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

• Status: Completed
• Trial end date: 2004-03-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novo Nordisk A/S
• Treatments: Liraglutide

Criteria

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