Effect on Weight Loss of Exenatide Versus Placebo

AstraZeneca196 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

196

Conditions

Type 2 Diabetes Mellitus

Interventions

exenatideDRUG

subcutaneous injection, 5mcg or 10mcg, twice a day

placeboDRUG

subcutaneous injection, volume equivalent to exenatide dose, twice a day

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (10)

Research Site

Peoria, Arizona, United States

Research Site

Jacksonville, Florida, United States

Research Site

Orlando, Florida, United States

Research Site

Indianapolis, Indiana, United States

Outcomes

Primary Outcomes

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).

Time frame: Baseline, Week 24

Secondary Outcomes

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.

Time frame: baseline, Week 24

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).

Time frame: baseline, Week 24

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).

Time frame: baseline, Week 24

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.

Data from ClinicalTrials.gov

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