Comparison of NN1250 Plus Insulin Aspart With Insulin Detemir Plus Insulin Aspart in Type 1 Diabetes

• Status: Completed
• Trial end date: 2010-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This trial is conducted in Asia, Europe, Japan and South America. The aim of the trial is to compare the efficacy, safety and tolerability of NN1250 (insulin degludec ([Deg]) with insulin detemir (IDet), both combined with insulin aspart.

The main period is registered internally at Novo Nordisk as NN1250-3585 while the extension period is registered as NN1250-3725.

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

Details

• Lead Sponsor: Novo Nordisk A/S
• Treatments: Insulin; Insulin Aspart; Insulin degludec, insulin aspart drug combination; Insulin Detemir; Insulin, Globin Zinc; Insulin, Long-Acting

Criteria

Inclusion Criteria:

• Type 1 diabetes mellitus for at least 12 months

• Current treatment with any basal bolus insulin for at least 12 months

• HbA1c below or equal to 10.0%

• Body Mass Index (BMI) below or equal to 35.0 kg/m^2

• For Japan only: Minimum age is 20 years

• For the extension trial only: Completed the six-month treatment period in trial NN1250-3585 (NCT01074268)

Exclusion Criteria:

• Use of any other antidiabetic drug than insulin within the last 3 months

• Cardiovascular disease within the last 6 months

• Uncontrolled treated/untreated severe hypertension

• Recurrent severe hypoglycemia or hypoglycemic unawareness or hospitalisation for diabetic ketoacidosis during the previous 6 months

• Pregnancy, breast-feeding, the intention of becoming pregnant or not using adequate contraceptive measures

• Cancer and medical history of cancer