Effect on Weight Loss of Exenatide Versus Placebo

Phase 3

Completed

• Conditions: Type 2 Diabetes Mellitus
• Interventions: Drug: exenatide; Drug: placebo

• Registration Number: NCT00375492
• Lead Sponsor: AstraZeneca

Brief 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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2006-09
• Study First Submitted: 2006-09-11
• Study First Submitted QC: 2006-09-11
• Study First Posted: 2006-09-13
• Primary Completion: 2008-02
• Study Completion: 2008-02
• Results First Submitted: 2009-02-25
• Results First Submitted QC: 2009-07-30
• Results First Posted: 2009-09-04
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-19
• Last Update Posted: 2015-04-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 196

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A	exenatide	-
Group B	placebo	-

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Body Weight	Baseline, Week 24	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).

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in High Density Lipoprotein (HDL) Cholesterol at Week 24	baseline, 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.
Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 24	baseline, 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.
Ratio of Homeostatic Model Assessment-Beta Cell (HOMA-B) at Week 24 to HOMA-B at Baseline	baseline, Week 24	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.
Change From Baseline in Low Density Lipoprotein (LDL) Cholesterol at Week 24	baseline, 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
Change From Baseline in 6-point Self Monitored Blood Glucose (SMBG) Profile at Week 24	baseline, 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).
Change From Baseline in Waist Circumference at Week 24	baseline, 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).
Ratio of Homeostatic Model Assessment-Insulin Sensitivity (HOMA-S) at Week 24 to HOMA-S at Baseline	baseline, Week 24	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.
Change From Baseline in Total Cholesterol at Week 24	baseline, 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.
Number of Participants With Hypoglycemic Events During the Study	Baseline to 24 weeks	Number of participants experiencing one or more events of hypoglycemia at any point in the study
Rate of Hypoglycemic Events	24 weeks	Overall rate of hypoglycemia, adjusted for 1 year (ie., events of hypoglycemia per participant per year).
Ratio of Triglycerides at Week 24 to Triglycerides at Baseline	baseline, Week 24	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.

Trial Locations

Locations (1)

Research Site; 🇺🇸 Renton, Washington, United States