Primary outcome
What NCT00375492 measured first
| Group A (Exenatide)n=70 | Group B (Placebo)n=72 |
|---|---|
| -6.16(0.54) | -3.97(0.52) |
Phase 3 · Exenatide
NCT00375492 trial results
Effect on Weight Loss of Exenatide Versus Placebo in Subjects With Type 2 Diabetes Participating in a Lifestyle Modification Program
Change From Baseline in Body Weight (kg), Baseline, Week 24. Group A (Exenatide): -6.16; Group B (Placebo): -3.97.
- Participants
- 196
- Status
- completed
- Completed
- 2008-02
- Sponsor
- AstraZeneca
As posted on ClinicalTrials.gov (NCT00375492), updated at source Apr 7, 2015. Read again whenever the registry updates it. Registry figures can differ from a published paper, which may use another analysis.
Side effects by arm
Side effects in NCT00375492
Percent of participants affected. The most common events the registry lists.
| Event | Group A (Exenatide) | Group B (Placebo) |
|---|---|---|
| Nausea | 44.8% | 19.4% |
| Vomiting | 21.9% | 9.2% |
| Diarrhea | 18.8% | 21.4% |
| Upper respiratory tract infection | 17.7% | 17.3% |
| Injection site bruising | 5.2% | 14.3% |
| Headache | 11.5% | 9.2% |
| Nasopharyngitis | 11.5% | 6.1% |
| Constipation | 9.4% | 10.2% |
| Back pain | 4.2% | 8.2% |
| Pain in extremity | 7.3% | 5.1% |
| Urinary tract infection | 3.1% | 7.1% |
| Decreased appetite | 6.3% | 6.1% |
| Contusion | 6.3% | 4.1% |
| Injection site pruritus | 6.3% | 0% |
| Cough | 5.2% | 6.1% |
| Dizziness | 5.2% | 5.1% |
| Myalgia | 5.2% | 2% |
| Dysgeusia | 5.2% | 1% |
| Injection site erythema | 5.2% | 0% |
| Nasal congestion | 5.2% | 0% |
| Musculoskeletal pain | 1% | 5.1% |
Secondary outcomes
What else it measured
| Group A (Exenatide)n=70 | Group B (Placebo)n=71 |
|---|---|
| -1.21(0.09) | -0.73(0.09) |
| Measure | Group A (Exenatide)n=69 | Group B (Placebo)n=72 |
|---|---|---|
| Morning Pre-Meal | -1.87(0.17) | -1.20(0.17) |
| 2 Hours Post Morning Meal | -2.67(0.22) | -1.92(0.22) |
| Midday Pre-Meal | -1.40(0.19) | -1.37(0.19) |
| 2 Hours Post Midday Meal | -2.12(0.21) | -1.51(0.20) |
| Evening Pre-Meal | -1.57(0.19) | -1.32(0.19) |
| 2 Hours Post Evening Meal | -3.09(0.22) | -2.28(0.23) |
| Group A (Exenatide)n=69 | Group B (Placebo)n=69 |
|---|---|
| -5.33(0.71) | -4.18(0.73) |
| Group A (Exenatide)n=68 | Group B (Placebo)n=76 |
|---|---|
| 1.46(0.12) | 1.29(0.10) |
| Group A (Exenatide)n=68 | Group B (Placebo)n=76 |
|---|---|
| 1.08(0.07) | 0.97(0.06) |
| Group A (Exenatide)n=81 | Group B (Placebo)n=89 |
|---|---|
| 0.02(0.02) | 0.02(0.02) |
| Group A (Exenatide)n=81 | Group B (Placebo)n=89 |
|---|---|
| -0.06(0.08) | -0.04(0.07) |
| Group A (Exenatide)n=81 | Group B (Placebo)n=89 |
|---|---|
| -0.16(0.10) | -0.03(0.10) |
| Group A (Exenatide)n=81 | Group B (Placebo)n=89 |
|---|---|
| 0.83(0.04) | 0.92(0.04) |
| Group A (Exenatide)n=96 | Group B (Placebo)n=98 |
|---|---|
| 33 | 30 |
| Group A (Exenatide)n=96 | Group B (Placebo)n=98 |
|---|---|
| 7.14(1.45) | 4.58(1.43) |
The trial
How NCT00375492 was run
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.
- Group A
- Group B
Who could join the trial
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
Published papers
Papers from NCT00375492
Trial averages do not predict what one person will experience. Results are shown as the registry posts them, without interpretation.
GLPcompare is an informational data platform, not a medical provider or pharmacy. Nothing here is medical advice, a diagnosis, or a recommendation to start, stop, or change any treatment. Data is aggregated from public sources and can be incomplete or out of date. Always confirm with a licensed clinician and the current FDA label.