Finding a Safe and Effective Dose of Linagliptin in Pediatric Patients With Type 2 Diabetes

Inclusion Criteria

• •1. Paediatric patients (children and adolescents), aged 10 to 17 years with documented diagnosis of type 2 diabetes mellitus
• •2. Insufficient glycaemic control (i.e. an HbA1c \> 6.5% and \<= 10.5%) despite treatment with diet and exercise and/or metformin (\>= 1000 mg per day (or the maximum tolerated dose) at a stable dose or dosing frequency for 8 weeks prior to randomisation) and/or concomitant stable basal insulin (total daily dose must be \<= 0.5U/kg with less than 10% of weekly dose change for 12 weeks prior to randomisation)
• •3. Negative for islet cell antigen (ICA) auto-antibodies and glutamic acid decarboxylase (GAD) auto-antibodies
• •4. C-peptide levels (serum) \>= 1.5 ng/ml (at 90 min following a Boost challenge)