title: Effects of taspoglutide on glycemic control and body weight in obese patients with type 2 diabetes (T-emerge 7 study).
abstract: OBJECTIVE
  Therapies that lower blood glucose and provide weight loss may provide meaningful benefits for obese patients with type 2 diabetes mellitus (T2DM). This study assessed the efficacy of taspoglutide compared with placebo on glycemic control and weight in obese patients with T2DM inadequately controlled with metformin monotherapy.
  
  
  METHODS
  In a 24-week, randomized, double-blind, placebo-controlled, multicenter trial, obese adults with T2DM were randomized (1:1) to weekly subcutaneous taspoglutide 20 mg (10 mg for first 4 weeks) (n = 154) or placebo (n = 151) for 24 weeks. Efficacy measures included hemoglobin A1c (HbA1c) levels, body weight, percentage of patients achieving HbA1c ≤6.5 and ≤7.0%, and fasting plasma glucose (FPG). Adverse events (AEs) were assessed.
  
  
  RESULTS
  Mean baseline HbA1c was 7.55% and mean baseline BMI was 36.7 kg/m(2) . HbA1c reductions from baseline were significantly greater with taspoglutide than placebo (least square mean [LSMean], -0.81% vs. -0.09%; P < 0.0001). Weight loss at week 24 was significantly greater with taspoglutide than placebo (LSMean, -3.16 vs. -1.85 kg; P < 0.01). In the taspoglutide and placebo groups, target HbA1c levels (≤6.5%) were achieved by 49 and 16% of patients, respectively, while 72 and 36% achieved HbA1c levels ≤7%. Decreases in FPG were significantly greater with taspoglutide than placebo (-23.59 vs. 0.09 mg/dl; P < 0.0001). Nausea and vomiting were the most common AEs associated with taspoglutide, but tended to be transient and generally mild or moderate.
  
  
  CONCLUSIONS
  In obese patients with T2DM, once-weekly taspoglutide provided the combined benefits of glycemic control and weight loss.
authors: Endocrinology Center, Baylor Medical Center, Dallas, Texas, USA. priscilh@BaylorHealth.edu
authors: Priscilla
authors: P
authors: Hollander
authors: Ben
authors: B
authors: Lasko
authors: Anthony H
authors: AH
authors: Barnett
authors: Monica
authors: M
authors: Bengus
authors: Linda
authors: L
authors: Kanitra
authors: F Xavier
authors: FX
authors: Pi-Sunyer
authors: Raffaella
authors: R
authors: Balena
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D019440:Anti-Obesity Agents / Q000627:therapeutic use; D001786:Blood Glucose / Q000032:analysis*; D015992:Body Mass Index; D003924:Diabetes Mellitus, Type 2 / Q000150:complications / Q000188:drug therapy; D004311:Double-Blind Method; D005215:Fasting; D005260:Female; D006442:Glycated Hemoglobin / Q000032:analysis / Q000378:metabolism; D006801:Humans; D007004:Hypoglycemic Agents / Q000627:therapeutic use; D008297:Male; D008687:Metformin / Q000627:therapeutic use; D008875:Middle Aged; D009765:Obesity / Q000150:complications / Q000188:drug therapy*; D010455:Peptides / Q000627:therapeutic use*; D015431:Weight Loss / Q000187:drug effects*; D055815:Young Adult
chemical_list: D019440:Anti-Obesity Agents; D001786:Blood Glucose; D006442:Glycated Hemoglobin; D007004:Hypoglycemic Agents; D008687:Metformin; D010455:Peptides; C541736:taspoglutide