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Clinical Trial Details

Trial ID: L4307
Source ID: NCT02531035
Associated Drug: Sotagliflozin
Title: A Phase 3 Study to Evaluate the Safety of Sotagliflozin in Patients With Type 1 Diabetes Who Have Inadequate Glycemic Control With Insulin Therapy Alone
Acronym: inTandem3
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT02531035/results
Conditions: Type 1 Diabetes Mellitus (T1DM)|High Level of Sugar (Glucose) in the Blood
Interventions: DRUG: Sotagliflozin|DRUG: Placebo
Outcome Measures: Primary: Percentage of Participants With A1C <7.0% at Week 24 and No Episode of Severe Hypoglycemia and No Episode of Diabetic Ketoacidosis (DKA) After Randomization, The primary composite endpoint included blood samples for the assessment of Hemoglobin A1C to determine the participants with a value \<7.0%. A central blinded adjudication process determined whether participants experienced either DKA or Severe Hypoglycemia., Week 24 | Secondary: Change From Baseline in A1C, Baseline value was defined as the last value collected prior to the first dose of double-blind study medication. Least Squares (LS) means were obtained from a mixed-effects model for repeated measures (MMRM) model including all available post baseline data. A negative change from Baseline (a lower AIC value at Week 24) indicates an improvement., Baseline to Week 24|Absolute Change From Baseline in Body Weight, Baseline value was defined as the last value collected prior to the first dose of double-blind study medication. LS means were obtained from MMRM model. A negative change from Baseline indicates a loss in body weight from Baseline to Week 24., Baseline to Week 24|Change From Baseline in Systolic Blood Pressure (SBP) in the Subset of Participants With Baseline SBP >=130 Millimeter of Mercury (mmHg), An automatic sphygmomanometer was used with instructions on blood pressure measurements to allow for standardization. Week 16 was used because the protocol required Investigators to keep participant's hypertensive medications stable between Baseline and Week 16, unless a change was required for safety reasons. Baseline was defined as the last value collected prior to the first does of double-blind study medication. LS means were obtained from MMRM model including all available post baseline values. A negative change indicates a decrease in SBP between Baseline and Week 16., Baseline to Week 16|Percent Change From Baseline in Mean Daily Bolus Insulin Dose, The mean bolus insulin dose in international units/day (IU/day) for Week 24 was the average over the 3 to 5 days prior to the Week 24 visit. The Baseline value was defined as the last value collected prior to the first dose of double-blind study medication. LS means were obtained from MMRM model including all available post Baseline values. A negative percent change from Baseline indicated a reduction in the amount of bolus insulin used and a positive percent change from Baseline indicated an increase in the amount of bolus insulin used between Baseline and Week 24., Baseline to Week 24
Sponsor/Collaborators: Sponsor: Lexicon Pharmaceuticals | Collaborators: Sanofi
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 1405
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2015-09
Completion Date: 2017-04
Results First Posted: 2019-11-19
Last Update Posted: 2020-02-12
Locations: Lexicon Investigational Site, Concord, California, 94520, United States|Lexicon Investigational Site, Escondido, California, 92025, United States|Lexicon Investigational Site, La Jolla, California, 92037, United States|Lexicon Investigational Site, San Marcos, California, 94401, United States|Lexicon Investigational Site, Ventura, California, 93003, United States|Lexicon Investigational Site, Walnut Creek, California, 94598, United States|Lexicon Investigational Site, Aurora, Colorado, 80045, United States|Lexicon Investigational Site, New Haven, Connecticut, 06511, United States|Lexicon Investigational