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Clinical Trial Details

Trial ID: L2119
Source ID: NCT00518882
Associated Drug: Liraglutide
Title: Effect of Liraglutide or Exenatide Added to an Ongoing Treatment on Blood Glucose Control in Subjects With Type 2 Diabetes
Acronym: LEAD-6
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT00518882/results
Conditions: Diabetes|Diabetes Mellitus, Type 2
Interventions: DRUG: liraglutide|DRUG: exenatide
Outcome Measures: Primary: Change in Glycosylated A1c (HbA1c) at Week 26, Percentage point change in glycosylated A1c (HbA1c) from baseline (week 0) to 26 weeks (end of randomisation), week 0, week 26 | Secondary: Change in Glycosylated A1c (HbA1c), Weeks 26-78, Percentage point change in glycosylated A1c (HbA1c) from Week 26 (end of randomisation) to Week 78 (end of treatment) within each treatment group (the liraglutide -\> liraglutide group and the exenatide -\> liraglutide group), week 26, week 78|Change in Glycosylated A1c (HbA1c) at Week 78, Percentage point change in glycosylated A1c (HbA1c) from baseline (week 0) to 78 weeks (end of treatment) within each treatment group (the liraglutide -\> liraglutide group and the exenatide -\> liraglutide group), week 0, week 78|Percentage of Subjects Achieving Treatment Target of Either HbA1c < 7.0% or =< 6.5% at Week 26, Percentage of subjects achieving treatment target of HbA1c less than 7.0% or less than or equal to 6.5% at Week 26 (end of randomisation), week 0, week 26|Percentage of Subjects Achieving Treatment Target of Either HbA1c < 7.0% or =< 6.5% at Week 78, Percentage of subjects achieving treatment target of HbA1c less than 7.0% or less than or equal to 6.5% at Week 78 (end of treatment), week 0, week 78|Change in Body Weight at Week 26, Change in body weight from baseline (week 0) to 26 weeks (end of randomisation), week 0, week 26|Change in Body Weight, Weeks 26-78, Change in body weight from Week 26 (end of randomisation) to Week 78 (end of treatment) within each treatment group (the liraglutide -\> liraglutide group and the exenatide -\> liraglutide group), week 26, week 78|Change in Body Weight at Week 78, Change in body weight from baseline (Week 0) to 78 weeks (end of treatment) within each treatment group (the liraglutide -\> liraglutide group and the exenatide -\> liraglutide group), week 0, week 78|Change in Fasting Plasma Glucose at Week 26, Change in fasting plasma glucose (FPG) from baseline (week 0) to 26 weeks (end of randomisation), week 0, week 26|Change in Fasting Plasma Glucose, Weeks 26-78, Change in fasting plasma glucose from Week 26 (end of randomisation) to Week 78 (end of treatment) within each treatment group (the liraglutide -\> liraglutide group and the exenatide -\> liraglutide group), week 26, week 78|Change in Fasting Plasma Glucose at Week 78, Change in fasting plasma glucose from baseline (week 0) to 78 weeks (end of treatment) within each treatment group (the liraglutide -\> liraglutide group and the exenatide -\> liraglutide group), week 0, week 78|Change in Mean Prandial Increment of Plasma Glucose After Breakfast at Week 26, Change in mean prandial increment of plasma glucose after breakfast from baseline (week 0) to 26 weeks (end of randomisation). Prandial increments of plasma glucose were calculated as the difference between glucose values measured before and after breakfast., week 0, week 26|Change in Mean Prandial Increment of Plasma Glucose After Lunch at Week 26, Change in mean prandial increment of plasma glucose after lunch from baseline (week 0) to 26 weeks (end of randomisation). Prandial increments of plasma glucose were calculated as the difference between plasma glucose values measured before and after lunch., week 0, week 26|Change in Mean Prandial Increment of Plasma Glucose After Dinner at Week 26, Change in mean prandial increment of plasma glucose after dinner from baseline (week 0) to 26 weeks (end of randomisation). Prandial increments of plasma glucose were calculated as the difference between plasma glucose values measured before and after dinner., week 0, week 26|Change in Mean Prandial Increment of Plasma Glucose After Breakfast, Weeks 26-78, Change in mean prandial increment of