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

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

Condition Intervention Phase
Diabetes Mellitus, Type 2
Drug: liraglutide
Drug: placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Investigator
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:
  • 24-hour profiles of serum calcitonin
  • 24-hour profiles of Ca2+ (ionised calcium)
  • 24-hour profiles of PTH (Parathyroid Hormone)
  • Adverse events

Secondary Outcome Measures:
  • 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

Enrollment: 15
Study Start Date: December 2003
Study Completion Date: March 2004
Primary Completion Date: March 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Fixed dose: 5 mcg/kg Drug: liraglutide
5 mcg/kg daily for 14 days. Injected subcutaneously once daily
Drug: placebo
Liraglutide placebo administered to subjects randomised at each dose level in the ratio of 3:1
Experimental: Escalated dose: 10 mcg/kg 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


Ages Eligible for Study:   20 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT01615978

Novo Nordisk Investigational Site
Tokyo, Japan, 1000005
Sponsors and Collaborators
Novo Nordisk A/S
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
  More Information

Additional Information:
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

Responsible Party: Novo Nordisk A/S Identifier: NCT01615978     History of Changes
Other Study ID Numbers: NN2211-1591
Study First Received: June 7, 2012
Last Updated: January 24, 2017

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hypoglycemic Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists processed this record on May 25, 2017