Site, Orlando, Florida, 32804, United States|Lexicon Investigational Site, West Palm Beach, Florida, 33401, United States|Lexicon Investigational Site, Atlanta, Georgia, 30318, United States|Lexicon Investigational Site, Macon, Georgia, 31210, United States|Lexicon Investigational Site, Roswell, Georgia, 30076, United States|Lexicon Investigational Site, New Orleans, Louisiana, 70112, United States|Lexicon Investigational Site, Rockville, Maryland, 20852, United States|Lexicon Investigational Site, Boston, Massachusetts, 02215, United States|Lexicon Investigational Site, Bloomfield Hills, Michigan, 48302, United States|Lexicon Investigational Site, Omaha, Nebraska, 68114, United States|Lexicon Investigational Site, Las Vegas, Nevada, 89148, United States|Lexicon Investigational Site, Albany, New York, 12206, United States|Lexicon Investigational Site, Bronx, New York, 10467, United States|Lexicon Investigational Site, Asheville, North Carolina, 28803, United States|Lexicon Investigational Site, Chapel Hill, North Carolina, 27517, United States|Lexicon Investigational Site, Greenville, North Carolina, 27834, United States|Lexicon Investigational Site, Morehead City, North Carolina, 28557, United States|Lexicon Investigational Site, Grand Forks, North Dakota, 58201, United States|Lexicon Investigational Site, Bend, Oregon, 97701, United States|Lexicon Investigational Site, Sioux Falls, South Dakota, 57104, United States|Lexicon Investigational Site, Austin, Texas, 78731, United States|Lexicon Investigational Site, San Antonio, Texas, 78229, United States|Lexicon Investigational Site, Shavano Park, Texas, 78231, United States|Lexicon Investigational Site, Salt Lake City, Utah, 84107, United States|Lexicon Investigational Site, Seattle, Washington, 98105, United States|Lexicon Investigational Site, Córdoba, Cordoba, X5006IKK, Argentina|Lexicon Investigational Site, Buenos Aires, B7600FZN, Argentina|Lexicon Investigational Site, Buenos Aires, C1180AAX, Argentina|Lexicon Investigational Site, Coffs Harbour, New South Wales, 2450, Australia|Lexicon Investigational Site, Merewether, New South Wales, 2291, Australia|Lexicon Investigational Site, St Leonards, New South Wales, 2065, Australia|Lexicon Investigational Site, Wollongong, New South Wales, 2500, Australia|Lexicon Investigational Site, Herston, Queensland, 4029, Australia|Lexicon Investigational Site, Keswick, South Australia, 5035, Australia|Lexicon Investigational Site, Box Hill, Victoria, 3128, Australia|Lexicon Investigational Site, Fitzroy, Victoria, 3065, Australia|Lexicon Investigational Site, Parkville, Victoria, 3050, Australia|Lexicon Investigational Site, Aalst, 9300, Belgium|Lexicon Investigational Site, Gent, 9000, Belgium|Lexicon Investigational Site, Sint-Niklaas, 9100, Belgium|Lexicon Investigational Site, Plovdiv, 4002, Bulgaria|Lexicon Investigational Site, Ruse, 7003, Bulgaria|Lexicon Investigational Site, Smolyan, 4700, Bulgaria|Lexicon Investigational Site, Sofia, 1431, Bulgaria|Lexicon Investigational Site, Sofia, 1750, Bulgaria|Lexicon Investigational Site, Varna, 9000, Bulgaria|Lexicon Investigational Site, Vancouver, British Columbia, V5Y 3W2, Canada|Lexicon Investigational Site, Halifax, Nova Scotia, B3H 2Y9, Canada|Lexicon Investigational Site, Barrie, Ontario, L4M 7G1, Canada|Lexicon Investigational Site, London, Ontario, N6A 4V2, Canada|Lexicon Investigational Site, Markham, Ontario, L6B 0P9, Canada|Lexicon Investigational Site, Oakville, Ontario, L6M 1M1, Canada|Lexicon Investigational Site, Thornhill, Ontario, L4J 8L7, Canada|Lexicon Investigational Site, Toronto, Ontario, M4G 3E8, Canada|Lexicon Investigational Site, Sherbrooke, Quebec, J1G 5K2, Canada|Lexicon Investigational Site, St. Laurent, Quebec, H4T 1Z9, Canada|Lexicon Investigational Site, Atlantico, 080020, Colombia|Lexicon Investigational Site, Cundinamarca, 110221, Colombia|Lexicon Investigational Site, Cundinamarca, 111211, Colombia|Lexicon Investigational Site, Cundinamarca, 111311, Colombia|Lexicon