plasma glucose after breakfast from Week 26 (end of randomisation) to Week 78 (end of treatment). Prandial increments of plasma glucose were calculated as the difference between plasma glucose values measured before and after breakfast., week 26, week 78|Change in Mean Prandial Increment of Plasma Glucose After Lunch, Weeks 26-78, Change in mean prandial increment of plasma glucose after lunch from Week 26 (end of randomisation) to Week 78 (end of treatment). Prandial increments of plasma glucose were calculated as the difference between plasma glucose values measured before and after a lunch., week 26, week 78|Change in Mean Prandial Increment of Plasma Glucose After Dinner, Weeks 26-78, Change in mean prandial increment of plasma glucose after dinner from Week 26 (end of randomisation) to Week 78 (end of treatment). Prandial increments of plasma glucose were calculated as the difference between plasma glucose values measured before and after dinner., week 26, week 78|Change in Mean Prandial Increment of Plasma Glucose After Breakfast at Week 78, Change in mean prandial increment of plasma glucose after breakfast from baseline (week 0) to 78 weeks (end of treatment). Prandial increments of plasma glucose were calculated as the difference between plasma glucose values measured before and after breakfast., week 0, week 78|Change in Mean Prandial Increment of Plasma Glucose After Lunch at Week 78, Change in mean prandial increment of plasma glucose after lunch from baseline (week 0) to 78 weeks (end of treatment). Prandial increments of plasma glucose were calculated as the difference between plasma glucose values measured before and after lunch., week 0, week 78|Change in Mean Prandial Increment of Plasma Glucose After Dinner at Week 78, Change in mean prandial increment of plasma glucose after dinner from baseline (week 0) to 78 weeks (end of treatment). Prandial increments of plasma glucose were calculated as the difference between plasma glucose values measured before and after dinner., week 0, week 78|Change in Mean Postprandial Increment of Plasma Glucose After Breakfast at Week 26, Change in mean postprandial increment of plasma glucose after breakfast from baseline (week 0) to 26 weeks (end of randomisation). Prandial increments of plasma glucose were calculated as the difference between plasma glucose values measured before and after breakfast., week 0, week 26|Change in Mean Postprandial Increment of Plasma Glucose After Lunch at Week 26, Change in mean postprandial increment of plasma glucose after lunch from baseline (week 0) to 26 weeks (end of randomisation). Prandial increments of plasma glucose were calculated as the difference between plasma glucose values measured before and after lunch., week 0. week 26|Change in Mean Postprandial Increment of Plasma Glucose After Dinner at Week 26, Change in mean postprandial increment of plasma glucose after dinner from baseline (week 0) to 26 weeks (end of randomisation). Prandial increments of plasma glucose were calculated as the difference between plasma glucose values measured before and after dinner., week 0, week 26|Change in Mean Postprandial Increment of Plasma Glucose After Breakfast, Weeks 26-78, Change in mean postprandial increment of plasma glucose after breakfast from Week 26 (end of randomisation) to Week 78 (end of treatment). Prandial increments of plasma glucose were calculated as the difference between plasma glucose values measured before and after breakfast., week 26, week 78|Change in Mean Postprandial Increment of Plasma Glucose After Lunch, Weeks 26-78, Change in mean postprandial increment of plasma glucose after lunch from Week 26 (end of randomisation) to Week 78 (end of treatment). Prandial increments of plasma glucose were calculated as the difference between plasma glucose values measured before and after lunch., week 26, week 78|Change in Mean Postprandial Increment of Plasma Glucose After Dinner, Weeks 26-78, Change in mean postprandial increment of plasma glucose after dinner from Week 26 (end of randomisation) to Week 78 (end of treatment). Prandial increments of plasma glucose were calculated as the difference between plasma glucose values measured before