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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01615978
First received: June 7, 2012
Last updated: January 24, 2017
Last verified: January 2017

June 7, 2012
January 24, 2017
December 2003
March 2004   (Final data collection date for primary outcome measure)
  • 24-hour profiles of serum calcitonin
  • 24-hour profiles of Ca2+ (ionised calcium)
  • 24-hour profiles of PTH (Parathyroid Hormone)
  • Adverse events
Same as current
Complete list of historical versions of study NCT01615978 on ClinicalTrials.gov Archive Site
  • 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 serum insulin
  • 24-hour profiles of plasma glucose
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
Intervention Model: Parallel Assignment
Masking: Participant, 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
Kageyama S, Hirao K, Shimizu A, Matsumura Y, Zdravkovic M, Rasmussen MF, Irie S. Tolerability, pharmacokinetics, and pharmacodynamics of liraglutide, long-acting human GLP-1 analogue - Phase 1 studies in Japanese healthy subjects with type 2 diabetes. Endocrinology and Diabetology 2007; 24 (6): 95-104

*   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
Sexes Eligible for Study: All
20 Years to 64 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
 
NCT01615978
NN2211-1591
No
Not Provided
Not Provided
Not Provided
Novo Nordisk A/S
Novo Nordisk A/S
Not Provided
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
Novo Nordisk A/S
January 2017

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