An Investigational Drug Study to Assess Weight Loss in Patients With Type 2 Diabetes Mellitus (0364-011)(TERMINATED)

Summary

A worldwide study with extension in patients with type 2 diabetes mellitus to assess the safety and tolerability as well as the effects of treatment with an investigational drug for weight loss on body weight.

Timeline

Start

2006-11

Primary completion

2008-01

Completion

2008-11

Outcome

Met primary endpoint

Stopped: “The overall profile does not support development for obesity”

paper all doses significant vs. placebo at both time points PMID 20518807 ↗

paper 1- and 2-mg doses significant vs. placebo at both time points PMID 20518807 ↗

Publications

• Results Kipnes MS, Hollander P, Fujioka K, Gantz I, Seck T, Erondu N, Shentu Y, Lu K, Suryawanshi S, Chou M, Johnson-Levonas AO, Heymsfield SB, Shapiro D, Kaufman KD, Amatruda JM. A one-year study to assess the safety and efficacy of the CB1R inverse agonist taranabant in overweight and obese patients with type 2 diabetes. Diabetes Obes Metab. 2010 Jun;12(6):517-31. doi: 10.1111/j.1463-1326.2009.01188.x.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	taranabant	Unknown	0.5 mg	—
Subject	taranabant	Unknown	1 mg	—
Subject	taranabant	Unknown	2 mg	—

Indications