Efficacy, Safety, and Tolerability Study of Sotagliflozin as Adjunct Therapy in Adult Patients With Type 1 Diabetes Mellitus Who Have Inadequate Glycemic Control With Insulin Therapy
NCT ID: NCT02421510
Last Updated: 2020-02-12
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
782 participants
INTERVENTIONAL
2015-05-31
2017-06-23
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Efficacy, Safety, and Tolerability Study of Sotagliflozin as Adjunct Therapy in Adult Patients With Type 1 Diabetes Mellitus Who Have Inadequate Glycemic Control With Insulin Therapy
NCT02384941
Efficacy and Safety of Sotagliflozin in Young Adult Patients With Type 1 Diabetes Mellitus and Elevated Hemoglobin A1C
NCT02383940
Dose-ranging Study in Patients With Type 1 Diabetes Mellitus
NCT02459899
Efficacy and Safety of Soliqua Versus Lantus in Ethnically/Racially Diverse Patients With Type 2 Diabetes Mellitus Inadequately Controlled on Basal Insulin and Oral Antidiabetic Agents
NCT03434119
Dapagliflozin Evaluation in Patients With Inadequately Controlled Type 1 Diabetes
NCT02460978
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Placebo
Two placebo-matching sotagliflozin tablets, once daily, orally, before the first meal of the day for 24 weeks followed by a 28-week extension period.
Placebo
Placebo, once daily, before the first meal of the day
Sotagliflozin 200 mg
Sotagliflozin 200 milligram (mg) (one 200 mg tablet and one placebo tablet), once daily, orally, before the first meal of the day for 24 weeks followed by a 28-week extension period.
Sotagliflozin
Low dose Sotagliflozin,once daily, before the first meal of the day
Sotagliflozin 400 mg
Sotagliflozin 400 mg (two 200 mg tablets), once daily, orally, before the first meal of the day for 24 weeks followed by a 28-week extension period.
Sotagliflozin
High dose Sotagliflozin, once daily, before the first meal of the day
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Sotagliflozin
High dose Sotagliflozin, once daily, before the first meal of the day
Sotagliflozin
Low dose Sotagliflozin,once daily, before the first meal of the day
Placebo
Placebo, once daily, before the first meal of the day
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Adult participants 18 years and older with a diagnosis of T1D made at least 1 year prior to informed consent.
* Participants treated with insulin or insulin analog delivered via continuous subcutaneous insulin infusion (CSII) or multiple daily injections (MDI).
* Willing and were able to perform Self-monitoring of blood glucose (SMBG) and completed the study diary as required per protocol.
* At the Screening Visit, A1C was between 7.0% to 11.0%.
* Females of childbearing potential must use an adequate method of contraception and have a negative pregnancy test.
Exclusion Criteria
* Use of sodium-glucose cotransporter (SGLT) inhibitors within 8 weeks prior to screening.
* Chronic systemic corticosteroid use.
* Type 2 diabetes mellitus (T2DM), or severely uncontrolled T1D as determined by the Investigator.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Sanofi
INDUSTRY
Lexicon Pharmaceuticals
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Sangeeta Sawhney, M.D.
Role: STUDY_DIRECTOR
Lexicon Pharmaceuticals, Inc.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Lexicon Investigational Site
Linz, , Austria
Lexicon Investigational Site
Vienna, , Austria
Lexicon Investigational Site
Vienna, , Austria
Lexicon Investigational Site
Vienna, , Austria
Lexicon Investigational Site
Vienna, , Austria
Lexicon Investigational Site
Antwerp, , Belgium
Lexicon Investigational Site
Brussels, , Belgium
Lexicon Investigational Site
Edegem, , Belgium
Lexicon Investigational Site
Leuven, , Belgium
Lexicon Investigational Site
Sint-Niklaas, , Belgium
Lexicon Investigational Site
Lovech, , Bulgaria
Lexicon Investigational Site
Plovdiv, , Bulgaria
Lexicon Investigational Site
Rousse, , Bulgaria
Lexicon Investigational Site
Smolyan, , Bulgaria
Lexicon Investigational Site
Sofia, , Bulgaria
Lexicon Investigational Site
Varna, , Bulgaria
Lexicon Investigational Site
Béziers, , France
Lexicon Investigational Site
Dijon, , France
Lexicon Investigational Site
Nantes, , France
Lexicon Investigational Site
Nantes, , France
Lexicon Investigational Site
Nîmes, , France
Lexicon Investigational Site
Düsseldorf, , Germany
Lexicon Investigational Site
Hamburg, , Germany
Lexicon Investigational Site
Hamburg, , Germany
Lexicon Investigational Site
Hanover, , Germany
Lexicon Investigational Site
Mainz, , Germany
Lexicon Investigational Site
Münster, , Germany
Lexicon Investigational Site
Neuwied, , Germany
Lexicon Investigational Site
Budapest, , Hungary
Lexicon Investigational Site
Budapest, , Hungary
Lexicon Investigational Site
Budapest, , Hungary
Lexicon Investigational Site
Budapest, , Hungary
Lexicon Investigational Site
Budapest, , Hungary
Lexicon Investigational Site
Gyula, , Hungary
Lexicon Investigational Site
Hódmezővásárhely, , Hungary
Lexicon Investigational Site
Zalaegerszeg, , Hungary
