A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Net Clinical Benefit of Sotagliflozin as Adjunct to Insulin Therapy in Type 1 Diabetes

CompletadoFase 3ClinicalTrials.gov

ID: NCT02531035Tipo: INTERVENTIONALInicio: 1 de sept de 2015Fin estimado: 1 de abr de 2017

Traducción no disponible, mostrando original

Resumen

This Phase 3 study was designed to demonstrate the net benefit of sotagliflozin versus placebo in patients with Type 1 Diabetes (T1D).

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

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
Willing and able to perform self-monitoring of blood glucose (SMBG) and complete the study diary as required per protocol
At the Screening Visit, A1C was between 7.0% to 11.0%
Females of childbearing potential used an adequate method of contraception and had a negative pregnancy test

Criterios de exclusión

Use of antidiabetic agent other than insulin or insulin analog at the time of screening
Use of sodium-glucose cotransporter (SGLT) inhibitors within 8 weeks prior to screening
Chronic systemic corticosteroid use
Type 2 diabetes mellitus (T2DM), or severely uncontrolled T1D as determined by the Investigator

Intervenciones

drug

Sotagliflozin

Sotagliflozin, once daily, before the first meal of the day

drug

Placebo

Placebo, once daily, before the first meal of the day

Ubicaciones

Lexicon Investigational Site

Córdoba, Córdoba Province, Argentina

Lexicon Investigational Site

Buenos Aires, Argentina

Lexicon Investigational Site

Buenos Aires, Argentina

Patrocinadores

PrincipalLexicon Pharmaceuticals

ColaboradorSanofi

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