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 Moderate Renal Impairment Who Have Inadequate Glycemic Control

CompletadoFase 3ClinicalTrials.gov

ID: NCT03242252Tipo: INTERVENTIONALInicio: 16 de ago de 2017Fin estimado: 25 de oct de 2019

Traducción no disponible, mostrando original

Resumen

Primary Objective: To demonstrate the superiority of Sotagliflozin 200 milligrams (mg) and Sotagliflozin 400 mg versus placebo on HbA1c reduction at 26 Weeks in participants with Type 2 diabetes who have inadequate glycemic control and moderate renal impairment. Secondary Objectives: * To assess the effects of Sotagliflozin 200 mg and 400 mg versus placebo with respect to additional measures of glycemic control, blood pressure, and body weight. * To evaluate the safety of Sotagliflozin 200 mg and 400 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 moderate renal insufficiency defined by an estimated glomerular filtration rate (eGFR) (based on the 4 variable Modification of Diet in Renal Disease (MDRD) equation) of ≥30 and \<60 milliliter per minute (mL/min)/1.73 meter square (m\^2) (chronic kidney disease \[CKD\] 3A, 3B).
Participants has given written informed consent to participate in the study in accordance with local regulations.

Criterios de exclusión

Hemoglobin A1c (HbA1c) of \<7.0% or \>11.0%.
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 a sodium-glucose cotransporter type 2 (SGLT2) inhibitor (Canagliflozin, Dapagliflozin, Empagliflozin) during the last 12 months.
Uncontrolled high blood pressure.
Participants with severe anemia, severe cardiovascular (including congestive heart failure New York Heart Association IV), respiratory, hepatic, neurological, psychiatric, or active malignant tumor or other major systemic disease or patients with short life expectancy that, according to the Investigator, 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. Route of administration: Oral

drug

Sotagliflozin

Sotagliflozin 200 mg, tablet, orally once daily. Route of administration: Oral

Ubicaciones

Investigational Site Number 0324001

Buenos Aires, Argentina

Investigational Site Number 0324002

Caba, Argentina

Investigational Site Number 0324005

Ciudad Autónoma Buenos Aires, Argentina

Investigational Site Number 0324008

Córdoba, Argentina

Investigational Site Number 0324006

Córdoba, Argentina

Investigational Site Number 0324009

La Plata, Argentina

Investigational Site Number 0324007

Mar del Plata, Argentina

Patrocinadores

PrincipalLexicon Pharmaceuticals

ColaboradorSanofi

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