Effect on Weight Loss of Exenatide Versus Placebo

Type 2 Diabetes Mellitus Clinical Trial

Official title:

Effect on Weight Loss of Exenatide Versus Placebo in Subjects With Type 2 Diabetes Participating in a Lifestyle Modification Program

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00375492
• Other study ID #: H8O-US-GWBM
• Status: Completed
• Phase: Phase 3
• First received: September 11, 2006
• Last updated: March 19, 2015
• Start date: September 2006
• Est. completion date: February 2008

Study information

• Verified date: March 2015
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This trial is designed to compare the effects of twice-daily exenatide and twice-daily placebo on weight loss. This trial will evaluate overweight and obese subjects with type 2 diabetes who have inadequate glycemic control with metformin, sulfonylurea, or metformin plus a sulfonylurea. Subjects will be treated with exenatide or placebo in addition to their current oral antidiabetes agent regimen and participate in a lifestyle modification program.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 196
• Est. completion date: February 2008
• Est. primary completion date: February 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Diagnosed with type 2 diabetes for at least 6 months

• Have been treated with a stable dose of the following for at least 6 weeks prior to screening: *immediate or extended release metformin, or *a sulfonylurea, or *a fixed-dose sulfonylurea/metformin combination therapy

• Have an HbA1c of 6.6% to 10.0%, inclusive

• Have a Body Mass Index (BMI) of 25 kg/m^2 to 39.9 kg/m^2, inclusive

Exclusion Criteria:

• Are treated with any of the following excluded medications: *exogenous insulin, thiazolidinedione, or alpha-glucosidase inhibitor for more than 1 week within 6 weeks of screening; *Symlin injection at any time; * Byetta injection within 3 months of screening or discontinuation of therapy at any time due to adverse reaction; *drugs that directly affect gastrointestinal motility; *use of a weight loss drug (including those available over the counter) within 3 months of screening; *chronic (lasting longer than 2 weeks) systemic corticosteroids (excluding topical, intranasal, and inhaled preparations) by oral, intravenous, or intramuscular route within 2 months of screening

• Have conditions contraindicating metformin and/or sulfonylurea use

• Have had a change in lipid-lowering agents within 6 weeks of screening

• Have received glucagon-like peptide-1 (GLP-1) analogs, or dipeptidyl peptidase-IV inhibitors (DPP-IV inhibitors) or have previously participated in this study

• Have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry

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
• Weight Loss

Intervention

Drug:
• exenatide
subcutaneous injection, 5mcg or 10mcg, twice a day
• placebo
subcutaneous injection, volume equivalent to exenatide dose, twice a day

Locations

Country	Name	City	State
United States	Research Site	Boston	Massachusetts
United States	Research Site	Indianapolis	Indiana
United States	Research Site	Jacksonville	Florida
United States	Research Site	Minneapolis	Minnesota
United States	Research Site	Orlando	Florida
United States	Research Site	Peoria	Arizona
United States	Research Site	Renton	Washington
United States	Research Site	San Antonio	Texas
United States	Research Site	Spartanburg	South Carolina
United States	Research Site	St. Louis	Missouri

Sponsors (2)

Lead Sponsor	Collaborator
AstraZeneca	Eli Lilly and Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in Body Weight	Change in body weight from baseline (Week 0) after 24 weeks of treatment (i.e., weight at week 24 minus weight at week 0). Body weight measured in kilograms (k).	Baseline, Week 24	No
Secondary	Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 24	Change in HbA1c from baseline (Week 0) after 24 weeks of treatment (i.e., HbA1c at week 24 minus HbA1c at week 0). HbA1c is measured as percent (%) of hemoglobin.	baseline, Week 24	No
Secondary	Change From Baseline in 6-point Self Monitored Blood Glucose (SMBG) Profile at Week 24	Change in SMBG at each of 6 time points throughout a day (blood glucose measurements before and 2 hours after the start of the morning, mid-day, and evening meals); week 24 compared to week 0 (i.e., SMBG at week 24 minus SMBG at week 0). Fasting Glucose measured in millimoles per liter (mmol/L).	baseline, Week 24	No
Secondary	Change From Baseline in Waist Circumference at Week 24	Change in waist circumference from baseline after 24 weeks of treatment (i.e., waist circumference at week 24 minus waist circumference at week 0). Waist measured in centimeters (cm).	baseline, Week 24	No
Secondary	Ratio of Homeostatic Model Assessment-Beta Cell (HOMA-B) at Week 24 to HOMA-B at Baseline	Ratio of HOMA-B at Week 24 to HOMA-B at baseline (Week 0). HOMA-B is a computer solved model used to predict the homeostatic concentrations which arise from varying degrees beta-cell deficiency. HOMA-B allows a quantitative assessment of the contributions of deficient beta cell function to the fasting hyperglycemia. HOMA-B is measured as a percent of the normal population (normal beta cell function = 100%, which is used as a reference in the calculation). The higher the percent the better for the participant.	baseline, Week 24	No
Secondary	Ratio of Homeostatic Model Assessment-Insulin Sensitivity (HOMA-S) at Week 24 to HOMA-S at Baseline	Ratio of HOMA-S at Week 24 to HOMA-S at baseline, week 0. HOMA-S is a computer solved model used to predict the homeostatic concentrations which arise from varying degrees of insulin sensitivity. HOMA-S allows a quantitative assessment of the contributions of insulin sensitivity to the fasting hyperglycemia. HOMA-S is measured as a percent of the normal population (normal insulin sensitivity = 100%, which is used as a reference in the calculation). The higher the percent the better for the participant.	baseline, Week 24	No
Secondary	Change From Baseline in High Density Lipoprotein (HDL) Cholesterol at Week 24	Change in HDL cholesterol from baseline after 24 weeks of treatment (i.e., HDL cholesterol at week 24 minus HDL cholesterol at week 0). HDL measured as mmol/L.	baseline, Week 24	No
Secondary	Change From Baseline in Low Density Lipoprotein (LDL) Cholesterol at Week 24	Change in LDL cholesterol from baseline (Week 0) after 24 weeks of treatment (ie., LDL cholesterol at week 24 minus LDL cholesterol at week 0). LDL cholesterol measured in mmol/L	baseline, Week 24	No
Secondary	Change From Baseline in Total Cholesterol at Week 24	Change in total cholesterol from baseline after 24 weeks of treatment (i.e., total cholesterol at week 24 minus total cholesterol at week 0). Total cholesterol measured in mmol/L.	baseline, week 24	No
Secondary	Ratio of Triglycerides at Week 24 to Triglycerides at Baseline	Ratio of triglyceride levels at Week 24 to triglyceride levels at baseline, Week 0 (ie., triglycerides at Week 24 divided by triglycerides at baseline, Week 0). Triglycerides measured in mmol/L.	baseline, Week 24	No
Secondary	Number of Participants With Hypoglycemic Events During the Study	Number of participants experiencing one or more events of hypoglycemia at any point in the study	Baseline to 24 weeks	No
Secondary	Rate of Hypoglycemic Events	Overall rate of hypoglycemia, adjusted for 1 year (ie., events of hypoglycemia per participant per year).	24 weeks	No