Efficacy, Safety, and Tolerability Study of Sotagliflozin as Adjunct Therapy in Adult Patients With Type 1 Diabetes Mellitus Who Have Inadequate Glycemic Control With Insulin Therapy

Sponsor
Lexicon Pharmaceuticals
Study ID
NCT02421510
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Sotagliflozin — DRUG
    High dose Sotagliflozin, once daily, before the first meal of the day
  • Sotagliflozin — DRUG
    Low dose Sotagliflozin,once daily, before the first meal of the day
  • Placebo — DRUG
    Placebo, once daily, before the first meal of the day

Study Details

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

Key Dates

Start date
May 31, 2015
Status verified
Feb 2020
Primary completion
Nov 30, 2016
Completion
Jun 23, 2017

Study Design

Enrollment
782 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Placebo Comparator: Placebo
    Two placebo-matching sotagliflozin tablets, once daily, orally, before the first meal of the day for 24 weeks followed by a 28-week extension period.
  • Experimental: Sotagliflozin 200 mg
    Sotagliflozin 200 milligram (mg) (one 200 mg tablet and one placebo tablet), once daily, orally, before the first meal of the day for 24 weeks followed by a 28-week extension period.
  • Experimental: Sotagliflozin 400 mg
    Sotagliflozin 400 mg (two 200 mg tablets), once daily, orally, before the first meal of the day for 24 weeks followed by a 28-week extension period.

Primary Outcome Measure

Change From Baseline in A1C at Week 24 [ Time Frame: Baseline to Week 24 ]

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