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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 (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT00333151
First received: June 1, 2006
Last updated: November 17, 2014
Last verified: November 2014

June 1, 2006
November 17, 2014
May 2006
August 2007   (final data collection date for primary outcome measure)
HbA1c [ Time Frame: after 26 weeks of treatment ] [ Designated as safety issue: No ]
HbA1c after 26 weeks of treatment
Complete list of historical versions of study NCT00333151 on ClinicalTrials.gov Archive Site
  • body weight [ Designated as safety issue: No ]
  • Safety and tolerability [ Designated as safety issue: No ]
  • Glycaemic control [ Designated as safety issue: No ]
  • body weight
  • Safety and tolerability
  • Glycaemic control
Not Provided
Not Provided
 
Effect of Liraglutide on Blood Glucose Control in Subjects With Type 2 Diabetes
Effect on Glycemic Control of Liraglutide in Combination With Rosiglitazone Plus Metformin Versus Rosiglitazone Plus Metformin 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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • Diabetes
  • Diabetes Mellitus, Type 2
  • Drug: liraglutide
  • Drug: rosiglitazone
  • Drug: metformin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
576
August 2007
August 2007   (final data collection date for primary outcome measure)

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
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada
 
NCT00333151
NN2211-1574
No
Novo Nordisk A/S
Novo Nordisk A/S
Not Provided
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
Novo Nordisk A/S
November 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP