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

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01615978
First received: June 7, 2012
Last updated: NA
Last verified: June 2012
History: No changes posted

June 7, 2012
June 7, 2012
December 2003
March 2004   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
No Changes Posted
  • 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 ]
Same as current
Not Provided
Not Provided
 
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

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.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • Diabetes
  • Diabetes Mellitus, Type 2
  • 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
  • Experimental: Fixed dose: 5 mcg/kg
    Interventions:
    • Drug: liraglutide
    • Drug: placebo
  • Experimental: Escalated dose: 10 mcg/kg
    Interventions:
    • Drug: liraglutide
    • Drug: placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
15
March 2004
March 2004   (final data collection date for primary outcome measure)

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
Both
20 Years to 64 Years
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT01615978
NN2211-1591
No
Public Access to Clinical Trials, Novo Nordisk A/S
Novo Nordisk A/S
Not Provided
Study Director: Milan Zdravkovic, MD, PhD Novo Nordisk A/S
Novo Nordisk A/S
June 2012

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