint (Addendum: 24 weeks [Week 48])
measure: ADDENDUM: Incremental Change From Baseline in Body Weight
timeFrame: Baseline (Addendum: Week 24), Weeks 6 (30 Weeks), 12 (36 Weeks), 24 (48 Weeks), Endpoint (LOCF)
measure: ADDENDUM: Body Weight
timeFrame: Baseline (Addendum Week 24), Weeks 6 (30 weeks), 12 (36 weeks), 24 (48 weeks), Endpoint (LOCF)
measure: ADDENDUM: Insulin Dose
timeFrame: Baseline (Addendum: Week 24), Weeks 1 (25 weeks), 2 (26 weeks), 3 (27 weeks), 4 (28 weeks), 5 (25 weeks), 6 (26 weeks), 8 (32 weeks), 10 (34 weeks), 12 (36 weeks), 24 (48 weeks), Endpoint (LOCF)
measure: ADDENDUM: Percentage of Participants With Self-reported Hypoglycemic Episodes
timeFrame: Weeks 6 (Addendum: 30 weeks), 12 (36 weeks), 24 (48 weeks), Endpoint (LOCF)
measure: ADDENDUM: Rate of Self-reported Hypoglycemic Episodes
timeFrame: Endpoint (Addendum 24 weeks), Overall (mean yearly rate of hypoglycemia during addendum phase
measure: ADDENDUM: Change From Baseline in 1,5-Anhydroglucitol to Week 24
timeFrame: Baseline (addendum: 24 weeks), Endpoint (24 weeks: Week 48)
measure: ADDENDUM: HbA1c at Specified Visits and Endpoint
timeFrame: Baseline (Addendum: 24 weeks), Weeks 12, 24, Endpoint (24 weeks: Week 48)
Other outcomes:
Locations:
city: Mobile
country: United States
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
state: Alabama
city: Litchfield Park
country: United States
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
state: Arizona
city: Little Rock
country: United States
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
state: Arkansas
city: Anaheim
country: United States
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
state: California
city: Beverly Hills
country: United States
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state: California
city: Burlingame
country: United States
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
state: California
city: Concord
country: United States
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
state: California
city: Fountain Valley
country: United States
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
state: California
city: Fresno
country: United States
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state: California
city: Greenbrae
country: United States
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state: California
city: La Jolla
country: United States
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state: California
city: La Mesa
country: United States
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state: California
city: Los Alamitos
country: United States
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state: California
city: Los Angeles
country: United States
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state: California
city: Los Gatos
country: United States
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state: California
city: Norwalk
country: United States
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state: California
city: Orange
country: United States
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state: California
city: Palm Springs
country: United States
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state: California
city: Sacramento
country: United States
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state: California
city: Salinas
country: United States
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state: California
city: San Diego
country: United States
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state: California
city: Spring Valley
country: United States
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state: California
city: Vacaville
country: United States
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state: California
city: Ventura
country: United States
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state: California
city: Colorado Springs
country: United States
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state: Colorado
city: Cromwell
country: United States
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state: Connecticut
city: Trumbull
country: United States
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state: Connecticut
city: Waterbury
country: United States
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state: Connecticut
city: Deerfield Beach
country: United States
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state: Florida
city: Gainesville
country: United States
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state: Florida
city: Inverness
country: United States
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state: Florida
city: Jacksonville
country: United States
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state: Florida
city: Kissimmee
country: United States
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state: Florida
city: Lake Worth
country: United States
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state: Florida
city: Melbourne
country: United States
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state: Florida
city: Miami
country: United States
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state: Florida
city: New Port Richey
country: United States
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state: Florida
city: Ocala
country: United States
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state: Florida
city: Tampa
country: United States
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
state: Florida
city: West Palm Beach
country: United States
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
state: Florida
city: Winter Park
country: United States
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
state: Florida
city: Athens
country: United States
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
state: Georgia
city: Atlanta
country: United States
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
state: Georgia
city: Honolulu
country: United States
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
state: Hawaii
city: Kellogg
country: United States
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
state: Idaho
city: Belleville
country: United States
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
state: Illinois
city: Chicago
country: United States
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
state: Illinois
city: Gurnee
country: United States
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
state: Illinois
city: O'Fallon
country: United States
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
state: Illinois
city: Peoria
country: United States
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
state: Illinois
city: Fort Wayne
country: United States
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state: Indiana
city: Indianapolis
country: United States
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state: Indiana
city: Waterloo
country: United States
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state: Iowa
city: Topeka
country: United States
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state: Kansas
city: Bowling Green
country: United States
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state: Kentucky
city: Madisonville
country: United States
