To Evaluate the Effect of Liraglutide Versus Glimepiride (Amaryl®) on Haemoglobin A1c

Condition(s) targeted: Diabetes Mellitus, Type 2

Intervention: liraglutide (Drug); glimepiride (Drug); liraglutide (Drug); glimepiride (Drug)

Phase: Phase 3

Status: Active, not recruiting

Sponsored by: Novo Nordisk

Official(s) and/or principal investigator(s):
Paula Hale, MD, Study Director, Affiliation: Novo Nordisk

Double blind trial with two open label extensions conducted in the United States of America (USA) and Mexico.

Trial dates:

Original trial: Start February 2006, finish November 2007 First extension: Start March 2007, finish November 2008 Second extension: Start March 2008, finish November 2011

The trial is designed to evaluate the effects of treatment with liraglutide versus glimipiride in subjects with type 2 diabetes

Official title: Liraglutide Effect and Action in Diabetes (LEAD 3): Effect on Glycemic Control of Liraglutide Versus Glimepiride in Type 2 Diabetes.

Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: Change in HbA1c

Secondary outcome:

Body weight

Safety and tolerability

Glycemic Control

Minimum age: 18 Years. Maximum age: 80 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Type 2 diabetes

- Treatment with diet/exercise or with oral anti-diabetic drugs alone for at least 2

months

- Diet/exercise treated subjects with HbA1c > 7. 0% and < 11%

- OAD treated subjects with HbA1c > 7. 0% and < 10%

- Body Mass Index (BMI) less than or equal to 45 kg/m2

Exclusion Criteria:

- Treatment with insulin for the last 3 months

- Treatment with any drug that could interfere with the glucose level (besides use of a

single anti-diabetic compound)

- Any serious medical condition

Novo Nordisk Clinical Trial Call Center, Santiago de Querétaro, Qro. 76178, Mexico

Novo Nordisk Clinical Trial Call Center, Hermosillo, Son. 83000, Mexico

Novo Nordisk Clinical Trial Call Center, Cuernavaca, Mor. 62250, Mexico

Novo Nordisk Clinical Trial Call Center, Guadalajara, JAL 44340, Mexico

Novo Nordisk Clinical Trial Call Center, Tampico 80109, Mexico

Novo Nordisk Clinical Trial Call Center, Mexico D.F. 06700, Mexico

Novo Nordisk Clinical Trial Call Center, Ciudad de México, D.F. 14050, Mexico

Novo Nordisk Clinical Trial Call Center, Guadalajara, Jal. 44650, Mexico

Novo Nordisk Clinical Trial Call Center, Monterrey, NL 66260, Mexico

Novo Nordisk Clinical Trial Call Center, Mexico, D.F. 01120, Mexico

Novo Nordisk Clinical Trial Call Center, Monterrey, N.L. 64000, Mexico

Novo Nordisk Clinical Trial Call Center, Ciudad de México, D.F. 06100, Mexico

Novo Nordisk Clinical Trial Call Center, Rio Piedras 00921, Puerto Rico

Novo Nordisk Clinical Trial Call Center, San Diego, California 92161, United States

Novo Nordisk Clinical Trial Call Center, Walnut Creek, California 94598, United States

Novo Nordisk Clinical Trial Call Center, Spring Valley, California 91978, United States

Novo Nordisk Clinical Trial Call Center, Concord, California 94520, United States

Novo Nordisk Clinical Trial Call Center, Orange, California 92869, United States

Novo Nordisk Clinical Trial Call Center, Vista, California 92084, United States

Novo Nordisk Clinical Trial Call Center, Santa Barbara, California 93105, United States

Novo Nordisk Clinical Trial Call Center, Inglewood, California 90301, United States

Novo Nordisk Clinical Trial Call Center, Escondido, California 92026, United States

Novo Nordisk Clinical Trial Call Center, Mission Viejo, California 92691, United States

Novo Nordisk Clinical Trial Call Center, Washington, District of Columbia 20003, United States

Novo Nordisk Clinical Trial Call Center, Jacksonville, Florida 32205, United States

