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Efficacy and Safety of Sotagliflozin in Young Adult Patients With Type 1 Diabetes Mellitus and Elevated Hemoglobin A1C

CompletedPhase 2

Sponsor: Lexicon Pharmaceuticals

Conditions: Type 1 Diabetes Mellitus

Interventions: Sotagliflozin, Placebo

Countries: United States

This Phase 2 study was intended to demonstrate superiority of sotagliflozin versus placebo on Hemoglobin A1C (A1C) reduction at Week 12 in young adult participants with type 1 diabetes mellitus (T1DM) who have poor glycemic control on their current insulin regimen.

Eligibility overview

Sex: ALL

Age: 18 Years to 30 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

* Participant had given written informed consent.
* Young adult participants \>=18 to \<=30 years old at Screening, with a confirmed diagnosis of T1DM made at least 1 year prior to informed consent.
* Participants were being treated with insulin or insulin analogue delivered via continuous subcutaneous insulin infusion (CSII) or multiple daily injections (MDI).
* At Screening, must had A1C \>= 9.0%.
* Must be willing and able to perform self-monitored blood glucose (SMBG) and complete the study diary.
* Females of childbearing potential must use an adequate method of contraception and had a negative pregnancy test.

Exclusion Criteria:

* Any prior use of LX4211/sotagliflozin.
* Use of antidiabetic agent other than insulin or insulin analogue at the time of screening.
* Use of sodium-glucose cotransporter (SGLT) inhibitors within 8 weeks prior to start of the placebo Run-in Period.
* Chronic systemic corticosteroid use.
* Type 2 diabetes, or severely uncontrolled diabetes mellitus as determined by the Investigator.
* History of diabetic ketoacidosis (DKA) or nonketotic hyperosmolar state within 6 months prior to the Screening Visit.
* History of severe hypoglycemic event within 1 month prior to the Screening Visit.

Locations (15)

Tustin, California, United States
Aurora, Colorado, United States
New Haven, Connecticut, United States
Tampa, Florida, United States
West Palm Beach, Florida, United States
Atlanta, Georgia, United States
Roswell, Georgia, United States
Indianapolis, Indiana, United States
New Orleans, Louisiana, United States
Auburn, Maine, United States
Boston, Massachusetts, United States
Buffalo, New York, United States
Wilmington, North Carolina, United States
Austin, Texas, United States
Salt Lake City, Utah, United States