and after dinner., week 26, week 78|Change in Mean Postprandial Increment of Plasma Glucose After Breakfast at Week 78, Change in mean postprandial increment of plasma glucose after breakfast from baseline (week 0) to 78 weeks (end of treatment). Prandial increments of plasma glucose were calculated as the difference between plasma glucose values measured before and after breakfast., week 0, week 78|Change in Mean Postprandial Increment of Plasma Glucose After Lunch at Week 78, Change in mean postprandial increment of plasma glucose after lunch from baseline (week 0) to 78 weeks (end of treatment). Prandial increments of plasma glucose were calculated as the difference between plasma glucose values measured before and after lunch., week 0, week 78|Change in Mean Postprandial Increment of Plasma Glucose After Dinner at Week 78, Change in mean postprandial increment of plasma glucose after dinner from baseline (week 0) to 78 weeks (end of treatment). Prandial increments of plasma glucose were calculated as the difference between plasma glucose values measured before and after dinner., week 0, week 78|Change in Beta-cell Function at Week 26, Change in Beta-cell function from baseline (week 0) to 26 weeks (end of randomisation). Beta-cell function was derived from fasting plasma glucose (FPG) and fasting insulin concentrations using the homeostasic model assessment (HOMA) method which uses the assumption that normal-weight normal subjects aged under 35 years have a 100% beta-cell function (HOMA-B). Beta-cell function: HOMA-B (%) = 20∙fasting insulin\[uU/mL\] divided by (FPG mmol/L\]-3.5)., week 0, week 26|Change in Beta-cell Function, Weeks 26-78, Change in Beta-cell function from Week 26 (end of randomisation) to Week 78 (end of treatment). Beta-cell function was derived from fasting plasma glucose (FPG) and fasting insulin concentrations using the homeostasic model assessment (HOMA) method which uses the assumption that normal-weight normal subjects aged under 35 years have a 100% beta-cell function (HOMA-B). Beta-cell function: HOMA-B (%) = 20∙fasting insulin\[uU/mL\] divided by (FPG mmol/L\]-3.5)., week 26, week 78|Change in Beta-cell Function at Week 78, Change in Beta-cell function from baseline (week 0) to 78 weeks (end of treatment). Beta-cell function was derived from fasting plasma glucose (FPG) and fasting insulin concentrations using the homeostasic model assessment (HOMA) method which uses the assumption that normal-weight normal subjects aged under 35 years have a 100% beta-cell function (HOMA-B). Beta-cell function: HOMA-B (%) = 20∙fasting insulin\[uU/mL\] divided by (FPG mmol/L\]-3.5)., week 0, week 78|Change in Total Cholesterol at Week 26, Change in total cholesterol (TC) from baseline (week 0) to 26 weeks (end of randomisation), week 0, week 26|Change in Total Cholesterol, Weeks 26-78, Change in total cholesterol (TC) from Week 26 (end of randomisation) to Week 78 (end of treatment) within each treatment group (the liraglutide -\> liraglutide group and the exenatide -\> liraglutide group)., week 26, week 78|Change in Total Cholesterol at Week 78, Change in total cholesterol (TC) from baseline (week 0) to 78 weeks (end of treatment) within each treatment group (the liraglutide -\> liraglutide group and the exenatide -\> liraglutide group)., week 0, week 78|Change in Low-density Lipoprotein-cholesterol at Week 26, Change in Low-density Lipoprotein-cholesterol (LDL-C) from baseline (week 0) to 26 weeks (end of randomisation), week 0, week 26|Change in Low-density Lipoprotein-cholesterol, Weeks 26-78, Change in low-density lipoprotein-cholesterol (LDL-C) from Week 26 (end of randomisation) to Week 78 (end of treatment) within each treatment group (the liraglutide -\> liraglutide group and the exenatide -\> liraglutide group)., week 26, week 78|Change in Low-density Lipoprotein-cholesterol at Week 78, Change in Low-density Lipoprotein-cholesterol (LDL-C) from baseline (week 0) to 78 weeks (end of treatment) within each treatment group (the liraglutide -\> liraglutide group and the exenatide -\> liraglutide group)., week 0, week 78|Change in Very Low-density Lipoprotein-cholesterol at Week 26, Change in very low-density lipoprotein-cholesterol (VLDL-C) from baseline (week 0) to 26 weeks (end of randomisation), week 0, week 26|Change in Very Low-density Lipoprotein-cholesterol, Weeks 26-78, Change in Very Low-density Lipoprotein-cholesterol (VLDL-C) from Week 26 (end of randomisation) to Week 78 (end of treatment) within each treatment group (the liraglutide -\> liraglutide group and the exenatide -\> liraglutide group)., week 26, week 78|Change in Very Low-density Lipoprotein-cholesterol at Week 78, Change in Very Low-density Lipoprotein-cholesterol (VLDL-C) from baseline (week 0) to 78 weeks (end of treatment) within each treatment group (the liraglutide -\> liraglutide group and the exenatide -\> liraglutide group)., week 0, week 78|Change in High-density Lipoprotein-cholesterol at Week 26, Change in High-density Lipoprotein-cholesterol (HDL-C) from baseline (week 0) to 26 weeks (end of randomisation), week 0, week 26|Change in High-density Lipoprotein-cholesterol, Weeks 26-78, Change in High-density Lipoprotein-cholesterol (HDL-C) from Week 26 (end of randomisation) to Week 78 (end of treatment) within each treatment group (the liraglutide -\> liraglutide group and the exenatide -\> liraglutide group)., week 26, week 78|Change in High-density Lipoprotein-cholesterol at Week 78, Change in High-density Lipoprotein-cholesterol (HDL-C) from baseline (week 0) to 78 weeks (end of treatment) within each treatment group (the liraglutide -\> liraglutide group and the exenatide -\> liraglutide group)., week 0, week 78|Change in Triglyceride at Week 26, Change in triglyceride (TG) from from baseline (week 0) to 26 weeks (end of randomisation), week 0, week 26|Change in Triglyceride, Weeks 26-78, Change in Triglyceride (TG) from Week 26 (end of randomisation) to Week 78 (end of treatment) within each treatment group (the liraglutide -\> liraglutide group and the exenatide -\> liraglutide group)., week 26, week 78|Change in Triglyceride at Week 78, Change in triglyceride (TG) from baseline (week 0) to 78 weeks (end of treatment) within each treatment group (the liraglutide -\> liraglutide group and the exenatide -\> liraglutide group)., week 0, week 78|Change in Free Fatty Acid at Week 26, Change in Free Fatty Acid (FFA) from baseline (week 0) to 26 weeks (end of randomisation), week 0, week 26|Change in Free Fatty Acid, Weeks 26-78, Change in Free Fatty Acid (FFA) from Week 26 (end of randomisation) to Week 78 (end of treatment) within each treatment group (the liraglutide -\> liraglutide group and the exenatide -\> liraglutide group)., week 26, week 78|Change in Free Fatty Acid at Week 78, Change in Free Fatty Acid (FFA) from baseline (week 0) to 78 weeks (end of treatment) within each treatment group (the liraglutide -\> liraglutide group and the exenatide -\> liraglutide group)., week 0, week 78|Change in Apolipoprotein B at Week 26, Change in apolipoprotein B (ApoB) from baseline (week 0) to 26 weeks (end of randomisation), week 0, week 26|Change in Apolipoprotein B, Weeks 26-78, Change in apolipoprotein B (ApoB) from Week 26 (end of randomisation) to Week 78 (end of treatment) within each treatment group (the liraglutide -\> liraglutide group and the exenatide -\> liraglutide group)., week 26, week 78|Change in Apolipoprotein B at Week 78, Change in apolipoprotein B (ApoB) from baseline (week 0) to 78 weeks (end of treatment) within each treatment group (the liraglutide -\> liraglutide group and the exenatide -\> liraglutide group)., week 0, week 78|Hypoglycaemic Episodes at Week 26, Total number of hypoglycaemic episodes occurring after baseline (week 0) and until week 26 (end of randomisation). 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 3.1 mmol/L. Symptoms only if subject was able to treat her/himself and with no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L., weeks 0-26|Hypoglyceamic Episodes, Weeks 26-78, Total number of hypoglycaemic episodes occurring after end of randomisation (week 26) and until week 78 (end of treatment). 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 3.1 mmol/L. Symptoms only if subject was able to treat her/himself and with no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L., weeks 26-78
Sponsor/Collaborators: Sponsor: Novo Nordisk A/S
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 467
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2007-08
Completion Date: 2009-04
Results First Posted: 2010-03-23
Last Update Posted: 2017-03-08
Locations: Novo Nordisk Investigational Site, Birmingham, Alabama, 35242, United States|Novo Nordisk Investigational Site, Goodyear, Arizona, 85395, United States|Novo Nordisk Investigational Site, Artesia, California, 90701, United States|Novo Nordisk Investigational Site, Encino, California, 91436, United States|Novo Nordisk Investigational Site, Escondido, California, 92025, United States|Novo Nordisk Investigational Site, Los Angeles, California, 90057, United States|Novo Nordisk Investigational Site, Orange, California, 92869, United States|Novo Nordisk Investigational Site, Sacramento, California, 95816, United States|Novo Nordisk Investigational Site, San Mateo, California, 94401, United States|Novo Nordisk Investigational Site, Spring Valley, California, 91978, United States|Novo Nordisk Investigational Site, Walnut Creek, California, 94598, United States|Novo Nordisk Investigational Site, Fort Myers, Florida, 33907, United States|Novo Nordisk Investigational Site, Hollywood, Florida, 33023, United States|Novo Nordisk Investigational Site, Jacksonville, Florida, 32205, United States|Novo Nordisk Investigational Site, Jacksonville, Florida, 32216, United States|Novo Nordisk Investigational Site, Jacksonville, Florida, 32259, United States|Novo Nordisk Investigational Site, Longwood, Florida, 32779, United States|Novo Nordisk Investigational Site, Ocala, Florida, 34471, United States|Novo Nordisk Investigational Site, Pembroke Pines, Florida, 33029, United States|Novo Nordisk Investigational Site, Plantation, Florida, 33324, United States|Novo Nordisk Investigational Site, St. Cloud, Florida, 34769, United States|Novo Nordisk Investigational Site, Atlanta, Georgia, 30318, United States|Novo Nordisk Investigational Site, Powder Springs, Georgia, 30127, United States|Novo Nordisk Investigational Site, Roswell, Georgia, 30076, United States|Novo Nordisk Investigational Site, Idaho Falls, Idaho, 83404-7596, United States|Novo Nordisk Investigational Site, Chicago, Illinois, 60616, United States|Novo Nordisk Investigational Site, Peoria, Illinois, 61615, United States|Novo Nordisk Investigational Site, Evansville, Indiana, 47714, United States|Novo Nordisk Investigational Site, Des Moines, Iowa, 50314-3027, United States|Novo Nordisk Investigational Site, New Orleans, Louisiana, 70121, United States|Novo Nordisk Investigational Site, Minneapolis, Minnesota, 55416, United States|Novo Nordisk Investigational Site, St. Paul, Minnesota, 55108, United States|Novo Nordisk Investigational Site, St. Peters, Missouri, 63376, United States|Novo Nordisk Investigational Site, Flemington, New Jersey, 08822, United States|Novo Nordisk Investigational Site, South Bound Brook, New Jersey, 08880, United States|Novo Nordisk Investigational Site, Northport, New York, 11768, United States|Novo Nordisk Investigational Site, Chapel Hill, North Carolina, 27517, United States|Novo Nordisk Investigational Site, Canton, Ohio, 44718, United States|Novo Nordisk Investigational Site, Cincinnati, Ohio, 45206, United States|Novo Nordisk Investigational Site, Dayton, Ohio, 45439, United States|Novo Nordisk Investigational Site, Kettering, Ohio, 45429, 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, Altoona, Pennsylvania, 16602, United States|Novo Nordisk Investigational Site, Philadelphia, Pennsylvania, 19152, United States|Novo Nordisk Investigational Site, Pittsburgh, Pennsylvania, 15213, United States|Novo Nordisk Investigational Site, Sumter, South Carolina, 29150, United States|Novo Nordisk Investigational Site, Chattanooga, Tennessee, 37404, United States|Novo Nordisk Investigational Site, Austin, Texas, 78731, United States|Novo Nordisk Investigational Site, Corpus Christi, Texas, 78412, 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, 77030, 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, Newport News, Virginia, 23606, United States|Novo Nordisk Investigational Site, Richmond, Virginia, 23294, United States|Novo Nordisk Investigational