Effect on Weight Loss of Exenatide Versus Placebo
This study has been completed.
Sponsor:
Amylin Pharmaceuticals, LLC.
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Amylin Pharmaceuticals, LLC.
ClinicalTrials.gov Identifier:
NCT00375492
First received: September 11, 2006
Last updated: February 26, 2013
Last verified: February 2013
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Type 2 Diabetes Mellitus |
Drug: exenatide Drug: placebo |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | Effect on Weight Loss of Exenatide Versus Placebo in Subjects With Type 2 Diabetes Participating in a Lifestyle Modification Program |
Resource links provided by NLM:
Further study details as provided by Amylin Pharmaceuticals, LLC.:
Primary Outcome Measures:
- Change in Body Weight [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]Change in body weight from baseline after 24 weeks of treatment (i.e., weight at week 24 minus weight at week 0)
Secondary Outcome Measures:
- Change in Glycosylated Hemoglobin (HbA1c) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]Change in HbA1c from baseline after 24 weeks of treatment (i.e., HbA1c at week 24 minus HbA1c at week 0)
- Change in 6-point Self Monitored Blood Glucose (SMBG) Profile. [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]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)
- Change in Waist Circumference. [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]Change in waist circumference from baseline after 24 weeks of treatment (i.e., waist circumference at week 24 minus waist circumference at week 0)
- Change in Homeostatic Model Assessment-Beta Cell (HOMA-B) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]Ratio of HOMA-B at week 24 to HOMA-B at week 0 (i.e., HOMA-B at week 24 divided by HOMA-B at week 0). HOMA-B is a measure of beta cell function.
- Change in Homeostatic Model Assessment-Insulin Sensitivity (HOMA-S) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]Ratio of HOMA-S at week 24 to HOMA-S at week 0 (i.e., HOMA-S at week 24 divided by HOMA-S at week 0). HOMA-S is a measure of insulin sensitivity.
- Change in High Density Lipoprotein (HDL) Cholesterol [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]Change in HDL cholesterol from baseline after 24 weeks of treatment (i.e., HDL cholesterol at week 24 minus HDL cholesterol at week 0)
- Change in Low Density Lipoprotein (LDL) Cholesterol [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]Change in LDL cholesterol from baseline after 24 weeks of treatment (i.e., LDL cholesterol at week 24 minus LDL cholesterol at week 0)
- Change in Total Cholesterol [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]Change in total cholesterol from baseline after 24 weeks of treatment (i.e., total cholesterol at week 24 minus total cholesterol at week 0)
- Change in Triglycerides [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]Ratio of triglyceride levels at week 24 to triglyceride levels at week 0 (i.e., triglycerides at week 24 divided by triglycerides at week 0)
- Incidence of Hypoglycemic Events [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]Number of patients experiencing one or more events of hypoglycemia at any point in the study
- Rate of Hypoglycemic Events [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]Overall rate of hypoglycemia, adjusted for 1 year (i.e., events of hypoglycemia per patient per year)
| Enrollment: | 190 |
| Study Start Date: | September 2006 |
| Study Completion Date: | February 2008 |
| Primary Completion Date: | February 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Group A |
Drug: exenatide
subcutaneous injection, 5mcg or 10mcg, twice a day
Other Name: Byetta
|
| Placebo Comparator: Group B |
Drug: placebo
subcutaneous injection, volume equivalent to exenatide dose, twice a day
|
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00375492
Locations
| United States, Arizona | |
| Research Site | |
| Peoria, Arizona, United States | |
| United States, Florida | |
| Research Site | |
| Jacksonville, Florida, United States | |
| Research Site | |
| Orlando, Florida, United States | |
| United States, Indiana | |
| Research Site | |
| Indianapolis, Indiana, United States | |
| United States, Massachusetts | |
| Research Site | |
| Boston, Massachusetts, United States | |
| United States, Minnesota | |
| Research Site | |
| Minneapolis, Minnesota, United States | |
| United States, Missouri | |
| Research Site | |
| St. Louis, Missouri, United States | |
| United States, South Carolina | |
| Research Site | |
| Spartanburg, South Carolina, United States | |
| United States, Texas | |
| Research Site | |
| San Antonio, Texas, United States | |
| United States, Washington | |
| Research Site | |
| Renton, Washington, United States | |
Sponsors and Collaborators
Amylin Pharmaceuticals, LLC.
Eli Lilly and Company
Investigators
| Study Director: | James Malone, MD | Eli Lilly and Company |
More Information
No publications provided by Amylin Pharmaceuticals, LLC.
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Amylin Pharmaceuticals, LLC. |
| ClinicalTrials.gov Identifier: | NCT00375492 History of Changes |
| Other Study ID Numbers: | H8O-US-GWBM |
| Study First Received: | September 11, 2006 |
| Results First Received: | February 25, 2009 |
| Last Updated: | February 26, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Amylin Pharmaceuticals, LLC.:
|
diabetes overweight obesity weight loss |
exenatide Amylin Lilly |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetes Mellitus, Type 2 Weight Loss Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Body Weight Changes |
Body Weight Signs and Symptoms Exenatide Hypoglycemic Agents Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 16, 2013