Clinical trial NCT00348374: Exubera vs Lispro in a Lantus-based Regimen for Improved Glycemic Control in Type 2 Diabetes
Official title: A Phase 3b, Randomized, Open-Label, Parallel Group, Multicenter Trial Assessing The Efficacy Of Exubera Vs. Lispro Introduced Into A Lantus Based Regimen In Suboptimally Controlled Patients With Type 2 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetes Mellitus
Keywords: type two diabetes, insulin, HbA1c
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2006-07-04
Enrollment: 191
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The current trial will examine the efficacy and safety of Exubera administered as a mealtime insulin compared to lispro, when added to an existing regimen of basal insulin glargine + or = Oral Agents (OAs). Dose titrations will be provided which should allow a large proportion of subjects to reach target glycosylated hemoglobin (A1C) levels.


Eligibility criteria: Inclusion Criteria:

* Adults with type 2 diabetes using Lantus® (insulin glargine) as their basal insulin, not at glycemic goal.

Exclusion Criteria:

* lung disease
* current smoking or discontinued smoking within past 6 months

Primary outcomes:
measure: Change From Baseline in Glycosylated Hemoglobin A1c (HbA1c) at End of Treatment
timeFrame: Baseline, Week 24 (End of Treatment)
Secondary outcomes:
measure: Change From Baseline in Glycosylated Hemoglobin A1c (HbA1c) at Each Visit
timeFrame: Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24
measure: Subjects That Attained Glycosylated Hemoglobin A1c (HbA1c) < 7.0%, < 6.5% and < 6.0% at Week 24
timeFrame: Week 24
measure: Subjects That Attained Glycosylated Hemoglobin A1c (HbA1c) Target Levels of <7%, < 6.5%, and < 6.0% Without an Episode of Severe Hypoglycemia at Week 24
timeFrame: Week 24
measure: Change From Baseline in Fasting and 2-hour Postprandial Glucose as Determined by 8-point Self-monitored Blood Glucose Profiles
timeFrame: Week 1, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24
measure: Change From Baseline in Fasting and Postprandial Plasma Glucose as Determined by Standardized Meal Tolerance Tests at Week 12
timeFrame: Baseline, Week 12
measure: Change From Baseline in Fasting and Postprandial Plasma Glucose as Determined by Standardized Meal Tolerance Tests at Week 24
timeFrame: Baseline, Week 24
measure: Change From Baseline in Fasting and Postprandial Lipids as Determined by Standard Meal Tolerance Tests
timeFrame: Baseline, Week 12, Week 24
measure: Number of Subjects With Change From Baseline in Fasting and Postprandial Markers of Cardiovascular (CV) Risk as Determined by Standardized Meal Tolerance Tests
timeFrame: Week 12, Week 24
measure: Change From Baseline Weight at Each Visit
timeFrame: Baseline, Week 1, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24
measure: Change From Baseline in Fasting Plasma Lipids
timeFrame: Baseline, Week 12, Week 24
measure: Change From Baseline in Insulin Glargine Dose at Each Visit (Office and/or Phone)
timeFrame: Baseline, Week 1, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24
measure: Baseline Prandial Insulin Dose (at Each Meal) at Each Visit
timeFrame: Week 0, Week 1, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24
measure: Number of Subjects With Hypoglycemic Events
timeFrame: Month 1, Month 2, Month 3, Month 4, Month 5, Month 6
measure: Number of Total Hypoglycemic Events
timeFrame: Month 1, Month 2, Month 3, Month 4, Month 5, Month 6
measure: Treatment Exposure for Hypoglycemic Subjects at Each Interval of the Study: Number of Subject Months of Treatment
timeFrame: Month 1, Month 2, Month 3, Month 4, Month 5, Month 6
measure: Crude Hypoglycemic Event Rate
timeFrame: Month 1, Month 2, Month 3, Month 4, Month 5, Month 6
measure: Change From Baseline in Patient Treatment Satisfaction (as Assessed by Patient Satisfaction With Insulin Treatment [PSIT] Questionnaire)
timeFrame: Week 4, Week 24
measure: Change in Patient Treatment Satisfaction (as Assessed by Patient Satisfaction With Insulin Treatment [PSIT] Questionnaire) From Week 4 to Week 24
timeFrame: Week 4, Week 24
measure: Change From Baseline in 24-hour Mean Glucose Values Measured by Continuous Glucose Monitoring System (CGMS)
timeFrame: Baseline, Week 12, Week 24
measure: Change From Baseline in Standard Deviation of 24-hour Glucose Values Measured by Continuous Glucose Monitoring System (CGMS)
timeFrame: Baseline, Week 12, Week 24
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Pfizer Investigational Site
state: Alabama
city: Mobile
country: United States
facility: Pfizer Investigational Site
state: Alabama
city: Phoenix
country: United States
facility: Pfizer Investigational Site
state: Arizona
city: Malvern
country: United States
facility: Pfizer Investigational Site
state: Arkansas
city: Foot Hill Ranch
country: United States
facility: Pfizer Investigational Site
state: California
city: Fresno
country: United States
