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: NCT02384941
Last Updated: 2020-02-12
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
793 participants
INTERVENTIONAL
2015-03-31
2017-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Placebo
Two placebo-matching sotagliflozin tables, orally for 24 weeks followed by a 28 week extension period.
Placebo
Placebo once daily, before first meal of the day.
Sotagliflozin 200 milligrams (mg)
Sotagliflozin 200 mg (one 200 mg tablet and one placebo tablet), orally, for 24 weeks followed by a 28 week extension period.
Placebo
Placebo once daily, before first meal of the day.
Sotagliflozin
Sotagliflozin once daily, before first meal of the day.
Sotagliflozin 400 mg
Sotagliflozin 400 mg (two 200 mg tablets), orally, for 24 weeks followed by a 28 week extension period.
Sotagliflozin
Sotagliflozin once daily, before first meal of the day.
Interventions
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Placebo
Placebo once daily, before first meal of the day.
Sotagliflozin
Sotagliflozin once daily, before first meal of the day.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Adult participants 18 years and older with a diagnosis of T1D made at least 1 year prior to informed consent.
* Participants were being treated with insulin or insulin analog delivered. via continuous subcutaneous insulin infusion (CSII) or multiple daily injections (MDI).
* Willing and able to perform self-monitored blood glucose (SMBG) and complete the study diary as required per protocol.
* At the Screening Visit, A1C must be 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 randomization.
* Chronic systemic corticosteroid use.
* Type 2 diabetes mellitus (T2D), or severely uncontrolled T1D as determined by the Investigator.
18 Years
ALL
No
Sponsors
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Sanofi
INDUSTRY
Lexicon Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Sangeeta Sawhney, M.D.
Role: STUDY_DIRECTOR
Lexicon Pharmaceuticals, Inc.
Locations
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Lexicon Investigational Site
Birmingham, Alabama, United States
Lexicon Investigational Site
Little Rock, Arkansas, United States
Lexicon Investigational Site
Escondido, California, United States
Lexicon Investigational Site
Greenbrae, California, United States
Lexicon Investigational Site
Huntington Beach, California, United States
Lexicon Investigational Site
La Jolla, California, United States
Lexicon Investigational Site
Los Angeles, California, United States
Lexicon Investigational Site
Orange, California, United States
Lexicon Investigational Site
Palm Springs, California, United States
Lexicon Investigational Site
San Mateo, California, United States
Lexicon Investigational Site
Tarzana, California, United States
Lexicon Investigational Site
Tustin, California, United States
Lexicon Investigational Site
Walnut Creek, California, United States
Lexicon Investigational Site
Aurora, Colorado, United States
Lexicon Investigational Site
Longmont, Colorado, United States
Lexicon Investigational Site
Fleming Island, Florida, United States
Lexicon Investigational Site
Jacksonville, Florida, United States
Lexicon Investigational Site
Jacksonville, Florida, United States
Lexicon Investigational Site
New Port Richey, Florida, United States
Lexicon Investigational Site
Ormond Beach, Florida, United States
Lexicon Investigational Site
West Palm Beach, Florida, United States
Lexicon Investigational Site
Atlanta, Georgia, United States
Lexicon Investigational Site
Lawrenceville, Georgia, United States
Lexicon Investigational Site
Roswell, Georgia, United States
Lexicon Investigational Site
Honolulu, Hawaii, United States
Lexicon Investigational Site
Crystal Lake, Illinois, United States
Lexicon Investigational Site
Elgin, Illinois, United States
Lexicon Investigational Site
Springfield, Illinois, United States
Lexicon Investigational Site
Topeka, Kansas, United States
Lexicon Investigational Site
Lexington, Kentucky, United States
Lexicon Investigational Site
Bangor, Maine, United States
Lexicon Investigational Site
Baltimore, Maryland, United States
Lexicon Investigational Site
Boston, Massachusetts, United States
Lexicon Investigational Site
Detroit, Michigan, United States
Lexicon Investigational Site
Chesterfield, Missouri, United States
Lexicon Investigational Site
St Louis, Missouri, United States
Lexicon Investigational Site
Omaha, Nebraska, United States
Lexicon Investigational Site
Henderson, Nevada, United States
Lexicon Investigational Site
Las Vegas, Nevada, United States
Lexicon Investigational Site
Albany, New York, United States
Lexicon Investigational Site
New York, New York, United States
Lexicon Investigational Site
Asheville, North Carolina, United States
Lexicon Investigational Site
Chapel Hill, North Carolina, United States
Lexicon Investigational Site
Morehead City, North Carolina, United States
Lexicon Investigational Site
Columbus, Ohio, United States
Lexicon Investigational Site
Oklahoma City, Oklahoma, United States
Lexicon Investigational Site
Portland, Oregon, United States
Lexicon Investigational Site
Greer, South Carolina, United States
Lexicon Investigational Site
Rapid City, South Dakota, United States
Lexicon Investigational Site
Chattanooga, Tennessee, United States
Lexicon Investigational Site
Chattanooga, Tennessee, United States
Lexicon Investigational Site
Memphis, Tennessee, United States
Lexicon Investigational Site
Austin, Texas, United States
Lexicon Investigational Site
Dallas, Texas, United States
Lexicon Investigational Site
Dallas, Texas, United States
Lexicon Investigational Site
Dallas, Texas, United States
Lexicon Investigational Site
Houston, Texas, United States
Lexicon Investigational Site
Houston, Texas, United States
Lexicon Investigational Site
San Antonio, Texas, United States
Lexicon Investigational Site
Schertz, Texas, United States
Lexicon Investigational Site
Chesapeake, Virginia, United States
Lexicon Investigational Site
Renton, Washington, United States
Lexicon Investigational Site
Seattle, Washington, United States
Lexicon Investigational Site
Calgary, Alberta, Canada
Lexicon Investigational Site
Vancouver, British Columbia, Canada
Lexicon Investigational Site
Winnipeg, Manitoba, Canada
Lexicon Investigational Site
Halifax, Nova Scotia, Canada
Lexicon Investigational Site
Barrie, Ontario, Canada
Lexicon Investigational Site
Hamilton, Ontario, Canada
Lexicon Investigational Site
London, Ontario, Canada
Lexicon Investigational Site
Ottawa, Ontario, Canada
Lexicon Investigational Site
Thornhill, Ontario, Canada
Lexicon Investigational Site
Toronto, Ontario, Canada
Lexicon Investigational Site
Montreal, Quebec, Canada
Lexicon Investigational Site
Saint-Laurent, Quebec, Canada
Countries
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References
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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.
Buse JB, Garg SK, Rosenstock J, Bailey TS, Banks P, Bode BW, Danne T, Kushner JA, Lane WS, Lapuerta P, McGuire DK, Peters AL, Reed J, Sawhney S, Strumph P. Sotagliflozin in Combination With Optimized Insulin Therapy in Adults With Type 1 Diabetes: The North American inTandem1 Study. Diabetes Care. 2018 Sep;41(9):1970-1980. doi: 10.2337/dc18-0343. Epub 2018 Jun 24.
Other Identifiers
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LX4211.1-309-T1DM
Identifier Type: -
Identifier Source: org_study_id
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