Safety and Tolerability of Liraglutide in Japanese Subjects With Type 2 Diabetes

A Randomised, Double-blind Within Dose Group, Single-centre, Placebo-controlled, Parallel 2-different Dose Group, 14-day Multiple s.c. Doses Study to Assess the Safety, Pharmacokinetics and Pharmacodynamics of Liraglutide (NNC 90-1170) in Subjects With Type 2 Diabetes

This trial is conducted in Japan. The aim of this trial is to assess the safety after multiple s.c. (subcutaneously) doses of liraglutide in Japanese subjects with type 2 diabetes.

Inclusion Criteria:

• Type 2 diabetes
• Duration of diabetes for more than 12 weeks
• Subjects currently on diet therapy (OHA-naïve) or treated with OHA (oral hypoglycaemic agent)
• monotherapy for more than 12 weeks
• HbA1c (Glycated haemoglobin A1c) between 6.0-9.0 %, both inclusive
• Body Mass Index (BMI): 18.5-30.0 kg/m^2

Exclusion Criteria:

• Recurrent severe hypoglycaemia
• Proliferative retinopathy or maculopathy requiring acute treatment
• Impaired hepatic function
• Impaired renal function
• Cardiac problems
• Uncontrolled treated/untreated hypertension
• Current treatment with insulin preparations or TZDs (thiazolidinediones)
• Current treatment or expected at the screening to start treatment with systemic corticosteroids