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

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ClinicalTrials.gov Identifier: NCT01615978
Recruitment Status : Completed
First Posted : June 11, 2012
Last Update Posted : January 25, 2017
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Diabetes Diabetes Mellitus, Type 2 Drug: liraglutide Drug: placebo Phase 1

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (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
Study Start Date : December 2003
Primary Completion Date : March 2004
Study Completion Date : March 2004

Resource links provided by the National Library of Medicine

Drug Information available for: Liraglutide
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :
  1. 24-hour profiles of serum calcitonin
  2. 24-hour profiles of Ca2+ (ionised calcium)
  3. 24-hour profiles of PTH (Parathyroid Hormone)
  4. Adverse events

Secondary Outcome Measures :
  1. Area under the plasma liraglutide curve
  2. Cmax, maximum plasma liraglutide concentration
  3. tmax, time to reach Cmax
  4. Terminal phase elimination rate-constant
  5. t½, terminal elimination half life
  6. 24-hour profiles of serum insulin
  7. 24-hour profiles of plasma glucose

Eligibility Criteria

Information from the National Library of Medicine

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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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
ClinicalTrials.gov Identifier: NCT01615978     History of Changes
Other Study ID Numbers: NN2211-1591
First Posted: June 11, 2012    Key Record Dates
Last Update Posted: January 25, 2017
Last Verified: January 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