Safety and Efficacy of Sotagliflozin (LX4211) in Patients With Inadequately Controlled Type 1 Diabetes Mellitus

Part of paid clinical trials in Aurora, Colorado.

Sponsor
Lexicon Pharmaceuticals
Study ID
NCT01742208
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 55 Years
Healthy Volunteers
Not accepted

Interventions

  • Sotagliflozin — DRUG
    Participants received sotagliflozin once daily for 29 days. Pioneer Group participants were to have completed dosing prior to any study drug administration in Expansion Groups.
  • Placebo — DRUG
    Participants received placebo-matching sotagliflozin tablets once daily for 29 days.
  • Sotagliflozin — DRUG
    Participants received sotagliflozin once daily for 29 days; pioneer participants completed dosing prior to dosing any other study participants.

Study Details

This Phase 2 study was intended to assess the pharmacodynamics (PD), pharmacokinetics (PK), safety and efficacy of sotagliflozin following daily oral administration for 29 days in participants with type 1 diabetes mellitus (T1DM).

Key Dates

Start date
Feb 28, 2013
Status verified
Feb 2020
Primary completion
Jan 31, 2014
Completion
Jan 31, 2014

Study Design

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

Arms

  • Experimental: Sotagliflozin 400 mg - Pioneer Group
    Sotagliflozin 400 milligram (mg) (two 200 mg tablets), once daily, orally, before breakfast for 29 days; open label administration.
  • Placebo Comparator: Placebo - Expansion Group
    Two placebo-matching sotagliflozin tablets, once daily, orally, before breakfast for 29 days; double-blind administration.
  • Experimental: Sotagliflozin 400 mg - Expansion Group
    Sotagliflozin 400 mg (two 200 mg tablets), once daily, orally, before breakfast for 29 days; double-blind administration.

Primary Outcome Measure

Percent Change From Baseline in Total Daily Bolus Amount of Exogenous Insulin Required Calculated Over Days 3 to 27 (Treatment Outpatient Period) [ Time Frame: Baseline, Day 3 to Day 27 ]

Locations (7)

FacilityCityStateZIPSite coordinators
Lexicon Investigational SiteAuroraColorado80045-
Lexicon Investigational SiteAtlantaGeorgia30318-
Lexicon Investigational SiteBaton RougeLouisiana70808-
Lexicon Investigational SiteOmahaNebraska68131-
Lexicon Investigational SiteThe BronxNew York10467-
Lexicon Investigational SiteDurhamNorth Carolina27713-
Lexicon Investigational SiteDallasTexas75230-

Find similar trials in Aurora, CO

By condition
Type 1 diabetes
By specialty
Endocrinology
By research site
Lexicon Investigational Site· Aurora, COLexicon Investigational Site· Atlanta, GALexicon Investigational Site· Baton Rouge, LALexicon Investigational Site· Omaha, NELexicon Investigational Site· The Bronx, NYLexicon Investigational Site· Durham, NC

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