Effect on Weight Loss of Exenatide Versus Placebo

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

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 or disease	Intervention/treatment	Phase
Type 2 Diabetes Mellitus	Drug: exenatide; Drug: placebo	Phase 3

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	196 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Double (Participant, 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
Study Start Date :	September 2006
Actual Primary Completion Date :	February 2008
Actual Study Completion Date :	February 2008

Arms and Interventions

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Arm	Intervention/treatment
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

Outcome Measures

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Primary Outcome Measures :

1. Change From Baseline in Body Weight [ Time Frame: Baseline, Week 24 ]
   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).

Secondary Outcome Measures :

1. Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 24 [ Time Frame: baseline, 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.
2. Change From Baseline in 6-point Self Monitored Blood Glucose (SMBG) Profile at Week 24 [ Time Frame: baseline, 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).
3. Change From Baseline in Waist Circumference at Week 24 [ Time Frame: baseline, 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).
4. Ratio of Homeostatic Model Assessment-Beta Cell (HOMA-B) at Week 24 to HOMA-B at Baseline [ Time Frame: baseline, Week 24 ]
   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.
5. Ratio of Homeostatic Model Assessment-Insulin Sensitivity (HOMA-S) at Week 24 to HOMA-S at Baseline [ Time Frame: baseline, Week 24 ]
   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.
6. Change From Baseline in High Density Lipoprotein (HDL) Cholesterol at Week 24 [ Time Frame: baseline, Week 24 ]
   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.
7. Change From Baseline in Low Density Lipoprotein (LDL) Cholesterol at Week 24 [ Time Frame: baseline, Week 24 ]
   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
8. Change From Baseline in Total Cholesterol at Week 24 [ Time Frame: baseline, week 24 ]
   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.
9. Ratio of Triglycerides at Week 24 to Triglycerides at Baseline [ Time Frame: baseline, Week 24 ]
   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.
10. Number of Participants With Hypoglycemic Events During the Study [ Time Frame: Baseline to 24 weeks ]
    Number of participants experiencing one or more events of hypoglycemia at any point in the study
11. Rate of Hypoglycemic Events [ Time Frame: 24 weeks ]
    Overall rate of hypoglycemia, adjusted for 1 year (ie., events of hypoglycemia per participant per year).

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 75 Years (Adult, Senior)
Sexes Eligible for Study:	All
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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

AstraZeneca

Eli Lilly and Company

Investigators

Study Director:	James Malone, MD	Eli Lilly and Company

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

Responsible Party:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00375492 History of Changes
Other Study ID Numbers:	H8O-US-GWBM
First Posted:	September 13, 2006
Results First Posted:	September 4, 2009
Last Update Posted:	April 7, 2015
Last Verified:	March 2015

Keywords provided by AstraZeneca:

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; Incretins; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists