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

Novo Nordisk

Status and phase: Completed; Phase 3

Conditions: Diabetes Mellitus, Type 1; Diabetes

Treatments: Drug: insulin detemir

Study type: Interventional

Funder types: Industry

Identifiers

NCT00184639

NN304-1630

Details and patient eligibility

About

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.

Enrollment: 71 patients

Sex: All

Ages: 12 to 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)