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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Diabetes, Diabetes Mellitus, Type 2

Intervention / Treatment
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* Drug: liraglutide
* Drug: liraglutide
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fixed dose: 5 mcg/kg<br> | Drug: liraglutide<br>* 5 mcg/kg daily for 14 days. Injected subcutaneously once daily<br>Drug: placebo<br>* Liraglutide placebo administered to subjects randomised at each dose level in the ratio of 3:1<br>|
| Experimental: Escalated dose: 10 mcg/kg<br> | Drug: liraglutide<br>* Initial dose of 5 mcg/kg for 7 days followed by 10 mcg/kg for 7 days. Injected subcutaneously once daily<br>Drug: placebo<br>* Liraglutide placebo administered to subjects randomised at each dose level in the ratio of 3:1<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 24-hour profiles of serum calcitonin |  |  | 
| 24-hour profiles of Ca2+ (ionised calcium) |  |  | 
| 24-hour profiles of PTH (Parathyroid Hormone) |  |  | 
| Adverse events |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the plasma liraglutide curve |  |  | 
| Cmax, maximum plasma liraglutide concentration |  |  | 
| tmax, time to reach Cmax |  |  | 
| Terminal phase elimination rate-constant |  |  | 
| t½, terminal elimination half life |  |  | 
| 24-hour profiles of serum insulin |  |  | 
| 24-hour profiles of plasma glucose |  |  |