Safety and Efficacy of Exenatide in Patients With Type 2 Diabetes Using Thiazolidinediones or Thiazolidinediones and Metformin

Type 2 Diabetes Mellitus Clinical Trial

Official title:

Safety and Efficacy of Exenatide in Patients With Type 2 Diabetes Using Thiazolidinediones or Thiazolidinediones and Metformin

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00099320
• Other study ID #: H8O-MC-GWAP
• Status: Completed
• Phase: Phase 3
• First received: December 10, 2004
• Last updated: February 20, 2015
• Start date: May 2004
• Est. completion date: August 2005

Study information

• Verified date: January 2015
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationCanada: Health CanadaSpain: Spanish Agency of Medicines
• Study type: Interventional

Clinical Trial Summary

This study is designed to compare the effects of twice-daily exenatide plus oral antidiabetic (OAD) agents and twice-daily placebo plus OAD with respect to glycemic control, as measured by hemoglobin A1c (HbA1c), in patients with type 2 diabetes who experience inadequate glycemic control with OAD alone.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 182
• Est. completion date: August 2005
• Est. primary completion date: August 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years to 75 Years

Eligibility

Inclusion Criteria:

• Treated with thiazolidinedione (TZD) alone or in combination with metformin. TZD dose stable for at least 120 days prior to screening, and those patients on metformin must have been on a stable dose for at least 30 days prior to screening.

• HbA1c between 7.1% and 10.0%, inclusive.

• Body mass index (BMI) between 25 kg/m^2 and 45 kg/m^2.

Exclusion Criteria:

• Patient previously in a study using exenatide or GLP-1 analogs.

• Treated with oral anti-diabetic medications other than TZD and metformin within 3 months of screening.

• Treated with oral insulin within 3 months of screening.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Drug:
• exenatide
After a 2-week placebo lead-in period (twice daily, given subcutaneously) in addition to their current therapy regimen, subjects will administer 20 mcg of exenatide (2 units [5 µg] ), twice daily by subcutaneous injection, for the first 4 weeks of therapy, and then 40 µL of study drug (4 units [10 µg] of exenatide) twice daily by subcutaneous injection, for the remaining 12 weeks of therapy.
• Placebo
After a 2-week placebo lead-in period (twice daily, given subcutaneously) in addition to their current therapy regimen, subjects will administer placebo (in equivalent amounts to exenatide) for 16 weeks of therapy.

Locations

Country	Name	City	State
Canada	Research Site	Calgary	Alberta
Canada	Research Site	Dartmouth	Nova Scotia
Canada	Research Site	London	Ontario
Canada	Research Site	Montreal	Quebec
Canada	Research Site	Toronto	Ontario
Canada	Research Site	Vancouver	British Columbia
Spain	Research Site	Granada
Spain	Research Site	Sevilla
Spain	Research Site	Valencia
Spain	Research Site	Valladolid
Spain	Research Site	Zaragoza
United States	Research Site	Albany	New York
United States	Research Site	Albuquerque	New Mexico
United States	Research Site	Atlanta	Georgia
United States	Research Site	Baton Rouge	Louisiana
United States	Research Site	Birmingham	Alabama
United States	Research Site	Butte	Montana
United States	Research Site	Charleston	West Virginia
United States	Research Site	Chattanooga	Tennessee
United States	Research Site	Chicago	Illinois
United States	Research Site	Cleveland	Ohio
United States	Research Site	Dallas	Texas
United States	Research Site	Georgetown	Texas
United States	Research Site	Greenville	South Carolina
United States	Research Site	Greenville	North Carolina
United States	Research Site	Hialeah	Florida
United States	Research Site	Honolulu	Hawaii
United States	Research Site	Huntington	West Virginia
United States	Research Site	Idaho Falls	Idaho
United States	Research Site	Jacksonville	Florida
United States	Research Site	Kalamazoo	Michigan
United States	Research Site	Knoxville	Tennessee
United States	Research Site	La Jolla	California
United States	Research Site	McCook	Nebraska
United States	Research Site	Melbourne	Florida
United States	Research Site	New York	New York
United States	Research Site	North Platte	Nebraska
United States	Research Site	Olympia	Washington
United States	Research Site	Omaha	Nebraska
United States	Research Site	Princeton	New Jersey
United States	Research Site	Renton	Washington
United States	Research Site	Rochester	New York
United States	Research Site	San Antonio	Texas
United States	Research Site	San Mateo	California
United States	Research Site	Santa Barbara	California
United States	Research Site	Scottsbluff	Nebraska
United States	Research Site	Spring Valley	California
United States	Research Site	Tacoma	Washington
United States	Research Site	The Colony	Texas
United States	Research Site	Troy	Michigan
United States	Research Site	West Palm Beach	Florida

Sponsors (2)

Lead Sponsor	Collaborator
AstraZeneca	Eli Lilly and Company

Countries where clinical trial is conducted

United States,  Canada,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in HbA1c (glycosylated hemoglobin) from Baseline to Week 16, and if measured, any visits in between	Change in HbA1c from Baseline (Visit 3) to study termination at Week 16, and at all study visits in between	Baseline, Week 4, Week 8, Week 12, Week 16	No
Primary	Change from Baseline to Week 16 in fasting serum glucose (FSG) and glucose	Change from Baseline to Week 16 in FSG and glucose measured at different times throughout the day derived from 7-point self-monitored glucose (SMG) profile (glucose measurements before and 2 hours after the start of the morning, midday, and evening meals, and at bedtime)	Baseline, Week 16	No
Secondary	Percentage of subjects reaching the target HbA1c (<7%)	The percentage of subjects reaching the target HbA1c (<7%) will be summarized and compared by treatment	Baseline, Week 2, Week 4, Week 8, Week 12, Week 16	No
Secondary	Change in body weight from Baseline to Week 16	Change in body weight (kg) from Baseline to Week 16	Baseline, Week 16	No
Secondary	Change from Baseline to Week 16 in fasting serum glucose (FSG) and glucose	Change from Baseline to Week 16 in FSG and glucose measured at different times throughout the day derived from 7-point self-monitored glucose (SMG) profile (glucose measurements before and 2 hours after the start of the morning, midday, and evening meals, and at bedtime)	Baseline, Week 16	No
Secondary	Changes in beta cell function and insulin sensitivity between Baseline and Week 16	Changes in beta cell function and insulin sensitivity as assessed by homeostasis model assessment (HOMA) analyses and the proinsulin/insulin ratio Between Baseline and Week 16	Baseline, Week 16	No
Secondary	Changes in lipids between Baseline and Week 16	Changes from Baseline to Week 16 in serum lipids (total cholesterol [TC], high-density lipoprotein cholesterol [HDL-C], fasting triglycerides, calculated low-density lipoprotein cholesterol [LDL-C]	Baseline, Week 16	No