Clinical trial NCT00375492: Effect on Weight Loss of Exenatide Versus Placebo
Official title: Effect on Weight Loss of Exenatide Versus Placebo in Subjects With Type 2 Diabetes Participating in a Lifestyle Modification Program
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Type 2 Diabetes Mellitus
Keywords: diabetes
overweight
obesity
weight loss
exenatide
Amylin
Lilly
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
Collaborators: name: Eli Lilly and Company
First posted: 2006-09-13
Enrollment: 196
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Change From Baseline in Body Weight
timeFrame: Baseline, Week 24
Secondary outcomes:
measure: Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 24
timeFrame: baseline, Week 24
measure: Change From Baseline in 6-point Self Monitored Blood Glucose (SMBG) Profile at Week 24
timeFrame: baseline, Week 24
measure: Change From Baseline in Waist Circumference at Week 24
timeFrame: baseline, Week 24
measure: Ratio of Homeostatic Model Assessment-Beta Cell (HOMA-B) at Week 24 to HOMA-B at Baseline
timeFrame: baseline, Week 24
measure: Ratio of Homeostatic Model Assessment-Insulin Sensitivity (HOMA-S) at Week 24 to HOMA-S at Baseline
timeFrame: baseline, Week 24
measure: Change From Baseline in High Density Lipoprotein (HDL) Cholesterol at Week 24
timeFrame: baseline, Week 24
measure: Change From Baseline in Low Density Lipoprotein (LDL) Cholesterol at Week 24
timeFrame: baseline, Week 24
measure: Change From Baseline in Total Cholesterol at Week 24
timeFrame: baseline, week 24
measure: Ratio of Triglycerides at Week 24 to Triglycerides at Baseline
timeFrame: baseline, Week 24
measure: Number of Participants With Hypoglycemic Events During the Study
timeFrame: Baseline to 24 weeks
measure: Rate of Hypoglycemic Events
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Peoria
country: United States
facility: Research Site
state: Arizona
city: Jacksonville
country: United States
facility: Research Site
state: Florida
city: Orlando
country: United States
facility: Research Site
state: Florida
city: Indianapolis
country: United States
facility: Research Site
state: Indiana
city: Boston
country: United States
facility: Research Site
state: Massachusetts
city: Minneapolis
country: United States
facility: Research Site
state: Minnesota
city: St. Louis
country: United States
facility: Research Site
state: Missouri
city: Spartanburg
country: United States
facility: Research Site
state: South Carolina
city: San Antonio
country: United States
facility: Research Site
state: Texas
city: Renton
country: United States
facility: Research Site
state: Washington
Study officials:
affiliation: Eli Lilly and Company
name: James Malone, MD
role: STUDY_DIRECTOR
References:
citation: 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.