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Clinical Trial Details

Trial ID: L5746
Source ID: NCT02128932
Associated Drug: Semaglutide
Title: Efficacy and Safety of Semaglutide Once Weekly Versus Insulin Glargine Once Daily as add-on to Metformin With or Without Sulphonylurea in Insulin-naïve Subjects With Type 2 Diabetes
Acronym: SUSTAIN™ 4
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT02128932/results
Conditions: Diabetes|Diabetes Mellitus, Type 2
Interventions: DRUG: semaglutide|DRUG: insulin glargine
Outcome Measures: Primary: Change in HbA1c From Baseline, Change in HbA1c from baseline to week 30., Week 0, week 30 | Secondary: Change in Body Weight From Baseline, Change in body weight from baseline to week 30., Week 0, week 30|Change in Fasting Plasma Glucose From Baseline, Change in fasting plasma glucose from baseline to week 30., Week 0, week 30|Change in Diastolic Blood Pressure., Change in diastolic blood pressure from baseline to week 30., Week 0, week 30|Change in Systolic Blood Pressure., Change in systolic blood pressure from baseline to week 30., Week 0, week 30|Change in Patient Reported Outcome (PRO) Questionnaire, Questionnaire SF-36v2™, The Short Form (SF)-36v2™ patient reported outcomes (PRO) questionnaire was used to assess the subject's overall health related quality of life (HRQoL. PRO questionnaire (SF-36v2™) measured the HRQoL on 8 domains on individual scale ranges. The scores 0-100 (where higher scores indicated a better HRQoL) from the SF-36 were converted to a norm-based score using a T-score transformation in order to obtain a direct interpretation in relation to the distribution of the scores in the 1998 U.S. general population. The (SF-36v2™) values displayed are the estimated mean change from baseline to week 30., Week 0, week 30|Change in Patient Reported Outcome Questionnaires. (PROs), Diabetes Treatment Satisfaction Questionnaire (DTSQs), The Diabetes Treatment Satisfaction Questionnaire (DTSQs) questionnaire was to be used to assess a subject's treatment satisfaction. This questionnaire contained 8 components and measured the treatment for diabetes (including insulin, tablets and/or diet) in terms of convenience, flexibility and general feelings regarding treatment. The value presented is the 'Treatment Satisfaction' summary score, which is the sum of 6 of the 8 items of the DTSQs questionnaire. Response options range from 6 (best case) to 0 (worst case). Total scores for treatment satisfaction range from 0-36. Higher scores indicate higher satisfaction. The values displayed are the estimated mean change from baseline to week 30., Week 0, week 30|Subjects Who Achieve HbA1c ≤6.5% (48 mmol/Mol), American Association of Clinical Endocrinologists (AACE), Subjects who achieve HbA1c ≤6.5% (48 mmol/mol), American Association of Clinical Endocrinologists (AACE) after 30 weeks of treatment, After 30 weeks treatment
Sponsor/Collaborators: Sponsor: Novo Nordisk A/S
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 1089
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2014-08-04
Completion Date: 2015-09-03
Results First Posted: 2018-03-08
Last Update Posted: 2019-06-13
Locations: Novo Nordisk Investigational Site, Birmingham, Alabama, 35216, United States|Novo Nordisk Investigational Site, Ozark, Alabama, 36360, United States|Novo Nordisk Investigational Site, Tuscumbia, Alabama, 35674, United States|Novo Nordisk Investigational Site, Gilbert, Arizona, 85295, United States|Novo Nordisk Investigational Site, Phoenix, Arizona, 85018, United States|Novo Nordisk Investigational Site, Phoenix, Arizona, 85032, United States|Novo Nordisk Investigational Site, Anaheim, California, 92801, United States|Novo Nordisk Investigational Site, Carmichael, California, 95608, United States|Novo Nordisk Investigational Site, Chula Vista, California, 91911, United States|Novo Nordisk Investigational Site, Elk