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

Novo Nordisk

Status and phase: Completed; Phase 1

Conditions: Diabetes; Diabetes Mellitus, Type 2

Treatments: Drug: liraglutide; Drug: placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01615978

NN2211-1591

Details and patient eligibility

About

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.

Enrollment: 15 patients

Sex: All

Ages: 20 to 64 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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15 participants in 2 patient groups

Fixed dose: 5 mcg/kg

Experimental group

Treatment:

Drug: placebo

Drug: liraglutide

Drug: liraglutide

Escalated dose: 10 mcg/kg

Experimental group

Treatment:

Drug: placebo

Drug: liraglutide

Drug: liraglutide