Efficacy and Safety of Sotagliflozin in Young Adult Patients With Type 1 Diabetes Mellitus and Elevated Hemoglobin A1C

Part of paid clinical trials in Tustin, California.

Sponsor
Lexicon Pharmaceuticals
Study ID
NCT02383940
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 30 Years
Healthy Volunteers
Not accepted

Interventions

  • Sotagliflozin — DRUG
    Sotagliflozin 400 mg, 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 2 study was intended to demonstrate superiority of sotagliflozin versus placebo on Hemoglobin A1C (A1C) reduction at Week 12 in young adult participants with type 1 diabetes mellitus (T1DM) who have poor glycemic control on their current insulin regimen.

Key Dates

Start date
Apr 30, 2015
Status verified
Feb 2020
Primary completion
Sep 30, 2016
Completion
Sep 30, 2016

Study Design

Enrollment
87 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 12 weeks.
  • Experimental: Sotagliflozin 400 mg
    Sotagliflozin 400 milligram (mg) (two 200 mg tablets), once daily, orally, before the first meal of the day for 12 weeks.

Primary Outcome Measure

Change From Baseline in Hemoglobin A1C (A1C) at Week 12 [ Time Frame: Baseline, Week 12 ]

Locations (15)

FacilityCityStateZIPSite coordinators
Lexicon Investigational SiteTustinCalifornia92780-
Lexicon Investigational SiteAuroraColorado80045-
Lexicon Investigational SiteNew HavenConnecticut06519-
Lexicon Investigational SiteTampaFlorida33612-
Lexicon Investigational SiteWest Palm BeachFlorida33401-
Lexicon Investigational SiteAtlantaGeorgia30318-
Lexicon Investigational SiteRoswellGeorgia30076-
Lexicon Investigational SiteIndianapolisIndiana46202-
Lexicon Investigational SiteNew OrleansLouisiana70121-
Lexicon Investigational SiteAuburnMaine04210-
Lexicon Investigational SiteBostonMassachusetts02215-
Lexicon Investigational SiteBuffaloNew York14222-
Lexicon Investigational SiteWilmingtonNorth Carolina28401-
Lexicon Investigational SiteAustinTexas78749-
Lexicon Investigational SiteSalt Lake CityUtah84107-

Find similar trials in Tustin, CA

By condition
Type 1 diabetes
By specialty
Endocrinology
By research site
Lexicon Investigational Site· Tustin, CALexicon Investigational Site· Aurora, COLexicon Investigational Site· New Haven, CTLexicon Investigational Site· Tampa, FLLexicon Investigational Site· West Palm Beach, FLLexicon Investigational Site· Atlanta, GA

Related Studies