Efficacy and safety of taspoglutide monotherapy in drug-naive type 2 diabetic patients after 24 weeks of treatment: results of a randomized, double-blind, placebo-controlled phase 3 study (T-emerge 1).

Abstract

OBJECTIVE:

To evaluate the efficacy and safety of taspoglutide monotherapy in drug-naive patients with type 2 diabetes inadequately controlled.

RESEARCH DESIGN AND METHODS:

In this 24-week double-blind, placebo-controlled, multicenter trial, 373 patients with type 2 diabetes naive to antihyperglycemic medication were randomized to weekly subcutaneous taspoglutide 10 or 20 mg or placebo.

RESULTS:

HbA(1c) reductions from baseline were greater with taspoglutide 10 and 20 mg than placebo (least squares mean [SE] changes: -1.01% [0.07], -1.18% [0.06], and -0.09% [0.07], respectively; both P < 0.0001 vs. placebo). Decreases in bodyweight were greater with taspoglutide 10 mg (-1.45 kg [0.32]) and with 20 mg (-2.25 kg [0.30]) than placebo (-1.23 kg [0.31]; P = 0.61 and P = 0.02 for taspoglutide 10 and 20 mg vs. placebo, respectively). Gastrointestinal adverse events and injection site reactions were more common with taspoglutide than placebo.

CONCLUSIONS:

In drug-naive patients, once-weekly taspoglutide improved glycemic control, reduced body weight, and was generally well tolerated.

• Authors: Itamar Raz, Vivian Fonseca, Mark Kipnes, Laurence Durrwell, John Hoekstra, Mark Boldrin, Raffaella Balena
• Journal: Diabetes care (Diabetes Care) Vol. 35 Issue 3 Pg. 485-7 (Mar 2012) ISSN: 1935-5548 [Electronic] United States
• PMID: 22301126 (Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Blood Glucose
• Glycated Hemoglobin A
• Hypoglycemic Agents
• Peptides
• taspoglutide

Topics

• Adolescent
• Adult
• Aged
• Aged, 80 and over
• Blood Glucose (drug effects)
• Body Weight (drug effects)
• Diabetes Mellitus, Type 2 (blood, drug therapy, metabolism)
• Double-Blind Method
• Female
• Glycated Hemoglobin (metabolism)
• Humans
• Hypoglycemic Agents (therapeutic use)
• Male
• Middle Aged
• Peptides (therapeutic use)
• Treatment Outcome
• Young Adult