Clinical trial NCT01435616: A Study in Patients With Type 2 Diabetes Mellitus
Official title: A Comparison of LY2605541 Versus Insulin Glargine as Basal Insulin Treatment in Combination With Oral Anti-Hyperglycemia Medications in Insulin-Naive Patients With Type 2 Diabetes Mellitus: A Double-Blind, Randomized Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetes Mellitus, Type 2
Keywords: diabetes mellitus
type 2 diabetes mellitus
insulin naive
insulin treatment
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2011-09-16
Enrollment: 1538
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is:

* To compare blood sugar control on LY2605541 with insulin glargine after 52 weeks of treatment.
* To compare the rate of night time low blood sugar episodes on LY2605541 with insulin glargine during 52 weeks of treatment.
* To compare the number of participants on LY2605541 reaching blood sugar targets without low blood sugar episodes at night to those taking insulin glargine after 52 weeks of treatment.
* To compare the rate of low blood sugar episodes on LY2605541 with insulin glargine after 52 weeks of treatment


Eligibility criteria: Inclusion Criteria:

* Have type 2 diabetes mellitus, not treated with insulin, for at least 1 year prior to the study
* Have been receiving at least 2 OAMs for at least 3 months before entering the study
* Have a hemoglobin A1c (HbA1c) value between 7.0% and 11.0%, inclusive, at screening
* Are capable of and willing to inject insulin with a vial and syringe and perform self blood glucose monitoring
* Women of childbearing potential only: are not breastfeeding, have a negative pregnancy test at the time of screening and randomization, intend to not become pregnant during the trial, have practiced a reliable method of birth control for at least 6 weeks prior to screening, and agree to use a reliable method of birth control during the study and until 2 weeks following the last dose of study drug

Exclusion Criteria:

* Have used insulin therapy (outside of pregnancy) anytime in the past 2 years, except for short-term treatment of acute conditions, and up to a maximum of 4 continuous weeks
* Use of rosiglitazone, pramlintide, or glucagon-like peptide 1 (GLP-1) receptor agonist (for example, exenatide, exenatide once weekly, or liraglutide) concurrently or within 3 months prior to screening
* Are currently taking, or have taken within the 3 months preceding screening, medications to promote weight loss
* Have had any episodes of severe hypoglycemia within 6 months prior to screening
* Have had 1 or more episodes of ketoacidosis or hyperosmolar state/coma in the 6 months prior to the study
* Have cardiac disease with functional status that is New York Heart Association Class III or IV (per New York Heart Association \[NYHA\] Cardiac Disease Classification)
* Have a history of renal transplantation, or are currently receiving renal dialysis or have serum creatinine greater or equal than 2 milligrams per deciliter (mg/dL)
* Have obvious clinical signs or symptoms of liver disease (excluding non- alcoholic fatty liver disease \[NAFLD\]), acute or chronic hepatitis, non-alcoholic steatohepatitis (NASH), or elevated liver enzyme measurements at screening
* Have had a blood transfusion or severe blood loss within 3 months prior to screening or have known hemoglobinopathy, hemolytic anemia or sickle cell anemia, or any other traits of hemoglobin abnormalities known to interfere with the measurement of HbA1c
* Have active or untreated malignancy or have been in remission from clinically significant malignancy for less than 5 years
* Have fasting or non-fasting triglycerides greater than 400 mg/dL (greater than 4.5 millimoles per liter \[mmol/L\]) at screening
* Are using lipid-lowering medication at a dose that has not been stable for 90 days prior to screening
* Are using niacin preparations as a lipid lowering medication and bile acid sequestrants within 90 days prior to screening

