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
NCT ID: NCT02531035
Last Updated: 2020-02-12
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
1405 participants
INTERVENTIONAL
2015-09-30
2017-04-30
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 to sotagliflozin tablets daily, orally, before the first meal of the day for 24 weeks.
Placebo
Placebo, once daily, before the first meal of the day
Sotagliflozin 400 mg
Sotagliflozin 400 milligram (mg) (two 200 mg tablets) once daily, orally, before the first meal of the day for 24 weeks.
Sotagliflozin
Sotagliflozin, once daily, before the first meal of the day
Interventions
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Sotagliflozin
Sotagliflozin, once daily, before the first meal of the day
Placebo
Placebo, once daily, before the 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 T1DM made at least 1 year prior to informed consent
* Participants were being treated with insulin or insulin analog
* Willing and able to perform self-monitoring of blood glucose (SMBG) and complete the study diary as required per protocol
* At the Screening Visit, A1C was between 7.0% to 11.0%
* Females of childbearing potential used an adequate method of contraception and had 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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Sangeeta Sawhney, MD
Role: STUDY_DIRECTOR
Lexicon Pharmaceuticals, Inc.
Locations
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Lexicon Investigational Site
Concord, California, United States
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Escondido, California, United States
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La Jolla, California, United States
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San Marcos, California, United States
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Ventura, California, United States
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Walnut Creek, California, United States
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Aurora, Colorado, United States
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New Haven, Connecticut, United States
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Orlando, Florida, United States
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West Palm Beach, Florida, United States
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Atlanta, Georgia, United States
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Macon, Georgia, United States
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Roswell, Georgia, United States
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New Orleans, Louisiana, United States
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Rockville, Maryland, United States
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Boston, Massachusetts, United States
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Bloomfield Hills, Michigan, United States
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Omaha, Nebraska, United States
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Las Vegas, Nevada, United States
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Albany, New York, United States
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The Bronx, New York, United States
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Asheville, North Carolina, United States
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Chapel Hill, North Carolina, United States
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Greenville, North Carolina, United States
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Morehead City, North Carolina, United States
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Grand Forks, North Dakota, United States
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Bend, Oregon, United States
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Sioux Falls, South Dakota, United States
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Austin, Texas, United States
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San Antonio, Texas, United States
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Shavano Park, Texas, United States
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Salt Lake City, Utah, United States
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Seattle, Washington, United States
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Córdoba, Córdoba Province, Argentina
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Buenos Aires, , Argentina
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Buenos Aires, , Argentina
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Coffs Harbour, New South Wales, Australia
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Merewether, New South Wales, Australia
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St Leonards, New South Wales, Australia
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Wollongong, New South Wales, Australia
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Herston, Queensland, Australia
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Keswick, South Australia, Australia
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Box Hill, Victoria, Australia
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Fitzroy, Victoria, Australia
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Parkville, Victoria, Australia
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Aalst, , Belgium
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Ghent, , Belgium
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Sint-Niklaas, , Belgium
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Plovdiv, , Bulgaria
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Rousse, , Bulgaria
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Smolyan, , Bulgaria
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Sofia, , Bulgaria
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Sofia, , Bulgaria
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Varna, , Bulgaria
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Vancouver, British Columbia, Canada
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Halifax, Nova Scotia, Canada
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Barrie, Ontario, Canada
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London, Ontario, Canada
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Markham, Ontario, Canada
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Oakville, Ontario, Canada
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Thornhill, Ontario, Canada
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Toronto, Ontario, Canada
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Saint-Laurent, Quebec, Canada
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Sherbrooke, Quebec, Canada
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Atlántico, , Colombia
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Cundinamarca, , Colombia
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Cundinamarca, , Colombia
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Cundinamarca, , Colombia
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Krnov, , Czechia
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Olomouc, , Czechia
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Ostrava, , Czechia
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Prague, , Czechia
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Prague, , Czechia
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Prague, , Czechia
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Corbeil-Essonnes, , France
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Pierre-Bénite, , France
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Mainz, Palatinate, Germany
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Sulzbach, Rosenberg Bavaria, Germany
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Münster, Westphalia, Germany
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Aschaffenburg, , Germany
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Aßlar, , Germany
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Budapest, , Hungary
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Budapest, , Hungary
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Budapest, , Hungary
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Budapest, , Hungary
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Eger, , Hungary
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Esztergom, , Hungary
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Győr, , Hungary
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Sátoraljaújhely, , Hungary
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Holon, , Israel
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Petach-Tikvah, , Israel
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Petah Tikva, , Israel
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Rehovot, , Israel
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Tel Litwinsky, , Israel
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Bologna, , Italy
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Catania, , Italy
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Catania, , Italy
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Latina, , Italy
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Milan, , Italy
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Rome, , Italy
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Epsom, Auckland, New Zealand
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Takapuna, Auckland, New Zealand
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Christchurch, Canterbury, New Zealand
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Dunedin, Otago, New Zealand
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Newtown, Wellington Region, New Zealand
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Christchurch, , New Zealand
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Otahuhu, , New Zealand
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Gdynia, , Poland
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Katowice, , Poland
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Katowice, , Poland
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Lublin, , Poland
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Warsaw, , Poland
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Warsaw, , Poland
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Warsaw, , Poland
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Bardejov, , Slovakia
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Bratislava, , Slovakia
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Bratislava, , Slovakia
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Levice, , Slovakia
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Goodwood, Cape Town, South Africa
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Middelburg, Mpumalanga, South Africa
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Bloemfontein, , South Africa
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Cape Town, , South Africa
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Cape Town, , South Africa
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Johannesburg, , South Africa
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Port Elizabeth, , South Africa
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Barcelona, , Spain
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Barcelona, , Spain
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Málaga, , Spain
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Seville, , Spain
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Seville, , Spain
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Dundee, Scotland, United Kingdom
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Blackburn, , United Kingdom
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Guildford, , United Kingdom
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Leicester, , United Kingdom
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Northampton, , United Kingdom
Countries
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References
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Garg SK, Henry RR, Banks P, Buse JB, Davies MJ, Fulcher GR, Pozzilli P, Gesty-Palmer D, Lapuerta P, Simo R, Danne T, McGuire DK, Kushner JA, Peters A, Strumph P. Effects of Sotagliflozin Added to Insulin in Patients with Type 1 Diabetes. N Engl J Med. 2017 Dec 14;377(24):2337-2348. doi: 10.1056/NEJMoa1708337. Epub 2017 Sep 13.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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LX4211.312
Identifier Type: OTHER
Identifier Source: secondary_id
LX4211.1-312-T1DM
Identifier Type: -
Identifier Source: org_study_id
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