A Dose Finding Study to Assess the Effect of LIK066 Compared to Placebo or Empagliflozin in Patie… (NCT03152552) | Clinical Trial Compass
TerminatedPhase 2
A Dose Finding Study to Assess the Effect of LIK066 Compared to Placebo or Empagliflozin in Patients With Type 2 Diabetes Mellitus and Heart Failure
Stopped: This study terminated prematurely because of slow enrollment
United States125 participantsStarted 2017-07-25
Plain-language summary
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
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Key Inclusion Criteria:
* 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)
Key Exclusion Criteria:
* 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
What they're measuring
1
Change From Baseline in N-terminal Pro B-type Natriuretic Peptide (NT-proBNP) at Week 12