Primary outcome
What NCT00456885 measured first
| Exenatiden=41 | Placebon=40 |
|---|---|
| -2.49(0.66) | 0.43(0.63) |
| Exenatiden=41 | Placebon=40 |
|---|---|
| -0.93(-1.44 to -0.41) | 0.18(-0.31 to 0.68) |
Phase 4 · Exenatide
NCT00456885 trial results
The Effect of Exenatide on Body Weight, Energy Expenditure and Hunger in Obese Women Without Diabetes Mellitus
Change in Weight (kilograms), 16 weeks after the beginning of each treatment. Exenatide: -2.49; Placebo: 0.43.
- Participants
- 41
- Status
- completed
- Completed
- 2010-09
- Sponsor
- Beth Israel Deaconess Medical Center
As posted on ClinicalTrials.gov (NCT00456885), updated at source Sep 11, 2017. 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 NCT00456885
Percent of participants affected, 37 weeks. The most common events the registry lists.
| Event | All Study Participants |
|---|---|
| Any serious event | 0% |
| Nausea | 75.6% |
| Constipation | 4.9% |
| Bloating | 2.4% |
| Irritation at injection site | 2.4% |
| Fatigue | 2.4% |
| Heartburn | 2.4% |
| Diarrhea | 2.4% |
Secondary outcomes
What else it measured
| Exenatiden=41 | Placebon=40 |
|---|---|
| -1.68(-3.3 to -0.07) | 0.94(-0.59 to 2.47) |
| Exenatiden=41 | Placebon=40 |
|---|---|
| -2.5(-6.6 to 1.6) | -1.3(-5.2 to 2.6) |
| Exenatiden=41 | Placebon=40 |
|---|---|
| -0.4(-1.5 to 0.7) | -0.7(-1.8 to 0.3) |
| Exenatiden=41 | Placebon=40 |
|---|---|
| -3.7(-7.4 to 0.05) | -0.2(-3.8 to 3.3) |
| Exenatiden=41 | Placebon=40 |
|---|---|
| -1.2(-3.6 to 1.1) | -0.4(-2.6 to 1.9) |
| Exenatiden=41 | Placebon=40 |
|---|---|
| 0.4(-0.3 to 1.0) | 0.07(-0.5 to 0.7) |
| Exenatiden=41 | Placebon=40 |
|---|---|
| 1.1(-0.6 to 2.8) | 0.4(-1.3 to 2.0) |
| Exenatiden=41 | Placebon=40 |
|---|---|
| 0.5(-3.6 to 4.5) | 3.1(-0.7 to 7.0) |
| Exenatiden=41 | Placebon=40 |
|---|---|
| -10(-21 to 1.2) | -0.5(-11 to 10) |
| Exenatiden=41 | Placebon=40 |
|---|---|
| 0.2(-0.3 to 0.6) | 0.2(-0.3 to 0.6) |
| Exenatiden=41 | Placebon=40 |
|---|---|
| -13.7(-60.6 to 33.2) | 6.5(-38.0 to 51.0) |
The trial
How NCT00456885 was run
This study will look at the effect of exenatide, a drug which has been approved for the treatment of type 2 diabetes, on body weight, appetite and energy expenditure among moderately obese women without diabetes. The study is 35 weeks long and includes 19 outpatient visits. Participants will receive exenatide for 16 weeks and placebo for 16 weeks with a 3 week rest period in between. Neither participants nor investigators will know whether exenatide or placebo is being administered. Participants will be started randomly on either exenatide or placebo. Our hypothesis is that treatment with exenatide will curb appetite and lead to weight loss and may lead to changes in energy expenditure.
- Exenatide First: Started on Exenatide, 3 week washout, start placebo
- Placebo First: Started on placebo, 3 week washout, start exenatide
Who could join the trial
Inclusion Criteria: 1. Females aged 25-60 2. BMI 28-35 kg/m2 3. No known diagnosis of diabetes 4. No known diagnosis of coronary heart disease 5. Self-described sedentary lifestyle with minimal regular cardiovascular exercise (no more than 1 hour per week) 6. Stable weight (variation \< 3 kg within 6 months of screening visit) 7. Ability to give informed consent 8. Ability to follow verbal and written instructions 9. Use of medically approved form of contraception (monophasic oral contraception, intra uterine device, surgical sterilization or 2 combined barrier methods) 10. Nonsmoker (tobacco, marijuana) 11. Outpatient visits every 2 weeks throughout the study period are required. While most of these visits are short (15 minutes)ability to commute to the performance site in Boston, on a regular basis, is necessary. Exclusion Criteria: 1. Type 1 or type 2 diabetes mellitus diagnosed according to American Diabetes Association criteria 2. Coronary heart disease (history of myocardial infarction or unstable angina pectoris) 3. Uncontrolled hypertension hypertension (BP \> 150/90 mmHg on or off antihypertensive medication) 4. Uncontrolled dyslipidemia (LDL \> 200 or TG \> 400 on or off lipid lowering medication) 5. Tobacco, marijuana or intravenous drug use 6. Shift workers (night shift or alternating day/night shifts) 7. Recent weight loss (\> 3 kg within 4 months of the screening visit) 8. Gastroparesis 9. Inflammatory bowel disease 10. Malignancy treated with chemotherapy within the past 3 years 11. History of pancreatitis 12. Depression requiring hospitalization or diagnosis of psychosis 13. Renal insufficiency (creatinine clearance \< 50 ml/min) 14. Transaminases \> 2x above the normal range 15. Pregnancy within 6 months of the screening visit 16. Breastfeeding 17. Failure to use medically approved contraceptive methods 18. History of an eating disorder (anorexia, bulimia or laxative abuse) 19. History of surgery for the treatment of obesity (gastric banding, gastric bypass, gastric stapling) 20. New diagnosis of hypo or hyperthyroidism within 1 year of screening visit 21. Previous participation in a clinical study with exenatide 22. Presence or history of allergic reaction to multiple drugs
Published papers
Papers from NCT00456885
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.