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

• Status: Completed
• Trial end date: 2017-02-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Lexicon Pharmaceuticals
• Collaborator: Sanofi
• Treatments: (2S,3R,4R,5S,6R)-2-(4-chloro-3-(4-ethoxybenzyl)phenyl)-6-(methylthio)tetrahydro-2H-pyran-3,4,5-triol

Criteria

Inclusion Criteria:

• 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 .

Exclusion Criteria:

• 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.