A Phase 3 interventional study of Empagliflozin and Placebo Oral Tablet in Type2 Diabetes Mellitus, sponsored by Caroline M Kistorp. Completed at 1 site in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-08-18.
Sponsored by Caroline M Kistorp · Phase 3, Interventional, and Treatment
Patients with type 2 diabetes (T2 DM) have a markedly increased risk of heart disease and it is estimated that, in the danish population, up 80% percent of patients with type 2 diabetes die from heart disease.
The sodium glucose cotransport-2 (SGLT-2) inhibitors were developed as an anti-diabetic therapy reducing blood glucose and weight by decreasing glucose reabsorption in the kidneys, leading to glucose excretion via the urine. However, in 2015 the EMPA-REG study showed that treatment with the SGLT-2 inhibitor empagliflozin significantly reduced the cardiovascular mortality and risk of admission under the diagnosis of heart failure in a population of patients with type 2 diabetes in addition to other risk factors for heart disease. The mechanism behind this surprising result is unknown and warrants further study.
The primary hypothesis of the present study is that treatment with empagliflozin improves the function and blood supply of the heart muscle cells in patients with type 2 diabetes and high risk of heart disease. The investigators will test this hypothesis by enrolling 92 participants with type 2 diabetes and other risk factors for heart disease, and treating them with either empagliflozin or a placebo. During the study period the investigators will monitor the effects of the treatment with various techniques such as heart scans using CT and ultrasound, measurements of the fluid pressures in the heart chambers, body composition measurements and a variety of relevant blood test.
This is the only study on the registry with Caroline M Kistorp as lead sponsor.
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OR at least one of the following: a positive noninvasive stress test, or A positive stress echocardiography showing regional systolic wall motion abnormalities, or A positive scintigraphic test showing stress-induced ischemia,
Exclusion Criteria:
Additional exclusion criteria for hemodynamics substudy
Empagliflozin, coated tablets, 25mg, once daily, for 13 weeks
Drug: Empagliflozin
Placebo, coated tablets, once daily, for 13 weeks
Drug: Placebo Oral Tablet
Empagliflozin tablet
Also known as: Jardiance
Sugar pill, visually identical to active comparator
Rb-82 PET
Between group difference in the change in myocardial flow reserve (MFR) by Rb-82 PET. Measured as change in global perfusion from rest to adenosine-induced stress.
Time frame: 13 weeks
Invasive hemodynamics
Substudy, performed on 38 participants from the main group. Using right heart catheterisation to measure between group difference in the change in pulmonary capillary weight pressure (PCWP) at 25 watts (supine bicycle ergometer)
Time frame: 13 weeks
Echocardiography
Between group difference in the change in global left ventricular function assessed by echocardiography
Time frame: 13 weeks
GFR
Between group difference in the change in renal function assessed by Cr-51 EDTA
Time frame: 13 weeks
U-alb/crea
Between group difference in the change urinary albumin/creatinine ratio
Time frame: 13 weeks
24 hour BP
Between group difference in the change in 24 hour BP
Time frame: 13 weeks
Pulse wave analysis
Between group difference in the change in pulse wave analysis
Time frame: 13 weeks
Insulin resistance
Between group difference in the changes in insulin resistance by Matsuda index
Time frame: 13 weeks
Insulin resistance
Between group difference in the changes in insulin resistance by HOMA
Time frame: 13 weeks
Biomarkers
Between group difference in the change in NT-proBNP, MR-proANP, MR-proADM, GAL-3, hsTNT, GDF-15, PIGF, sFlt-1, FFA, ADPN, leptin, TNF-α, IL-6, MCP-1, MAC-1, COLL-A1, FGF-21, beta-hydroxybutyrate, AGEs CML, sRAGE
Time frame: 13 weeks
Questionnaires
Between group difference in the change in Health status, assessed by the EuroQol EQ-5D-5L questionnaire
Time frame: 13 weeks
Questionnaires, continued
Between group difference in the change in Health status, assessed by the Minnesota Living with Heart Failure questionnaire
Time frame: 13 weeks
DEXA
Between group difference in the change in body composition by DEXA scan
Time frame: 13 weeks
Invasive hemodynamics - continued
Between group difference in the change in CO at rest, 25 watts and peak exercise
Time frame: 13 weeks
Invasive hemodynamics - continued
Between group difference in the change in CVP at rest, 25 watts and peak exercise
Time frame: 13 weeks
Invasive hemodynamics - continued
Between group difference in the change in PCWP at rest, 25 watts and peak exercise
Time frame: 13 weeks
Invasive hemodynamics - continued
Between group difference in the change in PAP at rest, 25 watts and peak exercise
Time frame: 13 weeks
Invasive hemodynamics - continued
Between group difference in the change in SvO2 at rest, 25 watts and peak exercise
Time frame: 13 weeks
Adipose tissue
Between group difference in the changes in levels of adipocyte differentiation
Time frame: 13 weeks
Adipose tissue
Between group difference in the changes in macrophage infiltration
Time frame: 13 weeks
Adipose tissue
Between group difference in the changes in extracellular matrix fibrosis
Time frame: 13 weeks
Daily activity
Between group difference in the change in daily activity levels measured by patient-worn accelerometers.
Time frame: 13 weeks
Plan to share: No — Any sharing of data must be approved by the regional ethics committee, and at the time of protocol writing there was no justification for data sharing outside of the current project
Ran from Mar 2017 to primary completion in May 2020, 37 months.
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Studies of the drug tested here: Empagliflozin