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Effect of Liraglutide on Blood Glucose Control in Subjects With Type 2 Diabetes (LEAD-4)

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk
ClinicalTrials.gov Identifier:
NCT00333151
First received: June 1, 2006
Last updated: June 19, 2012
Last verified: June 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Diabetes
Diabetes Mellitus, Type 2
 Drug: liraglutide
Drug: rosiglitazone
Drug: metformin
 Phase 3

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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Novo Nordisk:

Primary Outcome Measures:
  • HbA1c [ Time Frame: after 26 weeks of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • body weight [ Designated as safety issue: No ]
  • Safety and tolerability [ Designated as safety issue: No ]
  • Glycaemic control [ Designated as safety issue: No ]

Enrollment: 576
Study Start Date: May 2006
Study Completion Date: August 2007
Primary Completion Date: August 2007 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00333151

  Show 81 Study Locations
Sponsors and Collaborators
Novo Nordisk
Investigators
Study Director: Paula Hale, MD Novo Nordisk
  More Information

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

No publications provided by Novo Nordisk

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Public Access to Clinical Trials, Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00333151     History of Changes
Other Study ID Numbers: NN2211-1574
Study First Received: June 1, 2006
Last Updated: June 19, 2012
Health Authority: Canada: Health Canada
United States: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
 Rosiglitazone
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013