Efficacy and Bone Safety of Sotagliflozin 400 and 200 mg Versus Placebo in Participants With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control

Part of paid clinical trials in Escondido, California.

Sponsor
Lexicon Pharmaceuticals
Study ID
NCT03386344
Phase
PHASE3
Status
Terminated

Conditions

Eligibility Criteria

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

Interventions

  • Sotagliflozin — DRUG
    Pharmaceutical form: Tablet; Route of administration: Oral
  • Placebo — DRUG
    Pharmaceutical form: Tablet; Route of administration: Oral

Study Details

The primary objective is to demonstrate the superiority of Sotagliflozin 400 milligrams (mg) versus placebo with respect to hemoglobin A1c (Hb1Ac) reduction in participants with type 2 diabetes (T2D) who have inadequate glycemic control on diet and exercise only or with a stable antidiabetes regimen.

Key Dates

Start date
Feb 19, 2018
Status verified
Jun 2021
Primary completion
May 22, 2019
Completion
May 30, 2020

Study Design

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

Arms

  • Placebo Comparator: Placebo
    Following a 2 week run-in period, participants were randomized to matching placebo to sotagliflozin administered as 2 tablets, once daily, before the first meal of the day, for up to 26 weeks in the Core Treatment Period. Participants were eligible to continue treatment in the Extension Period. The total treatment duration was planned for up to 106 weeks.
  • Experimental: Sotagliflozin 200 mg
    Following a 2 week run-in period, participants were randomized to Sotagliflozin 200 mg administered as 1 sotagliflozin tablet and 1 matching placebo tablet, once daily, before the first meal of the day, for up to 26 weeks in the Core Treatment Period. Participants were eligible to continue treatment in the Extension Period. The total treatment duration was planned for up to 104 weeks.
  • Experimental: Sotagliflozin 400 mg
    Following a 2 week run-in period, participants were randomized to Sotagliflozin 400 mg administered as two 200 mg sotagliflozin tablets, once daily, before the first meal of the day, for up to 26 weeks in the Core Treatment Period. Participants were eligible to continue treatment in the Extension Period. The total treatment duration was planned for up to 104 weeks.

Primary Outcome Measure

Change From Baseline in Hemoglobin A1c (HbA1c) at Week 26 [ Time Frame: Baseline to Week 26 ]

Locations (14)

FacilityCityStateZIPSite coordinators
Investigational Site Number 8409009EscondidoCalifornia92025-
Investigational Site Number 8409010GreenbraeCalifornia94904-
Investigational Site Number 8409005Walnut CreekCalifornia94598-
Investigational Site Number 8409012ColumbusGeorgia31904-
Investigational Site Number 8409011EvansvilleIndiana47714-8011-
Investigational Site Number 8409014WichitaKansas67205-1138-
Investigational Site Number 8409015AlbuquerqueNew Mexico87106-
Investigational Site Number 8409002Chapel HillNorth Carolina27517-
Investigational Site Number 8409001WilmingtonNorth Carolina28401-6638-
Investigational Site Number 8409008DaytonOhio45419-4336-
Investigational Site Number 8409004ChattanoogaTennessee37404-
Investigational Site Number 8409013AustinTexas78749-
Investigational Site Number 8409003DallasTexas75230-
Investigational Site Number 8409007KatyTexas77450-

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