Comparison of Efficacy and Safety of Insulin Detemir and Insulin Glargine in Patients With Type 1 Diabetes

Novo Nordisk

Status and phase: Completed; Phase 3

Conditions: Diabetes Mellitus, Type 1; Diabetes

Treatments: Drug: insulin aspart; Drug: insulin detemir; Drug: insulin glargine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00312104

NN304-1372

Details and patient eligibility

About

The trial is conducted in Europe and Africa. The aim of the trial is to compare the use of insulin detemir twice daily combined with mealtime insulin aspart against that of insulin glargine once daily combined with mealtime insulin aspart. The trial involves patients with Type 1 Diabetes.

Enrollment: 325 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Type 1 diabetes for at least 12 months
• Current daily insulin dose of more than 1.4 IU/kg
• BMI lesser than or equal to 35 kg/m2
• HbA1c greater than 7.5% and less than or equal to 12.0%
• In Austria, age more than 19 years

Exclusion criteria

• Proliferate retinopathy or maculopathy
• Recurrent major hypoglycaemia
• Any condition or disease such as uncontrolled hypertension or AIDS/HIV that rule out trial participation according to the judgement of the investigator

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)