Dose-ranging Study in Patients With Type 1 Diabetes Mellitus
NCT ID: NCT02459899
Last Updated: 2020-02-12
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
141 participants
INTERVENTIONAL
2015-07-31
2016-08-31
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
QUADRUPLE
Study Groups
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Placebo
Two placebo-matching sotagliflozin tablets, once daily, orally for 12 weeks.
Placebo
Placebo, once daily, before the first meal of the day
Sotagliflozin 75 mg
Sotagliflozin 75 mg (one 75 mg tablet and one placebo tablet), once daily, orally for 12 weeks.
Placebo
Placebo, once daily, before the first meal of the day
Sotagliflozin
Sotagliflozin,once daily, before the first meal of the day
Sotagliflozin 200 mg
Sotagliflozin 200 mg (one 200 mg tablet and one placebo tablet), once daily, orally for 12 weeks.
Placebo
Placebo, once daily, before the first meal of the day
Sotagliflozin
Sotagliflozin,once daily, before the first meal of the day
Sotagliflozin 400 mg
Sotagliflozin 400 mg (two 200 mg tablets), once daily, orally for 12 weeks.
Sotagliflozin
Sotagliflozin,once daily, before the first meal of the day
Interventions
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Placebo
Placebo, once daily, before the first meal of the day
Sotagliflozin
Sotagliflozin,once daily, before the first meal of the day
Eligibility Criteria
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Inclusion Criteria
* Adult participants 18 years and older with a diagnosis of type 1 diabetes mellitus (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 injection (MDI).
* At the Screening Visit, A1C had to be between 7.0% and 10.0%.
* Females of childbearing potential had to 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
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Sanofi
INDUSTRY
Lexicon Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Suman Wason, MD
Role: STUDY_DIRECTOR
Lexicon Pharmaceuticals, Inc.
Locations
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Lexicon Investigational Site
Concord, California, United States
Lexicon Investigational Site
Ventura, California, United States
Lexicon Investigational Site
Denver, Colorado, United States
Lexicon Investigational Site
Jacksonville, Florida, United States
Lexicon Investigational Site
Miami, Florida, United States
Lexicon Investigational Site
Springfield, Illinois, United States
Lexicon Investigational Site
Metairie, Louisiana, United States
Lexicon Investigational Site
Auburn, Maine, United States
Lexicon Investigational Site
Rockville, Maryland, United States
Lexicon Investigational Site
Great Falls, Montana, United States
Lexicon Investigational Site
Omaha, Nebraska, United States
Lexicon Investigational Site
High Point, North Carolina, United States
Lexicon Investigational Site
Columbus, Ohio, United States
Lexicon Investigational Site
San Antonio, Texas, United States
Lexicon Investigational Site
Salt Lake City, Utah, United States
Lexicon Investigational Site
Chesapeake, Virginia, United States
Lexicon Investigational Site
Manassas, Virginia, United States
Countries
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References
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Baker C, Wason S, Banks P, Sawhney S, Chang A, Danne T, Gesty-Palmer D, Kushner JA, McGuire DK, Mikell F, O'Neill M, Peters AL, Strumph P. Dose-dependent glycometabolic effects of sotagliflozin on type 1 diabetes over 12 weeks: The inTandem4 trial. Diabetes Obes Metab. 2019 Nov;21(11):2440-2449. doi: 10.1111/dom.13825. Epub 2019 Aug 1.
Other Identifiers
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LX4211.206
Identifier Type: OTHER
Identifier Source: secondary_id
LX4211.1-206-T1DM
Identifier Type: -
Identifier Source: org_study_id
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