Comparison of Insulin Detemir and Insulin Semilente®MC in Type 1 Diabetes

• Status: Completed
• Trial end date: 2005-11-22
• Target enrollment: 0
• Participant gender: All

Summary

This trial is conducted in Europe.

A 32-week efficacy and safety comparison of insulin detemir and insulin semilente MC in children between 6 and 21 years with type 1 diabetes.

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

Details

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

Criteria

Inclusion Criteria:

• Type 1 diabetes

• Current intensified insulin treatment

• Injection of insulin Semilente®MC at bedtime for at least 6 weeks

• BMI maximum 32 kg/m^2

• HbA1c > 5.5 % and < 12.0 %

Exclusion Criteria:

• Current treatment with premixed insulin(s)

• Impaired hepatic or renal function

• Recurrent major hypoglycaemia