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:

MedlinePlus related topics: Blood Sugar Diabetes Diabetes Type 2

Drug Information available for: Metformin Metformin hydrochloride Rosiglitazone Rosiglitazone Maleate Liraglutide

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

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Locations

United States, Arizona
Novo Nordisk Clinical Trial Call Center
Goodyear, Arizona, United States, 85395
United States, California
Novo Nordisk Clinical Trial Call Center
Colton, California, United States, 92324
Novo Nordisk Clinical Trial Call Center
Concord, California, United States, 94520
Novo Nordisk Clinical Trial Call Center
Escondido, California, United States, 92026
Novo Nordisk Clinical Trial Call Center
La Jolla, California, United States, 92037
Novo Nordisk Clinical Trial Call Center
Long Beach, California, United States, 90822
Novo Nordisk Clinical Trial Call Center
Los Angeles, California, United States, 90057
Novo Nordisk Clinical Trial Call Center
Orange, California, United States, 92869
Novo Nordisk Clinical Trial Call Center
Santa Ana, California, United States, 92705
Novo Nordisk Clinical Trial Call Center
Santa Barbara, California, United States, 93105
Novo Nordisk Clinical Trial Call Center
Spring Valley, California, United States, 91978
United States, Connecticut
Novo Nordisk Clinical Trial Call Center
New Britain, Connecticut, United States, 06050
United States, District of Columbia
Novo Nordisk Clinical Trial Call Center
Washington, District of Columbia, United States, 20010
United States, Florida
Novo Nordisk Clinical Trial Call Center
Fort Myers, Florida, United States, 33907
Novo Nordisk Clinical Trial Call Center
Jacksonville, Florida, United States, 32204
Novo Nordisk Clinical Trial Call Center
Lake Mary, Florida, United States, 32746
Novo Nordisk Clinical Trial Call Center
Plantation, Florida, United States, 33324
United States, Georgia
Novo Nordisk Clinical Trial Call Center
Athens, Georgia, United States, 30606
Novo Nordisk Clinical Trial Call Center
Atlanta, Georgia, United States, 30309
Novo Nordisk Clinical Trial Call Center
Powder Springs, Georgia, United States, 30127
United States, Idaho
Novo Nordisk Clinical Trial Call Center
Idaho Falls, Idaho, United States, 83404-7542
United States, Illinois
Novo Nordisk Clinical Trial Call Center
Peoria, Illinois, United States, 61615
United States, Indiana
Novo Nordisk Clinical Trial Call Center
New Albany, Indiana, United States, 47150
United States, Iowa
Novo Nordisk Clinical Trial Call Center
Des Moines, Iowa, United States, 50314
United States, Kansas
Novo Nordisk Clinical Trial Call Center
Topeka, Kansas, United States, 66606
United States, Kentucky
Novo Nordisk Clinical Trial Call Center
Lexington, Kentucky, United States, 40503
United States, Louisiana
Novo Nordisk Clinical Trial Call Center
Baton Rouge, Louisiana, United States, 70808
Novo Nordisk Clinical Trial Call Center
New Orleans, Louisiana, United States, 70121
United States, Maryland
Novo Nordisk Clinical Trial Call Center
Hyattsville, Maryland, United States, 20782
United States, Mississippi
Novo Nordisk Clinical Trial Call Center
Tupelo, Mississippi, United States, 38801
United States, Missouri
Novo Nordisk Clinical Trial Call Center
St. Louis, Missouri, United States, 63110
United States, Nevada
Novo Nordisk Clinical Trial Call Center
Las Vegas, Nevada, United States, 89103
United States, New Jersey
Novo Nordisk Clinical Trial Call Center
Berlin, New Jersey, United States, 08009
Novo Nordisk Clinical Trial Call Center
Princeton, New Jersey, United States, 08540
United States, New York
Novo Nordisk Clinical Trial Call Center
Albany, New York, United States, 12206
Novo Nordisk Clinical Trial Call Center
Northport, New York, United States, 11768
United States, North Carolina
Novo Nordisk Clinical Trial Call Center
Asheville, North Carolina, United States, 28801
Novo Nordisk Clinical Trial Call Center
Chapel Hill, North Carolina, United States, 27599-7172
Novo Nordisk Clinical Trial Call Center
Durham, North Carolina, United States, 27710
Novo Nordisk Clinical Trial Call Center
Greenville, North Carolina, United States, 27834
United States, Ohio
Novo Nordisk Clinical Trial Call Center
Cincinnati, Ohio, United States, 45245
Novo Nordisk Clinical Trial Call Center
Cleveland, Ohio, United States, 44195
Novo Nordisk Clinical Trial Call Center
Columbus, Ohio, United States, 43212
Novo Nordisk Clinical Trial Call Center
Columbus, Ohio, United States, 43203
Novo Nordisk Clinical Trial Call Center
Dayton, Ohio, United States, 45406
Novo Nordisk Clinical Trial Call Center
Kettering, Ohio, United States, 45429
Novo Nordisk Clinical Trial Call Center
Mentor, Ohio, United States, 44060
United States, South Carolina
Novo Nordisk Clinical Trial Call Center
Duncan, South Carolina, United States, 29334
United States, Tennessee
Novo Nordisk Clinical Trial Call Center
Chattanooga, Tennessee, United States, 37404
United States, Texas
Novo Nordisk Clinical Trial Call Center
Arlington, Texas, United States, 76014
Novo Nordisk Clinical Trial Call Center
Dallas, Texas, United States, 75390-8858
Novo Nordisk Clinical Trial Call Center
Dallas, Texas, United States, 75230
Novo Nordisk Clinical Trial Call Center
Dallas, Texas, United States, 75246
Novo Nordisk Clinical Trial Call Center
Dallas, Texas, United States, 75231
Novo Nordisk Clinical Trial Call Center
Houston, Texas, United States, 77030
Novo Nordisk Clinical Trial Call Center
Houston, Texas, United States, 77025
Novo Nordisk Clinical Trial Call Center
Midland, Texas, United States, 79707
Novo Nordisk Clinical Trial Call Center
San Antonio, Texas, United States, 78229
Novo Nordisk Clinical Trial Call Center
San Antonio, Texas, United States, 78209
United States, Utah
Novo Nordisk Clinical Trial Call Center
Salt Lake City, Utah, United States, 84102
United States, Virginia
Novo Nordisk Clinical Trial Call Center
Norfolk, Virginia, United States, 23502
Novo Nordisk Clinical Trial Call Center
Richmond, Virginia, United States, 23294
United States, Washington
Novo Nordisk Clinical Trial Call Center
Spokane, Washington, United States, 99207
United States, Wisconsin
Novo Nordisk Clinical Trial Call Center
Milwaukee, Wisconsin, United States, 53209
Canada, Alberta

