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

NCT02531035 | Completed Phase 3 Results DMC

• 2 other identifiers: LX4211.1-312-T1DMLX4211.312
• Study Type: interventional
• Target: 1,405
• Locations: 19 countries
• Sites: 135

Brief Summary

This Phase 3 study was designed to demonstrate the net benefit of sotagliflozin versus placebo in patients with Type 1 Diabetes (T1D).

Conditions

Type 1 Diabetes Mellitus (T1DM); High Level of Sugar (Glucose) in the Blood

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With A1C <7.0% at Week 24 and No Episode of Severe Hypoglycemia and No Episode of Diabetic Ketoacidosis (DKA) After Randomization

  The primary composite endpoint included blood samples for the assessment of Hemoglobin A1C to determine the participants with a value \<7.0%. A central blinded adjudication process determined whether participants experienced either DKA or Severe Hypoglycemia.

  Week 24

Secondary Outcomes (4)

• Change From Baseline in A1C

  Baseline to Week 24

• Absolute Change From Baseline in Body Weight

  Baseline to Week 24

• Change From Baseline in Systolic Blood Pressure (SBP) in the Subset of Participants With Baseline SBP >=130 Millimeter of Mercury (mmHg)

  Baseline to Week 16

• Percent Change From Baseline in Mean Daily Bolus Insulin Dose

  Baseline to Week 24

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Two placebo-matching to sotagliflozin tablets daily, orally, before the first meal of the day for 24 weeks.

Drug: Placebo

Sotagliflozin 400 mg

EXPERIMENTAL

Sotagliflozin 400 milligram (mg) (two 200 mg tablets) once daily, orally, before the first meal of the day for 24 weeks.

Drug: Sotagliflozin

Interventions

Sotagliflozin DRUG

Sotagliflozin, once daily, before the first meal of the day

Also known as: LX4211

Sotagliflozin 400 mg

Placebo DRUG

Placebo, once daily, before the first meal of the day

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants had given written informed consent to participate in the study in accordance with local regulations
• 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

You may not qualify if:

• Use of antidiabetic agent other than insulin or insulin analog at the time of screening
• 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

Sponsors & Collaborators

• Lexicon Pharmaceuticals: lead
• Sanofi: collaborator

Study Sites (135)

Lexicon Investigational Site

Concord, California, 94520, United States

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Escondido, California, 92025, United States

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La Jolla, California, 92037, United States

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San Marcos, California, 94401, United States

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Ventura, California, 93003, United States

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Walnut Creek, California, 94598, United States

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Aurora, Colorado, 80045, United States

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New Haven, Connecticut, 06511, United States

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Orlando, Florida, 32804, United States

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West Palm Beach, Florida, 33401, United States

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Atlanta, Georgia, 30318, United States

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Macon, Georgia, 31210, United States

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Roswell, Georgia, 30076, United States

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New Orleans, Louisiana, 70112, United States

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Rockville, Maryland, 20852, United States

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Boston, Massachusetts, 02215, United States

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Bloomfield Hills, Michigan, 48302, United States

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Omaha, Nebraska, 68114, United States

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Las Vegas, Nevada, 89148, United States

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Albany, New York, 12206, United States

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The Bronx, New York, 10467, United States

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Asheville, North Carolina, 28803, United States

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Chapel Hill, North Carolina, 27517, United States

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Greenville, North Carolina, 27834, United States

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Morehead City, North Carolina, 28557, United States

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Grand Forks, North Dakota, 58201, United States

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Bend, Oregon, 97701, United States

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Sioux Falls, South Dakota, 57104, United States

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Austin, Texas, 78731, United States

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San Antonio, Texas, 78229, United States

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Shavano Park, Texas, 78231, United States

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Salt Lake City, Utah, 84107, United States

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Seattle, Washington, 98105, United States

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Córdoba, Córdoba Province, X5006IKK, Argentina

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Buenos Aires, B7600FZN, Argentina

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Buenos Aires, C1180AAX, Argentina

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Coffs Harbour, New South Wales, 2450, Australia

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Merewether, New South Wales, 2291, Australia

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St Leonards, New South Wales, 2065, Australia

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Wollongong, New South Wales, 2500, Australia

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Herston, Queensland, 4029, Australia

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Keswick, South Australia, 5035, Australia

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Box Hill, Victoria, 3128, Australia

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Fitzroy, Victoria, 3065, Australia

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Parkville, Victoria, 3050, Australia

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Aalst, 9300, Belgium

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Ghent, 9000, Belgium

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Sint-Niklaas, 9100, Belgium

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Plovdiv, 4002, Bulgaria

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Rousse, 7003, Bulgaria

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Smolyan, 4700, Bulgaria

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Sofia, 1431, Bulgaria

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Sofia, 1750, Bulgaria

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Varna, 9000, Bulgaria

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Vancouver, British Columbia, V5Y 3W2, Canada

