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

Novo Nordisk A/S1 site in 1 country15 target enrollmentDecember 2003

ConditionsDiabetes Diabetes Mellitus, Type 2

Interventionsplacebo liraglutide

Drugsliraglutide placebo

Overview

Phase: Phase 1
Intervention: placebo
Conditions: Diabetes
Sponsor: Novo Nordisk A/S
Enrollment: 15
Locations: 1
Primary Endpoint: Adverse events
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

December 2003

End Date

March 2004

Last Updated

9 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Novo Nordisk A/S

Responsible Party

Sponsor

Eligibility 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