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

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: NCT00333151
Recruitment Status : Completed
First Posted : June 2, 2006
Last Update Posted : January 25, 2017
Information provided by (Responsible Party):
Novo Nordisk A/S

June 1, 2006
June 2, 2006
January 25, 2017
May 2006
August 2007   (Final data collection date for primary outcome measure)
HbA1c [ Time Frame: after 26 weeks of treatment ]
HbA1c after 26 weeks of treatment
Complete list of historical versions of study NCT00333151 on Archive Site
  • body weight
  • Safety and tolerability
  • Glycaemic control
  • body weight
  • Glycaemic control
  • Safety and tolerability
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
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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 Identifier (NCT Number) in Medline.
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
Sexes Eligible for Study: All
18 Years to 80 Years   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
Canada,   United States
Not Provided
Not Provided
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
January 2017

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