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

Phase 1

Completed

• Conditions: Diabetes; Diabetes Mellitus, Type 2
• Interventions: Drug: liraglutide; Drug: placebo

• Registration Number: NCT01615978
• Lead Sponsor: Novo Nordisk A/S

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-12
• Primary Completion: 2004-03
• Study Completion: 2004-03
• Study First Submitted: 2012-06-07
• Study First Submitted QC: 2012-06-07
• Study First Posted: 2012-06-11
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-24
• Last Update Posted: 2017-01-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fixed dose: 5 mcg/kg	placebo	-
Escalated dose: 10 mcg/kg	placebo	-
Fixed dose: 5 mcg/kg	liraglutide	-
Escalated dose: 10 mcg/kg	liraglutide	-

Primary Outcome Measures

Name	Time	Method
Adverse events
24-hour profiles of Ca2+ (ionised calcium)
24-hour profiles of PTH (Parathyroid Hormone)
24-hour profiles of serum calcitonin

Secondary Outcome Measures

Name	Time	Method
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 plasma glucose
24-hour profiles of serum insulin

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇯🇵 Tokyo, Japan