Site, Olympia, Washington, 98502, United States|Novo Nordisk Investigational Site, Spokane, Washington, 99218, United States|Novo Nordisk Investigational Site, Milwaukee, Wisconsin, 53209, United States|Novo Nordisk Investigational Site, Graz, 8036, Austria|Novo Nordisk Investigational Site, Wien, 1030, Austria|Novo Nordisk Investigational Site, Wien, 1130, Austria|Novo Nordisk Investigational Site, Aalborg, 9000, Denmark|Novo Nordisk Investigational Site, Gentofte, 2820, Denmark|Novo Nordisk Investigational Site, Hvidovre, 2650, Denmark|Novo Nordisk Investigational Site, Odense, 5000, Denmark|Novo Nordisk Investigational Site, Århus C, 8000, Denmark|Novo Nordisk Investigational Site, Helsinki, 00029, Finland|Novo Nordisk Investigational Site, Lahti, 15110, Finland|Novo Nordisk Investigational Site, Oulu, FI-90100, Finland|Novo Nordisk Investigational Site, Antibes, 06600, France|Novo Nordisk Investigational Site, Dommartin Les Toul, 54201, France|Novo Nordisk Investigational Site, LA ROCHELLE cedex, 17019, France|Novo Nordisk Investigational Site, Narbonne, 11108, France|Novo Nordisk Investigational Site, NEVERS cedex, 58033, France|Novo Nordisk Investigational Site, Bochum, 44791, Germany|Novo Nordisk Investigational Site, Dreieich-Sprendlingen, 63303, Germany|Novo Nordisk Investigational Site, Falkensee, 14612, Germany|Novo Nordisk Investigational Site, Frankfurt, 60388, Germany|Novo Nordisk Investigational Site, Hamburg, 22607, Germany|Novo Nordisk Investigational Site, Hannover, 30625, Germany|Novo Nordisk Investigational Site, Herrenberg, 71083, Germany|Novo Nordisk Investigational Site, Lampertheim, 68623, Germany|Novo Nordisk Investigational Site, Ludwigshafen, 67059, Germany|Novo Nordisk Investigational Site, Marburg, 35039, Germany|Novo Nordisk Investigational Site, Pohlheim, 35415, Germany|Novo Nordisk Investigational Site, Rehlingen-Siersburg, 66780, Germany|Novo Nordisk Investigational Site, Speyer, 67346, Germany|Novo Nordisk Investigational Site, Tübingen, 72072, Germany|Novo Nordisk Investigational Site, Dublin 24, Ireland|Novo Nordisk Investigational Site, Dublin 9, Ireland|Novo Nordisk Investigational Site, Dublin, DUBLIN 7, Ireland|Novo Nordisk Investigational Site, Dublin, DUBLIN 8, Ireland|Novo Nordisk Investigational Site, Skopje, 1000, Macedonia, The Former Yugoslav Republic of|Novo Nordisk Investigational Site, Bergen, 5021, Norway|Novo Nordisk Investigational Site, Bergen, NO-5012, Norway|Novo Nordisk Investigational Site, Stavanger, 4011, Norway|Novo Nordisk Investigational Site, Trondheim, NO-7030, Norway|Novo Nordisk Investigational Site, Bydgoszcz, 85-822, Poland|Novo Nordisk Investigational Site, Gniewkowo, 88-140, Poland|Novo Nordisk Investigational Site, Krakow, 31-501, Poland|Novo Nordisk Investigational Site, Lublin, 20-081, Poland|Novo Nordisk Investigational Site, Poznan, 60-821, Poland|Novo Nordisk Investigational Site, Tychy, 43-100, Poland|Novo Nordisk Investigational Site, Warszawa, 01-911, Poland|Novo Nordisk Investigational Site, Wroclaw, 50-127, Poland|Novo Nordisk Investigational Site, Zabrze, 41-800, Poland|Novo Nordisk Investigational Site, Manati, 00674, Puerto Rico|Novo Nordisk Investigational Site, Alba Iulia, Alba, 510053, Romania|Novo Nordisk Investigational Site, Resita, 320076, Romania|Novo Nordisk Investigational Site, Suceava, 720237, Romania|Novo Nordisk Investigational Site, Koper, SI-6000, Slovenia|Novo Nordisk Investigational Site, Ljubljana, 1525, Slovenia|Novo Nordisk Investigational Site, Novo mesto, 8000, Slovenia|Novo Nordisk Investigational Site, Hospitalet de Llobregat, 08907, Spain|Novo Nordisk Investigational Site, Oviedo, 33006, Spain|Novo Nordisk Investigational Site, Palma de Mallorca, 07010, Spain|Novo Nordisk Investigational Site, Puerto del Rosario, 35600, Spain|Novo Nordisk Investigational Site, Stockholm, 141 86, Sweden|Novo Nordisk Investigational Site, Stockholm, 171 76, Sweden|Novo Nordisk Investigational Site, Basel, 4031, Switzerland|Novo Nordisk Investigational Site, Bern, 3010, Switzerland|Novo Nordisk Investigational Site, Genève 14, 1211, Switzerland|Novo Nordisk Investigational Site, Lugano, 6900, Switzerland
URL: https://clinicaltrials.gov/show/NCT00518882