Primary outcomes:
measure: Change From Baseline to 52 Week Endpoint in Hemoglobin A1c (HbA1c)
timeFrame: Baseline, 52 weeks
Secondary outcomes:
measure: Rate of Total and Nocturnal Hypoglycemia Events
timeFrame: Baseline to 52 weeks
measure: Percentage of Participants With Hemoglobin A1c Equal or Less Than 6.5% and Less Than 7.0 %
timeFrame: 52 weeks
measure: Fasting Serum Glucose (By Laboratory Measurement)
timeFrame: 52 weeks
measure: Fasting Blood Glucose (By Participant Self-monitored Blood Glucose Readings)
timeFrame: 52 weeks
measure: 6 Point Self-monitored Blood Glucose (SMBG)
timeFrame: 52 weeks
measure: Change From Baseline to 52 Weeks in Body Weight
timeFrame: Baseline, 52 weeks
measure: Hemoglobin A1c
timeFrame: 52 weeks
measure: Insulin Dose Per Body Weight
timeFrame: 52 weeks
measure: Number of Insulin Dose Adjustments to Steady-State
timeFrame: Baseline to 52 weeks
measure: European Quality of Life-5 Dimension (EQ-5D)
timeFrame: 52 weeks
measure: Insulin Treatment Satisfaction Questionnaire
timeFrame: Up to 52 weeks
measure: Adult Low Blood Sugar Survey
timeFrame: Up to 52 weeks
measure: Change From Baseline to 52 Weeks in Triglycerides, Low Density Lipoprotein Cholesterol (LDL-C), and High Density Lipoprotein Cholesterol (HDL-C)
timeFrame: Baseline, 52 weeks
measure: Percentage of Participants With Equal or Above 2-, and 3-fold Upper Limits of Normal (ULN) for Total Bilirubin
timeFrame: Up to 52 weeks
measure: Overall Treatment-Emergent Anti-LY2065541 Antibody Response (TEAR)
timeFrame: Baseline to 78 weeks
measure: Intra-participant Variability of the Fasting Blood Glucose (FBG)
timeFrame: 52 weeks
measure: Percentage of Participants With Total and Nocturnal Hypoglycemic Events
timeFrame: Baseline to 52 weeks
measure: Percentage of Participants With HbA1C Equal or Less Than 6.5% and Less Than 7.0 % and Without Nocturnal Hypoglycemia
timeFrame: Up to 52 weeks
measure: Percentage of Participants With Equal or Above 2- and 3-fold ULN for Alanine Transaminase/Serum Glutamic Pyruvic Transaminase (ALT/SGPT) and Aspartate Transaminase/Serum Glutamic Oxaloacetic Transaminase (AST/SGOT)
timeFrame: Up to 52 weeks
Other outcomes:
Locations:
city: Anniston
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: 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: Chandler
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: Mesa
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: Tempe
country: United States
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state: Arizona
city: Tucson
country: United States
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state: Arizona
city: Concord
country: United States
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state: California
city: Escondido
country: United States
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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: Huntington Beach
country: United States
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state: California
city: Lancaster
country: United States
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state: California
city: Los Angeles
country: United States
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state: California
city: Mission Viejo
country: United States
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state: California
city: Northridge
country: United States
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state: California
city: Palm Springs
country: United States
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state: California
city: San Mateo
country: United States
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state: California
city: Tustin
country: United States
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state: California
city: Denver
country: United States
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state: Colorado
city: Daytona Beach
country: United States
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state: Florida
city: Jacksonville
country: United States
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state: Florida
city: Tampa
country: United States
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state: Florida
city: Winter Haven
country: United States
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state: Florida
city: Athens
country: United States
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state: Georgia
city: Atlanta
country: United States
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state: Georgia
city: Decatur
country: United States
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state: Georgia
city: Honolulu
country: United States
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state: Hawaii
city: Idaho Falls
country: United States
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state: Idaho
city: Meridian
country: United States
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state: Idaho
city: Chicago
country: United States
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state: Illinois
city: Springfield
country: United States
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state: Illinois
city: West Des Moines
country: United States
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state: Iowa
city: Topeka
country: United States
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state: Kansas
city: Shreveport
country: United States
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state: Louisiana
city: Bangor
country: United States
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state: Maine
city: Haverhill
country: United States
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state: Massachusetts
city: Saint Louis
country: United States
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state: Missouri
city: Billings
country: United States
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state: Montana
city: Nashua
country: United States
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state: New Hampshire
city: Toms River
country: United States
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state: New Jersey
city: Cincinnati
country: United States
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state: Ohio
city: Gallipolis
country: United States
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state: Ohio
city: Perrysburg
country: United States
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state: Ohio
city: Corvallis
country: United States
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state: Oregon
city: Springfield
country: United States
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state: Oregon
city: Beaver
country: United States
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state: Pennsylvania
city: Downingtown
country: United States
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state: Pennsylvania
city: Lansdale
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: Pottstown
country: United States
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state: Pennsylvania
city: Greer
country: United States
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state: South Carolina
city: Myrtle Beach
country: United States
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state: South Carolina
city: Bristol
country: United States
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state: Tennessee
city: Knoxville
country: United States
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state: Tennessee
city: Memphis
country: United States
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state: Tennessee
city: Spring Hill
country: United States
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state: Tennessee
city: Austin
country: United States
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state: Texas
city: Marshall
country: United States
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state: Texas
city: Sugar Land
country: United States
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state: Texas
city: Bountiful
country: United States
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state: Utah
city: Clinton
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: Utah
city: Ogden
country: United States
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state: Utah
city: Olympia
country: United States
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state: Washington
city: Port Orchard
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: Washington
city: Spokane
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: Washington
city: Buenos Aires
country: Argentina
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: Caba
