Phase 3 N=194 Randomized Double-blind Treatment

Effect on Weight Loss of Exenatide Versus Placebo

Type 2 Diabetes Mellitus

Bottom Line

View on ClinicalTrials.gov: NCT00375492 ↗

Enrolled (actual)

194

Serious AEs

—

Results posted

Sep 2009

Primary outcome: Primary: Change From Baseline in Body Weight — -6.16; -3.97 kg — p=0.0030

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: exenatide (Drug); placebo (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: AstraZeneca
Primary completion: Feb 2008

Outcome Measures

Outcome	Result	p-value
PRIMARY Change From Baseline in Body Weight	-6.16; -3.97	0.0030 sig
SECONDARY Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 24	-1.21; -0.73	<0.0001 sig
SECONDARY Change From Baseline in 6-point Self Monitored Blood Glucose (SMBG) Profile at Week 24	-1.87; -1.20; -2.67; -1.92; -1.40; -1.37	—
SECONDARY Change From Baseline in Waist Circumference at Week 24	-5.33; -4.18	0.1985
SECONDARY Ratio of Homeostatic Model Assessment-Beta Cell (HOMA-B) at Week 24 to HOMA-B at Baseline	1.46; 1.29	0.1827
SECONDARY Ratio of Homeostatic Model Assessment-Insulin Sensitivity (HOMA-S) at Week 24 to HOMA-S at Baseline	1.08; 0.97	0.1584
SECONDARY Change From Baseline in High Density Lipoprotein (HDL) Cholesterol at Week 24	0.02; 0.02	0.8279
SECONDARY Change From Baseline in Low Density Lipoprotein (LDL) Cholesterol at Week 24	-0.06; -0.04	0.8334
SECONDARY Change From Baseline in Total Cholesterol at Week 24	-0.16; -0.03	0.2881
SECONDARY Ratio of Triglycerides at Week 24 to Triglycerides at Baseline	0.83; 0.92	0.0654
SECONDARY Number of Participants With Hypoglycemic Events During the Study	33; 30	0.728
SECONDARY Rate of Hypoglycemic Events	7.14; 4.58	0.127

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00375492). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.