Diabetes, type 2 MedDRA version: 20.0 Level: LLT Classification code 10045242 Term: Type II diabetes mellitus System Organ Class: 100000072461
Conditions
Interventions
Trade Name: Jardiance
Pharmaceutical Form: Coated tablet
INN or Proposed INN: Empagliflozin
CAS Number: 864070-44-0
Other descriptive name: EMPAGLIFLOZIN
Concentration unit: mg milligram(s)
Concentra
Sponsors
Aarhus University Hospital, Department of Endocrinology
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Age: 50-70 years • Type 2 diabetes for > 1 år • HbA1c: 53-75 mmol/mol • Metformin treatment as only anti diabetic medicin Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 9 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 3
Exclusion criteria
Exclusion criteria: • Diabetes for less than 1 year • Changes in any kind of medicine through the last one month before beginning of the study. • Recent acute myocardial infarction ( x 3 of upper normal range), kidney failure (eGFR<60 ml/min), current or previous cancer disease, anaemia (Hb < 6,5) • Previous ketoacidosis • Several genital infections (bacterial/fungal infections) • Blooddonation the last 3 months before beginning of the study • Participation in examinations with radioactive isotopes during the last 6 months before beginning of the study • Current alcohol abuse (more than 21 units per week)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Empagliflozin is a sodium–glucose cotransporter 2 (SGLT-2) inhibitor, and is used in treatment of diabetes type 2. It is previously shown that SGLT-2 inhibitors have a remarkable protective effect on the heart by reducing death caused by cardiac diseases with 38%. The reasons for these effects are still unknown, but it is known that SGLT-2 treatment increase ketogenesis. We have in a previous study found that ketone body infusion shifts cardiac metabolism towards ketone body oxidation, which possibly increases cardiac efficiency. It is also shown that SGLT-2 inhibitors have reno protective effects. The aim of this study is to examine the effects of SGLT-2 treatment by: - Examination of substrate metabolism in heart and kidney measured by PET. - Examination of perfusion and total energy consumption in the heart and kidney measured by PET. - Indirect calorimetry, bloodsamples, fat- and muscle biopsies, DXA-scan, measurement of arterial stiffness and oral glucose tolerance test. ;Secondary Objective: Not applicable;Primary end point(s): Cardiac and renal: - Free fatty acids uptake, oxidation and re-esterification - Glucose uptake - Oxygen consumption and energy efficiency - Perfusion ;Timepoint(s) of evaluation of this end point: After 4 weeks treatment with - placebo - Empagliflozin | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Body composition (DXA) - Energy expenditure (Indirect calorimetry) - Insulin sensitivity and secretion (Oral glucose tolerance test) - Intracelular signalling in muscle and adipose tissue - Arterial stiffness ;Timepoint(s) of evaluation of this end point: After 4 weeks treatment with - placebo - Empagliflozin | — |
Countries
Denmark
Contacts
Public ContactDepartment of Endorcrinology
Aarhus University Hospital
Outcome results
None listed