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Completed

NCT Number: NCT00154414

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

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.

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Key information

Conditions

Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

20 year–74 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Novo Nordisk Investigational Site

Tokyo, 1000005, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

liraglutide

Drug

Primary outcomes

  1. HbA1c

    Time frame: after 14 weeks treatment

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

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

Important dates

Study start
2005
Primary completion
2006
Study completion
2006
First posted
Sep 12, 2005
Registry last updated
Jan 25, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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