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
| Status: | Terminated |
|---|---|
| Conditions: | Cardiology, Diabetes, Diabetes |
| Therapuetic Areas: | Cardiology / Vascular Diseases, Endocrinology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/3/2019 |
| Start Date: | July 25, 2017 |
| End Date: | June 6, 2018 |
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
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
different doses of LIK066 compared to placebo or empagliflozin in T2DM patients with heart
failure
The study was prematurely discontinued on 04-May-2018 due to slow enrollment that would
preclude obtaining study results in a timely manner.
preclude obtaining study results in a timely manner.
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
We found this trial at
22
sites
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Novartis Novartis, which was created in 1996 by the merger of the Swiss companies Ciba-Geigy...
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