Comparison of NN5401 Versus Insulin Glargine, Both Combined With Metformin Treatment, in Subjects With Type 2 Diabetes

• Status: Completed
• Trial end date: 2010-10-01
• Target enrollment: 0
• Participant gender: All

Summary

This trial is conducted in Asia, Europe and the United States of America (USA). The aim of this trial is to compare the efficacy and safety of NN5401 (insulin degludec/insulin aspart (IDegAsp)) with insulin glargine (IGlar), both as add-on to subject's ongoing treatment with metformin + at least one OAD (oral anti-diabetic drug).

The main period is registered internally at Novo Nordisk as NN5401-3590 while the extension period is registered as NN5401-3726.

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

Details

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

Criteria

Inclusion Criteria:

• For MAIN period (NN5401-3590):

• Diagnosis of type 2 diabetes mellitus for at least 6 months

• Insulin naïve subjects

• Treatment with metformin and at least one other oral antidiabetic drug for at least 3 months before trial start

• Glycosylated haemoglobin (HbA1c) between 7.5 - 11.0% (both inclusive)

• Body Mass Index (BMI) no higher than 40.0 kg/m^2

• For EXTENSION period (NN5401-3726):

• Informed consent obtained before any trial-related activities

• Must have completed the 26-week treatment period (visit 28) in trial NN5401-3590

Exclusion Criteria:

• For MAIN period (NN5401-3590):

• Treatment with glucagon like peptide-1 (GLP-1) receptor agonists and/or thiazolidinedione(s) within the last 3 months prior to trial start

• Cardiovascular disease diagnosed within 6 months before trial start

• For EXTENSION period (NN5401-3726):

• Anticipated change in concomitant medication known to interfere significantly with glucose metabolism, such as systemic corticosteroids, beta-blockers, Monoamine oxidase (MAO) inhibitors

• Anticipated significant lifestyle changes during the trial, e.g. shift work (including permanent night/evening shift workers), as well as highly variable eating habits as judged by the physician)

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