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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01615978

Enrollment

Registered

2012-06-11

Start date

2003-12-31

Completion date

2004-03-31

Last updated

2017-01-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes, Diabetes Mellitus, Type 2

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.

Interventions

DRUGliraglutide

5 mcg/kg daily for 14 days. Injected subcutaneously once daily

DRUGplacebo

Liraglutide placebo administered to subjects randomised at each dose level in the ratio of 3:1

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

20 Years to 64 Years

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

Design outcomes

Primary

Measure	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

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

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026