Comparison of NN1250 Versus Insulin Glargine in Subjects With Type 2 Diabetes (BEGIN™)

Novo Nordisk

Status and phase: Completed; Phase 3

Conditions: Diabetes; Diabetes Mellitus, Type 2

Treatments: Drug: insulin glargine; Drug: insulin degludec

Study type: Interventional

Funder types: Industry

Identifiers

NCT00982644

NN1250-3579

2008-005776-27 (EudraCT Number)

2009-015754-38 (EudraCT Number)

U1111-1114-9426 (Other Identifier)

U1111-1111-8692 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 1,030 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,030 participants in 2 patient groups

IDeg OD

Experimental group

Treatment:

Drug: insulin degludec

IGlar OD

Active Comparator group

Treatment:

Drug: insulin glargine