Grove, California, 95758, United States|Novo Nordisk Investigational Site, Inglewood, California, 90301, United States|Novo Nordisk Investigational Site, La Mesa, California, 91942, United States|Novo Nordisk Investigational Site, Long Beach, California, 90807, United States|Novo Nordisk Investigational Site, Los Angeles, California, 90057, United States|Novo Nordisk Investigational Site, Oceanside, California, 92056, United States|Novo Nordisk Investigational Site, Orange, California, 92868-2863, United States|Novo Nordisk Investigational Site, Pomona, California, 91767-3008, United States|Novo Nordisk Investigational Site, Rialto, California, 92376, United States|Novo Nordisk Investigational Site, Rolling Hills Estates, California, 90274, United States|Novo Nordisk Investigational Site, Roseville, California, 95661, United States|Novo Nordisk Investigational Site, San Diego, California, 92111, United States|Novo Nordisk Investigational Site, San Mateo, California, 94401, United States|Novo Nordisk Investigational Site, Sherman Oaks, California, 91403, United States|Novo Nordisk Investigational Site, Spring Valley, California, 91978, United States|Novo Nordisk Investigational Site, Tustin, California, 92780, United States|Novo Nordisk Investigational Site, Walnut Creek, California, 94598, United States|Novo Nordisk Investigational Site, Colorado Springs, Colorado, 80909, United States|Novo Nordisk Investigational Site, Denver, Colorado, 80220, United States|Novo Nordisk Investigational Site, Denver, Colorado, 80239-3133, United States|Novo Nordisk Investigational Site, Clearwater, Florida, 33761, United States|Novo Nordisk Investigational Site, Cooper City, Florida, 33024, United States|Novo Nordisk Investigational Site, Hialeah, Florida, 33012, 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, 32256, United States|Novo Nordisk Investigational Site, Kissimmee, Florida, 34741, United States|Novo Nordisk Investigational Site, Lakeland, Florida, 33805, United States|Novo Nordisk Investigational Site, Miami Lakes, Florida, 33016, United States|Novo Nordisk Investigational Site, Miami, Florida, 33135, United States|Novo Nordisk Investigational Site, Miami, Florida, 33156, United States|Novo Nordisk Investigational Site, Spring Hill, Florida, 34609, United States|Novo Nordisk Investigational Site, Winter Haven, Florida, 33880, United States|Novo Nordisk Investigational Site, Winter Park, Florida, 32789, United States|Novo Nordisk Investigational Site, Conyers, Georgia, 30013, United States|Novo Nordisk Investigational Site, Johns Creek, Georgia, 30097, United States|Novo Nordisk Investigational Site, Marietta, Georgia, 30060, United States|Novo Nordisk Investigational Site, Norcross, Georgia, 30092, United States|Novo Nordisk Investigational Site, Roswell, Georgia, 30076, United States|Novo Nordisk Investigational Site, Meridian, Idaho, 83646, United States|Novo Nordisk Investigational Site, Chicago, Illinois, 60611, United States|Novo Nordisk Investigational Site, Gurnee, Illinois, 60031, United States|Novo Nordisk Investigational Site, Peoria, Illinois, 61602, United States|Novo Nordisk Investigational Site, Avon, Indiana, 46123, United States|Novo Nordisk Investigational Site, Indianapolis, Indiana, 46254, United States|Novo Nordisk Investigational Site, Council Bluffs, Iowa, 51501, United States|Novo Nordisk Investigational Site, Park City, Kansas, 67219, United States|Novo Nordisk Investigational Site, Lexington, Kentucky, 40503, United States|Novo Nordisk Investigational Site, Madisonville, Kentucky, 42431, United States|Novo Nordisk Investigational Site, Paducah, Kentucky, 42003, United States|Novo Nordisk Investigational Site, Lake Charles, Louisiana, 70601, United States|Novo Nordisk Investigational Site, Metairie, Louisiana, 70002, United States|Novo Nordisk Investigational Site, Natchitoches, Louisiana, 71457-5881, United States|Novo Nordisk