Lexicon Investigational Site
Haifa, , Israel
Lexicon Investigational Site
Holon, , Israel
Lexicon Investigational Site
Jerusalem, , Israel
Lexicon Investigational Site
Petah Tikva, , Israel
Lexicon Investigational Site
Tel Aviv, , Israel
Lexicon Investigational Site
Tel Litwinsky, , Israel
Lexicon Investigational Site
Ẕerifin, , Israel
Lexicon Investigational Site
Catania, , Italy
Lexicon Investigational Site
Milan, , Italy
Lexicon Investigational Site
Palermo, , Italy
Lexicon Investigational Site
Perugia, , Italy
Lexicon Investigational Site
Pisa, , Italy
Lexicon Investigational Site
Roma, , Italy
Lexicon Investigational Site
Jonava, , Lithuania
Lexicon Investigational Site
Kaunas, , Lithuania
Lexicon Investigational Site
Kaunas, , Lithuania
Lexicon Investigational Site
Dordrecht, , Netherlands
Lexicon Investigational Site
Katowice, , Poland
Lexicon Investigational Site
Krakow, , Poland
Lexicon Investigational Site
Lodz, , Poland
Lexicon Investigational Site
Lublin, , Poland
Lexicon Investigational Site
Poznan, , Poland
Lexicon Investigational Site
Szczecin, , Poland
Lexicon Investigational Site
Warsaw, , Poland
Lexicon Investigational Site
Warsaw, , Poland
Lexicon Investigational Site
Warsaw, , Poland
Lexicon Investigational Site
Bacau, , Romania
Lexicon Investigational Site
Bucharest, , Romania
Lexicon Investigational Site
Bucharest, , Romania
Lexicon Investigational Site
Buzău, , Romania
Lexicon Investigational Site
Galati, , Romania
Lexicon Investigational Site
Oradea, , Romania
Lexicon Investigational Site
Sibiu, , Romania
Lexicon Investigational Site
Târgu Mureş, , Romania
Lexicon Investigational Site
Bratislava, , Slovakia
Lexicon Investigational Site
Bratislava, , Slovakia
Lexicon Investigational Site
Košice, , Slovakia
Lexicon Investigational Site
Nové Zámky, , Slovakia
Lexicon Investigational Site
Štúrovo, , Slovakia
Lexicon Investigational Site
Vrútky, , Slovakia
Lexicon Investigational Site
Barcelona, , Spain
Lexicon Investigational Site
Barcelona, , Spain
Lexicon Investigational Site
Granada, , Spain
Lexicon Investigational Site
Málaga, , Spain
Lexicon Investigational Site
Seville, , Spain
Lexicon Investigational Site
Seville, , Spain
Lexicon Investigational Site
Seville, , Spain
Lexicon Investigational Site
Seville, , Spain
Lexicon Investigational Site
Valencia, , Spain
Lexicon Investigational Site
Härnösand, , Sweden
Lexicon Investigational Site
Kristianstad, , Sweden
Lexicon Investigational Site
Stockholm, , Sweden
Lexicon Investigational Site
Sankt Gallen, , Switzerland
Lexicon Investigational Site
Birmingham, , United Kingdom
Lexicon Investigational Site
Blackburn, , United Kingdom
Lexicon Investigational Site
Bristol, , United Kingdom
Lexicon Investigational Site
Glasgow, , United Kingdom
Lexicon Investigational Site
Leeds, , United Kingdom
Lexicon Investigational Site
Leicester, , United Kingdom
Lexicon Investigational Site
Sheffield, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Peters AL, McGuire DK, Danne T, Kushner JA, Rodbard HW, Dhatariya K, Sawhney S, Banks P, Jiang W, Davies MJ, Lapuerta P. Diabetic Ketoacidosis and Related Events With Sotagliflozin Added to Insulin in Adults With Type 1 Diabetes: A Pooled Analysis of the inTandem 1 and 2 Studies. Diabetes Care. 2020 Nov;43(11):2713-2720. doi: 10.2337/dc20-0924. Epub 2020 Sep 14.
Danne T, Joish VN, Afonso M, Banks P, Sawhney S, Lapuerta P, Davies MJ, Buse JB, Lin D, Reaney M, Guillonneau S, Snoek FJ, Bailey TS, Polonsky WH. Improvement in Patient-Reported Outcomes in Adults with Type 1 Diabetes Treated with Sotagliflozin plus Insulin Versus Insulin Alone. Diabetes Technol Ther. 2021 Jan;23(1):70-77. doi: 10.1089/dia.2020.0068.
Ervin C, Joish VN, Evans E, DiBenedetti D, Reaney M, Preblick R, Castro R, Danne T, Buse JB, Lapuerta P. Insights Into Patients' Experience With Type 1 Diabetes: Exit Interviews From Phase III Studies of Sotagliflozin. Clin Ther. 2019 Nov;41(11):2219-2230.e6. doi: 10.1016/j.clinthera.2019.09.003. Epub 2019 Oct 3.
Danne T, Cariou B, Buse JB, Garg SK, Rosenstock J, Banks P, Kushner JA, McGuire DK, Peters AL, Sawhney S, Strumph P. Improved Time in Range and Glycemic Variability With Sotagliflozin in Combination With Insulin in Adults With Type 1 Diabetes: A Pooled Analysis of 24-Week Continuous Glucose Monitoring Data From the inTandem Program. Diabetes Care. 2019 May;42(5):919-930. doi: 10.2337/dc18-2149. Epub 2019 Mar 4.
Danne T, Cariou B, Banks P, Brandle M, Brath H, Franek E, Kushner JA, Lapuerta P, McGuire DK, Peters AL, Sawhney S, Strumph P. HbA1c and Hypoglycemia Reductions at 24 and 52 Weeks With Sotagliflozin in Combination With Insulin in Adults With Type 1 Diabetes: The European inTandem2 Study. Diabetes Care. 2018 Sep;41(9):1981-1990. doi: 10.2337/dc18-0342. Epub 2018 Jun 24.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
LX4211.310
Identifier Type: OTHER
Identifier Source: secondary_id
2014-005153-39
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
LX4211.1-310-T1DM
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.