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Halifax, Nova Scotia, B3H 2Y9, Canada

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Barrie, Ontario, L4M 7G1, Canada

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London, Ontario, N6A 4V2, Canada

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Markham, Ontario, L6B 0P9, Canada

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Oakville, Ontario, L6M 1M1, Canada

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Thornhill, Ontario, L4J 8L7, Canada

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Toronto, Ontario, M4G 3E8, Canada

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Saint-Laurent, Quebec, H4T 1Z9, Canada

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Sherbrooke, Quebec, J1G 5K2, Canada

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Atlántico, 080020, Colombia

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Cundinamarca, 110221, Colombia

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Cundinamarca, 111211, Colombia

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Cundinamarca, 111311, Colombia

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Krnov, 794 01, Czechia

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Olomouc, 779 00, Czechia

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Ostrava, 702 00, Czechia

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Prague, 104 00, Czechia

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Prague, 149 00, Czechia

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Prague, 150 98, Czechia

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Corbeil-Essonnes, 91106, France

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Pierre-Bénite, 69495, France

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Mainz, Palatinate, 55116, Germany

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Sulzbach, Rosenberg Bavaria, 92237, Germany

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Münster, Westphalia, 48153, Germany

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Aschaffenburg, 63739, Germany

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Aßlar, 35614, Germany

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Budapest, 1027, Hungary

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Budapest, 1033, Hungary

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Budapest, 1088, Hungary

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Budapest, 1213, Hungary

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Eger, 3300, Hungary

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Esztergom, 2500, Hungary

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Győr, 9023, Hungary

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Sátoraljaújhely, 3980, Hungary

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Holon, 58100, Israel

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Petach-Tikvah, 4920235, Israel

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Petah Tikva, 4941492, Israel

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Rehovot, 76100, Israel

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Tel Litwinsky, 56261, Israel

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Bologna, 40138, Italy

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Catania, 95122, Italy

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Catania, 95123, Italy

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Latina, 04100, Italy

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Milan, 20132, Italy

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Rome, 00128, Italy

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Epsom, Auckland, 1051, New Zealand

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Takapuna, Auckland, 0620, New Zealand

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Christchurch, Canterbury, 8001, New Zealand

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Dunedin, Otago, 9016, New Zealand

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Newtown, Wellington Region, 6021, New Zealand

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Christchurch, 8011, New Zealand

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Otahuhu, 1640, New Zealand

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Gdynia, 81-338, Poland

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Katowice, 40-060, Poland

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Katowice, 40-954, Poland

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Lublin, 20-538, Poland

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Warsaw, 01-868, Poland

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Warsaw, 02-507, Poland

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Warsaw, 04-736, Poland

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Bardejov, 085 01, Slovakia

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Bratislava, 851 01, Slovakia

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Bratislava, 85101, Slovakia

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Levice, 934 01, Slovakia

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Goodwood, Cape Town, 7460, South Africa

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Middelburg, Mpumalanga, 1055, South Africa

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Bloemfontein, 9300, South Africa

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Cape Town, 7130, South Africa

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Cape Town, 7580, South Africa

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Johannesburg, 2198, South Africa

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Port Elizabeth, 6045, South Africa

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Barcelona, 08035, Spain

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Barcelona, 08036, Spain

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Málaga, 29006, Spain

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Seville, 41009, Spain

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Seville, 41071, Spain

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Dundee, Scotland, DD1 9SY, United Kingdom

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Blackburn, BB2 3HH, United Kingdom

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Guildford, GU2 7XX, United Kingdom

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Leicester, LE5 4PW, United Kingdom

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Northampton, NN1 5BD, United Kingdom

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Related Publications (1)

• 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.

  PMID: 28899222 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

(2S,3R,4R,5S,6R)-2-(4-chloro-3-(4-ethoxybenzyl)phenyl)-6-(methylthio)tetrahydro-2H-pyran-3,4,5-triol

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Results Point of Contact

• Title: Trial Transparency Team
• Organization: Sanofi

Contact-US@sanofi.com

800-633-1610

Study Officials

• Sangeeta Sawhney, MD

  Lexicon Pharmaceuticals, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 20, 2015
• First Posted: August 21, 2015
• Study Start: September 1, 2015
• Primary Completion: April 1, 2017
• Study Completion: April 1, 2017
• Last Updated: February 12, 2020
• Results First Posted: November 19, 2019

Record last verified: 2020-02

Locations

IL (5); BE (3); DE (5); GB (5); ZA (7); CZ (6); BU (6); HU (8); AR (3); PL (7); ES (5); CO (4); US (33); NZ (7); IT (6); CA (10); FR (2); SL (4); AU (9)