Investigational Site, Shreveport, Louisiana, 71107, United States|Novo Nordisk Investigational Site, Hyattsville, Maryland, 20782, United States|Novo Nordisk Investigational Site, Buckley, Michigan, 49620, United States|Novo Nordisk Investigational Site, Flint, Michigan, 48504, United States|Novo Nordisk Investigational Site, Sterling Heights, Michigan, 48310-3503, United States|Novo Nordisk Investigational Site, Troy, Michigan, 48098, United States|Novo Nordisk Investigational Site, Saint Louis, Missouri, 63128, United States|Novo Nordisk Investigational Site, Saint Louis, Missouri, 63141, United States|Novo Nordisk Investigational Site, Butte, Montana, 59701, United States|Novo Nordisk Investigational Site, Las Vegas, Nevada, 89109, United States|Novo Nordisk Investigational Site, Las Vegas, Nevada, 89119, United States|Novo Nordisk Investigational Site, Las Vegas, Nevada, 89120, United States|Novo Nordisk Investigational Site, Berlin, New Jersey, 08009, United States|Novo Nordisk Investigational Site, Toms River, New Jersey, 08755-8050, United States|Novo Nordisk Investigational Site, Trenton, New Jersey, 08611, United States|Novo Nordisk Investigational Site, Albuquerque, New Mexico, 87108, United States|Novo Nordisk Investigational Site, Brooklyn, New York, 11229, United States|Novo Nordisk Investigational Site, New Windsor, New York, 12553, United States|Novo Nordisk Investigational Site, West Seneca, New York, 14224, United States|Novo Nordisk Investigational Site, Greensboro, North Carolina, 27408, United States|Novo Nordisk Investigational Site, Morehead City, North Carolina, 28557, United States|Novo Nordisk Investigational Site, Morganton, North Carolina, 28655, United States|Novo Nordisk Investigational Site, Shelby, North Carolina, 28150, 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, Fargo, North Dakota, 58104, United States|Novo Nordisk Investigational Site, Canal Fulton, Ohio, 44614, United States|Novo Nordisk Investigational Site, Carlisle, Ohio, 45005, United States|Novo Nordisk Investigational Site, Cincinnati, Ohio, 45219, United States|Novo Nordisk Investigational Site, Cincinnati, Ohio, 45227, United States|Novo Nordisk Investigational Site, Cincinnati, Ohio, 45242, United States|Novo Nordisk Investigational Site, Cincinnati, Ohio, 45255, United States|Novo Nordisk Investigational Site, Cleveland, Ohio, 44122, United States|Novo Nordisk Investigational Site, Kettering, Ohio, 45429, United States|Novo Nordisk Investigational Site, Mason, Ohio, 45040-6815, United States|Novo Nordisk Investigational Site, Maumee, Ohio, 43537, United States|Novo Nordisk Investigational Site, Toledo, Ohio, 43623, United States|Novo Nordisk Investigational Site, Corvallis, Oregon, 97330-3737, United States|Novo Nordisk Investigational Site, Altoona, Pennsylvania, 16602, United States|Novo Nordisk Investigational Site, Beaver, Pennsylvania, 15009, United States|Novo Nordisk Investigational Site, Clairton, Pennsylvania, 15025-3730, United States|Novo Nordisk Investigational Site, Jersey Shore, Pennsylvania, 17740, United States|Novo Nordisk Investigational Site, Lansdale, Pennsylvania, 19446-1002, United States|Novo Nordisk Investigational Site, Philadelphia, Pennsylvania, 19114, United States|Novo Nordisk Investigational Site, Gaffney, South Carolina, 29341, United States|Novo Nordisk Investigational Site, Murrells Inlet, South Carolina, 29576, United States|Novo Nordisk Investigational Site, Rapid City, South Dakota, 57701, United States|Novo Nordisk Investigational Site, Chattanooga, Tennessee, 37404, United States|Novo Nordisk Investigational Site, Knoxville, Tennessee, 37912, United States|Novo Nordisk Investigational Site, Amarillo, Texas, 79106, United States|Novo Nordisk Investigational Site, Austin, Texas, 78756, United States|Novo Nordisk Investigational Site, Dallas, Texas, 75251, United States|Novo Nordisk Investigational Site, Fort