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

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

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 [ 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 ]

Secondary Outcome Measures:
  • 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 ]

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
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its identifier: NCT01615978

Tokyo, Japan, 103
Sponsors and Collaborators
Novo Nordisk A/S
Study Director: Milan Zdravkovic, MD, PhD Novo Nordisk A/S
  More Information

Additional Information:
No publications provided

Responsible Party: Public Access to Clinical Trials, Novo Nordisk A/S Identifier: NCT01615978     History of Changes
Other Study ID Numbers: NN2211-1591
Study First Received: June 7, 2012
Last Updated: June 7, 2012
Health Authority: Japan: Ministry of Health, Labor and Welfare

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Glucagon-Like Peptide 1
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions processed this record on April 17, 2014