Effect of Exenatide Plus Metformin vs. Insulin Aspart Plus Metformin on Glycemic Control and Hypoglycemia in Patients With Type 2 Diabetes

Summary

This study in Germany is designed to compare the effects of twice-daily exenatide plus metformin and twice-daily premixed human insulin aspart plus metformin with respect to glycemic control, as measured by HbA1c, combined with the percentage of patients with at least one treatment-emergent hypoglycemic episode. Patients will be treated with study therapy for approximately 26 weeks.

Timeline

Start

2007-02

Primary completion

2009-06

Completion

2009-06

Outcome

Met primary endpoint

registry Non-inferiority: upper limit of 95% Confidence Interval (CI) to be \< 0.4%. NCT00434954 ↗

paper Exenatide BID (n = 181) was noninferior to PIA (n = 173) for A1C control PMID 21285388 ↗

paper Exenatide BID (n = 181) was noninferior to PIA (n = 173) for A1C control (least squares [LS] mean change -1.0 vs. -1.14% PMID 21285388 ↗

paper 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]) PMID 21285388 ↗

Publications

• Pencek R, Blickensderfer A, Li Y, Brunell SC, Anderson PW. Exenatide twice daily: analysis of effectiveness and safety data stratified by age, sex, race, duration of diabetes, and body mass index. Postgrad Med. 2012 Jul;124(4):21-32. doi: 10.3810/pgm.2012.07.2567.
• Gallwitz B, Bohmer M, Segiet T, Molle A, Milek K, Becker B, Helsberg K, Petto H, Peters N, Bachmann O. 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.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Exenatide	Peptide	5 ug	Subcutaneous
Subject	Exenatide	Peptide	10 ug	Subcutaneous
Comparator	insulin aspart	Protein / enzyme biologic	—	Subcutaneous

Indications