facility: Pfizer Investigational Site
state: California
city: Greenbrae
country: United States
facility: Pfizer Investigational Site
state: California
city: Los Gatos
country: United States
facility: Pfizer Investigational Site
state: California
city: San Diego
country: United States
facility: Pfizer Investigational Site
state: California
city: San Mateo
country: United States
facility: Pfizer Investigational Site
state: California
city: Tustin
country: United States
facility: Pfizer Investigational Site
state: California
city: Denver
country: United States
facility: Pfizer Investigational Site
state: Colorado
city: New Britain
country: United States
facility: Pfizer Investigational Site
state: Connecticut
city: Washington
country: United States
facility: Pfizer Investigational Site
state: District of Columbia
city: Jacksonville
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Jacksonville
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Miami
country: United States
facility: Pfizer Investigational Site
state: Florida
city: West Palm Beach
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Winter Park
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Columbus
country: United States
facility: Pfizer Investigational Site
state: Georgia
city: Decatur
country: United States
facility: Pfizer Investigational Site
state: Georgia
city: Honolulu
country: United States
facility: Pfizer Investigational Site
state: Hawaii
city: Honululu
country: United States
facility: Pfizer Investigational Site
state: Hawaii
city: Idaho Falls
country: United States
facility: Pfizer Investigational Site
state: Idaho
city: Chicago
country: United States
facility: Pfizer Investigational Site
state: Illinois
city: Gurnee
country: United States
facility: Pfizer Investigational Site
state: Illinois
city: Des Moines
country: United States
facility: Pfizer Investigational Site
state: Iowa
city: Lexington
country: United States
facility: Pfizer Investigational Site
state: Kentucky
city: Louisville
country: United States
facility: Pfizer Investigational Site
state: Kentucky
city: Baltimore
country: United States
facility: Pfizer Investigational Site
state: Maryland
city: Bethesda
country: United States
facility: Pfizer Investigational Site
state: Maryland
city: Boston
country: United States
facility: Pfizer Investigational Site
state: Massachusetts
city: Flint
country: United States
facility: Pfizer Investigational Site
state: Michigan
city: Minneapolis
country: United States
facility: Pfizer Investigational Site
state: Minnesota
city: St. Louis
country: United States
facility: Pfizer Investigational Site
state: Missouri
city: St. Louis
country: United States
facility: Pfizer Investigational Site
state: Missouri
city: Omaha
country: United States
facility: Pfizer Investigational Site
state: Nebraska
city: East Syracuse
country: United States
facility: Pfizer Investigational Site
state: New York
city: Greenville
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Morehead City
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Statesville
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Kettering
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Oklahoma City
country: United States
facility: Pfizer Investigational Site
state: Oklahoma
city: Tulsa
country: United States
facility: Pfizer Investigational Site
state: Oklahoma
city: Bend
country: United States
facility: Pfizer Investigational Site
state: Oregon
city: Bensalem
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Greenville
country: United States
facility: Pfizer Investigational Site
state: South Carolina
city: Bartlett
country: United States
facility: Pfizer Investigational Site
state: Tennessee
city: Memphis
country: United States
facility: Pfizer Investigational Site
state: Tennessee
city: Arlington
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Arlington
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Dallas
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Dallas
country: United States
facility: Pfizer Investigational Site
state: Texas
city: El Paso
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Houston
country: United States
facility: Pfizer Investigational Site
state: Texas
city: San Antonio
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Bennington
country: United States
facility: Pfizer Investigational Site
state: Vermont
city: Norfolk
country: United States
facility: Pfizer Investigational Site
state: Virginia
city: Virginia Beach
country: United States
facility: Pfizer Investigational Site
state: Virginia
city: Renton
country: United States
facility: Pfizer Investigational Site
state: Washington
city: Spokane
country: United States
facility: Pfizer Investigational Site
state: Washington
city: Milwaukee
country: United States
facility: Pfizer Investigational Site
state: Wisconsin
city: San Juan
country: Puerto Rico
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: