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



Status:Completed
Conditions:Diabetes, Diabetes
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:September 2009
End Date:December 2011

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NN1250-3579: A 52-week Randomised, Controlled, Open Label, Multicentre, Multinational Treat-to-target Trial Comparing the Efficacy and Safety of SIBA and Insulin Glargine, Both Injected Once Daily in Combination With Oral Anti-diabetic Drugs (OAD), in Subjects With Type 2 Diabetes Mellitus Currently Treated With OAD(s) and Qualifying for More Intensified Treatment / NN1250-3643: An Extension Trial to NN1250-3579 Comparing Safety and Efficacy of NN1250 Plus OAD(s) With Insulin Glargine Plus OAD(s) in Type 2 Diabetes (BEGIN™: Once Long)

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.


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
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Nashville, Tennessee 37232
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