Patients with type 2 diabetes mellitus for at least 12 weeks at
Visit 1A
Insufficient glycaemic control (HbA1c ≥ 6.5% and ≤ 10.5%)
as measured by the central laboratory at Visit 1A
Patients treated with diet and exercise and metformin at a
stable dose for 8 weeks prior to randomisation and/or stable
insulin therapy (basal or MDI) for 8 weeks prior to
randomisation (stable insulin therapy is defined as a weekly
average variation of the basal insulin dose ≤ 0.1 IU/kg over 8
weeks prior to randomisation)
Patients not tolerating metformin and treated with diet and
exercise only are also eligible for inclusion
BMI ≥ 85th percentile according to WHO references at Visit
1B
Negative for islet cell antigen auto-antibodies (IA-2) and
glutamic acid decarboxylase (GAD) auto-antibodies as
measured by the central laboratory at Visit 1A
Non-fasting serum C-peptide levels ≥ 0.6 ng/ml as measured
by the central laboratory at Visit 1A