Format

Send to

Choose Destination
Diabetes Care. 2014 Dec;37(12):3309-16. doi: 10.2337/dc14-0930. Epub 2014 Sep 23.

Weight-loss therapy in type 2 diabetes: effects of phentermine and topiramate extended release.

Author information

1
Department of Nutrition Sciences, University of Alabama at Birmingham, Birmingham, AL Birmingham VA Medical Center, Birmingham, AL garveyt@uab.edu.
2
Pennington Biomedical Research Center, Baton Rouge, LA.
3
Monteagle Medical Center, San Francisco, CA.
4
Northwestern University Feinberg School of Medicine, Chicago, IL.
5
University of Alabama at Birmingham, Birmingham, AL.
6
VIVUS, Inc., Mountain View, CA.

Abstract

OBJECTIVE:

Treatment algorithms for type 2 diabetes recommend weight loss for disease management. The safety and efficacy of treatment with phentermine (PHEN)/topiramate (TPM) extended release (ER) plus lifestyle modification for weight loss and glycemic benefits were assessed in two randomized, double-blind, placebo-controlled 56-week studies of obese/overweight adults with type 2 diabetes.

RESEARCH DESIGN AND METHODS:

The OB-202/DM-230 Study was a 56-week phase 2 trial that randomized subjects to receive once-daily placebo or PHEN/TPM ER 15 mg/92 mg (15/92). The primary end point was change in HbA₁c level. A post hoc analysis of a subpopulation with type 2 diabetes from a second study, CONQUER, is also presented. All subjects made lifestyle modifications, and comorbidities were managed to the standard of care.

RESULTS:

The study groups comprised 130 subjects with type 2 diabetes enrolled in the OB-202/DM-230 Study (mean baseline HbA₁c 8.7% [72 mmol/mol]) and 388 subjects with type 2 diabetes in the CONQUER Study (mean baseline HbA1c 6.8% [51 mmol/mol]). At week 56 in the OB-202/DM-230, change in weight (from intent-to-treat sample with last observation carried forward [ITT-LOCF]) was -2.7% for placebo and -9.4% for PHEN/TPM ER 15/92 (P < 0.0001 vs. placebo). Change in HbA1c level (from ITT-LOCF) was -1.2% (-13.1 mmol/mol) for placebo and -1.6% (-17.5 mmol/mol) for PHEN/TPM ER 15/92 (P = 0.0381). In both the OB-202/DM-230 and CONQUER, greater numbers of patients randomized to receive PHEN/TPM ER treatment achieved HbA₁c targets with reduced need for diabetic medications when compared with the placebo group. Common adverse events included paraesthesia, constipation, and insomnia.

CONCLUSIONS:

PHEN/TPM ER plus lifestyle modification can effectively promote weight loss and improve glycemic control as a treatment approach in obese/overweight patients with type 2 diabetes.

TRIAL REGISTRATION:

ClinicalTrials.gov NCT00553787 NCT00600067.

PMID:
25249652
DOI:
10.2337/dc14-0930
[Indexed for MEDLINE]

Supplemental Content

Full text links

Icon for HighWire
Loading ...
Support Center