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state: Kentucky
city: Owensboro
country: United States
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state: Kentucky
city: Baton Rouge
country: United States
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state: Louisiana
city: Metairie
country: United States
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state: Louisiana
city: Bangor
country: United States
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state: Maine
city: Baltimore
country: United States
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state: Maryland
city: Elkridge
country: United States
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state: Maryland
city: Elkton
country: United States
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state: Maryland
city: Reisterstown
country: United States
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state: Maryland
city: Rockville
country: United States
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state: Maryland
city: Towson
country: United States
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state: Maryland
city: Haverhill
country: United States
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state: Massachusetts
city: Waltham
country: United States
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state: Massachusetts
city: Worcester
country: United States
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state: Massachusetts
city: Bloomfield Hills
country: United States
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state: Michigan
city: Troy
country: United States
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state: Michigan
city: Bloomington
country: United States
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state: Minnesota
city: Chesterfield
country: United States
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state: Missouri
city: St Louis
country: United States
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state: Missouri
city: Las Vegas
country: United States
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state: Nevada
city: Reno
country: United States
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state: Nevada
city: Nashua
country: United States
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state: New Hampshire
city: Cherry Hill
country: United States
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state: New Jersey
city: Flemington
country: United States
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state: New Jersey
city: Hamilton
country: United States
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state: New Jersey
city: Stratford
country: United States
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state: New Jersey
city: Teaneck
country: United States
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state: New Jersey
city: Toms River
country: United States
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state: New Jersey
city: Cooperstown
country: United States
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state: New York
city: Mamaroneck
country: United States
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state: New York
city: Massapequa
country: United States
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state: New York
city: New Hartford
country: United States
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state: New York
city: New York
country: United States
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state: New York
city: Syracuse
country: United States
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state: New York
city: Westfield
country: United States
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state: New York
city: Charlotte
country: United States
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state: North Carolina
city: Greenville
country: United States
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state: North Carolina
city: Huntersville
country: United States
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state: North Carolina
city: Morehead City
country: United States
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state: North Carolina
city: Morganton
country: United States
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state: North Carolina
city: Tabor City
country: United States
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state: North Carolina
city: Fargo
country: United States
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state: North Dakota
city: Jamestown
country: United States
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state: North Dakota
city: Akron
country: United States
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state: Ohio
city: Cincinnati
country: United States
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state: Ohio
city: Cleveland
country: United States
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state: Ohio
city: Columbus
country: United States
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state: Ohio
city: Dayton
country: United States
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state: Ohio
city: Franklin
country: United States
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state: Ohio
city: London
country: United States
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state: Ohio
city: Oklahoma City
country: United States
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state: Oklahoma
city: Bend
country: United States
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state: Oregon
city: Eugene
country: United States
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state: Oregon
city: Medford
country: United States
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state: Oregon
city: Portland
country: United States
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state: Oregon
city: Beaver
country: United States
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state: Pennsylvania
city: Fleetwood
country: United States
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state: Pennsylvania
city: Levittown
country: United States
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state: Pennsylvania
city: Philadelphia
country: United States
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state: Pennsylvania
city: Charleston
country: United States
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state: South Carolina
city: Greenville
country: United States
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state: South Carolina
city: Hartsville
country: United States
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state: South Carolina
city: Johnson City
country: United States
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state: Tennessee
city: Kingsport
country: United States
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state: Tennessee
city: Memphis
country: United States
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state: Tennessee
city: Abilene
country: United States
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state: Texas
city: Dallas
country: United States
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state: Texas
city: El Paso
country: United States
