A Randomized, Double-blind, Placebo-controlled, 3-arm, Parallel-group 52-week Multicenter Study to Evaluate the Efficacy and Safety of Sotagliflozin in Patients With Type 2 Diabetes Mellitus and Severe Renal Impairment Who Have Inadequate Glycemic Control

CompletadoFase 3ClinicalTrials.gov

ID: NCT03242018Tipo: INTERVENTIONALInicio: 16 de ago de 2017Fin estimado: 11 de dic de 2019

Traducción no disponible, mostrando original

Resumen

Primary Objective: To demonstrate the superiority of sotagliflozin 400 milligrams (mg) versus placebo with respect to hemoglobin A1c (HbA1c) reduction at Week 26 in participants with Type 2 diabetes who have inadequate glycemic control and severe renal impairment Secondary Objectives: * To assess the effects of sotagliflozin 200 mg versus placebo based on change from baseline in HbA1c * To assess the effects of sotagloflozin 400 mg and 200 mg versus placebo * To evaluate the safety of sotagliflozin 400 mg and 200 mg versus placebo

Descripción detallada

The study duration is up to 60 weeks including 4 weeks prior to randomization, 52 weeks of randomized treatment and a visit 4 weeks after completion of the randomized treatment period.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Participants with Type 2 Diabetes (drug-naïve or on antidiabetic therapy) and documented severe renal insufficiency - CKD4 - defined by an estimated glomerular filtration rate (eGFR) equation (based on the 4 variable modification of diet in renal disease (MDRD) equation) of ≥15 and \<30 milliliter per minute (mL/min)/1.73 per meter square (m\^2).
Signed written informed consent to participate in the study in accordance with local regulations.

Criterios de exclusión

At the time of screening, age \<18 years.
Hemoglobin A1c (HbA1c) \<7% or \>11%.
Type 1 diabetes.
Women of childbearing potential (WOCBP) not willing to use highly effective method(s) of birth control during the study treatment period and the follow-up period, or who are unwilling or unable to be tested for pregnancy during the study.
Treatment with an sodium-glucose cotransporter type 2 (SGLT2) inhibitor (canagliflozin, dapagliflozin, empagliflozin) during the last 12 months.
Uncontrolled high blood pressure, severe anemia, severe cardiovascular problems, such as heart failure, active cancer, or other conditions that the Investigator believes with result in a short life expectancy, will preclude their safe participation in this study, or will make implementation of the protocol or interpretation of the study results difficult.
Lower extremity complications (such as skin ulcers, infection, osteomyelitis and gangrene) identified during the Screening period, and still requiring treatment at Randomization.
The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

Intervenciones

drug

Placebo

Placebo tablet (identical to sotagliflozin 200 mg in appearance) orally, once daily.

drug

Sotagliflozin

Sotagliflozin 200 mg, tablet, orally, once daily.

Ubicaciones

Investigational Site Number 0325001

Buenos Aires, Argentina

Investigational Site Number 0325003

Launs Este, Argentina

Investigational Site Number 0325004

Mar del Plata, Argentina

Patrocinadores

PrincipalLexicon Pharmaceuticals

ColaboradorSanofi

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