Comparison of the Efficacy and Safety of Two Intensification Strategies in Subjects With Type 2 Diabetes Inadequately Controlled on Basal Insulin and Metformin (BEGIN™)

Novo Nordisk

Status and phase: Completed; Phase 3

Conditions: Diabetes; Diabetes Mellitus, Type 2

Treatments: Drug: insulin aspart; Drug: insulin degludec; Drug: liraglutide

Study type: Interventional

Funder types: Industry

Identifiers

NCT01388361

U1111-1120-2782 (Other Identifier)

2011-001493-25 (EudraCT Number)

NN1250-3948

Details and patient eligibility

About

This trial is conducted in Europe and North America. The aim of this trial is to compare the efficacy and safety of adding liraglutide versus addition of insulin aspart with the largest meal to insulin degludec in subjects with type 2 diabetes.

Eligible subjects with an HbA1c equal to or above 7% at end of treatment in NN1250-3643 (NCT01193309) trial will be randomised to receive treatment intensification while subjects with an HbA1c below 7% at end of treatment in NN1250-3643 (NCT01193309) may continue to receive insulin degludec treatment. Subjects are to continue their pre-trial metformin treatment.

Enrollment: 413 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Informed consent obtained before any trial-related activities. (Trial-related activities are any procedure that would not have been performed during normal management of the subject).
• The subject must have completed the end of treatment visit of NN1250-3643 with Insulin degludec once daily + metformin.
• Ability and willingness to adhere to the protocol including self measurement of plasma glucose according to the protocol

Exclusion criteria

• Participated in NN1250-3643 and treated with insulin glargine
• Previous treatment with glucacon like peptide (GLP-1) receptor agonists (e.g. exenatide, liraglutide)
• Impaired liver function, defined as alanine aminotransferase (ALAT) 2.5 times the upper limit of normal at end of treatment in NN1250-3643
• Impaired renal function defined as serum-creatinine = 125 µmol/l (= 1.4 mg/dl) for males and = 110 µmol/L (= 1.3 mg/dl) for females or according to local label for metformin [For France: glomerular filtration rate below 60 ml/min, calculated by the Cockroft & Gault formula] at end of treatment in NN1250-3643.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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413 participants in 3 patient groups

IDeg (non-randomised)

Experimental group

Treatment:

Drug: insulin degludec

IDeg + IAsp

Experimental group

Treatment:

Drug: insulin aspart

Drug: insulin degludec

IDeg + liraglutide

Experimental group

Treatment:

Drug: insulin degludec

Drug: liraglutide