CKDkb: a knowledge base and platform for drug development against non-alcoholic fatty liver disease

Clinical Trial Details

Trial ID:	L1892
Source ID:	NCT03285594
Associated Drug:	Sotagliflozin
Title:	Efficacy and Safety of Sotagliflozin Versus Placebo in Participants With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control While Taking Insulin Alone or With Other Oral Antidiabetic Agents
Acronym:	SOTA-INS
Status:	COMPLETED
Study Results:	YES
Results:	https://ClinicalTrials.gov/show/NCT03285594/results
Conditions:	Type 2 Diabetes Mellitus
Interventions:	DRUG: Sotagliflozin\|DRUG: Insulin glargine (HOE901)\|DRUG: Placebo\|DRUG: Oral Antidiabetes Drugs (OADs)
Outcome Measures:	Primary: Change From Baseline in Hemoglobin A1c (HbA1c) at Week 18, An analysis of covariance (ANCOVA) model was used for the analysis., Baseline and Week 18 \| Secondary: Change From Baseline in Fasting Plasma Glucose (FPG) at Week 18, FPG was performed in fasting state, that is, without any food intake (except for water) for at least 8 hours. An ANCOVA model was used for the analysis., Baseline and Week 18\|Change From Baseline in Body Weight at Week 18, An ANCOVA model was used for the analysis., Baseline and Week 18\|Change From Baseline in Systolic Blood Pressure (SBP) for Participants With Baseline SBP ≥130 mmHg at Week 12, An ANCOVA model was used for the analysis. Here, N is the number of participants with data available at a given time point., Baseline and Week 12\|Change From Baseline in SBP at Week 12 for All Participants, An ANCOVA model was used for the analysis., Baseline to Week 12\|Change From Baseline in HbA1c at Week 52, An ANCOVA model was used for the analysis., Baseline and Week 52\|Change From Baseline in Body Weight at Week 52, An ANCOVA model was used for the analysis., Baseline and Week 52\|Percentage of Participants With Adverse Events (AEs), An AE is any untoward medical occurrence in a participants or clinical investigation participants administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment., First dose of study drug to last dose of study drug (up to 55.7 weeks) + 2 weeks \| Other: Percentage of Participants With Hypoglycemic Events, Percentage of participants with hypoglycemic events are reported for the following 3 categories: Any hypoglycemia (as reported in the Electronic Case Report Form); Documented symptomatic hypoglycemia \[typical symptoms of hypoglycemia (increased sweating, nervousness, asthenia/weakness, tremor, dizziness, increased appetite, palpitations, headache, sleep disorder, confusion, seizures, unconsciousness, and/or coma) and plasma glucose ≤ 70 mg/dL (3.9 mmol/L)\]; Severe \[an event requiring assistance of another person to actively administer carbohydrate, glucagon, intravenous glucose or other resuscitative actions\] or documented symptomatic hypoglycemia \[typical symptoms of hypoglycemia and plasma glucose ≤ 70 mg/dL\]., Up to 55.7 weeks
Sponsor/Collaborators:	Sponsor: Lexicon Pharmaceuticals \| Collaborators: Sanofi
Gender:	ALL
Age:	ADULT, OLDER_ADULT
Phases:	PHASE3
Enrollment:	571
Study Type:	INTERVENTIONAL
Study Designs:	Allocation: RANDOMIZED\|Intervention Model: PARALLEL\|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)\|Primary Purpose: TREATMENT
Start Date:	2017-09-15
Completion Date:	2019-09-27
Results First Posted:	2021-05-11
Last Update Posted:	2021-05-11
Locations:	Investigational Site Number 8406028, Mesa, Arizona, 85213-5226, United States\|Investigational Site Number 8406013, Phoenix, Arizona, 85018, United States\|Investigational Site Number 8406020, Phoenix, Arizona, 85020, United States\|Investigational Site Number 8406006, Huntington Park, California, 90255, United States\|Investigational Site Number 8406053, Lincoln, California, 95648, United States\|Investigational Site Number 8406040, Los Angeles, California, 90057, United States\|Investigational Site Number 8406043, Coral Gables, Florida, 33134, United States\|Investigational Site Number 8406008, DeLand, Florida, 32720, United States\|Investigational Site Number 8406030, Maitland, Florida, 32751, United States\|Investigational Site Number 8406003, New Port Richey, Florida, 34652, United States\|Investigational Site Number 8406029, North Miami Beach, Florida, 33162, United States\|Investigational Site Number 8406052, Ocoee, Florida, 34761, United States\|Investigational Site Number 8406001, Port Charlotte, Florida, 33952, United States\|Investigational Site Number 8406022, Saint Petersburg, Florida, 33700, United States\|Investigational Site Number 8406025, Tampa, Florida, 33634, United States\|Investigational Site Number 8406002, West Palm Beach, Florida, 33401-3430, United States\|Investigational Site Number 8406054, Chicago, Illinois, 60602, United States\|Investigational Site Number 8406027, Chicago, Illinois, 60604, United States\|Investigational Site Number 8406042, Evansville, Indiana, 47714, United States\|Investigational Site Number 8406044, New Orleans, Louisiana, 70119-6302, United States\|Investigational Site Number 8406051, New Orleans, Louisiana, 70124, United States\|Investigational Site Number 8406024, Rockville, Maryland, 20852, United States\|Investigational Site Number 8406016, Detroit, Michigan, 48202, United States\|Investigational Site Number 8406011, Saint Louis, Missouri, 63110, United States\|Investigational Site Number 8406010, Papillion, Nebraska, 68046-3136, United States\|Investigational Site Number 8406018, New York, New York, 10016-6023, United States\|Investigational Site Number 8406034, Asheville, North Carolina, 28803, United States\|Investigational Site Number 8406046, Chapel Hill, North Carolina, 27517, United States\|Investigational Site Number 8406026, Charlotte, North Carolina, 28209, United States\|Investigational Site Number 8406038, Greenville, North Carolina, 27834, United States\|Investigational Site Number 8406036, Hickory, North Carolina, 28601, United States\|Investigational Site Number 8406015, Wilmington, North Carolina, 28401-6638, United States\|Investigational Site Number 8406019, Winston-Salem, North Carolina, 27103, United States\|Investigational Site Number 8406031, Beachwood, Ohio, 44122, United States\|Investigational Site Number 8406023, Columbus, Ohio, 43201, United States\|Investigational Site Number 8406005, Dublin, Ohio, 43016, United States\|Investigational Site Number 8406004, Mentor, Ohio, 44060, United States\|Investigational Site Number 8406033, Oklahoma City, Oklahoma, 73111, United States\|Investigational Site Number 8406032, Moncks Corner, South Carolina, 29461-5017, United States\|Investigational Site Number 8406009, Chattanooga, Tennessee, 37421, United States\|Investigational Site Number 8406045, Seymour, Tennessee, 37865-5270, United States\|Investigational Site Number 8406047, Dallas, Texas, 75230, United States\|Investigational Site Number 8406017, Dallas, Texas, 75231, United States\|Investigational Site Number 8406048, Houston, Texas, 77079, United States\|Investigational Site Number 8406037, Houston, Texas, 77099, United States\|Investigational Site Number 8406039, McAllen, Texas, 78504, United States\|Investigational Site Number 8406050, San Antonio, Texas, 78229, United States\|Investigational Site Number 8406021, Shavano Park, Texas, 78231, United States\|Investigational Site Number 8406035, Salt Lake City, Utah, 84102-1553, United States\|Investigational Site Number 8406014, West Jordan, Utah, 84088-8865, United States\|Investigational Site Number 1006009, Gabrovo, 5300, Bulgaria\|Investigational Site Number 1006003, Plovdiv, 4002, Bulgaria\|Investigational Site Number 1006004, Ruse, 7002, Bulgaria\|Investigational Site Number 1006001, Ruse, 7003, Bulgaria\|Investigational Site Number 1006006, Smolyan, 4700, Bulgaria\|Investigational Site Number 1006002, Sofia, 1606, Bulgaria\|Investigational Site Number 1006010, Sofia, 1750, Bulgaria\|Investigational Site Number 1006005, Stara Zagora, 6000, Bulgaria\|Investigational Site Number 1006007, Varna, 9000, Bulgaria\|Investigational Site Number 1246003, Brampton, L6S 0C9, Canada\|Investigational Site Number 1246005, Burlington, L7R 1E2, Canada\|Investigational Site Number 1246004, Etobicoke, M9R 4E1, Canada\|Investigational Site Number 1246002, Toronto, M4G 3E8, Canada\|Investigational Site Number 1246001, Vancouver, V5Y 3W2, Canada\|Investigational Site Number 2036003, Holesov, 769 01, Czechia\|Investigational Site Number 2036002, Krnov, 794 01, Czechia\|Investigational Site Number 2036001, Olomouc, 779 00, Czechia\|Investigational Site Number 2036005, Ostrava, 702 00, Czechia\|Investigational Site Number 2036006, Praha 10 - Uhrineves, 104 00, Czechia\|Investigational Site Number 2036007, Praha 4, 140 46, Czechia\|Investigational Site Number 2036008, Praha 4, 149 00, Czechia\|Investigational Site Number 2506008, Besançon Cedex, 25030, France\|Investigational Site Number 2506003, Corbeil-Essonnes, 91106, France\|Investigational Site Number 2506005, Dijon, 21079, France\|Investigational Site Number 2506012, Mulhouse, 68100, France\|Investigational Site Number 2506004, Nantes, 44093, France\|Investigational Site Number 2506007, Narbonne, 11100, France\|Investigational Site Number 2506006, Paris, 75018, France\|Investigational Site Number 2506010, Pierre-Benite, 69495, France\|Investigational Site Number 2506009, Poitiers, 86021, France\|Investigational Site Number 2506011, Saint-Mande, 94160, France\|Investigational Site Number 2506002, Vénissieux, 69200, France\|Investigational Site Number 3486007, Budapest, 1106, Hungary\|Investigational Site Number 3486002, Budapest, 1134, Hungary\|Investigational Site Number 3486006, Hatvan, 3000, Hungary\|Investigational Site Number 3486009, Kecskemet, 6000, Hungary\|Investigational Site Number 3486003, Komarom, 2900, Hungary\|Investigational Site Number 3486005, Nyíregyháza, 4400, Hungary\|Investigational Site Number 3486001, Pécs, 7623, Hungary\|Investigational Site Number 3486008, Zalaegerszeg, 8900, Hungary\|Investigational Site Number 7036004, Bardejov, 085 01, Slovakia\|Investigational Site Number 7036008, Bratislava, 831 06, Slovakia\|Investigational Site Number 7036001, Bratislava, 85101, Slovakia\|Investigational Site Number 7036010, Kosice, 040 01, Slovakia\|Investigational Site Number 7036003, Kosice, 4014, Slovakia\|Investigational Site Number 7036007, Levice, 934 01, Slovakia\|Investigational Site Number 7036009, Levice, 934 05, Slovakia\|Investigational Site Number 7036011, Lucenec, 98401, Slovakia\|Investigational Site Number 7036006, Nitra, 949 11, Slovakia\|Investigational Site Number 7036005, Sabinov, 08301, Slovakia\|Investigational Site Number 8266002, Darlington, DL3 6HX, United Kingdom\|Investigational Site Number 8266006, Doncaster, DN9 2HY, United Kingdom\|Investigational Site Number 8266008, Dundee, DD1 9SY, United Kingdom\|Investigational Site Number 8266001, Leicester, LE5 4PW, United Kingdom\|Investigational Site Number 8266004, London, EC1M 6BQ, United Kingdom\|Investigational Site Number 8266003, Salford, M6 8HD, United Kingdom
URL:	https://clinicaltrials.gov/show/NCT03285594

Knowledge Graph
Associated Data

Drug ID	Drug Name	Type	DrugBank ID	Targets	Category	Latest Progress

Clinical Trial Details

Summary

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Associated Data

Associated NAFLD Drugs (0)