country: Argentina
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: Córdoba
country: Argentina
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: Mar Del Plata
country: Argentina
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: Merewether
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: New South Wales
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: 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: Fremantle
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: Marilia
country: Brazil
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city: Rio De Janeiro
country: Brazil
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city: Setor Oeste/Goiania
country: Brazil
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city: São Paulo
country: Brazil
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city: Edmonton
country: Canada
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state: Alberta
city: Kelowna
country: Canada
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state: British Columbia
city: Victoria
country: Canada
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state: British Columbia
city: Winnipeg
country: Canada
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state: Manitoba
city: Etobicoke
country: Canada
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state: Ontario
city: Markham
country: Canada
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state: Ontario
city: Toronto
country: Canada
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state: Ontario
city: Laval
country: Canada
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state: Quebec
city: Pointe-Claire
country: Canada
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state: Quebec
city: Sherbrooke
country: Canada
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state: Quebec
city: Oulu
country: Finland
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city: Seinajoki
country: Finland
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city: Dippoldiswalde
country: Germany
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city: Dresden
country: Germany
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city: Friedrichsthal
country: Germany
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city: Furth Im Wald
country: Germany
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city: Goch
country: Germany
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city: Hamburg
country: Germany
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city: Ludwigshafen
country: Germany
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city: Münster
country: Germany
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city: Saarbrücken
country: Germany
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city: Schweinfurt
country: Germany
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city: Sulzbach
country: Germany
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city: Ampelokipoi
country: Greece
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city: Athens
country: Greece
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city: Thessaloniki
country: Greece
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city: Budapest
country: Hungary
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city: Debrecen
country: Hungary
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city: Mako
country: Hungary
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city: Salgotarjan
country: Hungary
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city: Sopron
country: Hungary
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city: Beer Sheva
country: Israel
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city: Haifa
country: Israel
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city: Raanana
country: Israel
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city: Carpi
country: Italy
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city: Castellanza
country: Italy
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city: Foggia
country: Italy
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city: Forli
country: Italy
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city: Rome
country: Italy
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city: Sesto San Giovanni
country: Italy
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: Utena
country: Lithuania
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: Vilnius
country: Lithuania
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city: Coatzacoalcos
country: Mexico
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city: Mexico City
country: Mexico
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: Monterrey
country: Mexico
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city: Auckland
country: New Zealand
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city: Kamieniec Zabkowicki
country: Poland
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city: Katowice
country: Poland
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city: Krakow
country: Poland
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city: Lodz
country: Poland
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city: Ruda Slaska
country: Poland
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city: Szczecin
country: Poland
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city: Tychy
country: Poland
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city: Warsaw
country: Poland
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city: Hato Rey
country: Puerto Rico
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city: Manati
country: Puerto Rico
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city: San Juan
country: Puerto Rico
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city: Bucharest
country: Romania
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city: Cluj-Napoca
country: Romania
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city: Iasi
country: Romania
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city: Oradea
country: Romania
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city: Ploiesti
country: Romania
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city: Resita
country: Romania
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city: Targu-Mures
country: Romania
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city: Cheboksary
country: Russian Federation
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city: Kazan
country: Russian Federation
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city: Kursk
country: Russian Federation
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city: Novosibirsk
country: Russian Federation
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city: Saint Petersburg
country: Russian Federation
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city: Bratislava
country: Slovakia
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city: Sala
country: Slovakia
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city: Vranov Nad Toplou
country: Slovakia
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: Paarl
country: South Africa
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: Parow
country: South Africa
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city: Somerset West
country: South Africa
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city: Alicante
country: Spain
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city: Cordoba
country: Spain
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city: Pozuelo De Alarcon
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: Seville
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: Toledo
country: Spain
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city: Gaziantep
country: Turkey
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: Hatay
country: Turkey
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city: Izmir
country: Turkey
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: Kayseri
country: Turkey
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: Mortimer
country: United Kingdom
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: Berks
city: Leicester
country: United Kingdom
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: Leicestershire
city: Guildford
country: United Kingdom
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: Surrey
city: Swansea
country: United Kingdom
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: Wales
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References:
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