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

Completed · Phase 3 · Has a placebo group

Conditions studied: Type 1 Diabetes Mellitus

In brief

This Phase 3 study was intended to demonstrate superiority of either sotagliflozin high dose or low dose versus placebo on glycosylated hemoglobin A1C (A1C) reduction at Week 24 when used as an adjunct in adult participants with type 1 diabetes mellitus (T1D) who have inadequate glycemic control with insulin therapy.

Key facts

Study ID

NCT02384941

Run by

Lexicon Pharmaceuticals

People needed

793

Starts

2015-03-01

Expected to finish

2017-02-01

Last updated by the study team

2020-02-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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 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 .

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 randomization.
• Chronic systemic corticosteroid use.
• Type 2 diabetes mellitus (T2D), or severely uncontrolled T1D as determined by the Investigator.

Where it is running

• 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 — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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