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

• Status: Completed
• Trial end date: 2003-03-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novo Nordisk A/S
• Treatments: Insulin; Insulin Aspart; Insulin Detemir; Insulin Glargine; Insulin, Globin Zinc

Criteria

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