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state: Texas
city: Houston
country: United States
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state: Texas
city: Killeen
country: United States
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state: Texas
city: Midland
country: United States
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state: Texas
city: New Braunfels
country: United States
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state: Texas
city: San Antonio
country: United States
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state: Texas
city: Ogden
country: United States
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state: Utah
city: Provo
country: United States
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state: Utah
city: South Burlington
country: United States
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state: Vermont
city: Bellingham
country: United States
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state: Washington
city: Everett
country: United States
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state: Washington
city: Olympia
country: United States
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state: Washington
city: Renton
country: United States
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state: Washington
city: Wenatchee
country: United States
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state: Washington
city: Eau Claire
country: United States
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state: Wisconsin
city: Marshfield
country: United States
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state: Wisconsin
city: Buenos Aires
country: Argentina
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city: Mar Del Plata
country: Argentina
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city: Pilar
country: Argentina
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city: Kingswood Penrith
country: Australia
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state: New South Wales
city: Elizabeth Vale
country: Australia
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
state: South Australia
city: Keswick
country: Australia
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
state: South Australia
city: Burnie
country: Australia
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
state: Tasmania
city: Box Hill
country: Australia
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
state: Victoria
city: Nedlands
country: Australia
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
state: Western Australia
city: Curitiba
country: Brazil
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Porto Alegre
country: Brazil
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Setor Oeste/Goiania
country: Brazil
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: SÃ£o Paulo
country: Brazil
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Calgary
country: Canada
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
state: Alberta
city: Red Deer
country: Canada
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
state: Alberta
city: Winnipeg
country: Canada
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
state: Manitoba
city: Petitcodiac
country: Canada
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
state: New Brunswick
city: Ajax
country: Canada
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
state: Ontario
city: Mississauga
country: Canada
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
state: Ontario
city: Niagara Falls
country: Canada
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
state: Ontario
city: Laval
country: Canada
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
state: Quebec
city: Sherbrooke
country: Canada
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
state: Quebec
city: Athens
country: Greece
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Nikaias - Piraeus
country: Greece
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Thessaloniki
country: Greece
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Eger
country: Hungary
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Pecs
country: Hungary
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Szekszard
country: Hungary
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Szentes
country: Hungary
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Ahemdabad
country: India
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Aligarh
country: India
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Bangalore
country: India
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Coimbatore
country: India
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Hyderabaad
country: India
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Karnal/Haryana
country: India
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Trivandrum
country: India
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Amsterdam
country: Netherlands
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Brunssum
country: Netherlands
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Emmen
country: Netherlands
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Hoogeveen
country: Netherlands
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Nijmegen
country: Netherlands
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Venlo
country: Netherlands
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Zwijndrecht
country: Netherlands
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Bayamon
country: Puerto Rico
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Carolina
country: Puerto Rico
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Orcorvis
country: Puerto Rico
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Ponce
country: Puerto Rico
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Rio Piedras
country: Puerto Rico
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: San Juan
country: Puerto Rico
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Brasov
country: Romania
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Bucharest
country: Romania
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Cluj-Napoca
country: Romania
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Targu-Mures
country: Romania
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Timisoara
country: Romania
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Alcira
country: Spain
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Dos Hermanas
country: Spain
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Madrid
country: Spain
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Malaga
country: Spain
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Mosteles
country: Spain
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Requena
country: Spain
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Santander
country: Spain
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References:
citation: Herman WH, Dungan KM, Wolffenbuttel BH, Buse JB, Fahrbach JL, Jiang H, Martin S. Racial and ethnic differences in mean plasma glucose, hemoglobin A1c, and 1,5-anhydroglucitol in over 2000 patients with type 2 diabetes. J Clin Endocrinol Metab. 2009 May;94(5):1689-94. doi: 10.1210/jc.2008-1940. Epub 2009 Mar 10.
