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

Phase 3

Completed

Interventions: Drug: insulin degludec
Drug: liraglutide
Drug: insulin aspart

Brief Summary: 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.

Recruitment & Eligibility

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.

Arm && Interventions

Primary Outcome Measures

Name	Time	Method
Change From Baseline in HbA1c (%) (Glycosylated Haemoglobin)	week 0, week 26	Values for change in HbA1c from baseline to 26 weeks of treatment period.

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in Fasting Plasma Glucose (FPG)	week 0, week 26	Values for change in FPG in mmol/L from baseline to week 26 of randomised period.
Change From Baseline in Body Weight	week 0, week 26	Corresponds to the values of change in body weight in kilograms from baseline to week 26.
Number of Severe and Minor Treatment Emergent Hypoglycaemic Episodes	Onset on or after the first day of exposure to investigational product for 26 weeks of treatment period and no later than 7 days after last exposure to investigational product.	Corresponds to number of treatment emergent hypoglycaemic events from onset on or after the first day of exposure to investigational product and no later than 7 days after last exposure to investigational product. Confirmed hypoglycaemia was defined as the pool of severe hypoglycaemic episodes and minor episodes with a plasma glucose (PG) value \< 3.1 mmol/L (56 mg/dL).