Safety and Efficacy of Insulin Detemir Plus Insulin Aspart Against Insulin Glargine Plus Insulin Aspart as Mealtime Insulin in Type 1 Diabetes

Novo Nordisk

Status and phase: Completed; Phase 3

Conditions: Diabetes Mellitus, Type 1; Diabetes

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT00095082

NN304-1430

2004-000086-35 (EudraCT Number)

Details and patient eligibility

About

This trial is conducted in Europe and the United States of America (USA). The purpose of this study is to test whether insulin detemir is a safe and at least as effective alternative to insulin glargine for the control of blood glucose in basal/bolus therapy in patients with type I diabetes.

Enrollment: 447 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Type 1 diabetes for at least 12 months
• Current treatment with basal-bolus insulin regimen for more than or equal to 3 months
• HbA1c less than or equal to 11.0%

Exclusion criteria

• Proliferative retinopathy or maculopathy
• Recurrent major hypoglycaemia
• Impaired hepatic or renal function
• Cardiac problems or uncontrolled hypertension

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)