citation: Fahrbach J, Jacober S, Jiang H, Martin S. The DURABLE trial study design: comparing the safety, efficacy, and durability of insulin glargine to insulin lispro mix 75/25 added to oral antihyperglycemic agents in patients with type 2 diabetes. J Diabetes Sci Technol. 2008 Sep;2(5):831-8. doi: 10.1177/193229680800200514.
citation: Scheen AJ, Schmitt H, Jiang HH, Ivanyi T. Individualizing treatment of type 2 diabetes by targeting postprandial or fasting hyperglycaemia: Response to a basal vs a premixed insulin regimen by HbA1c quartiles and ethnicity. Diabetes Metab. 2015 Jun;41(3):216-22. doi: 10.1016/j.diabet.2015.03.002. Epub 2015 Apr 14.
citation: Jovanovic L, Peters AL, Jiang HH, Hardin DS. Durability of glycemic control with insulin lispro mix 75/25 versus insulin glargine for older patients with type 2 diabetes. Aging Clin Exp Res. 2014 Apr;26(2):115-21. doi: 10.1007/s40520-013-0140-8. Epub 2013 Oct 3.
citation: Wolffenbuttel BH, Herman WH, Gross JL, Dharmalingam M, Jiang HH, Hardin DS. Ethnic differences in glycemic markers in patients with type 2 diabetes. Diabetes Care. 2013 Oct;36(10):2931-6. doi: 10.2337/dc12-2711. Epub 2013 Jun 11.
citation: Qu Y, Jacober SJ, Zhang Q, Wolka LL, DeVries JH. Rate of hypoglycemia in insulin-treated patients with type 2 diabetes can be predicted from glycemic variability data. Diabetes Technol Ther. 2012 Nov;14(11):1008-12. doi: 10.1089/dia.2012.0099.
citation: Buse JB, Wolffenbuttel BH, Herman WH, Hippler S, Martin SA, Jiang HH, Shenouda SK, Fahrbach JL. The DURAbility of Basal versus Lispro mix 75/25 insulin Efficacy (DURABLE) trial: comparing the durability of lispro mix 75/25 and glargine. Diabetes Care. 2011 Feb;34(2):249-55. doi: 10.2337/dc10-1701.
citation: Miser WF, Arakaki R, Jiang H, Scism-Bacon J, Anderson PW, Fahrbach JL. Randomized, open-label, parallel-group evaluations of basal-bolus therapy versus insulin lispro premixed therapy in patients with type 2 diabetes mellitus failing to achieve control with starter insulin treatment and continuing oral antihyperglycemic drugs: a noninferiority intensification substudy of the DURABLE trial. Clin Ther. 2010 May;32(5):896-908. doi: 10.1016/j.clinthera.2010.05.001.
citation: Wolffenbuttel BH, Klaff LJ, Bhushan R, Fahrbach JL, Jiang H, Martin S. Initiating insulin therapy in elderly patients with Type 2 diabetes: efficacy and safety of lispro mix 25 vs. basal insulin combined with oral glucose-lowering agents. Diabet Med. 2009 Nov;26(11):1147-55. doi: 10.1111/j.1464-5491.2009.02824.x.
citation: Buse JB, Wolffenbuttel BH, Herman WH, Shemonsky NK, Jiang HH, Fahrbach JL, Scism-Bacon JL, Martin SA. DURAbility of basal versus lispro mix 75/25 insulin efficacy (DURABLE) trial 24-week results: safety and efficacy of insulin lispro mix 75/25 versus insulin glargine added to oral antihyperglycemic drugs in patients with type 2 diabetes. Diabetes Care. 2009 Jun;32(6):1007-13. doi: 10.2337/dc08-2117. Epub 2009 Mar 31.