Investigational Site, Krnov, 794 01, Czechia|Lexicon Investigational Site, Olomouc, 779 00, Czechia|Lexicon Investigational Site, Ostrava, 702 00, Czechia|Lexicon Investigational Site, Praha 10, 104 00, Czechia|Lexicon Investigational Site, Praha 4, 149 00, Czechia|Lexicon Investigational Site, Praha 5, 150 98, Czechia|Lexicon Investigational Site, Corbeil-Essonnes, 91106, France|Lexicon Investigational Site, Pierre-Bénite, 69495, France|Lexicon Investigational Site, Mainz, Palatinate, 55116, Germany|Lexicon Investigational Site, Sulzbach, Rosenberg Bavaria, 92237, Germany|Lexicon Investigational Site, Münster, Westphalia, 48153, Germany|Lexicon Investigational Site, Aschaffenburg, 63739, Germany|Lexicon Investigational Site, Asslar, 35614, Germany|Lexicon Investigational Site, Budapest, 1027, Hungary|Lexicon Investigational Site, Budapest, 1033, Hungary|Lexicon Investigational Site, Budapest, 1088, Hungary|Lexicon Investigational Site, Budapest, 1213, Hungary|Lexicon Investigational Site, Eger, 3300, Hungary|Lexicon Investigational Site, Esztergom, 2500, Hungary|Lexicon Investigational Site, Gyor, 9023, Hungary|Lexicon Investigational Site, Sátoraljaújhely, 3980, Hungary|Lexicon Investigational Site, Holon, 58100, Israel|Lexicon Investigational Site, Petach-Tikvah, 4920235, Israel|Lexicon Investigational Site, Petah Tikva, 4941492, Israel|Lexicon Investigational Site, Rehovot, 76100, Israel|Lexicon Investigational Site, Tel Hashomer, 56261, Israel|Lexicon Investigational Site, Bologna, 40138, Italy|Lexicon Investigational Site, Catania, 95122, Italy|Lexicon Investigational Site, Catania, 95123, Italy|Lexicon Investigational Site, Latina, 04100, Italy|Lexicon Investigational Site, Milan, 20132, Italy|Lexicon Investigational Site, Rome, 00128, Italy|Lexicon Investigational Site, Epsom, Auckland, 1051, New Zealand|Lexicon Investigational Site, Takapuna, Auckland, 0620, New Zealand|Lexicon Investigational Site, Christchurch, Canterbury, 8001, New Zealand|Lexicon Investigational Site, Dunedin, Otago, 9016, New Zealand|Lexicon Investigational Site, Newtown, Wellington, 6021, New Zealand|Lexicon Investigational Site, Christchurch, 8011, New Zealand|Lexicon Investigational Site, Otahuhu, 1640, New Zealand|Lexicon Investigational Site, Gdynia, 81-338, Poland|Lexicon Investigational Site, Katowice, 40-060, Poland|Lexicon Investigational Site, Katowice, 40-954, Poland|Lexicon Investigational Site, Lublin, 20-538, Poland|Lexicon Investigational Site, Warsaw, 01-868, Poland|Lexicon Investigational Site, Warsaw, 04-736, Poland|Lexicon Investigational Site, Warszawa, 02-507, Poland|Lexicon Investigational Site, Bardejov, 085 01, Slovakia|Lexicon Investigational Site, Bratislava, 851 01, Slovakia|Lexicon Investigational Site, Bratislava, 85101, Slovakia|Lexicon Investigational Site, Levice, 934 01, Slovakia|Lexicon Investigational Site, Goodwood, Cape Town, 7460, South Africa|Lexicon Investigational Site, Middelburg, Mpumalanga, 1055, South Africa|Lexicon Investigational Site, Bloemfontein, 9300, South Africa|Lexicon Investigational Site, Cape Town, 7130, South Africa|Lexicon Investigational Site, Cape Town, 7580, South Africa|Lexicon Investigational Site, Johannesburg, 2198, South Africa|Lexicon Investigational Site, Port Elizabeth, 6045, South Africa|Lexicon Investigational Site, Barcelona, 08035, Spain|Lexicon Investigational Site, Barcelona, 08036, Spain|Lexicon Investigational Site, Malaga, 29006, Spain|Lexicon Investigational Site, Sevilla, 41009, Spain|Lexicon Investigational Site, Sevilla, 41071, Spain|Lexicon Investigational Site, Dundee, Scotland, DD1 9SY, United Kingdom|Lexicon Investigational Site, Blackburn, BB2 3HH, United Kingdom|Lexicon Investigational Site, Guildford, GU2 7XX, United Kingdom|Lexicon Investigational Site, Leicester, LE5 4PW, United Kingdom|Lexicon Investigational Site, Northampton, NN1 5BD, United Kingdom
URL: https://clinicaltrials.gov/show/NCT02531035

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress