title: Weight-loss therapy in type 2 diabetes: effects of phentermine and topiramate extended release.
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.
  
  
  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.
authors.affiliation: Department of Nutrition Sciences, University of Alabama at Birmingham, Birmingham, AL Birmingham VA Medical Center, Birmingham, AL garveyt@uab.edu.
authors.forename: W Timothy
authors.initials: WT
authors.lastname: Garvey
authors.affiliation: Pennington Biomedical Research Center, Baton Rouge, LA.
authors.forename: Donna H
authors.initials: DH
authors.lastname: Ryan
authors.affiliation: Monteagle Medical Center, San Francisco, CA.
authors.forename: Nancy J V
authors.initials: NJ
authors.lastname: Bohannon
authors.affiliation: Northwestern University Feinberg School of Medicine, Chicago, IL.
authors.forename: Robert F
authors.initials: RF
authors.lastname: Kushner
authors.affiliation: University of Alabama at Birmingham, Birmingham, AL.
authors.forename: Miriam
authors.initials: M
authors.lastname: Rueger
authors.affiliation: VIVUS, Inc., Mountain View, CA.
authors.forename: Roman V
authors.initials: RV
authors.lastname: Dvorak
authors.affiliation: VIVUS, Inc., Mountain View, CA.
authors.forename: Barbara
authors.initials: B
authors.lastname: Troupin
mesh_terms: D000328:Adult; D019440:Anti-Obesity Agents / Q000008:administration & dosage* / Q000009:adverse effects; D001786:Blood Glucose; D003692:Delayed-Action Preparations; D003924:Diabetes Mellitus, Type 2 / Q000150:complications / Q000188:drug therapy* / Q000628:therapy; D004311:Double-Blind Method; D005260:Female; D005632:Fructose / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D006801:Humans; D008019:Life Style; D008297:Male; D008875:Middle Aged; D009765:Obesity / Q000150:complications / Q000188:drug therapy* / Q000628:therapy; D010645:Phentermine / Q000008:administration & dosage / Q000009:adverse effects; D000077236:Topiramate; D016896:Treatment Outcome; D015431:Weight Loss / Q000187:drug effects
chemical_list: D019440:Anti-Obesity Agents; D001786:Blood Glucose; D003692:Delayed-Action Preparations; D000077236:Topiramate; D005632:Fructose; D010645:Phentermine