A Multi-center, Randomized, Double-blind, Parallel-group Dose-finding Study to Assess the Effect of 3 Doses of LIK066 Compared to Placebo or Empagliflozin in Type 2 Diabetes Mellitus Patients With Heart Failure

TerminadoFase 2ClinicalTrials.gov

ID: NCT03152552Tipo: INTERVENTIONALInicio: 25 de jul de 2017Fin estimado: 6 de jun de 2018

Traducción no disponible, mostrando original

Resumen

This was a dose-finding study to evaluate the efficacy, safety and tolerability of 3 different doses of LIK066 compared to placebo or empagliflozin in T2DM patients with heart failure

Descripción detallada

The study was prematurely discontinued on 04-May-2018 due to slow enrollment that would preclude obtaining study results in a timely manner.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

BMI ≥ 22kg/m\^2
Type 2 diabetes with HbA1c between 6.5% and 10.0%
Documented symptomatic chronic heart failure (NYHA II-IV)
Plasma NT-proBNP \> 300pg/ml
eGFR ≥ 45ml/min/1.73m\^2 (calculated by MDRD)

Criterios de exclusión

Pregnant or nursing (lactating) women
Type 1 diabetes, monogenic diabetes, diabetes resulting from pancreatic injury, or secondary forms of diabetes
History of ketoacidosis, lactic acidosis, or hyperosmolar coma
Symptomatic genital infection or UTI within 4 weeks of screening
Myocardial infarction, stroke, surgery for heart disease, percutaneous coronary intervention within 3 months of randomization
Unstable angina within 3 months of screening
Isolated right HF due to pulmonary disease
Patients with a mean sitting systolic blood pressure ≤ 100mmHg, at randomization
History of lower limb amputation
Diabetic foot ulcer at screening

Intervenciones

drug

LIK066

LIK066 was supplied in different doses as tablets taken orally.

drug

Placebo

Placebo was supplied as tablets and capsules taken orally.

drug

Empagliflozin

Empagliflozin was supplied as capsules taken orally.

Ubicaciones

Novartis Investigative Site

CABA, Buenos Aires, Argentina

Novartis Investigative Site

CABA, Buenos Aires, Argentina

Novartis Investigative Site

CABA, Buenos Aires F.D., Argentina

Novartis Investigative Site

Buenos Aires, Argentina

Patrocinadores

PrincipalNovartis Pharmaceuticals

Aviso: La información de este ensayo proviene de fuentes públicas y tiene carácter exclusivamente informativo. No constituye asesoramiento médico, regulatorio ni de ningún otro tipo. Las traducciones son automatizadas y no poseen validez oficial. Consultá siempre con un profesional de la salud. Ver Términos de Uso.

A Multi-center, Randomized, Double-blind, Parallel-group ... | EligiMed