Calgary, Alberta, Canada, T2H 2G4

Edmonton, Alberta, Canada, T5J 3N4
Canada, Manitoba

Winnipeg, Manitoba, Canada, R3E 3P4
Canada, Nova Scotia

Halifax, Nova Scotia, Canada, B3H 1V7
Canada, Ontario

London, Ontario, Canada, N6A 4V2

Ottawa, Ontario, Canada, K1N 6N5

Toronto, Ontario, Canada, M5C 2T2
Canada, Quebec

Laval, Quebec, Canada, H7T 2P5
Canada

Gatineau, Canada, J8T 8M1

Mississauga, Canada, L5M 2V8

Montreal, Canada, H2W 1R7

Montreal, Canada, H3A 1A1

Red Deer, Canada, T4N 6V7

St John's, Canada, A1B 3V6

Toronto, Canada, M5G 1X5

Vancouver, Canada, V5Z 1C6

Windsor, Canada, N8W 3K2

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):

Buse JB, Garber A, Rosenstock J, Schmidt WE, Brett JH, Videbæk N, Holst J, Nauck M. Liraglutide treatment is associated with a low frequency and magnitude of antibody formation with no apparent impact on glycemic response or increased frequency of adverse events: results from the Liraglutide Effect and Action in Diabetes (LEAD) trials. J Clin Endocrinol Metab. 2011 Jun;96(6):1695-702. Epub 2011 Mar 30.

Hegedüs L, Moses AC, Zdravkovic M, Le Thi T, Daniels GH. GLP-1 and calcitonin concentration in humans: lack of evidence of calcitonin release from sequential screening in over 5000 subjects with type 2 diabetes or nondiabetic obese subjects treated with the human GLP-1 analog, liraglutide. J Clin Endocrinol Metab. 2011 Mar;96(3):853-60. Epub 2011 Jan 5.

Zinman B, Gerich J, Buse JB, Lewin A, Schwartz S, Raskin P, Hale PM, Zdravkovic M, Blonde L; LEAD-4 Study Investigators. Efficacy and safety of the human glucagon-like peptide-1 analog liraglutide in combination with metformin and thiazolidinedione in patients with type 2 diabetes (LEAD-4 Met+TZD). Diabetes Care. 2009 Jul;32(7):1224-30. Epub 2009 Mar 16.

Sullivan SD, Alfonso-Cristancho R, Conner C, Hammer M, Blonde L. Long-term outcomes in patients with type 2 diabetes receiving glimepiride combined with liraglutide or rosiglitazone. Cardiovasc Diabetol. 2009 Feb 26;8:12.

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 22, 2013

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