Worth, Texas, 76117, United States|Novo Nordisk Investigational Site, Houston, Texas, 77040, United States|Novo Nordisk Investigational Site, Houston, Texas, 77055, United States|Novo Nordisk Investigational Site, Houston, Texas, 77058, United States|Novo Nordisk Investigational Site, Houston, Texas, 77070, United States|Novo Nordisk Investigational Site, Houston, Texas, 77074, United States|Novo Nordisk Investigational Site, Humble, Texas, 77338, United States|Novo Nordisk Investigational Site, Hurst, Texas, 76054, United States|Novo Nordisk Investigational Site, Irving, Texas, 75061-2210, United States|Novo Nordisk Investigational Site, Longview, Texas, 75605, United States|Novo Nordisk Investigational Site, Marshall, Texas, 75670, United States|Novo Nordisk Investigational Site, Plano, Texas, 75075, United States|Novo Nordisk Investigational Site, San Antonio, Texas, 78209, United States|Novo Nordisk Investigational Site, San Antonio, Texas, 78229, United States|Novo Nordisk Investigational Site, Saint George, Utah, 84790, United States|Novo Nordisk Investigational Site, Salt Lake City, Utah, 84107, United States|Novo Nordisk Investigational Site, Arlington, Virginia, 22206, United States|Novo Nordisk Investigational Site, Winchester, Virginia, 22601, United States|Novo Nordisk Investigational Site, Olympia, Washington, 98502, United States|Novo Nordisk Investigational Site, Renton, Washington, 98057, United States|Novo Nordisk Investigational Site, Wenatchee, Washington, 98801-2028, United States|Novo Nordisk Investigational Site, Kenosha, Wisconsin, 53144, United States|Novo Nordisk Investigational Site, Buenos Aires, C1425AGC, Argentina|Novo Nordisk Investigational Site, Caba, C1119ACN, Argentina|Novo Nordisk Investigational Site, Capital Federal, C1056ABJ, Argentina|Novo Nordisk Investigational Site, Godoy Cruz, M5501ARP, Argentina|Novo Nordisk Investigational Site, Cakovec, 40000, Croatia|Novo Nordisk Investigational Site, Karlovac, 47000, Croatia|Novo Nordisk Investigational Site, Krapinske Toplice, 49217, Croatia|Novo Nordisk Investigational Site, Zagreb, 10 000, Croatia|Novo Nordisk Investigational Site, Bobigny, 93009, France|Novo Nordisk Investigational Site, Bois-Guillaume, 76320, France|Novo Nordisk Investigational Site, Bourgoin-jallieu, 38302, France|Novo Nordisk Investigational Site, LA ROCHE-sur-YON cedex 9, 85295, France|Novo Nordisk Investigational Site, Le Creusot, 71200, France|Novo Nordisk Investigational Site, MARSEILLE cedex 08, 13285, France|Novo Nordisk Investigational Site, MARSEILLE Cédex 05, 13385, France|Novo Nordisk Investigational Site, Nanterre, 92014, France|Novo Nordisk Investigational Site, Narbonne, 11108, France|Novo Nordisk Investigational Site, NICE cedex 3, 06202, France|Novo Nordisk Investigational Site, Paris, 75014, France|Novo Nordisk Investigational Site, Pierre-Bénite, 69495, France|Novo Nordisk Investigational Site, Pointe À Pitre, 97159, France|Novo Nordisk Investigational Site, Rang-du-fliers, 62180, France|Novo Nordisk Investigational Site, Saint Herblain, 44800, France|Novo Nordisk Investigational Site, Saint Nazaire, 44600, France|Novo Nordisk Investigational Site, Strasbourg, 67098, France|Novo Nordisk Investigational Site, Trinité - La Martinique, 97235, France|Novo Nordisk Investigational Site, Venissieux, 69200, France|Novo Nordisk Investigational Site, Berlin, 10409, Germany|Novo Nordisk Investigational Site, Essen, 45276, Germany|Novo Nordisk Investigational Site, Jerichow, 39319, Germany|Novo Nordisk Investigational Site, Lampertheim, 68623, Germany|Novo Nordisk Investigational Site, Ludwigshafen, 67059, Germany|Novo Nordisk Investigational Site, Münster, 48145, Germany|Novo Nordisk Investigational Site, Neuwied, 56564, Germany|Novo Nordisk Investigational Site, Rehlingen-Siersburg, 66780, Germany|Novo Nordisk Investigational Site, Rostock, 18057, Germany|Novo Nordisk Investigational Site, Saint Ingbert-Oberwürzbach, 66386, Germany|Novo Nordisk Investigational Site, Stuttgart, 70378, Germany|Novo Nordisk Investigational Site, Wangen, 88239, Germany|Novo Nordisk Investigational Site, Ahmedabad, Gujarat, 380006, India|Novo Nordisk Investigational Site, Ahmedabad, Gujarat, 380007, India|Novo Nordisk Investigational Site, Bangalore, Karnataka, 560092, India|Novo Nordisk Investigational Site, Mysore, Karnataka, 570001, India|Novo Nordisk Investigational Site, Mysore, Karnataka, 570004, India|Novo Nordisk Investigational Site, Indore, Madhya Pradesh, 452010, India|Novo Nordisk Investigational Site, Mumbai, Maharashtra, 400008, India|Novo Nordisk Investigational Site, Mumbai, Maharashtra, 400010, India|Novo Nordisk Investigational Site, Mumbai, Maharashtra, 400012, India|Novo Nordisk Investigational Site, Mumbai, Maharashtra, 400022, India|Novo Nordisk Investigational Site, New Dehli, New Delhi, 110029, India|Novo Nordisk Investigational Site, Chennai, Tamil Nadu, 600031, India|Novo Nordisk Investigational Site, Kolkata, West Bengal, 700107, India|Novo Nordisk Investigational Site, Kolkata, 700026, India|Novo Nordisk Investigational Site, New Delhi, 110001, India|Novo Nordisk Investigational Site, Guadalajara, Jalisco, 44150, Mexico|Novo Nordisk Investigational Site, Distrito Federal, México, D.F., 14080, Mexico|Novo Nordisk Investigational Site, México D.F., México, D.F., 11550, Mexico|Novo Nordisk Investigational Site, Aguascalientes, 20230, Mexico|Novo Nordisk Investigational Site, Amsterdam, 1105 AZ, Netherlands|Novo Nordisk Investigational Site, Hoofddorp, 2134 TM, Netherlands|Novo Nordisk Investigational Site, Rotterdam, 3039 BD, Netherlands|Novo Nordisk Investigational Site, Skopje, 1000, North Macedonia|Novo Nordisk Investigational Site, Tetovo, 1220, North Macedonia|Novo Nordisk Investigational Site, Ponce, 00717, Puerto Rico|Novo Nordisk Investigational Site, Pitesti, Arges, 110084, Romania|Novo Nordisk Investigational Site, Oradea, Bihor, 410469, Romania|Novo Nordisk Investigational Site, Cluj Napoca, Cluj, 400006, Romania|Novo Nordisk Investigational Site, Bucharest, 011234, Romania|Novo Nordisk Investigational Site, Iasi, 700469, Romania|Novo Nordisk Investigational Site, Kosice, 04011, Slovakia|Novo Nordisk Investigational Site, Moldava nad Bodvou, 045 01, Slovakia|Novo Nordisk Investigational Site, Piestany, 92101, Slovakia|Novo Nordisk Investigational Site, Puchov, 02001, Slovakia|Novo Nordisk Investigational Site, Trencin, 91101, Slovakia|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, Johannesburg, Gauteng, 1829, South Africa|Novo Nordisk Investigational Site, Johannesburg, Gauteng, 2001, South Africa|Novo Nordisk Investigational Site, Pretoria, Gauteng, 0183, South Africa|Novo Nordisk Investigational Site, Durban, KwaZulu-Natal, 4001, South Africa|Novo Nordisk Investigational Site, Cape Town, Western Cape, 7450, South Africa|Novo Nordisk Investigational Site, Basingstoke, RG24 9GT, United Kingdom|Novo Nordisk Investigational Site, Bristol, BS10 5NB, United Kingdom|Novo Nordisk Investigational Site, Harrogate, North Yorkshire, HG2 7SX, United Kingdom|Novo Nordisk Investigational Site, Haxey, DN9 2HY, United Kingdom|Novo Nordisk Investigational Site, Hull, HU3 2RW, United Kingdom|Novo Nordisk Investigational Site, Ipswich, IP4 5PD, United Kingdom|Novo Nordisk Investigational Site, Northwood, HA6 2RN, United Kingdom|Novo Nordisk Investigational Site, Plymouth, PL6 8BQ, United Kingdom|Novo Nordisk Investigational Site, Salford, M6 8HD, United Kingdom|Novo Nordisk Investigational Site, Sidcup, DA14 6LT, United Kingdom|Novo Nordisk Investigational Site, Soham, CB7 5JD, United Kingdom|Novo Nordisk Investigational Site, Swansea, SA2 8PP, United Kingdom|Novo Nordisk Investigational Site, Taunton, TA1 5DA, United Kingdom
URL: https://clinicaltrials.gov/show/NCT02128932

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress