Overview

This trial is active, not recruiting.

Condition type 1 diabetes mellitus
Treatments sotagliflozin, placebo
Phase phase 3
Sponsor Lexicon Pharmaceuticals
Start date May 2015
End date November 2016
Trial size 750 participants
Trial identifier NCT02421510, 2014-005153-39, LX4211.1-310-T1DM, LX4211.310

Summary

This Phase 3 study is 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 patients with type 1 diabetes mellitus (T1D) who have inadequate glycemic control with insulin therapy.

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)
High dose Sotagliflozin (fasted conditions)
sotagliflozin
High dose Sotagliflozin, once daily, before the first meal of the day
(Experimental)
Low dose Sotagliflozin (fasted conditions)
sotagliflozin
Low dose 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
Change from Baseline to Week 24 in A1C
time frame: Week 24

Secondary Outcomes

Measure
Change from Baseline in proportion of patients with A1C <7.0%
time frame: Week 24
Change from Baseline in body weight
time frame: Week 24
Mean change from Baseline in mean daily bolus insulin dose
time frame: Week 24
Change from Baseline in fasting plasma glucose (FPG)
time frame: Week 24

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 T1D made at least 1 year prior to informed consent - Patients are being treated with insulin or insulin analog delivered via CSII or MDI - Willing and able to perform 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 Efficacy, Safety, and Tolerability of LX4211 as Adjunct Therapy in Adult Patients With Type 1 Diabetes Mellitus Who Have Inadequate Glycemic Control With Insulin Therapy
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by Lexicon Pharmaceuticals.