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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00154414
Recruitment Status : Completed
First Posted : September 12, 2005
Last Update Posted : January 25, 2017
Information provided by (Responsible Party):
Novo Nordisk A/S

Brief Summary:
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 or disease Intervention/treatment Phase
Diabetes Diabetes Mellitus, Type 2 Drug: liraglutide Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 226 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Effect of Liraglutide on Glycaemic Control in Japanese Subjects With Type 2 Diabetes.
Study Start Date : January 2005
Actual Primary Completion Date : May 2006
Actual Study Completion Date : May 2006

Resource links provided by the National Library of Medicine

Drug Information available for: Liraglutide

Primary Outcome Measures :
  1. HbA1c [ Time Frame: after 14 weeks treatment ]

Secondary Outcome Measures :
  1. Glycaemic control parameters (fasting plasma glucose, post prandial plasma glucose) after 14-week treatment
  2. Body weight after 14 weeks.
  3. Safety and tolerability

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 74 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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/m^2

Exclusion Criteria:

  • Subjects treated with thiazolidinediones or insulin
  • Subjects with any serious medical conditions

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 identifier (NCT number): NCT00154414

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Novo Nordisk Investigational Site
Tokyo, Japan, 1000005
Sponsors and Collaborators
Novo Nordisk A/S
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Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
Additional Information:
Publications of Results:
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Responsible Party: Novo Nordisk A/S Identifier: NCT00154414    
Other Study ID Numbers: NN2211-1334
JapicCTI-050131 ( Registry Identifier: Japic )
First Posted: September 12, 2005    Key Record Dates
Last Update Posted: January 25, 2017
Last Verified: January 2017
Additional relevant MeSH terms:
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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