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Clinical Trial Details

Trial ID: L4810
Source ID: NCT00294723
Associated Drug: Liraglutide
Title: To Evaluate the Effect of Liraglutide Versus Glimepiride (Amaryl®) on Haemoglobin A1c
Acronym: LEAD-3
Status: TERMINATED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT00294723/results
Conditions: Diabetes|Diabetes Mellitus, Type 2
Interventions: DRUG: liraglutide|DRUG: glimepiride|DRUG: liraglutide|DRUG: placebo|DRUG: placebo|DRUG: placebo
Outcome Measures: Primary: Change in Glycosylated Haemoglobin A1c (HbA1c) at Week 52, Percentage point change in Glycosylated Haemoglobin A1c (HbA1c) from baseline (week 0) to 52 weeks (end of double-blind period), week 0, week 52|Change in Glycosylated Haemoglobin A1c (HbA1c) at Week 104, Percentage point change in Glycosylated Haemoglobin A1c (HbA1c) from baseline (week 0) to 104 weeks (end of 52-week extension), week 0, week 104|Change in Glycosylated Haemoglobin A1c (HbA1c) at Week 156, Percentage point change in Glycosylated Haemoglobin A1c (HbA1c) from baseline (week 0) to 156 weeks, week 0, week 156 | Secondary: Change in Body Weight at Week 52, Change in body weight from baseline (week 0) to 52 weeks (end of double-blind period), week 0, week 52|Change in Body Weight at Week 104, Change in body weight from baseline (week 0) to 104 weeks (end of 52-week extension), week 0, week 104|Change in Body Weight at Week 156, Change in body weight from baseline (week 0) to 156 weeks, week 0, week 156|Change in Fasting Plasma Glucose at Week 52, Change in fasting plasma glucose (FPG) from baseline (week 0) to 52 weeks (end of double-blind period), week 0, week 52|Change in Fasting Plasma Glucose at Week 104, Change in fasting plasma glucose (FPG) from baseline (week 0) to 104 weeks (end of 52-week extension), week 0, week 104|Change in Fasting Plasma Glucose at Week 156, Change in fasting plasma glucose (FPG) from baseline (week 0) to 156 weeks, week 0, week 156|Change in Mean Postprandial Glucose Based on Self-measured 8-point Plasma Glucose Profiles at Week 52, Change in mean postprandial glucose (PPG) based on self-measured 8-point plasma glucose profiles from baseline (week 0) to 52 weeks (end of double-blind period). The 8 time points for self-measurements of plasma glucose were: before each meal (breakfast, lunch and dinner), at 90 min after start of each meal (breakfast, lunch and dinner), at bedtime, and at 3:00 AM ± 30 min., week 0, week 52|Change in Mean Postprandial Glucose Based on Self-measured 8-point Plasma Glucose Profiles at Week 104, Change in mean postprandial glucose (PPG) based on self-measured 8-point plasma glucose profiles from baseline (week 0) to 104 weeks (end of 52-week extension). The 8 time points for self-measurements of plasma glucose were: before each meal (breakfast, lunch and dinner), at 90 min after start of each meal (breakfast, lunch and dinner), at bedtime, and at 3:00 AM ± 30 min., week 0, week 104|Change in Mean Postprandial Glucose Based on Self-measured 8-point Plasma Glucose Profiles at Week 156, Change in mean postprandial glucose (PPG) based on self-measured 8-point plasma glucose profiles from baseline (week 0) to 156 weeks. The 8 time points for self-measurements of plasma glucose were: before each meal (breakfast, lunch and dinner), at 90 min after start of each meal (breakfast, lunch and dinner), at bedtime, and at 3:00 AM ± 30 min., week 0, week 156|Change in Prandial Increments of Plasma Glucose Based on Self-measured 8-point Plasma Glucose Profiles at Week 52, Change in mean prandial increments of plasma glucose from baseline (week 0) to 52 weeks (end of double-blind period). The 8 time points for self-measured 8-point plasma glucose profiles were: before each meal (breakfast, lunch and dinner), at 90 min after start of each meal (breakfast, lunch and dinner), at bedtime, and at 3:00 AM ± 30 min. Mean prandial increments of plasma glucose were calculated as the sum of the plasma glucose differences between post- and pre-meal values (for breakfast, lunch and dinner) divided by three., week 0, week 52|Change in Prandial Increments of Plasma Glucose Based on Self-measured 8-point Plasma Glucose Profiles at Week 104, Change in mean prandial increments of plasma glucose from baseline (week 0) to 104 weeks (end of 52-week extension). The 8 time points for self-measured 8-point plasma glucose profiles were: before each meal (breakfast, lunch and dinner), at 90 min after start of each meal (breakfast, lunch and dinner), at bedtime, and at 3:00 AM ± 30 min. Mean prandial increments of plasma glucose were calculated as the sum of the plasma glucose differences between post- and pre-meal values (for breakfast, lunch and dinner) divided by three., week 0, week 104|Change in Prandial Increments of Plasma Glucose Based on Self-measured 8-point Plasma Glucose Profiles at Week 156, Change in mean prandial increments (incr.) of plasma glucose from baseline (week 0) to 156 weeks. The 8 time points for self-measured 8-point plasma glucose profiles were: before each meal (breakfast, lunch and dinner), at 90 min after start of each meal (breakfast, lunch and dinner), at bedtime, and at 3:00 AM ± 30 min. Mean prandial increments of plasma glucose were calculated as the sum of the plasma glucose differences between post- and pre-meal values (for breakfast, lunch and dinner) divided by three., week 0, week 156|Hypoglycaemic Episodes, Total number of hypoglycaemic episodes occuring from baseline (week 0) to 104 weeks (end of the 52-week extension). Hypoglycaemic episodes were defined as major, minor, or symptoms only. Major if the subject was unable to treat her/himself. Minor if subject was able to treat her/himself and plasma glucose was below 56 mg/dL. Symptoms only if subject was able to treat her/himself and with no plasma glucose measurement or plasma glucose higher than or equal to 56 mg/dL., weeks 0-104|Hypoglycaemic Episodes, Total number of hypoglycaemic episodes occuring from week 104 to end of trial (week 195). Hypoglycaemic episodes were defined as major, minor, or symptoms only. Major if the subject was unable to treat her/himself. Minor if subject was able to treat her/himself and plasma glucose was below 56 mg/dL. Symptoms only if subject was able to treat her/himself and with no plasma glucose measurement or plasma glucose higher than or equal to 56 mg/dL., weeks 104-195
Sponsor/Collaborators: Sponsor: Novo Nordisk A/S
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 746
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2006-02
Completion Date: 2008-11
Results First Posted: 2010-03-12
Last Update Posted: 2017-03-07
Locations: Novo Nordisk Investigational Site, Concord, California, 94520, United States|Novo Nordisk Investigational Site, Escondido, California, 92025, United States|Novo Nordisk Investigational Site, Fullerton, California, 92835, United States|Novo Nordisk Investigational Site, Inglewood, California, 90301, United States|Novo Nordisk Investigational Site, Mission Viejo, California, 92691, United States|Novo Nordisk Investigational Site, Orange, California, 92869, United States|Novo Nordisk Investigational Site, Santa Barbara, California, 93105, United States|Novo Nordisk Investigational Site, Spring Valley, California, 91978, United States|Novo Nordisk Investigational Site, Vista, California, 92084, United States|Novo Nordisk Investigational Site, Walnut Creek, California, 94598, United States|Novo Nordisk Investigational Site, Daytona Beach, Florida, 32117, United States|Novo Nordisk Investigational Site, Delray Beach, Florida, 33484, United States|Novo Nordisk Investigational Site, Jacksonville, Florida, 32205, United States|Novo Nordisk Investigational Site, Jacksonville, Florida, 32216, United States|Novo Nordisk Investigational Site, Longwood, Florida, 32779, United States|Novo Nordisk Investigational Site, Ocala, Florida, 34471, United States|Novo Nordisk Investigational Site, St. Cloud, Florida, 34769, United States|Novo Nordisk Investigational Site, Athens, Georgia, 30606, United States|Novo Nordisk Investigational Site, Atlanta, Georgia, 30032, United States|Novo Nordisk Investigational Site, Atlanta, Georgia, 30034, United States|Novo Nordisk Investigational Site, Atlanta, Georgia, 30318, United States|Novo Nordisk Investigational Site, Atlanta, Georgia, 30339, United States|Novo Nordisk Investigational Site, Blue Ridge, Georgia, 30513, United States|Novo Nordisk Investigational Site, Columbus, Georgia, 31904, United States|Novo Nordisk Investigational Site, Marietta, Georgia, 30060, United States|Novo Nordisk Investigational Site, Powder Springs, Georgia, 30127, United States|Novo Nordisk Investigational Site, Tucker, Georgia, 30084, United States|Novo Nordisk Investigational Site, Honolulu, Hawaii, 96813, United States|Novo Nordisk Investigational Site, Chicago, Illinois, 60607, United States|Novo Nordisk Investigational Site, Chicago, Illinois, 60611, United States|Novo Nordisk Investigational Site, Maywood, Illinois, 60153, United States|Novo Nordisk Investigational Site, Indianapolis, Indiana, 46202, United States|Novo Nordisk Investigational Site, Des Moines, Iowa, 50314, United States|Novo Nordisk Investigational Site, Shawnee Mission, Kansas, 66204, United States|Novo Nordisk Investigational Site, Topeka, Kansas, 66606, United States|Novo Nordisk Investigational Site, Lexington, Kentucky, 40503, United States|Novo Nordisk Investigational Site, Lexington, Kentucky, 40536, United States|Novo Nordisk Investigational Site, New Orleans, Louisiana, 70121, United States|Novo Nordisk Investigational Site, Baltimore, Maryland, 21218, United States|Novo Nordisk Investigational Site, Hyattsville, Maryland, 20782, United States|Novo Nordisk Investigational Site, Minneapolis, Minnesota, 55407, United States|Novo Nordisk Investigational Site, St. Paul, Minnesota, 55108, United States|Novo Nordisk Investigational Site, Jackson, Mississippi, 39216, United States|Novo Nordisk Investigational Site, Tupelo, Mississippi, 38801, United States|Novo Nordisk Investigational Site, Chesterfield, Missouri, 63017, United States|Novo Nordisk Investigational Site, St. Louis, Missouri, 63104, United States|Novo Nordisk Investigational Site, St. Louis, Missouri, 63110, United States|Novo Nordisk Investigational Site, St. Peters, Missouri, 63376, United States|Novo Nordisk Investigational Site, Butte, Montana, 59701, United States|Novo Nordisk Investigational Site, Omaha, Nebraska, 68114, United States|Novo Nordisk Investigational Site, Reno, Nevada, 89502, United States|Novo Nordisk Investigational Site, Berlin, New Jersey, 08009, United States|Novo Nordisk Investigational Site, Lawrenceville, New Jersey, 08648, United States|Novo Nordisk Investigational Site, Plainsboro, New Jersey, 08536, United States|Novo Nordisk Investigational Site, Albany, New York, 12206, United States|Novo Nordisk Investigational Site, Lewiston, New York, 14092, United States|Novo Nordisk Investigational Site, New York, New York, 10023, United States|Novo Nordisk Investigational Site, Northport, New York, 11768, United States|Novo Nordisk Investigational Site, Staten Island, New York, 10301, United States|Novo Nordisk Investigational Site, Syracuse, New York, 13210, United States|Novo Nordisk Investigational Site, West Seneca, New York, 14224, United States|Novo Nordisk Investigational Site, Asheville, North Carolina, 28803, United States|Novo Nordisk Investigational Site, Charlotte, North Carolina, 28277, United States|Novo Nordisk Investigational Site, Durham, North Carolina, 27710, United States|Novo Nordisk Investigational Site, Greensboro, North Carolina, 27408, United States|Novo Nordisk Investigational Site, Cleveland, Ohio, 44195, United States|Novo Nordisk Investigational Site, Dayton, Ohio, 45439, United States|Novo Nordisk Investigational Site, Mentor, Ohio, 44060, United States|Novo Nordisk Investigational Site, Oklahoma City, Oklahoma, 73103, United States|Novo Nordisk Investigational Site, Oklahoma City, Oklahoma, 73104, United States|Novo Nordisk Investigational Site, Tulsa, Oklahoma, 74104, United States|Novo Nordisk Investigational Site, Bend, Oregon, 97710, United States|Novo Nordisk Investigational Site, Eugene, Oregon, 97401, United States|Novo Nordisk Investigational Site, Medford, Oregon, 97504-8491, United States|Novo Nordisk Investigational Site, Medford, Oregon, 97504, United States|Novo Nordisk Investigational Site, Lancaster, Pennsylvania, 17601, United States|Novo Nordisk Investigational Site, Norristown, Pennsylvania, 19401, United States|Novo Nordisk Investigational Site, Philadelphia, Pennsylvania, 19107, United States|Novo Nordisk Investigational Site, East Providence, Rhode Island, 02914, United States|Novo Nordisk Investigational Site, Greer, South Carolina, 29651, United States|Novo Nordisk Investigational Site, Spartanburg, South Carolina, 29303, United States|Novo Nordisk Investigational Site, Chattanooga, Tennessee, 37411, United States|Novo Nordisk Investigational Site, Arlington, Texas, 76014, United States|Novo Nordisk Investigational Site, Corpus Christi, Texas, 78412, United States|Novo Nordisk Investigational Site, Dallas, Texas, 75208, United States|Novo Nordisk Investigational Site, Dallas, Texas, 75224, United States|Novo Nordisk Investigational Site, Dallas, Texas, 75230, United States|Novo Nordisk Investigational Site, Dallas, Texas, 75231, United States|Novo Nordisk Investigational Site, Dallas, Texas, 75246, United States|Novo Nordisk Investigational Site, Houston, Texas, 77024, United States|Novo Nordisk Investigational Site, Houston, Texas, 77025, United States|Novo Nordisk Investigational Site, Houston, Texas, 77030, United States|Novo Nordisk Investigational Site, Houston, Texas, 77074, United States|Novo Nordisk Investigational Site, Midland, Texas, 79707, United States|Novo Nordisk Investigational Site, San Antonio, Texas, 78229, United States|Novo Nordisk Investigational Site, Salt Lake City, Utah, 84132, United States|Novo Nordisk Investigational Site, Richmond, Virginia, 23249, United States|Novo Nordisk Investigational Site, Edmonds, Washington, 98026-7610, United States|Novo Nordisk Investigational Site, Olympia, Washington, 98502, United States|Novo Nordisk Investigational Site, Renton, Washington, 98057, United States|Novo Nordisk Investigational Site, Spokane, Washington, 99218, United States|Novo Nordisk Investigational Site, Tacoma, Washington, 98405, United States|Novo Nordisk Investigational Site, Guadalajara, Jalisco, 44650, Mexico|Novo Nordisk Investigational Site, Cuernavaca, Morelos, 62250, Mexico|Novo Nordisk Investigational Site, Monterrey, Nuevo León, 64460, Mexico|Novo Nordisk Investigational Site, Chihuahua, Chih, 31000, Mexico|Novo Nordisk Investigational Site, Ciudad de México, D.F., 06100, Mexico|Novo Nordisk Investigational Site, Ciudad de México, D.F., 14050, Mexico|Novo Nordisk Investigational Site, Guadalajara, 44600, Mexico|Novo Nordisk Investigational Site, Hermosillo, Son., 83000, Mexico|Novo Nordisk Investigational Site, Mexico D.F., 06700, Mexico|Novo Nordisk Investigational Site, Mexico, D.F., 01120, Mexico|Novo Nordisk Investigational Site, Monterrey, N.L., 64000, Mexico|Novo Nordisk Investigational Site, Monterrey, NL, 66260, Mexico|Novo Nordisk Investigational Site, Santiago de Querétaro, Qro., 76178, Mexico|Novo Nordisk Investigational Site, Tampico, 80109, Mexico|Novo Nordisk Investigational Site, Rio Piedras, 00921, Puerto Rico
URL: https://clinicaltrials.gov/show/NCT00294723

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress