Overview
Efficacy and Safety of Sotagliflozin in Young Adult Patients With Type 1 Diabetes Mellitus and Elevated Hemoglobin A1C
Status:
Completed
Completed
Trial end date:
2016-09-01
2016-09-01
Target enrollment:
0
0
Participant gender:
All
All
Summary
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.Phase:
Phase 2Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Lexicon PharmaceuticalsCollaborators:
Juvenile Diabetes Research Foundation
SanofiTreatments:
(2S,3R,4R,5S,6R)-2-(4-chloro-3-(4-ethoxybenzyl)phenyl)-6-(methylthio)tetrahydro-2H-pyran-3,4,5-triol
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.