Novo Nordisk Clinical Trial Call Center, Jacksonville, Florida 32259, United States

Novo Nordisk Clinical Trial Call Center, Longwood, Florida 32779, United States

Novo Nordisk Clinical Trial Call Center, Ocala, Florida 34471, United States

Novo Nordisk Clinical Trial Call Center, St. Cloud, Florida 34769, United States

Novo Nordisk Clinical Trial Call Center, Daytona Beach, Florida 32114, United States

Novo Nordisk Clinical Trial Call Center, Columbus, Georgia 31904, United States

Novo Nordisk Clinical Trial Call Center, Tucker, Georgia 30083, United States

Novo Nordisk Clinical Trial Call Center, Atlanta, Georgia 30034, United States

Novo Nordisk Clinical Trial Call Center, Atlanta, Georgia 30309, United States

Novo Nordisk Clinical Trial Call Center, Atlanta, Georgia 30032, United States

Novo Nordisk Clinical Trial Call Center, Blue Ridge, Georgia 30513, United States

Novo Nordisk Clinical Trial Call Center, Atlanta, Georgia 30339, United States

Novo Nordisk Clinical Trial Call Center, Marietta, Georgia 30060, United States

Novo Nordisk Clinical Trial Call Center, Athens, Georgia 30606, United States

Novo Nordisk Clinical Trial Call Center, Honolulu, Hawaii 96813, United States

Novo Nordisk Clinical Trial Call Center, Chicago, Illinois 60607, United States

Novo Nordisk Clinical Trial Call Center, Indianapolis, Indiana 46202, United States

Novo Nordisk Clinical Trial Call Center, Des Moines, Iowa 50314, United States

Novo Nordisk Clinical Trial Call Center, Shawnee Mission, Kansas 66204, United States

Novo Nordisk Clinical Trial Call Center, Topeka, Kansas 66606, United States

Novo Nordisk Clinical Trial Call Center, Lexington, Kentucky 40503, United States

Novo Nordisk Clinical Trial Call Center, Lexington, Kentucky 40504-2681, United States

Novo Nordisk Clinical Trial Call Center, New Orleans, Louisiana 70121, United States

Novo Nordisk Clinical Trial Call Center, Baltimore, Maryland 21218, United States

Novo Nordisk Clinical Trial Call Center, St. Paul, Minnesota 55108, United States

Novo Nordisk Clinical Trial Call Center, Minneapolis, Minnesota 55407, United States

Novo Nordisk Clinical Trial Call Center, Tupelo, Mississippi 38801, United States

Novo Nordisk Clinical Trial Call Center, Jacksonville, Mississippi 39216, United States

Novo Nordisk Clinical Trial Call Center, St. Peters, Missouri 63376, United States

Novo Nordisk Clinical Trial Call Center, St. Louis (Chesterfield), Missouri 63017, United States

Novo Nordisk Clinical Trial Call Center, St. Louis, Missouri 63104, United States

Novo Nordisk Clinical Trial Call Center, St. Louis, Missouri 63110, United States

Novo Nordisk Clinical Trial Call Center, Butte, Montana 59701, United States

Novo Nordisk Clinical Trial Call Center, Omaha, Nebraska 68131, United States

Novo Nordisk Clinical Trial Call Center, Reno, Nevada 89502, United States

Novo Nordisk Clinical Trial Call Center, Las Vegas, Nevada 89103, United States

Novo Nordisk Clinical Trial Call Center, Berlin, New Jersey 08009, United States

Novo Nordisk Clinical Trial Call Center, Princeton, New Jersey 08540, United States

Novo Nordisk Clinical Trial Call Center, Lawrenceville, New Jersey 08648, United States

Novo Nordisk Clinical Trial Call Center, Syracuse, New York 13210, United States

Novo Nordisk Clinical Trial Call Center, Staten Island, New York 10301, United States

Novo Nordisk Clinical Trial Call Center, West Seneca, New York 14224, United States

