Overview

This trial is active, not recruiting.

Conditions type 1 diabetes mellitus (t1dm), high level of sugar (glucose) in the blood
Treatments sotagliflozin, placebo
Phase phase 3
Sponsor Lexicon Pharmaceuticals
Start date September 2015
End date March 2017
Trial size 1400 participants
Trial identifier NCT02531035, LX4211.1-312-T1DM, LX4211.312

Summary

This Phase 3 study is designed to demonstrate the net benefit of sotagliflozin versus placebo in patients with T1D.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
Sotagliflozin (fasted conditions)
sotagliflozin LX4211
Sotagliflozin, once daily, before the first meal of the day
(Placebo Comparator)
Placebo (fasted conditions)
placebo
Placebo, once daily, before the first meal of the day

Primary Outcomes

Measure
Proportion of patients with A1C <7.0% at Week 24 and no episode of severe hypoglycemia and no episode of DKA after randomization
time frame: Week 24

Secondary Outcomes

Measure
Change from Baseline to Week 24 in A1C
time frame: Week 24
Change from Baseline in body weight
time frame: Week 24
Change from Baseline in systolic blood pressure (SBP)
time frame: Week 16

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Patient has given written informed consent to participate in the study in accordance with local regulations - Adult patients 18 years and older with a diagnosis of T1DM made at least 1 year prior to informed consent - Patients are 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 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 screening - Chronic systemic corticosteroid use - Type 2 diabetes mellitus (T2DM), or severely uncontrolled T1D as determined by the Investigator

Additional Information

Official title A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Net Clinical Benefit of Sotagliflozin as Adjunct to Insulin Therapy in Type 1 Diabetes
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by Lexicon Pharmaceuticals.