Comparison of Insulin Detemir Given Once or Twice Daily in Type 1 Diabetes

Phase 4 Completed 520 enrolled Novo Nordisk A/S

RandomizedParallel-groupOpen-labelTreatment

Summary

This trial is conducted in Europe. The aim of this research study is to compare the efficacy (reduction in HbA1c and in blood glucose levels) of insulin detemir once daily injection compared to insulin detemir twice daily injection administered as basal insulin for the treatment of type 1 diabetes and to verify the safety of use (number and severity of episodes of hypoglycemia, body weight and side effects).

Timeline

Start: 2005-06
Primary completion: 2006-10
Completion: 2006-10

Outcome

Met primary endpoint

paper adjusted between-group difference of 0.12% (95% CI -0.01 to 0.25%), showing noninferiority for once-daily dosing. PMID 18945928 ↗

Publications

Results Le Floch JP, Levy M, Mosnier-Pudar H, Nobels F, Laroche S, Gonbert S, Eschwege E, Fontaine P; Assessment of Detemir Administration in Progressive Treat-to-Target Trial (ADAPT) Study Group. Comparison of once- versus twice-daily administration of insulin detemir, used with mealtime insulin aspart, in basal-bolus therapy for type 1 diabetes: assessment of detemir administration in a progressive treat-to-target trial (ADAPT). Diabetes Care. 2009 Jan;32(1):32-7. doi: 10.2337/dc08-0332. Epub 2008 Oct 22.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	insulin detemir	Protein / enzyme biologic	29 iu	Other
Subject	insulin detemir	Protein / enzyme biologic	39 iu	Other
Background	insulin aspart	Protein / enzyme biologic	26 iu	—
Background	insulin aspart	Protein / enzyme biologic	34 iu	—