Overview

Comparison of NN1250 Versus Insulin Glargine in Subjects With Type 2 Diabetes

Status:
Completed
Trial end date:
2010-12-01
Target enrollment:
0
Participant gender:
All
Summary
This trial is conducted in Europe and the United States of America (USA). The aim of this trial is to compare NN1250 (insulin degludec (IDeg)) with insulin glargine (IGlar) in subjects with type 2 diabetes never treated with insulin followed by the extension trial investigating the long-term safety and tolerability in terms of comparing NN1250 with insulin glargine in subjects with type 2 diabetes. All oral anti-diabetic drug (OAD) treatment will be discontinued when trial participant enters the main trial (NN1250-3579) with the exception of metformin and dipeptidyl peptidase-IV (DPP-IV) inhibitor treatment (only in countries where DPP-IV inhibitor treatment is approved for combination treatment together with insulin, otherwise DPP-IV inhibitor treatment is also discontinued). Subjects who consent to participate in the extension trial will continue the treatment (NN1250 or insulin glargine + oral antidiabetic drugs (OADs)) to which they were randomly allocated in the 52 week main trial. The main period is registered internally at Novo Nordisk as NN1250-3579 while the extension period is registered as NN1250-3643.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Novo Nordisk A/S
Treatments:
Insulin
Insulin Glargine
Insulin, Globin Zinc
Criteria
Inclusion Criteria:

- Type 2 diabetes mellitus

- Treatment with oral antidiabetic drugs (OADs) for at least three months before trial
start at an unchanged dose

- HbA1c: 7.0-10.0%

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

- For the extension trial only: Completion of the 52 week treatment period in trial
NN1250-3579 (NCT00982644)

Exclusion Criteria:

- Treatment with exenatide or liraglutide within the last 3 months before trial start

- 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