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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:
Novo Nordisk
ClinicalTrials.gov Identifier:
NCT01615978
First received: June 7, 2012
Last updated: NA
Last verified: June 2012
History: No changes posted
  Purpose

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
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:

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

Further study details as provided by Novo Nordisk:

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

  Eligibility

Ages Eligible for Study:   20 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 ClinicalTrials.gov identifier: NCT01615978

Locations
Japan
Tokyo, Japan, 103
Sponsors and Collaborators
Novo Nordisk
Investigators
Study Director: Milan Zdravkovic, MD, PhD Novo Nordisk
  More Information

Additional Information:
Clinical Trials at Novo Nordisk  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Public Access to Clinical Trials, Novo Nordisk A/S
ClinicalTrials.gov 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
 Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013