Effect of Exenatide on Abdominal Fat Distribution in Patients With Type 2 Diabetes Pretreated With Metformin

Summary

A multicenter, randomized, double-blind, placebo-controlled trial will assess the effects of twice-daily subcutaneous injection with exenatide versus treatment with matching placebo injection on abdominal visceral fat content.

Timeline

Start

2008-08

Primary completion

2012-01

Completion

2012-01

Outcome

Missed primary endpoint

Stopped (Enrollment): “Enrollment was much slower than anticipated, leading to a decision to terminate the study early for enrollment futility.”

registry analysis (superiority or other test); Exenatide BID vs Placebo; p = 0.8252; Mean Difference (Final Values) -0.98 (95% CI -9.92 to 7.95); ANCOVA; NCT00701935 ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Exenatide	Peptide	10 ug	Subcutaneous

Indications