Novo Nordisk Clinical Trial Call Center, Albany, New York 12206, United States

Novo Nordisk Clinical Trial Call Center, Northport, New York 11768, United States

Novo Nordisk Clinical Trial Call Center, New York, New York 10024, United States

Novo Nordisk Clinical Trial Call Center, Asheville, North Carolina 28801, United States

Novo Nordisk Clinical Trial Call Center, Charlotte, North Carolina 28211, United States

Novo Nordisk Clinical Trial Call Center, Greensboro, North Carolina 27408, United States

Novo Nordisk Clinical Trial Call Center, Durham, North Carolina 27710, United States

Novo Nordisk Clinical Trial Call Center, Monterrey, N.L., Nuevo Leon 64460, Mexico

Novo Nordisk Clinical Trial Call Center, Dayton, Ohio 45439, United States

Novo Nordisk Clinical Trial Call Center, Cleveland, Ohio 44195, United States

Novo Nordisk Clinical Trial Call Center, Mentor, Ohio 44060, United States

Novo Nordisk Clinical Trial Call Center, Oklahoma City, Oklahoma 73103, United States

Novo Nordisk Clinical Trial Call Center, Tulsa, Oklahoma 74105, United States

Novo Nordisk Clinical Trial Call Center, Eugene, Oregon 97401, United States

Novo Nordisk Clinical Trial Call Center, Bend, Oregon 97710, United States

Novo Nordisk Clinical Trial Call Center, Medford, Oregon 97504, United States

Novo Nordisk Clinical Trial Call Center, Norristown, Pennsylvania 19401, United States

Novo Nordisk Clinical Trial Call Center, Philadelphia, Pennsylvania 19107, United States

Novo Nordisk Clinical Trial Call Center, Reading, Pennsylvania 19606, United States

Novo Nordisk Clinical Trial Call Center, East Providence, Rhode Island 02914, United States

Novo Nordisk Clinical Trial Call Center, Spartanburg, South Carolina 29303, United States

Novo Nordisk Clinical Trial Call Center, Greer, South Carolina 29651, United States

Novo Nordisk Clinical Trial Call Center, Chattanooga, Tennessee 37403, United States

Novo Nordisk Clinical Trial Call Center, Houston, Texas 77074, United States

Novo Nordisk Clinical Trial Call Center, Dallas, Texas 75224, United States

Novo Nordisk Clinical Trial Call Center, Dallas, Texas 75208, United States

Novo Nordisk Clinical Trial Call Center, Houston, Texas 77030, United States

Novo Nordisk Clinical Trial Call Center, Sugarland, Texas 77478, United States

Novo Nordisk Clinical Trial Call Center, Arlington, Texas 76014, United States

Novo Nordisk Clinical Trial Call Center, Houston, Texas 77024, United States

Novo Nordisk Clinical Trial Call Center, Dallas, Texas 75231, United States

Novo Nordisk Clinical Trial Call Center, San Antonio, Texas 78229, United States

Novo Nordisk Clinical Trial Call Center, Houston, Texas 77025, United States

Novo Nordisk Clinical Trial Call Center, Dallas, Texas 75246, United States

Novo Nordisk Clinical Trial Call Center, Midland, Texas 79705, United States

Novo Nordisk Clinical Trial Call Center, Dallas, Texas 75230, United States

Novo Nordisk Clinical Trial Call Center, Corpus Christi, Texas 78412, United States

Novo Nordisk Clinical Trial Call Center, Salt Lake City, Utah 84132, United States

Novo Nordisk Clinical Trial Call Center, Richmond, Virginia 23249, United States

Novo Nordisk Clinical Trial Call Center, Olympia, Washington 98502, United States

Novo Nordisk Clinical Trial Call Center, Tacoma, Washington 98405, United States

Novo Nordisk Clinical Trial Call Center, Renton, Washington 98057, United States

Novo Nordisk Clinical Trial Call Center, Spokane, Washington 99207, United States

Clinical Trials at Novo Nordisk

Starting date: February 2006
Ending date: November 2011
Last updated: March 14, 2008