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

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 - CLIK066B2204

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON45545

Enrollment

Registered

2017-10-19

Start date

2018-01-08

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

decompensatio cordis Diabetes

Interventions

Treatment with LIK066, Empagliflozine or placebo.

efficacy

Heart failure

SGLT1 & SGLT2 inhibitors

Type 2 Diabetes

Eligibility

Age

18 Years to 64 Years

Inclusion criteria

Inclusion criteria: * BMI * 22kg/m2 * 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/1.73m2 (MDRD)

Exclusion criteria

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 screening * 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

Design outcomes

Primary

Measure	Time frame
To determine the dose-response signal and assess the dose-response relationship of 3 doses of LIK066 as measured by the change from baseline in NT-proBNP relative to placebo after 12 weeks of treatment in T2DM patients with HF.	—

Secondary

Measure	Time frame
1. To evaluate the effect of all LIK066 doses vs placebo at 12 weeks and 36 weeks on: - Change from BL in glycated hemoglobin (HbA1c) - Change from BL in fasting plasma glucose (FPG) - Change from BL in weight - Change from BL in body composition (bio-impedance in all patients where appropriate and dual-energy x-ray absorptiometry (DXA) in a subset of patients) - Change from BL in sitting systolic blood pressure (SBP) and diastolic blood pressure (DBP) - Change from BL in the fasting lipid profile and hsCRP - Change from BL in 24h urinary glucose and sodium excretion,in a subset of patients - Change from BL in left atrial size and volume assessed by echocardiography - Change from BL in NYHA class 2. To evaluate the effect of all LIK066 doses vs empagliflozin at 12 weeks and 36 weeks on: - Change from BL in HbA1c - Change from BL in FPG - Change from BL in weight - Change from BL in body composition (bio-impedance in all patients where appropriate and DXA in a subset of patients) - Change from BL in sitting SBP and DBP - Change from BL in the fasting lipid profile and hsCRP - Change from BL in 24h urinary glucose and sodium excretion, in a subset of patients 3. To evaluate the change from BL to 36 weeks in all LIK066 doses vs placebo on NT-proBNP. 4. To evaluate safety (adverse events (AEs) and lab parameters) and tolerability of LIK066 over 12 weeks and over 36 weeks for all patients 5. To evaluate 24h urinary calcium and phosphate excretion after 12 weeks and after 36 weeks in a subset of patients 6. To evaluate bone mineral density in a subset of patients	—

Measure

Time frame

1. To evaluate the effect of all LIK066 doses vs placebo at 12 weeks and 36 weeks on: - Change from BL in glycated hemoglobin (HbA1c) - Change from BL in fasting plasma glucose (FPG) - Change from BL in weight - Change from BL in body composition (bio-impedance in all patients where appropriate and dual-energy x-ray absorptiometry (DXA) in a subset of patients) - Change from BL in sitting systolic blood pressure (SBP) and diastolic blood pressure (DBP) - Change from BL in the fasting lipid profile and hsCRP - Change from BL in 24h urinary glucose and sodium excretion,in a subset of patients - Change from BL in left atrial size and volume assessed by echocardiography - Change from BL in NYHA class 2. To evaluate the effect of all LIK066 doses vs empagliflozin at 12 weeks and 36 weeks on: - Change from BL in HbA1c - Change from BL in FPG - Change from BL in weight - Change from BL in body composition (bio-impedance in all patients where appropriate and DXA in a subset of patients) - Change from BL in sitting SBP and DBP - Change from BL in the fasting lipid profile and hsCRP - Change from BL in 24h urinary glucose and sodium excretion, in a subset of patients 3. To evaluate the change from BL to 36 weeks in all LIK066 doses vs placebo on NT-proBNP. 4. To evaluate safety (adverse events (AEs) and lab parameters) and tolerability of LIK066 over 12 weeks and over 36 weeks for all patients 5. To evaluate 24h urinary calcium and phosphate excretion after 12 weeks and after 36 weeks in a subset of patients 6. To evaluate bone mineral density in a subset of patients

—

Countries

The Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)