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OpenTrials
Completed

NCT Number: NCT00333151

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

This trial is conducted in the United States of America (USA) and Canada. This trial is designed to show the effect of treatment with liraglutide when added to existing rosiglitazone and metformin combination therapy and to compare it with the effects of therapy with rosiglitazone and metformin alone.

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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

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Novo Nordisk Investigational Site, Calgary, Alberta, Canada

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Type 2 diabetes
  • Treated with oral anti-diabetic (OAD) drugs for at least 3 months
  • Treated with one or more OAD and in moderate to poor glycemic control
  • Body Mass Index (BMI) less than or equal to 45.0 kg/m2

Exclusion criteria

  • Treatment with insulin within the last three months prior to the trial except due to intercurrent illness, at the discretion of the Investigator
  • Any serious medical condition
  • Treatment with any drug that could interfere with glucose level

Treatment and study plan

liraglutide

Drug

rosiglitazone

Drug

metformin

Drug

Primary outcomes

  1. HbA1c

    Time frame: after 26 weeks of treatment

Secondary outcomes

  1. body weight

  2. Safety and tolerability

  3. Glycaemic control

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

Effect on Glycemic Control of Liraglutide in Combination With Rosiglitazone Plus Metformin Versus Rosiglitazone Plus Metformin in Subjects With Type 2 Diabetes

Acronym: LEAD-4

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
Jun 2, 2006
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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