Variable Bolus Regimen 1-2-3 for Type 2 Diabetes Mellitus

Phase 3 Completed 347 enrolled Sanofi

RandomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this study is to show the non-inferiority of insulin glulisine administered with 1 meal versus 2 meals versus 3 daily meals, as measured by the change in hemoglobin A1c (HbA1c), from baseline to study week 24.

Timeline

Start: 2004-08
Primary completion: —
Completion: 2007-11

Outcome

Met primary endpoint

paper A1C reductions with insulin glulisine once or twice daily were noninferior to insulin glulisine 3 times daily (confidence intervals: -0.39 to 0.36 and -0.30 to 0.43; P>.5 for both). PMID 21324825 ↗

Publications

Davidson MB, Raskin P, Tanenberg RJ, Vlajnic A, Hollander P. A stepwise approach to insulin therapy in patients with type 2 diabetes mellitus and basal insulin treatment failure. Endocr Pract. 2011 May-Jun;17(3):395-403. doi: 10.4158/EP10323.OR.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Insulin glulisine	Protein / enzyme biologic	10 iu	—