Comparison of Efficacy and Safety of Insulin Detemir Once or Twice Daily in a Basal-Bolus Regimen With Insulin Aspart in Patients With Type 1 Diabetes (ADAPT)

NCT00117780 Phase 4 COMPLETED

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).

Details

Lead sponsor	Novo Nordisk A/S
Phase	Phase 4
Status	COMPLETED
Enrolment	520
Start date	2005-06
Completion	2006-10

Conditions

• Diabetes
• Diabetes Mellitus, Type 1

Interventions

• insulin detemir
• insulin aspart

Primary outcomes

• Mean HbA1c — after 4 months of insulin detemir treatment

Countries

Belgium, France, Luxembourg