Effect of Liraglutide on Blood Glucose Control in Japanese Subjects With Type 2 Diabetes

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT00154414
First received: September 8, 2005
Last updated: July 9, 2012
Last verified: July 2012
  Purpose

This trial is conducted in Japan. The aim of this research trial is to evaluate the effect of treatment with liraglutide or placebo on blood glucose control after 14 weeks in Japanese subjects with type 2 diabetes. Liraglutide or placebo is administered by injection once daily in the evening. The trial is a multi-national trial with treatment concealed to participating subjects, investigators and the sponsor. Treatment allocation is random with equal chance of being assigned to each group.


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

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: Effect of Liraglutide on Glycaemic Control in Japanese Subjects With Type 2 Diabetes.

Resource links provided by NLM:


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

Primary Outcome Measures:
  • HbA1c [ Time Frame: after 14 weeks treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Glycaemic control parameters (fasting plasma glucose, post prandial plasma glucose) after 14-week treatment [ Designated as safety issue: No ]
  • Body weight after 14 weeks. [ Designated as safety issue: No ]
  • Safety and tolerability [ Designated as safety issue: No ]

Enrollment: 226
Study Start Date: January 2005
Study Completion Date: May 2006
Primary Completion Date: May 2006 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   20 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects diagnosed with type 2 diabetes and treated with diet therapy with or without single oral drug therapy
  • 7.0 % = HbA1c < 10.0 %
  • Body Mass Index (BMI) < 30.0 kg/m2

Exclusion Criteria:

  • Subjects treated with thiazolidinediones or insulin
  • Subjects with any serious medical conditions
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00154414

Locations
Japan
Osaka, Japan
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Mads F. Rasmussen, MD, PhD Novo Nordisk A/S
Study Director: Izumi Hagihara Novo Nordisk Pharma Ltd.
  More Information

Additional Information:
No publications provided

Responsible Party: Public Access to Clinical Trials, Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00154414     History of Changes
Other Study ID Numbers: NN2211-1334, JapicCTI-050131
Study First Received: September 8, 2005
Last Updated: July 9, 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

ClinicalTrials.gov processed this record on July 22, 2014