Main study objective is to find out which dose among three different doses of LIK066 is the most efficacious, safe and well tolerated in type 2 diabetes patients with heart failure. We will also learn which medication is better at managing patients…
ID
Source
Brief title
Condition
- Cardiac disorders, signs and symptoms NEC
- Glucose metabolism disorders (incl diabetes mellitus)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
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
Background summary
Diabetes type 2 is a severe condition with increased risk of cardiovascular
conditions and its complications such as heart failure. SGLT2 inhibitors are
approved for the treatment of type2 diabetes. Since LIK066 is a SGLT1 as well
as a SGLT2 inhibitor, it has a double mode of action on kidneys as well as
intestines. Moreover, SGLT1 receptors are also located in the heart, where the
mode of action is not clear yet. This study will investigatore the effect of
SGLT1/2 inhibitor LIK066 on heart failure biomarker NT-proBNP in a population
with type 2 diabetes and reduced cardiac function. Also, the glucose-lowering
potential of LIK066 will be studied.
Study objective
Main study objective is to find out which dose among three different doses of
LIK066 is the most efficacious, safe and well tolerated in type 2 diabetes
patients with heart failure. We will also learn which medication is better at
managing patients` blood sugar and heart failure, compared to either
empagliflozin or placebo.
Study design
This is a multi-center, randomized, double-blind, double-dummy, parallel-group
study evaluating the efficacy, safety and tolerability of 3 doses of LIK066 vs
placebo and vs empagliflozin in type 2 diabetes patients with heart failure.
After the screenings visit, eligible patients will enter the run-in period.
After completion of the run-in period, eligible patients will be randomized and
treated during 36 weeks. The total duration of the study is max. 40 weeks.
Intervention
Treatment with LIK066, Empagliflozine or placebo.
Study burden and risks
Risks: Side effects of study medication and burden assessments.
Burden:
- Physical exam: 9x
- Length: 1x
- Vital signs: 9x
- Blood tests (fasting): 4x
- Blood tests (non-fasting): 2x
- Daily measurement of blood sugar at home
- Pregnancy test: 4x (if applicable)
- Urine testsk: 6x
- Bioimpedance: 3x
- ECG: 3x
- Echocardiogram: 3x
- Questionnaires (5 items): 5x
- Optional blood- and urine tests: 3x
- Optional DEXA test: 3x
Raapopseweg 1
Arnhem 6824 DP
NL
Raapopseweg 1
Arnhem 6824 DP
NL
Listed location countries
Age
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
* 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
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2016-003084-19-NL |
| ClinicalTrials.gov | NCT03152552 |
| CCMO | NL60488.100.17 |