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Clinical Trial Details

Trial ID: L6556
Source ID: NCT03078478
Associated Drug: Insulin Degludec
Title: A Trial Comparing the Efficacy and Safety of Insulin Degludec and Insulin Glargine 300 Units/mL in Subjects With Type 2 Diabetes Mellitus Inadequately Treated With Basal Insulin With or Without Oral Antidiabetic Drugs
Acronym: CONCLUDE
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT03078478/results
Conditions: Diabetes|Diabetes Mellitus, Type 2
Interventions: DRUG: Insulin degludec|DRUG: Insulin glargine
Outcome Measures: Primary: Number of Severe or BG-confirmed Symptomatic Hypoglycaemic Episodes During Maintenance 2 (36 Weeks), Severe or BG confirmed symptomatic hypoglycaemia was evaluated during maintenance 2 (36 weeks) period. Severe or BG confirmed symptomatic hypoglycaemia: An episode that is severe according to the ADA 2013 classification or blood glucose (BG) confirmed by a plasma glucose value \<3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia. The observed rates (number of episodes divided by patient years of exposure multiplied by 100) of severe or BG-confirmed symptomatic hypoglycaemic episodes per patient years of exposure (PYE) is presented in this endpoint results., 36 Weeks | Secondary: Basal Insulin Dose (U) at End of Treatment (up to 88 Weeks), The observed mean daily basal insulin doses was evaluated at the end of trial (88 weeks)., 88 weeks|Number of Nocturnal, Severe or BG-confirmed Symptomatic Hypoglycaemic Episodes During Maintenance 2 (36 Weeks), Nocturnal severe or BG confirmed symptomatic hypoglycaemia was evaluated during maintenance 2 (36 weeks). The nocturnal period defined as the period between 00:01 and 05:59 a.m. (both inclusive). Severe or BG confirmed symptomatic hypoglycaemia: An episode that is severe according to the ADA 2013 classification or blood glucose (BG) confirmed by a plasma glucose value \<3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia. The observed rates (number of episodes divided by patient years of exposure multiplied by 100) of severe or BG-confirmed symptomatic hypoglycaemic episodes per patient years of exposure (PYE) is presented in this endpoint results., 36 weeks|Number of Severe Hypoglycaemic Episodes During Maintenance 2 (36 Weeks), Severe hypoglycaemia are those episodes positively adjudicated by the event adjudication committee according to the ADA definition of a severe hypoglycaemic episode. This was evaluated for maintenance 2 period. The observed rates (number of episodes divided by patient years of exposure multiplied by 100) of severe hypoglycaemic episodes per patient years of exposure (PYE) is presented in this endpoint results., 36 weeks (maintenance 2)|Change in HbA1c From Baseline to End of Treatment (up to 88 Weeks), Change in glycosylated haemoglobin (HbA1c) was evaluated from baseline to end of treatment period (week 88)., Week 0, week 88|Change in Fasting Plasma Glucose (FPG) From Baseline to End of Treatment (up to 88 Weeks), Change in fasting plasma glucose (FPG) was evaluated from baseline to end of treatment period (week 88)., Week 0, week 88|Percentage of Participants With FPG ≤ 7.2 mmol/L (130 mg/dL) at End of Treatment (up to 88 Weeks) (Yes/no), Participants achieving a fasting plasma glucose value of less than or equal to 7.2 mmol/L (130 mg/dL) at end of treatment (up to 88 weeks)., At 88 weeks|Percentage of Participants With FPG ≤ 5.0 mmol/L (90 mg/dL) at End of Treatment (up to 88 Weeks) (Yes/no), Participants achieving a fasting plasma glucose value of less than or equal to 5.0 mmol/L (90 mg/dL) at end of treatment (up to 88 weeks)., At 88 weeks|Percentage of Participants With HbA1c < 7.0% (53 mmol/Mol) at End of Treatment (up to 88 Weeks) and no Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes During Maintenance 2 (36 Weeks) (Yes/no), Participants achieving target HbA1c of less than 7.0% at the end of treatment (88 weeks) without severe or BG-confirmed hypoglycaemia during maintenance 2 (36 weeks)., End of Treatment (up to 88 Weeks)|Percentage of Participants With HbA1c < 7.0% (53 mmol/Mol) at End of Treatment (up to 88 Weeks) and no Nocturnal, Severe or BG-confirmed Symptomatic Hypoglycaemic Episodes During Maintenance 2 (36 Weeks) (Yes/no), Participants achieving target HbA1c of less than 7.0% at the end of treatment (88 weeks) without nocturnal severe or BG-confirmed hypoglycaemia during maintenance 2 (36 weeks)., At 88 weeks|Change in Mean Pre-breakfast Self-measured Plasma Glucose Used for Titration From Baseline to End of Treatment (up to 88 Weeks), Participants measured their pre-breakfast self-measured plasma glucose (SMPG) value until end of treatment (week 88). Mean pre-breakfast self-measured plasma glucose used for titration at baseline and end of treatment (up to 88 weeks) are presented., Week 0, week 88|Number of Severe or BG-confirmed Symptomatic Hypoglycaemic Episodes During Treatment (up to 88 Weeks), Severe or BG confirmed symptomatic hypoglycaemia was evaluated during treatment (up to 88 weeks). Severe or BG confirmed symptomatic hypoglycaemia: An episode that is severe according to the ADA 2013 classification or blood glucose (BG) confirmed by a plasma glucose value \<3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia. The observed rates (number of episodes divided by patient years of exposure multiplied by 100) of severe or BG-confirmed symptomatic hypoglycaemic episodes per patient years of exposure (PYE) is presented in this endpoint results., 88 weeks|Number of Nocturnal, Severe or BG-confirmed Symptomatic Hypoglycaemic Episodes During Treatment (up to 88 Weeks), Nocturnal severe or BG confirmed symptomatic hypoglycaemia was evaluated at the end of trial (88 weeks). The nocturnal period defined as the period between 00:01 and 05:59 a.m. (both inclusive). Severe or BG confirmed symptomatic hypoglycaemia: An episode that is severe according to the ADA 2013 classification or blood glucose (BG) confirmed by a plasma glucose value \<3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia. The observed rates (number of episodes divided by patient years of exposure multiplied by 100) of severe or BG-confirmed symptomatic hypoglycaemic episodes per patient years of exposure (PYE) is presented in this endpoint results., 88 weeks|Number of Severe Hypoglycaemic Episodes During Treatment (up to 88 Weeks), Severe hypoglycaemia are those episodes positively adjudicated by the event adjudication committee according to the ADA definition of a severe hypoglycaemic episode. This was evaluated for the total trial period (88 weeks). The observed rates (number of episodes divided by patient years of exposure multiplied by 100) of severe hypoglycaemic episodes per patient years of exposure (PYE) is presented in this endpoint results., 88 weeks|Number of Adverse Events From Randomisation to End of Maintenance Period 2 (up to 88 Weeks), The adverse events presented are treatment emergent. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment. Number of adverse events expressed in rates, from randomisation to end of maintenance period 2 (up to 88 weeks) is presented. Rate = number of events divided by patient years of exposure multiplied by 100., 88 weeks|Change in Body Weight From Baseline to End of Treatment (up to 88 Weeks), Change in body weight, measured in kilograms, from baseline (week 0) to end of treatment (week 88)., Week 0, week 88
Sponsor/Collaborators: Sponsor: Novo Nordisk A/S
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 1609
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2017-03-13
Completion Date: 2019-03-04
Results First Posted: 2020-03-12
Last Update Posted: 2022-01-11
Locations: Novo Nordisk Investigational Site, Anniston, Alabama, 36207, United States|Novo Nordisk Investigational Site, Birmingham, Alabama, 35211, United States|Novo Nordisk Investigational Site, Chandler, Arizona, 85224, United States|Novo Nordisk Investigational Site, Fountain Hills, Arizona, 85268, United States|Novo Nordisk Investigational Site, Glendale, Arizona, 85306-4652, United States|Novo Nordisk Investigational Site, Glendale, Arizona, 85306, United States|Novo Nordisk Investigational Site, Glendale, Arizona, 85308, United States|Novo Nordisk Investigational Site, Phoenix, Arizona, 85037, United States|Novo Nordisk Investigational Site, Tucson, Arizona, 85741, United States|Novo Nordisk Investigational Site, Buena Park, California, 90620, United States|Novo Nordisk Investigational Site, Concord, California, 94520, United States|Novo Nordisk Investigational Site, Downey, California, 90242, United States|Novo Nordisk Investigational Site, Duarte, California, 91010, United States|Novo Nordisk Investigational Site, Fresno, California, 93720, United States|Novo Nordisk Investigational Site, La Jolla, California, 92037, United States|Novo Nordisk Investigational Site, Lancaster, California, 93534, United States|Novo Nordisk Investigational Site, Lomita, California, 90717, United States|Novo Nordisk Investigational Site, Los Alamitos, California, 90720, United States|Novo Nordisk Investigational Site, Los Angeles, California, 90057, United States|Novo Nordisk Investigational Site, Moreno Valley, California, 92555, United States|Novo Nordisk Investigational Site, Northridge, California, 91325, United States|Novo Nordisk Investigational Site, Palm Springs, California, 92262, United States|Novo Nordisk Investigational Site, Pomona, California, 91766-2007, United States|Novo Nordisk Investigational Site, Poway, California, 92064, United States|Novo Nordisk Investigational Site, Riverside, California, 92506, United States|Novo Nordisk Investigational Site, Roseville, California, 95661, United States|Novo Nordisk Investigational Site, Sacramento, California, 95821, United States|Novo Nordisk Investigational Site, San Mateo, California, 94401, United States|Novo Nordisk Investigational Site, San Ramon, California, 94583, United States|Novo Nordisk Investigational Site, Stanford, California, 94305, United States|Novo Nordisk Investigational Site, Vista, California, 92083, United States|Novo Nordisk Investigational Site, Walnut Creek, California, 94598, United States|Novo Nordisk Investigational Site, West Hills, California, 91304, United States|Novo Nordisk Investigational Site, Colorado Springs, Colorado, 80918, United States|Novo Nordisk Investigational Site, Englewood, Colorado, 80113, United States|Novo Nordisk Investigational Site, Waterbury, Connecticut, 06708, United States|Novo Nordisk Investigational Site, Bradenton, Florida, 34201, United States|Novo Nordisk Investigational Site, Brandon, Florida, 33511, United States|Novo Nordisk Investigational Site, Clearwater, Florida, 33765, United States|Novo Nordisk Investigational Site, Cooper City, Florida, 33024, United States|Novo Nordisk Investigational Site, Jacksonville, Florida, 32258, United States|Novo Nordisk Investigational Site, Jacksonville, Florida, 32277, United States|Novo Nordisk Investigational Site, Miami Springs, Florida, 33166, United States|Novo Nordisk Investigational Site, Miami, Florida, 33175, United States|Novo Nordisk Investigational Site, New Port Richey, Florida, 34652, United States|Novo Nordisk Investigational Site, Orlando, Florida, 32825, United States|Novo Nordisk Investigational Site, Ormond Beach, Florida, 32174, United States|Novo Nordisk Investigational Site, Palm Harbor, Florida, 34684-3609, United States|Novo Nordisk Investigational Site, Pembroke Pines, Florida, 33027, United States|Novo Nordisk Investigational Site, Port Charlotte, Florida, 33952, United States|Novo Nordisk Investigational Site, Tampa, Florida, 33606, United States|Novo Nordisk Investigational Site, Marietta, Georgia, 30067, United States|Novo Nordisk Investigational Site, Roswell, Georgia, 30076, United States|Novo Nordisk Investigational Site, Honolulu, Hawaii, 96814, United States|Novo Nordisk Investigational Site, Blackfoot, Idaho, 83221, United States|Novo Nordisk Investigational Site, Chicago, Illinois, 60607, United States|Novo Nordisk Investigational Site, Gurnee, Illinois, 60031, United States|Novo Nordisk