Overview

This trial has been completed.

Condition type 1 diabetes mellitus
Treatments placebo, sotagliflozin
Phase phase 2
Sponsor Lexicon Pharmaceuticals
Start date July 2015
End date August 2016
Trial size 141 participants
Trial identifier NCT02459899, LX4211.1-206-T1DM, LX4211.206

Summary

The primary objective of this study is to define the dose leading to desirable efficacy, as measured by the change in hemoglobin A1C (A1C) between Baseline and Week 12.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

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

Primary Outcomes

Measure
Change from Baseline to Week 12 in A1C
time frame: Week 12

Secondary Outcomes

Measure
Change from Baseline to Week 12 in 2-hour PPG
time frame: Week 12
Change from Baseline to Week 12 in Body Weight
time frame: Week 12
Change from Baseline to Week 12 in UGE
time frame: Week 12
Change from Baseline to Week 12 in FPG
time frame: Week 12

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 - At the Screening Visit, A1C must be between 7.0% to 10.0% - 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 2b, Dose-ranging, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study in 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.