Comparison of NN1250 With Insulin Glargine Plus Insulin Aspart With/Without Metformin and With/Without Pioglitazone in Type 2 Diabetes

• Status: Completed
• Trial end date: 2010-10-28
• Target enrollment: 0
• Participant gender: All

Summary

This trial is conducted in Africa, Asia, Europe, and the United States of America (USA).

The aim of this clinical trial is to compare NN1250 (insulin degludec (IDeg)) with insulin glargine (IGlar) plus insulin aspart (IAsp) with/without metformin and with/without pioglitazone in subjects with type 2 diabetes (main period) followed by investigating the long-term safety in terms of comparing NN1250 with insulin glargine plus insulin aspart with or without metformin and with or without pioglitazone in subjects with type 2 diabetes.

All oral anti-diabetic drug (OAD) treatment will be discontinued, if applicable, when trial participant enters the trial (NN1250-3582) with the exception of metformin and pioglitazone.

Subjects who consent to participate in the extension trial (NN1250-3667) will continue to receive the treatment to which they were randomly allocated in the 52 week trial NN1250-3582.

The main period is registered internally at Novo Nordisk as NN1250-3582 while the extension period is registered as NN1250-3667.

• 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 Glargine; Insulin, Globin Zinc; Insulin, Long-Acting; Metformin; Pioglitazone

Criteria

Inclusion Criteria:

• For MAIN period (NN1250-3582):

• Type 2 diabetes mellitus for at least 6 months

• Ongoing daily treatment with insulin (premix, self-mix, basal only, basal bolus) for at least 3 months with/without oral anti-diabetics drug (OAD) prior to trial start

• HbA1c 7.0-10.0 % (both inclusive)

• Body Mass Index (BMI) below or equal to 40.0 kg/m^2

• For EXTENSION period (NN1250-3667):

• Completion of the 52 week treatment period in NN1250-3582

Exclusion Criteria:

• For MAIN period (NN1250-3582):

• Treatment with other insulin regimens than premix, self-mix, basal only, basal bolus within 3 months

• Cardiovascular disease within the last 6 months

• Uncontrolled treated/untreated severe hypertension

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

• Cancer and medical history of cancer