Dose-ranging Study in Patients With Type 1 Diabetes Mellitus

Part of paid clinical trials in Concord, California.

Sponsor
Lexicon Pharmaceuticals
Study ID
NCT02459899
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

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

Study Details

The primary objective of this study was to define the dose leading to desirable efficacy, as measured by the change in hemoglobin A1C (A1C) between Baseline and Week 12.

Key Dates

Start date
Jul 31, 2015
Status verified
Feb 2020
Primary completion
Aug 31, 2016
Completion
Aug 31, 2016

Study Design

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

Arms

  • Placebo Comparator: Placebo
    Two placebo-matching sotagliflozin tablets, once daily, orally for 12 weeks.
  • Experimental: Sotagliflozin 75 mg
    Sotagliflozin 75 mg (one 75 mg tablet and one placebo tablet), once daily, orally for 12 weeks.
  • Experimental: Sotagliflozin 200 mg
    Sotagliflozin 200 mg (one 200 mg tablet and one placebo tablet), once daily, orally for 12 weeks.
  • Experimental: Sotagliflozin 400 mg
    Sotagliflozin 400 mg (two 200 mg tablets), once daily, orally for 12 weeks.

Primary Outcome Measure

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

Locations (17)

FacilityCityStateZIPSite coordinators
Lexicon Investigational SiteConcordCalifornia94520-
Lexicon Investigational SiteVenturaCalifornia93003-
Lexicon Investigational SiteDenverColorado80209-
Lexicon Investigational SiteJacksonvilleFlorida32225-
Lexicon Investigational SiteMiamiFlorida33175-
Lexicon Investigational SiteSpringfieldIllinois62711-
Lexicon Investigational SiteMetairieLouisiana70006-
Lexicon Investigational SiteAuburnMaine04210-
Lexicon Investigational SiteRockvilleMaryland20852-
Lexicon Investigational SiteGreat FallsMontana59405-
Lexicon Investigational SiteOmahaNebraska68114-
Lexicon Investigational SiteHigh PointNorth Carolina27265-
Lexicon Investigational SiteColumbusOhio43213-
Lexicon Investigational SiteSan AntonioTexas78229-
Lexicon Investigational SiteSalt Lake CityUtah84107-
Lexicon Investigational SiteChesapeakeVirginia23321-
Lexicon Investigational SiteManassasVirginia20110-

Find similar trials in Concord, CA

By condition
Type 1 diabetes
By specialty
Endocrinology
By research site
Lexicon Investigational Site· Concord, CALexicon Investigational Site· Ventura, CALexicon Investigational Site· Denver, COLexicon Investigational Site· Jacksonville, FLLexicon Investigational Site· Miami, FLLexicon Investigational Site· Springfield, IL

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