Comparison of Insulin Detemir Plus Insulin Aspart Against Insulin Glargine Plus Insulin Aspart in Type 2 Diabetes

Novo Nordisk

Status and phase: Completed; Phase 3

Conditions: Diabetes; Diabetes Mellitus, Type 2

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT00097084

2004-000087-27 (EudraCT Number)

NN304-1431

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 2 diabetes.

Enrollment: 324 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Type 2 diabetes for at least 12 months
• Treated with oral antidiabetic drugs or with any insulin regimen with or without oral antidiabetic drugs
• BMI of maximum 40 kg/m2
• HbA1c greater than or equal to 7.0% and 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)