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Clinical Trial Details

Trial ID: L5600
Source ID: NCT03989232
Associated Drug: Semaglutide
Title: A Research Study to Compare Two Doses of Semaglutide Taken Once Weekly in People With Type 2 Diabetes
Acronym: SUSTAIN FORTE
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT03989232/results
Conditions: Diabetes Mellitus, Type 2
Interventions: DRUG: Semaglutide|DRUG: Placebo (semaglutide)
Outcome Measures: Primary: Change in HbA1c, Change from baseline (week 0) to week 40 in glycosylated haemoglobin (HbA1c) was evaluated. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose of trial product to either first initiation of rescue medication or the day of last dose of trial product, whichever came first; and 'In-trial' observation period which started at the date of randomisation and ended at the first of the following dates, both inclusive: end-of-treatment visit (week 40), death, participant withdrew informed consent, last contact for participant lost to follow-up., Week 0, week 40 | Secondary: Change in Body Weight, Change from baseline (week 0) to week 40 in body weight was evaluated. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose of trial product to either first initiation of rescue medication or the day of last dose of trial product, whichever came first; and 'In-trial' observation period which started at the date of randomisation and ended at the first of the following dates, both inclusive: end-of-treatment visit (week 40), death, participant withdrew informed consent, last contact for participant lost to follow-up., Week 0, week 40|Change in Fasting Plasma Glucose (FPG), Change from baseline (week 0) to week 40 in FPG was evaluated. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose of trial product to either first initiation of rescue medication or the day of last dose of trial product, whichever came first., Week 0, week 40|Change in Body Mass Index (BMI), Change from baseline (week 0) to week 40 in BMI was evaluated. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose of trial product to either first initiation of rescue medication or the day of last dose of trial product, whichever came first., Week 0, week 40|Change in Waist Circumference, Change from baseline (week 0) to week 40 in waist circumference was evaluated. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose of trial product to either first initiation of rescue medication or the day of last dose of trial product, whichever came first., Week 0, week 40|Participants Who Achieved HbA1c < 7.0%, Percentage of participants who achieved HbA1c \< 7.0% is presented. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose of trial product to either first initiation of rescue medication or the day of last dose of trial product, whichever came first. Missing HbA1c assessment at week 40 was imputed using observed data from participants within same treatment group., Week 40|Participants Who Achieved HbA1c ≤ 6.5%, Percentage of participants who achieved HbA1c ≤ 6.5% is presented. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose of trial product to either first initiation of rescue medication or the day of last dose of trial product, whichever came first. Missing HbA1c assessment at week 40 was imputed using observed data from participants within same treatment group., Week 40|Participants Who Achieved Weight Loss ≥5%, Percentage of participants who achieved weight loss ≥5% is presented. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose of trial product to either first initiation of rescue medication or the day of last dose of trial product, whichever came first. Missing body weight assessment at week 40 was imputed using observed data from participants within same treatment group., Week 40|Participants Who Achieved Weight Loss ≥10%, Percentage of participants who achieved weight loss ≥10% is presented. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose of trial product to either first initiation of rescue medication or the day of last dose of trial product, whichever came first. Missing body weight assessment at week 40 was imputed using observed data from participants within same treatment group., Week 40|Number of Treatment-emergent Severe or Blood Glucose (BG) Confirmed Symptomatic Hypoglycaemic Episodes, Hypoglycaemic episodes defined as treatment-emergent if the onset of the episode occurs within the on-treatment observation period. Severe or BG-confirmed symptomatic hypoglycaemia is an episode that required assistance from another person for recovery and blood glucose-confirmed by a plasma glucose value \<3.1 mmol/L (56 milligrams per deciliter (mg/dL)) with symptoms consistent with hypoglycaemia. Results are based on the 'on-treatment' observation period, which started at the date of first dose of trial product and ended at the first date of any of the following: the follow-up visit (week 47), the treatment discontinuation follow-up visit (end of treatment + 7 weeks), the date of last dose of trial product +49 days or the end-date for the 'in-trial' observation period., Week 0 to week 47|Change in Pulse Rate, Change from baseline (week 0) to week 40 in pulse rate is presented. Results are based on the 'on-treatment' observation period, which started at the date of first dose of trial product and ended at the endpoint-specific end-date., Week 0, week 40
Sponsor/Collaborators: Sponsor: Novo Nordisk A/S
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 961
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2019-06-19
Completion Date: 2020-11-09
Results First Posted: 2021-10-22
Last Update Posted: 2023-02-13
Locations: Novo Nordisk Investigational Site, Birmingham, Alabama, 35205, United States|Novo Nordisk Investigational Site, Chandler, Arizona, 85224, United States|Novo Nordisk Investigational Site, Glendale, Arizona, 85306, United States|Novo Nordisk Investigational Site, Glendale, Arizona, 85308, United States|Novo Nordisk Investigational Site, Mesa, Arizona, 85213, United States|Novo Nordisk Investigational Site, Phoenix, Arizona, 85050, United States|Novo Nordisk Investigational Site, Buena Park, California, 90620, United States|Novo Nordisk Investigational Site, Fresno, California, 93720, United States|Novo Nordisk Investigational Site, Los Angeles, California, 90057, United States|Novo Nordisk Investigational Site, San Diego, California, 92103, 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, West Hills, California, 91304, United States|Novo Nordisk Investigational Site, Colorado Springs, Colorado, 80906, United States|Novo Nordisk Investigational Site, Coral Gables, Florida, 33134, United States|Novo Nordisk Investigational Site, Hollywood, Florida, 33024, United States|Novo Nordisk Investigational Site, Jacksonville, Florida, 32216, United States|Novo Nordisk Investigational Site, Adairsville, Georgia, 30103, United States|Novo Nordisk Investigational Site, Alpharetta, Georgia, 30022, United States|Novo Nordisk Investigational Site, Roswell, Georgia, 30076, United States|Novo Nordisk Investigational Site, Meridian, Idaho, 83646, United States|Novo Nordisk Investigational Site, Carlinville, Illinois, 62626, United States|Novo Nordisk Investigational Site, Chicago, Illinois, 60607, United States|Novo Nordisk Investigational Site, Peoria, Illinois, 61603, United States|Novo Nordisk Investigational Site, Topeka, Kansas, 66606, United States|Novo Nordisk Investigational Site, Lexington, Kentucky, 40503, United States|Novo Nordisk Investigational Site, Louisville, Kentucky, 40213, United States|Novo Nordisk Investigational Site, Lake Charles, Louisiana, 70601, United States|Novo Nordisk Investigational Site, Sterling Heights, Michigan, 48310-3503, United States|Novo Nordisk Investigational Site, Jefferson City, Missouri, 65109, United States|Novo Nordisk Investigational Site, Butte, Montana, 59701, United States|Novo Nordisk Investigational Site, Trenton, New Jersey, 08611, United States|Novo Nordisk Investigational Site, New Windsor, New York, 12553, United States|Novo Nordisk Investigational Site, Chapel Hill, North Carolina, 27514, United States|Novo Nordisk Investigational Site, Greensboro, North Carolina, 27408, United States|Novo Nordisk Investigational Site, Salisbury, North Carolina, 28144, 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, 43213, United States|Novo Nordisk Investigational Site, Mason, Ohio, 45040-6815, United States|Novo Nordisk Investigational Site, Norman, Oklahoma, 73069, United States|Novo Nordisk Investigational Site, Corvallis, Oregon, 97330-3737, 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, Chattanooga, Tennessee, 37404, United States|Novo Nordisk Investigational Site, Kingsport, Tennessee, 37660, United States|Novo Nordisk Investigational Site, Memphis, Tennessee, 38119, United States|Novo Nordisk Investigational Site, Dallas, Texas, 75230, United States|Novo Nordisk Investigational Site, Dallas, Texas, 75390-9302, 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, Katy, Texas, 77450, United States|Novo Nordisk Investigational Site, Plano, Texas, 75075, United States|Novo Nordisk Investigational Site, San Antonio, Texas, 78229, United States|Novo Nordisk Investigational Site, San Antonio, Texas, 78230, United States|Novo Nordisk Investigational Site, Shavano Park, Texas, 78231, United States|Novo Nordisk Investigational Site, Sugar Land, Texas, 77479, United States|Novo Nordisk Investigational Site, Olympia, Washington, 98502, United States|Novo Nordisk Investigational Site, Walla Walla, Washington, 99362-4445, United States|Novo Nordisk Investigational Site, Wenatchee, Washington, 98801-2028, United States|Novo Nordisk Investigational Site, Kozloduy, 3320, Bulgaria|Novo Nordisk Investigational Site, Montana, 3400, Bulgaria|Novo Nordisk Investigational Site, Petrich, 2850, Bulgaria|Novo Nordisk Investigational Site, Sofia, 1407, Bulgaria|Novo Nordisk Investigational Site, Sofia, 1431, Bulgaria|Novo Nordisk Investigational Site, Stara Zagora, 6000, Bulgaria|Novo Nordisk Investigational Site, Yambol, 8600, Bulgaria|Novo Nordisk Investigational Site, Mount Pearl, Newfoundland and Labrador, A1N 1W7, Canada|Novo Nordisk Investigational Site, Brampton, Ontario, L6S 0C6, Canada|Novo Nordisk Investigational Site, Brampton, Ontario, L6T 0G1, Canada|Novo Nordisk Investigational Site, Etobicoke, Ontario, M9R 4E1, Canada|Novo Nordisk Investigational Site, London, Ontario, N5W 6A2, Canada|Novo Nordisk Investigational Site, Markham, Ontario, L3P 7P2, Canada|Novo Nordisk Investigational Site, Stoney Creek, Ontario, L8J 0B6, Canada|Novo Nordisk Investigational Site, Toronto, Ontario, M4G 3E8, Canada|Novo Nordisk Investigational Site, Ceske Budejovice, 370 01, Czechia|Novo Nordisk Investigational Site, Praha 10, 102 00, Czechia|Novo Nordisk Investigational Site, Praha 5, 150 00, Czechia|Novo Nordisk Investigational Site, Vlasim, 25801, Czechia|Novo Nordisk Investigational Site, Athens, 115 25, Greece|Novo Nordisk Investigational Site, Athens, GR-10676, Greece|Novo Nordisk Investigational Site, Athens, GR-11521, Greece|Novo Nordisk Investigational Site, Athens, GR-11527, Greece|Novo Nordisk Investigational Site, Athens, GR-17562, 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, 1042, Hungary|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, 1132, Hungary|Novo Nordisk Investigational Site, Budapest, 1152, 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, Komarom, 2900, Hungary|Novo Nordisk Investigational Site, Szeged, H-6725, Hungary|Novo Nordisk Investigational Site, Szekszárd, 7100, Hungary|Novo Nordisk Investigational Site, Tokyo, 103-0027, Japan|Novo Nordisk Investigational Site, Tokyo, 104-0031, Japan|Novo Nordisk Investigational Site, Bialystok, 15-404, Poland|Novo Nordisk Investigational Site, Bialystok, 15-435, Poland|Novo Nordisk Investigational Site, Gdansk, 80-214, Poland|Novo Nordisk Investigational Site, Gorzow Wielkopolski, 66-400, Poland|Novo Nordisk Investigational Site, Katowice, 40-752, Poland|Novo Nordisk Investigational Site, Lodz, 90-242, Poland|Novo Nordisk Investigational Site, Lodz, 91-849, Poland|Novo Nordisk Investigational Site, Lublin, 20-044, Poland|Novo Nordisk Investigational Site, Warszawa, 02-097, Poland|Novo Nordisk Investigational Site, Wroclaw, 52-416, Poland|Novo Nordisk Investigational Site, Manati, 00674, Puerto Rico|Novo Nordisk Investigational Site, Bratislava, 83103, Slovakia|Novo Nordisk Investigational Site, Hnusta, 98101, Slovakia|Novo Nordisk Investigational Site, Kezmarok, 06001, Slovakia|Novo Nordisk Investigational Site, Kosice, 04022, Slovakia|Novo Nordisk Investigational Site, Krupina, 96301, Slovakia|Novo Nordisk Investigational Site, Levice, 93401, Slovakia|Novo Nordisk Investigational Site, Nove Zamky, 94070, Slovakia|Novo Nordisk Investigational Site, Pezinok, 90201, Slovakia|Novo Nordisk Investigational Site, Poprad, 05801, Slovakia|Novo Nordisk Investigational Site, Povazska Bystrica, 01701, Slovakia|Novo Nordisk Investigational Site, Puchov, 02001, Slovakia|Novo Nordisk Investigational Site, Dnipro, 49038, Ukraine|Novo Nordisk Investigational Site, Mykolaiv, 54003, Ukraine|Novo Nordisk Investigational Site, Ternopil, 46002, Ukraine|Novo Nordisk Investigational Site, Vinnytsia, 21010, Ukraine|Novo Nordisk Investigational Site, Zhytomyr, 10002, Ukraine
URL: https://clinicaltrials.gov/show/NCT03989232

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress