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

Novo Nordisk

Status and phase: Completed; Phase 4

Conditions: Diabetes Mellitus, Type 1; Diabetes

Treatments: Drug: insulin aspart; Drug: insulin detemir

Study type: Interventional

Funder types: Industry

Identifiers

NCT00117780

NN304-1708

2005-001522-88 (EudraCT Number)

Details and patient eligibility

About

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).

Enrollment: 520 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Type 1 diabetes for more than 1 year
• Subject treated by any kind of insulin regimen and whatever the number of injections
• HbA1c = 7.5% and = 10%

Exclusion criteria

• Type 2 diabetes
• Treatment by oral anti-diabetic drugs
• Severe medical conditions

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)