Overview

This trial has been completed.

Condition type 1 diabetes mellitus
Treatments sotagliflozin, placebo
Phase phase 2
Sponsor Lexicon Pharmaceuticals
Collaborator Juvenile Diabetes Research Foundation
Start date March 2015
End date September 2016
Trial size 87 participants
Trial identifier NCT02383940, LX4211.1-204-T1DM, LX4211.204

Summary

This Phase 2 study is intended to demonstrate superiority of Sotagliflozin versus placebo on A1C reduction at Week 12 in young adult patients with T1DM who have poor glycemic control on their current insulin regimen.

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)
Primary purpose treatment
Arm
(Experimental)
Sotagliflozin (fasted conditions)
sotagliflozin
Sotagliflozin high dose, 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
A1C reduction
time frame: Week 12

Secondary Outcomes

Measure
Change in bolus insulin
time frame: Baseline to Week 12
Change in 2-hour PPG following standardized mixed meal
time frame: Baseline to Week 12
Change in Continuous Glucose Monitoring area under the concentration time-curve outside target ranges
time frame: Baseline to Week 12
Change in Hypoglycemic events/day (≤70 mg/dL) by SMBG
time frame: Baseline to Week 12
Change in Total basal insulin
time frame: Baseline to Week 12

Eligibility Criteria

Male or female participants from 18 years up to 30 years old.

Inclusion Criteria: - Patient has given written informed consent - Young adult patients ≥18 to ≤30 years old at Screening, with a confirmed diagnosis of T1DM made at least 1 year prior to informed consent - Patients are being treated with insulin or insulin analogue delivered via CSII or MDI - At Screening, must have A1C ≥9.0% - Must be willing and able to perform SMBG and complete the study diary - Females of childbearing potential must use an adequate method of contraception and have 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 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 DKA or nonketotic hyperosmolar state within 6 months prior to the Screening Visit - History of severe hypoglycemic event within 1 month prior to Screening Visit

Additional Information

Official title A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy and Safety of LX4211 in Young Adult Patients With Type 1 Diabetes Mellitus and Elevated Hemoglobin A1C
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by Lexicon Pharmaceuticals.