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

This study has been completed.

Sponsor:

Information provided by:

Novo Nordisk

ClinicalTrials.gov Identifier:

NCT01615978

First received: June 7, 2012

Last updated: NA

Last verified: June 2012

History: No changes posted

Tracking Information

First Received Date ^ICMJE

June 7, 2012

Last Updated Date

June 7, 2012

Start Date ^ICMJE

December 2003

Primary Completion Date

March 2004 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

24-hour profiles of serum calcitonin [ Designated as safety issue: No ]
24-hour profiles of Ca2+ (ionised calcium) [ Designated as safety issue: No ]
24-hour profiles of PTH (Parathyroid Hormone) [ Designated as safety issue: No ]
Adverse events [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

Area under the plasma liraglutide curve [ Designated as safety issue: No ]
Cmax, maximum plasma liraglutide concentration [ Designated as safety issue: No ]
tmax, time to reach Cmax [ Designated as safety issue: No ]
Terminal phase elimination rate-constant [ Designated as safety issue: No ]
t½, terminal elimination half life [ Designated as safety issue: No ]
24-hour profiles of serum insulin [ Designated as safety issue: No ]
24-hour profiles of plasma glucose [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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 Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 1

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment

Condition ^ICMJE

Diabetes
Diabetes Mellitus, Type 2

Intervention ^ICMJE

Drug: liraglutide
5 mcg/kg daily for 14 days. Injected subcutaneously once daily
Drug: liraglutide
Initial dose of 5 mcg/kg for 7 days followed by 10 mcg/kg for 7 days. Injected subcutaneously once daily
Drug: placebo
Liraglutide placebo administered to subjects randomised at each dose level in the ratio of 3:1

Study Arm (s)

Experimental: Fixed dose: 5 mcg/kg
Interventions:
- Drug: liraglutide
- Drug: placebo
Experimental: Escalated dose: 10 mcg/kg
Interventions:
- Drug: liraglutide
- Drug: placebo

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

March 2004

Primary Completion Date

March 2004 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

20 Years to 64 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Japan

Administrative Information

NCT Number ^ICMJE

NCT01615978

Other Study ID Numbers ^ICMJE

NN2211-1591

Has Data Monitoring Committee

Responsible Party

Public Access to Clinical Trials, Novo Nordisk A/S

Study Sponsor ^ICMJE

Novo Nordisk

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Milan Zdravkovic, MD, PhD

Novo Nordisk

Information Provided By

Novo Nordisk

Verification Date

June 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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