Exenatide twice daily versus premixed insulin aspart 70/30 in metformin-treated patients with type 2 diabetes: a randomized 26-week study on glycemic control and hypoglycemia

Diabetes Care. 2011 Mar;34(3):604-6. doi: 10.2337/dc10-1900. Epub 2011 Feb 1.

Abstract

Objective: Hypoglycemia causes recurrent morbidity in patients with type 2 diabetes. This study evaluated if exenatide twice daily (BID) was noninferior to premixed insulin aspart 70/30 BID (PIA) for glycemic control and associated with less hypoglycemia.

Research design and methods: In this open-label study, metformin-treated adults with type 2 diabetes were randomized to 26-week treatment with exenatide BID (4 weeks 5 μg, then 10 μg) or PIA.

Results: Exenatide BID (n = 181) was noninferior to PIA (n = 173) for A1C control (least squares [LS] mean change -1.0 vs. -1.14%; difference [95% CI] 0.14 [-0.003 to 0.291]) and associated with a lower risk for hypoglycemia (8.0 vs. 20.5%, P < 0.05). LS mean weight decreased by 4.1 kg and increased by 1.0 kg with PIA (P < 0.001). A total of 39.2 vs. 20.8% of patients reached the composite end point of A1C <7.0%, no weight gain, and no hypoglycemia (P < 0.001; post hoc analysis).

Conclusions: In metformin-treated patients, exenatide BID was noninferior to PIA for glycemic control but superior for hypoglycemia and weight control.

Trial registration: ClinicalTrials.gov NCT00434954.

Publication types

  • Randomized Controlled Trial

MeSH terms

  • Aged
  • Blood Glucose / drug effects
  • Diabetes Mellitus, Type 2 / blood
  • Diabetes Mellitus, Type 2 / drug therapy*
  • Drug Administration Schedule
  • Exenatide
  • Humans
  • Hypoglycemia / blood
  • Hypoglycemia / drug therapy
  • Hypoglycemic Agents / administration & dosage
  • Hypoglycemic Agents / therapeutic use
  • Insulin / administration & dosage
  • Insulin / analogs & derivatives*
  • Insulin / therapeutic use
  • Insulin Aspart
  • Metformin / administration & dosage*
  • Metformin / therapeutic use*
  • Middle Aged
  • Peptides / administration & dosage*
  • Peptides / therapeutic use*
  • Treatment Outcome
  • Venoms / administration & dosage*
  • Venoms / therapeutic use*

Substances

  • Blood Glucose
  • Hypoglycemic Agents
  • Insulin
  • Peptides
  • Venoms
  • Metformin
  • Exenatide
  • Insulin Aspart

Associated data

  • ClinicalTrials.gov/NCT00434954