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

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Lexicon Pharmaceuticals
Study ID
NCT02384941
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Placebo — DRUG
    Placebo once daily, before first meal of the day.
  • Sotagliflozin — DRUG
    Sotagliflozin once daily, before 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
Mar 31, 2015
Status verified
Feb 2020
Primary completion
Sep 30, 2016
Completion
Feb 28, 2017

Study Design

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

Arms

  • Placebo Comparator: Placebo
    Two placebo-matching sotagliflozin tables, orally for 24 weeks followed by a 28 week extension period.
  • Experimental: Sotagliflozin 200 milligrams (mg)
    Sotagliflozin 200 mg (one 200 mg tablet and one placebo tablet), orally, for 24 weeks followed by a 28 week extension period.
  • Experimental: Sotagliflozin 400 mg
    Sotagliflozin 400 mg (two 200 mg tablets), orally, 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 ]

Locations (63)

FacilityCityStateZIPSite coordinators
Lexicon Investigational SiteBirminghamAlabama35294-
Lexicon Investigational SiteLittle RockArkansas72205-
Lexicon Investigational SiteEscondidoCalifornia92025-
Lexicon Investigational SiteGreenbraeCalifornia94904-
Lexicon Investigational SiteHuntington BeachCalifornia92648-
Lexicon Investigational SiteLa JollaCalifornia92037-
Lexicon Investigational SiteLos AngelesCalifornia90057-3550-
Lexicon Investigational SiteOrangeCalifornia92868-
Lexicon Investigational SitePalm SpringsCalifornia92262-
Lexicon Investigational SiteSan MateoCalifornia94401-
Lexicon Investigational SiteTarzanaCalifornia91356-
Lexicon Investigational SiteTustinCalifornia92780-
Lexicon Investigational SiteWalnut CreekCalifornia94598-
Lexicon Investigational SiteAuroraColorado70045-
Lexicon Investigational SiteLongmontColorado80501-
Lexicon Investigational SiteFleming IslandFlorida32003-
Lexicon Investigational SiteJacksonvilleFlorida32204-
Lexicon Investigational SiteJacksonvilleFlorida32216-
Lexicon Investigational SiteNew Port RicheyFlorida34652-
Lexicon Investigational SiteOrmond BeachFlorida32174-
Lexicon Investigational SiteWest Palm BeachFlorida33401-
Lexicon Investigational SiteAtlantaGeorgia30318-
Lexicon Investigational SiteLawrencevilleGeorgia30046-
Lexicon Investigational SiteRoswellGeorgia30076-
Lexicon Investigational SiteHonoluluHawaii96814-
Lexicon Investigational SiteCrystal LakeIllinois60012-
Lexicon Investigational SiteElginIllinois60123-
Lexicon Investigational SiteSpringfieldIllinois62711-
Lexicon Investigational SiteTopekaKansas66606-
Lexicon Investigational SiteLexingtonKentucky40503-
Lexicon Investigational SiteBangorMaine04401-
Lexicon Investigational SiteBaltimoreMaryland21204-
Lexicon Investigational SiteBostonMassachusetts02215-
Lexicon Investigational SiteDetroitMichigan46214-
Lexicon Investigational SiteChesterfieldMissouri63017-
Lexicon Investigational SiteSt LouisMissouri63110-
Lexicon Investigational SiteOmahaNebraska68131-
Lexicon Investigational SiteHendersonNevada89052-
Lexicon Investigational SiteLas VegasNevada89148-
Lexicon Investigational SiteAlbanyNew York12206-
Lexicon Investigational SiteNew YorkNew York10029-
Lexicon Investigational SiteAshevilleNorth Carolina28803-
Lexicon Investigational SiteChapel HillNorth Carolina27517-
Lexicon Investigational SiteMorehead CityNorth Carolina28557-
Lexicon Investigational SiteColumbusOhio43201-
Lexicon Investigational SiteOklahoma CityOklahoma73112-
Lexicon Investigational SitePortlandOregon97239-
Lexicon Investigational SiteGreerSouth Carolina29651-
Lexicon Investigational SiteRapid CitySouth Dakota57701-
Lexicon Investigational SiteChattanoogaTennessee37404-
Lexicon Investigational SiteChattanoogaTennessee37411-
Lexicon Investigational SiteMemphisTennessee38119-
Lexicon Investigational SiteAustinTexas78749-
Lexicon Investigational SiteDallasTexas75230-
Lexicon Investigational SiteDallasTexas75231-
Lexicon Investigational SiteDallasTexas75246-
Lexicon Investigational SiteHoustonTexas77079-
Lexicon Investigational SiteHoustonTexas77095-
Lexicon Investigational SiteSan AntonioTexas78258-
Lexicon Investigational SiteSchertzTexas78154-
Lexicon Investigational SiteChesapeakeVirginia23321-
Lexicon Investigational SiteRentonWashington98057-
Lexicon Investigational SiteSeattleWashington98105-

Find similar trials in Birmingham, AL

By condition
Type 1 diabetes
By specialty
Endocrinology
By research site
Lexicon Investigational Site· Birmingham, ALLexicon Investigational Site· Little Rock, ARLexicon Investigational Site· Escondido, CALexicon Investigational Site· Greenbrae, CALexicon Investigational Site· Huntington Beach, CALexicon Investigational Site· La Jolla, CA

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