Investigational Site, Peoria, Illinois, 61603, United States|Novo Nordisk Investigational Site, Skokie, Illinois, 60077, United States|Novo Nordisk Investigational Site, Springfield, Illinois, 62711, United States|Novo Nordisk Investigational Site, Wauconda, Illinois, 60084, United States|Novo Nordisk Investigational Site, Evansville, Indiana, 47713, United States|Novo Nordisk Investigational Site, Mishawaka, Indiana, 46544, United States|Novo Nordisk Investigational Site, Valparaiso, Indiana, 46383, United States|Novo Nordisk Investigational Site, Council Bluffs, Iowa, 51501, United States|Novo Nordisk Investigational Site, West Des Moines, Iowa, 50265, United States|Novo Nordisk Investigational Site, Topeka, Kansas, 66606, United States|Novo Nordisk Investigational Site, Lexington, Kentucky, 40502, United States|Novo Nordisk Investigational Site, Lexington, Kentucky, 40503, United States|Novo Nordisk Investigational Site, Louisville, Kentucky, 40213, United States|Novo Nordisk Investigational Site, Paducah, Kentucky, 42001, United States|Novo Nordisk Investigational Site, New Orleans, Louisiana, 70119, United States|Novo Nordisk Investigational Site, Rockville, Maryland, 20852, United States|Novo Nordisk Investigational Site, Bloomfield Hills, Michigan, 48302, United States|Novo Nordisk Investigational Site, Richfield, Minnesota, 55432, United States|Novo Nordisk Investigational Site, Chesterfield, Missouri, 63017, United States|Novo Nordisk Investigational Site, Kalispell, Montana, 59901, United States|Novo Nordisk Investigational Site, Elkhorn, Nebraska, 68022, United States|Novo Nordisk Investigational Site, Fremont, Nebraska, 68025, United States|Novo Nordisk Investigational Site, Omaha, Nebraska, 68144, United States|Novo Nordisk Investigational Site, Henderson, Nevada, 89052, United States|Novo Nordisk Investigational Site, Las Vegas, Nevada, 89109, United States|Novo Nordisk Investigational Site, Las Vegas, Nevada, 89118, United States|Novo Nordisk Investigational Site, Las Vegas, Nevada, 89148, United States|Novo Nordisk Investigational Site, Nashua, New Hampshire, 03063, United States|Novo Nordisk Investigational Site, East Brunswick, New Jersey, 08816, United States|Novo Nordisk Investigational Site, Lawrenceville, New Jersey, 08648, United States|Novo Nordisk Investigational Site, Albuquerque, New Mexico, 87102, United States|Novo Nordisk Investigational Site, Albuquerque, New Mexico, 87109-2134, United States|Novo Nordisk Investigational Site, Albany, New York, 12203, United States|Novo Nordisk Investigational Site, New Windsor, New York, 12553, United States|Novo Nordisk Investigational Site, New York, New York, 10016, United States|Novo Nordisk Investigational Site, Northport, New York, 11768, United States|Novo Nordisk Investigational Site, West Seneca, New York, 14224, United States|Novo Nordisk Investigational Site, Charlotte, North Carolina, 28210, United States|Novo Nordisk Investigational Site, Charlotte, North Carolina, 28277, United States|Novo Nordisk Investigational Site, Greensboro, North Carolina, 27408, United States|Novo Nordisk Investigational Site, Greenville, North Carolina, 27834, United States|Novo Nordisk Investigational Site, Greenville, North Carolina, 27858, United States|Novo Nordisk Investigational Site, Morehead City, North Carolina, 28557-4346, United States|Novo Nordisk Investigational Site, Statesville, North Carolina, 28625, United States|Novo Nordisk Investigational Site, Wilmington, North Carolina, 28401, United States|Novo Nordisk Investigational Site, Columbus, Ohio, 43212, United States|Novo Nordisk Investigational Site, Columbus, Ohio, 43213, United States|Novo Nordisk Investigational Site, Maumee, Ohio, 43537, United States|Novo Nordisk Investigational Site, Toledo, Ohio, 43614, United States|Novo Nordisk Investigational Site, Norman, Oklahoma, 73069, United States|Novo Nordisk Investigational Site, Beaver, Pennsylvania, 15009, United States|Novo Nordisk Investigational Site, McMurray, Pennsylvania, 15317, United States|Novo Nordisk Investigational Site, Philadelphia, Pennsylvania, 19114, United States|Novo Nordisk Investigational Site, Anderson, South Carolina, 29621, United States|Novo Nordisk Investigational Site, Gaffney, South Carolina, 29341, United States|Novo Nordisk Investigational Site, Greenville, South Carolina, 29615, United States|Novo Nordisk Investigational Site, Greer, South Carolina, 29651, United States|Novo Nordisk Investigational Site, Mount Pleasant, South Carolina, 29464, United States|Novo Nordisk Investigational Site, Pelzer, South Carolina, 29669, United States|Novo Nordisk Investigational Site, West Columbia, South Carolina, 29169, United States|Novo Nordisk Investigational Site, Dakota Dunes, South Dakota, 57049, United States|Novo Nordisk Investigational Site, Bristol, Tennessee, 37620-7352, United States|Novo Nordisk Investigational Site, Chattanooga, Tennessee, 37404, United States|Novo Nordisk Investigational Site, Chattanooga, Tennessee, 37411, United States|Novo Nordisk Investigational Site, Kingsport, Tennessee, 37660, United States|Novo Nordisk Investigational Site, Knoxville, Tennessee, 37909, United States|Novo Nordisk Investigational Site, Nashville, Tennessee, 37203, United States|Novo Nordisk Investigational Site, Nashville, Tennessee, 37232, United States|Novo Nordisk Investigational Site, Amarillo, Texas, 79106, United States|Novo Nordisk Investigational Site, Arlington, Texas, 76012-4637, United States|Novo Nordisk Investigational Site, Austin, Texas, 78731, United States|Novo Nordisk Investigational Site, Dallas, Texas, 75226, United States|Novo Nordisk Investigational Site, Dallas, Texas, 75390-9302, United States|Novo Nordisk Investigational Site, Fort Worth, Texas, 76132, United States|Novo Nordisk Investigational Site, Houston, Texas, 77024, United States|Novo Nordisk Investigational Site, Houston, Texas, 77066, United States|Novo Nordisk Investigational Site, Humble, Texas, 77338, United States|Novo Nordisk Investigational Site, Kerrville, Texas, 78028, United States|Novo Nordisk Investigational Site, New Braunfels, Texas, 78130, United States|Novo Nordisk Investigational Site, Plano, Texas, 75075, United States|Novo Nordisk Investigational Site, San Antonio, Texas, 78215, United States|Novo Nordisk Investigational Site, San Antonio, Texas, 78224, United States|Novo Nordisk Investigational Site, San Antonio, Texas, 78228-6205, United States|Novo Nordisk Investigational Site, San Antonio, Texas, 78229, United States|Novo Nordisk Investigational Site, San Antonio, Texas, 78249, United States|Novo Nordisk Investigational Site, Waco, Texas, 76710, United States|Novo Nordisk Investigational Site, Bountiful, Utah, 84010, United States|Novo Nordisk Investigational Site, Murray, Utah, 84123, United States|Novo Nordisk Investigational Site, Ogden, Utah, 84405, United States|Novo Nordisk Investigational Site, Bennington, Vermont, 05201, United States|Novo Nordisk Investigational Site, Chesapeake, Virginia, 23321, United States|Novo Nordisk Investigational Site, Midlothian, Virginia, 23114, United States|Novo Nordisk Investigational Site, Norfolk, Virginia, 23510-2015, United States|Novo Nordisk Investigational Site, Richmond, Virginia, 23219, United States|Novo Nordisk Investigational Site, Virginia Beach, Virginia, 23454, United States|Novo Nordisk Investigational Site, Olympia, Washington, 98502, United States|Novo Nordisk Investigational Site, Spokane, Washington, 99201, United States|Novo Nordisk Investigational Site, Kenosha, Wisconsin, 53144, United States|Novo Nordisk Investigational Site, West Allis, Wisconsin, 53227, United States|Novo Nordisk Investigational Site, Calgary, Alberta, T2H 2G4, Canada|Novo Nordisk Investigational Site, Brampton, Ontario, L6S 0C6, Canada|Novo Nordisk Investigational Site, Etobicoke, Ontario, M9R 4E1, Canada|Novo Nordisk Investigational Site, Hamilton, Ontario, L8N 3Z5, Canada|Novo Nordisk Investigational Site, Markham, Ontario, L3P 7P2, Canada|Novo Nordisk Investigational Site, Oakville, Ontario, L6M 1M1, Canada|Novo Nordisk Investigational Site, Toronto, Ontario, M4G 3E8, Canada|Novo Nordisk Investigational Site, Mirabel, Quebec, J7J 2K8, Canada|Novo Nordisk Investigational Site, Sherbrooke, Quebec, J1L 0H8, Canada|Novo Nordisk Investigational Site, Aarhus N, 8200, Denmark|Novo Nordisk Investigational Site, Esbjerg, 6700, Denmark|Novo Nordisk Investigational Site, Hellerup, 2900, Denmark|Novo Nordisk Investigational Site, Hillerød, 3400, Denmark|Novo Nordisk Investigational Site, Hvidovre, 2650, Denmark|Novo Nordisk Investigational Site, Odense, 5000, Denmark|Novo Nordisk Investigational Site, Pärnu, 80018, Estonia|Novo Nordisk Investigational Site, Tallinn, 10138, Estonia|Novo Nordisk Investigational Site, Tallinn, 13419, Estonia|Novo Nordisk Investigational Site, Viljandi, 71024, Estonia|Novo Nordisk Investigational Site, Bad Mergentheim, 97980, Germany|Novo Nordisk Investigational Site, Berlin, 13597, Germany|Novo Nordisk Investigational Site, Elsterwerda, 04910, Germany|Novo Nordisk Investigational Site, Essen, 45136, Germany|Novo Nordisk Investigational Site, Essen, 45219, Germany|Novo Nordisk Investigational Site, Falkensee, 14612, Germany|Novo Nordisk Investigational Site, Friedrichsthal, 66299, Germany|Novo Nordisk Investigational Site, Hamburg, 22041, Germany|Novo Nordisk Investigational Site, Hamburg, 22607, Germany|Novo Nordisk Investigational Site, Lingen, 49808, Germany|Novo Nordisk Investigational Site, Rehlingen-Siersburg, 66780, Germany|Novo Nordisk Investigational Site, Saint Ingbert-Oberwürzbach, 66386, Germany|Novo Nordisk Investigational Site, Athens, GR-115 27, Greece|Novo Nordisk Investigational Site, Athens, GR-11527, Greece|Novo Nordisk Investigational Site, Larissa, GR-41110, Greece|Novo Nordisk Investigational Site, Nikaia, GR-18454, Greece|Novo Nordisk Investigational Site, Thessaloniki, GR-54642, Greece|Novo Nordisk Investigational Site, Thessaloniki, GR-57001, Greece|Novo Nordisk Investigational Site, Thessaloniki, GR-57010, Greece|Novo Nordisk Investigational Site, Budapest, 1089, Hungary|Novo Nordisk Investigational Site, Budapest, 1125, Hungary|Novo Nordisk Investigational Site, Budapest, 1131, Hungary|Novo Nordisk Investigational Site, Budapest, H-1083, Hungary|Novo Nordisk Investigational Site, Debrecen, 4043, Hungary|Novo Nordisk Investigational Site, Debrecen, H-4032, Hungary|Novo Nordisk Investigational Site, Kaposvár, 7400, Hungary|Novo Nordisk Investigational Site, Szeged, H-6725, Hungary|Novo Nordisk Investigational Site, Szombathely, H-9700, Hungary|Novo Nordisk Investigational Site, Hamar, 2318, Norway|Novo Nordisk Investigational Site, Hoenefoss, 3515, Norway|Novo Nordisk Investigational Site, Oslo, 0176, Norway|Novo Nordisk Investigational Site, Oslo, 0373, Norway|Novo Nordisk Investigational Site, Oslo, 0424, Norway|Novo Nordisk Investigational Site, Skedsmokorset, NO-2020, Norway|Novo Nordisk Investigational Site, Trondheim, 7030, Norway|Novo Nordisk Investigational Site, Bialystok, 15-445, Poland|Novo Nordisk Investigational Site, Bytom, 41-902, Poland|Novo Nordisk Investigational Site, Gdansk, 80-546, Poland|Novo Nordisk Investigational Site, Gdansk, 80-858, Poland|Novo Nordisk Investigational Site, Lublin, 20-362, Poland|Novo Nordisk Investigational Site, Lublin, 20-538, Poland|Novo Nordisk Investigational Site, Szczecin, 70-506, Poland|Novo Nordisk Investigational Site, Warsaw, 00-465, Poland|Novo Nordisk Investigational Site, Zabrze, 41-800, Poland|Novo Nordisk Investigational Site, Manati, 00674, Puerto Rico|Novo Nordisk Investigational Site, Ponce, 00716, Puerto Rico|Novo Nordisk Investigational Site, Oradea, Bihor, 410469, Romania|Novo Nordisk Investigational Site, Bucharest, 022441, Romania|Novo Nordisk Investigational Site, Bucharest, 13682, Romania|Novo Nordisk Investigational Site, Buzau, 120203, Romania|Novo Nordisk Investigational Site, Galati, 800578, Romania|Novo Nordisk Investigational Site, Belgrade, 11000, Serbia|Novo Nordisk Investigational Site, Belgrade, 11080, Serbia|Novo Nordisk Investigational Site, Nis, 18000, Serbia
URL: https://clinicaltrials.gov/show/NCT03078478