A Phase 3 Study to Evaluate the Safety of Sotagliflozin in Patients With Type 1 Diabetes Who Have Inadequate Glycemic Control With Insulin Therapy Alone

Part of paid clinical trials in Concord, California.

Sponsor
Lexicon Pharmaceuticals
Study ID
NCT02531035
Phase
PHASE3
Status
Completed

Conditions

  • High Level of Sugar (Glucose) in the Blood
  • Type 1 Diabetes Mellitus (T1DM)

Eligibility Criteria

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

Interventions

  • Sotagliflozin — DRUG
    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 designed to demonstrate the net benefit of sotagliflozin versus placebo in patients with Type 1 Diabetes (T1D).

Key Dates

Start date
Sep 30, 2015
Status verified
Feb 2020
Primary completion
Apr 30, 2017
Completion
Apr 30, 2017

Study Design

Enrollment
1,405 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Placebo Comparator: Placebo
    Two placebo-matching to sotagliflozin tablets daily, orally, before the first meal of the day for 24 weeks.
  • Experimental: Sotagliflozin 400 mg
    Sotagliflozin 400 milligram (mg) (two 200 mg tablets) once daily, orally, before the first meal of the day for 24 weeks.

Primary Outcome Measure

Percentage of Participants With A1C <7.0% at Week 24 and No Episode of Severe Hypoglycemia and No Episode of Diabetic Ketoacidosis (DKA) After Randomization [ Time Frame: Week 24 ]

Locations (33)

FacilityCityStateZIPSite coordinators
Lexicon Investigational SiteConcordCalifornia94520-
Lexicon Investigational SiteEscondidoCalifornia92025-
Lexicon Investigational SiteLa JollaCalifornia92037-
Lexicon Investigational SiteSan MarcosCalifornia94401-
Lexicon Investigational SiteVenturaCalifornia93003-
Lexicon Investigational SiteWalnut CreekCalifornia94598-
Lexicon Investigational SiteAuroraColorado80045-
Lexicon Investigational SiteNew HavenConnecticut06511-
Lexicon Investigational SiteOrlandoFlorida32804-
Lexicon Investigational SiteWest Palm BeachFlorida33401-
Lexicon Investigational SiteAtlantaGeorgia30318-
Lexicon Investigational SiteMaconGeorgia31210-
Lexicon Investigational SiteRoswellGeorgia30076-
Lexicon Investigational SiteNew OrleansLouisiana70112-
Lexicon Investigational SiteRockvilleMaryland20852-
Lexicon Investigational SiteBostonMassachusetts02215-
Lexicon Investigational SiteBloomfield HillsMichigan48302-
Lexicon Investigational SiteOmahaNebraska68114-
Lexicon Investigational SiteLas VegasNevada89148-
Lexicon Investigational SiteAlbanyNew York12206-
Lexicon Investigational SiteThe BronxNew York10467-
Lexicon Investigational SiteAshevilleNorth Carolina28803-
Lexicon Investigational SiteChapel HillNorth Carolina27517-
Lexicon Investigational SiteGreenvilleNorth Carolina27834-
Lexicon Investigational SiteMorehead CityNorth Carolina28557-
Lexicon Investigational SiteGrand ForksNorth Dakota58201-
Lexicon Investigational SiteBendOregon97701-
Lexicon Investigational SiteSioux FallsSouth Dakota57104-
Lexicon Investigational SiteAustinTexas78731-
Lexicon Investigational SiteSan AntonioTexas78229-
Lexicon Investigational SiteShavano ParkTexas78231-
Lexicon Investigational SiteSalt Lake CityUtah84107-
Lexicon Investigational SiteSeattleWashington98105-

Find similar trials in Concord, CA

By research site
Lexicon Investigational Site· Concord, CALexicon Investigational Site· Escondido, CALexicon Investigational Site· La Jolla, CALexicon Investigational Site· San Marcos, CALexicon Investigational Site· Ventura, CALexicon Investigational Site· Walnut Creek, CA

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