title: Efficacy and safety of taspoglutide in patients with type 2 diabetes inadequately controlled with metformin plus pioglitazone over 24 weeks: T-Emerge 3 trial.
abstract: OBJECTIVE
  This study assessed the efficacy and safety of once-weekly taspoglutide in patients with type 2 diabetes mellitus inadequately controlled with metformin plus pioglitazone compared with placebo.
  
  
  METHODS
  In this randomized, double-blind, parallel-group, placebo-controlled trial (T-emerge 3), 326 patients were randomized to once-weekly sc injections of taspoglutide 10 mg, taspoglutide 20 mg (10 mg for first 4 wk), or placebo. The primary endpoint was change from baseline in glycosylated hemoglobin (HbA1c) at 24 wk.
  
  
  RESULTS
  A significant reduction in HbA1c was observed with taspoglutide 10 mg and 20 mg vs. placebo (least square mean -1.35 and -1.40% vs. -0.45%, respectively; P < 0.0001). A greater proportion of taspoglutide-treated patients reached HbA1c target 7% or less (69.8 and 76.1% vs. 35.1%). With taspoglutide 10 mg and 20 mg vs. placebo, significantly greater reductions in fasting plasma glucose [-1.87 mmol/liter (-34 mg/dl) and -2.12 mmol/liter (-38 mg/dl) vs. -0.57 mmol/liter (-10 mg/dl); P < 0.0001], improvements in homeostasis model assessment of β-cell function score (20.65 and 33.52 vs. -2.03; P < 0.0001), and significant weight loss (-0.64 kg and -1.04 kg vs. 0.59 kg; P < 0.01) were observed. Adverse events were generally mild to moderate; the most frequent adverse events with taspoglutide 10 mg, taspoglutide 20 mg, and placebo were nausea (35, 44, and 10%), vomiting (21, 24, and 2%), and injection site reactions (24, 24, and 5%).
  
  
  CONCLUSIONS
  Taspoglutide provided glycemic control with weight loss as add-on therapy to metformin plus pioglitazone for inadequately controlled type 2 diabetes mellitus.
authors.affiliation: University of California San Diego and Veteran Affairs San Diego Healthcare System, San Diego, California 92161, USA. rrhenry@vapop.ucsd.edu
authors.forename: Robert R
authors.initials: RR
authors.lastname: Henry
authors.forename: Sunder
authors.initials: S
authors.lastname: Mudaliar
authors.forename: Linda
authors.initials: L
authors.lastname: Kanitra
authors.forename: Michael
authors.initials: M
authors.lastname: Woloschak
authors.forename: Raffaella
authors.initials: R
authors.lastname: Balena
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D003692:Delayed-Action Preparations; D003924:Diabetes Mellitus, Type 2 / Q000188:drug therapy*; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D004338:Drug Combinations; D005260:Female; D006801:Humans; D007004:Hypoglycemic Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D008297:Male; D008687:Metformin / Q000008:administration & dosage*; D008875:Middle Aged; D010455:Peptides / Q000008:administration & dosage / Q000009:adverse effects* / Q000627:therapeutic use*; D000077205:Pioglitazone; D010919:Placebos; D045162:Thiazolidinediones / Q000008:administration & dosage*; D017211:Treatment Failure; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D003692:Delayed-Action Preparations; D004338:Drug Combinations; D007004:Hypoglycemic Agents; D010455:Peptides; D010919:Placebos; D045162:Thiazolidinediones; C541736:taspoglutide; D008687:Metformin; D000077205:Pioglitazone