A Phase 3 Study to Evaluate the Safety of Sotagliflozin in Patients With Type 1 Diabetes Who Have Inadequate Glycemic Control With Insulin Therapy Alone

• Status: Completed
• Trial end date: 2017-04-01
• Target enrollment: 0
• Participant gender: All

Summary

This Phase 3 study was designed to demonstrate the net benefit of sotagliflozin versus placebo in patients with Type 1 Diabetes (T1D).

• 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 T1DM made at least 1 year prior to informed consent

• Participants were being treated with insulin or insulin analog

• Willing and able to perform self-monitoring of blood glucose (SMBG) and complete the study diary as required per protocol

• At the Screening Visit, A1C was between 7.0% to 11.0%

• Females of childbearing potential used an adequate method of contraception and had 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 screening

• Chronic systemic corticosteroid use

• Type 2 diabetes mellitus (T2DM), or severely uncontrolled T1D as determined by the Investigator