Effect on Weight Loss of Exenatide Versus Placebo

This study has been completed.
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00375492
First received: September 11, 2006
Last updated: June 6, 2014
Last verified: June 2014

September 11, 2006
June 6, 2014
September 2006
February 2008   (final data collection date for primary outcome measure)
Change From Baseline in Body Weight [ Time Frame: Baseline, Week 24 ] [ Designated as safety issue: No ]
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).
To test the hypothesis that treatment with exenatide plus caloric restriction and physical activity will result in greater weight loss in overweight or obese subjects with type 2 diabetes than placebo plus caloric restriction and physical activity.
Complete list of historical versions of study NCT00375492 on ClinicalTrials.gov Archive Site
  • Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 24 [ Time Frame: baseline, Week 24 ] [ Designated as safety issue: No ]
    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.
  • Change From Baseline in 6-point Self Monitored Blood Glucose (SMBG) Profile at Week 24 [ Time Frame: baseline, Week 24 ] [ 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). Fasting Glucose measured in millimoles per liter (mmol/L).
  • Change From Baseline in Waist Circumference at Week 24 [ Time Frame: baseline, Week 24 ] [ 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). Waist measured in centimeters (cm).
  • Ratio of Homeostatic Model Assessment-Beta Cell (HOMA-B) at Week 24 to HOMA-B at Baseline [ Time Frame: baseline, Week 24 ] [ Designated as safety issue: No ]
    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.
  • Ratio of Homeostatic Model Assessment-Insulin Sensitivity (HOMA-S) at Week 24 to HOMA-S at Baseline [ Time Frame: baseline, Week 24 ] [ Designated as safety issue: No ]
    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 High Density Lipoprotein (HDL) Cholesterol at Week 24 [ Time Frame: baseline, Week 24 ] [ 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). HDL measured as mmol/L.
  • Change From Baseline in Low Density Lipoprotein (LDL) Cholesterol at Week 24 [ Time Frame: baseline, Week 24 ] [ Designated as safety issue: No ]
    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 Total Cholesterol at Week 24 [ Time Frame: baseline, week 24 ] [ 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). Total cholesterol measured in mmol/L.
  • Ratio of Triglycerides at Week 24 to Triglycerides at Baseline [ Time Frame: baseline, Week 24 ] [ Designated as safety issue: No ]
    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.
  • Number of Participants With Hypoglycemic Events During the Study [ Time Frame: Baseline to 24 weeks ] [ Designated as safety issue: No ]
    Number of participants 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 (ie., events of hypoglycemia per participant per year).
To compare exenatide and placebo with respect to the following: hemoglobin A1c, self-monitored blood glucose, lipids, waist circumference, beta cell function and insulin sensitivity, incidence/rate of hypoglycemic events, and adverse events.
Not Provided
Not Provided
 
Effect on Weight Loss of Exenatide Versus Placebo
Effect on Weight Loss of Exenatide Versus Placebo in Subjects With Type 2 Diabetes Participating in a Lifestyle Modification Program

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Type 2 Diabetes Mellitus
  • Drug: exenatide
    subcutaneous injection, 5mcg or 10mcg, twice a day
    Other Name: Byetta
  • Drug: placebo
    subcutaneous injection, volume equivalent to exenatide dose, twice a day
  • Experimental: Group A
    Intervention: Drug: exenatide
  • Placebo Comparator: Group B
    Intervention: Drug: placebo
Pencek R, Blickensderfer A, Li Y, Brunell SC, Anderson PW. Exenatide twice daily: analysis of effectiveness and safety data stratified by age, sex, race, duration of diabetes, and body mass index. Postgrad Med. 2012 Jul;124(4):21-32. doi: 10.3810/pgm.2012.07.2567.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
196
February 2008
February 2008   (final data collection date for primary outcome measure)

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
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00375492
H8O-US-GWBM
No
AstraZeneca
AstraZeneca
Eli Lilly and Company
Study Director: James Malone, MD Eli Lilly and Company
AstraZeneca
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP