Comparison of Insulin Detemir or Insulin Glargine as Add on to Oral Antidiabetic Drugs in Type 2 Diabetes

Phase 3 Completed 583 enrolled Novo Nordisk A/S

RandomizedParallel-groupOpen-labelTreatment

Summary

This trial is conducted in Europe and the United States of America (USA). The aim of the trial is to test if Insulin Detemir as add-on to current Oral Antidiabetic Drug treatment is at least as effective as Insulin Glargine as add-on to current Oral Antidiabetic Drug treatment in reducing HbA1c in patients with Type 2 Diabetes.

Timeline

Start: 2003-03
Primary completion: 2004-11
Completion: 2004-11

Outcome

Met primary endpoint

paper Non-inferiority was demonstrated for detemir using higher insulin doses (mainly patients on twice daily dosing); PMID 18204830 ↗

Publications

Results Rosenstock J, Davies M, Home PD, Larsen J, Koenen C, Schernthaner G. A randomised, 52-week, treat-to-target trial comparing insulin detemir with insulin glargine when administered as add-on to glucose-lowering drugs in insulin-naive people with type 2 diabetes. Diabetologia. 2008 Mar;51(3):408-16. doi: 10.1007/s00125-007-0911-x. Epub 2008 Jan 16.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	insulin detemir	Protein / enzyme biologic	0.78 iu/kg	Other
Subject	insulin glargine	Protein / enzyme biologic	0.44 iu/kg	Other