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
(inTandem3 Trial)
Recruiting in Palo Alto (17 mi)
+119 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Waitlist Available
Sponsor: Lexicon Pharmaceuticals
Pivotal Trial (Near Approval)
Prior Safety Data
Trial Summary
What is the purpose of this trial?
This Phase 3 study was designed to demonstrate the net benefit of sotagliflozin versus placebo in patients with Type 1 Diabetes (T1D).
Eligibility Criteria
Inclusion Criteria
Participants had given written informed consent to participate in the study in accordance with local regulations
Adult participants 18 years and older with a diagnosis of T1DM made at least 1 year prior to informed consent
Participants were being treated with insulin or insulin analog
See 3 more
Treatment Details
Interventions
- Placebo (Drug)
- Sotagliflozin (SGLT2 Inhibitor)
Participant Groups
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Sotagliflozin 400 mgExperimental Treatment1 Intervention
Sotagliflozin 400 milligram (mg) (two 200 mg tablets) once daily, orally, before the first meal of the day for 24 weeks.
Group II: PlaceboPlacebo Group1 Intervention
Two placebo-matching to sotagliflozin tablets daily, orally, before the first meal of the day for 24 weeks.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Lexicon Investigational SiteEscondido, CA
Lexicon Investigational SiteLa Jolla, CA
Lexicon Investigational SiteSan Marcos, CA
Lexicon Investigational SiteAurora, CO
More Trial Locations
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Who Is Running the Clinical Trial?
Lexicon PharmaceuticalsLead Sponsor
SanofiIndustry Sponsor