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

Completed · Phase 2 · Has a placebo group

Conditions studied: Type 1 Diabetes Mellitus

In brief

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.

Key facts

Study ID

NCT02383940

Run by

Lexicon Pharmaceuticals

People needed

87

Starts

2015-04-01

Expected to finish

2016-09-01

Last updated by the study team

2020-02-12

Who can join

Age: 18 and older, up to 30. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

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

Full record on ClinicalTrials.gov

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