NCT03151343 (SIMPLE) is a Phase 3 clinical trial of Empagliflozin in Type2 Diabetes Mellitus, sponsored by Caroline M Kistorp.

Who is sponsoring NCT03151343?

NCT03151343 is sponsored by Caroline M Kistorp.

What drugs are being tested in NCT03151343?

Interventions in NCT03151343: Empagliflozin, Placebo Oral Tablet.

What condition does NCT03151343 study?

NCT03151343 studies Type2 Diabetes Mellitus.

Is NCT03151343 still recruiting?

NCT03151343 is currently completed. Last updated 18 August 2022.

Last reviewed 2022-08-18 · How we verify

NCT03151343: SIMPLE

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

SGLT-2 Inhibitor and Myocardial Perfusion, Function and Metabolism in T2 DM Patients at High Cardiovascular Risk

Completed Phase 3 Last updated 18 August 2022

What this trial tests

Phase 3 trial testing Empagliflozin in Type2 Diabetes Mellitus in 92 participants. Completed in 22 May 2020.

Timeline

29 March 2017

Primary endpoint
22 May 2020

22 May 2020

Quick facts

Lead sponsor	Caroline M Kistorp
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	92
Start date	29 March 2017
Primary completion	22 May 2020
Estimated completion	22 May 2020
Sites	1 location across Denmark

Drugs / interventions tested

Empagliflozin (empagliflozin) — full drug profile →
Placebo Oral Tablet — full drug profile →

Conditions studied

Type2 Diabetes Mellitus — all drugs for Type2 Diabetes Mellitus →

Sponsor

Caroline M Kistorp

Who can join

18 and older, any sex, with Type2 Diabetes Mellitus. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

Effects of the sodium-glucose co-transporter-2 inhibitor dapagliflozin on estimated plasma volume in patients with type 2 diabetes.
Dekkers CCJ, Sjöström CD, Greasley PJ, Cain V, et al · · 2019 · cited 81× · PMID 31407856 · DOI 10.1111/dom.13855
Effects of Empagliflozin on Myocardial Flow Reserve in Patients With Type 2 Diabetes Mellitus: The SIMPLE Trial.
Jürgens M, Schou M, Hasbak P, Kjær A, et al · · 2021 · cited 22× · PMID 34278803 · DOI 10.1161/jaha.120.020418
Design of a randomised controlled trial of the effects of empagliflozin on myocardial perfusion, function and metabolism in type 2 diabetes patients at high cardiovascular risk (the SIMPLE trial).
Jürgens M, Schou M, Hasbak P, Kjær A, et al · · 2019 · cited 8× · PMID 31780586 · DOI 10.1136/bmjopen-2019-029098
Reduction of cardiac adipose tissue volume with short-term empagliflozin treatment in patients with type 2 diabetes: A substudy from the SIMPLE randomized clinical trial.
Brandt-Jacobsen NH, Jürgens M, Hasbak P, Gaede P, et al · · 2023 · cited 6× · PMID 36484428 · DOI 10.1111/dom.14933
Coronary microvascular dysfunction and left heart filling pressures in patients with type 2 diabetes.
Wolsk E, Jürgens M, Schou M, Ersbøll M, et al · · 2024 · cited 5× · PMID 39073008 · DOI 10.1002/ehf2.14929
Macrophage and inflammation in diabetes and metabolic dysfunction-associated steatotic liver disease: From mechanisms to therapeutic strategies.
Zhang CY, Liu S, Yang M. · · 2025 · cited 2× · PMID 40980303 · DOI 10.4239/wjd.v16.i9.110515

Verify or expand the search:

Other trials of Empagliflozin

Trials testing the same drug.

NCT07060417 — Vascular Effects of SGLT2i in Non-diabetic CKD · Phase 2 · not yet recruiting
NCT06625073 — Randomized Trial of SGLT2i in Heart Transplant Recipients · Phase 4 · recruiting
NCT07107945 — A Study to Find Out How EMPAgliflozin is Tolerated and if it Helps Children and Adolescents With Chronic KIDNEY Disease · Phase 3 · recruiting
NCT07214818 — SGLT2 Inhibitors in Adult Primary Nephrotic Syndrome · Phase 2, PHASE3 · active not recruiting
NCT07180745 — Empagliflozin Versus Statins in Non-Alcoholic Fatty Liver Disease · Phase 4 · not yet recruiting

Other recruiting trials for Type2 Diabetes Mellitus

Currently open trials in the same condition.

NCT07533604 — SnapDandCGMinType2Diabetes · NA · recruiting
NCT06961019 — Clinical Study to Assess the Safety, Efficacy and In-Use Tolerability of Herbal-Based Sugar Support Effervescent Tablets · NA · recruiting
NCT06497842 — Effort During Resistance Training in Type 2 Diabetes · NA · active not recruiting
NCT06257966 — A Phase 3 Study to Evaluate the Efficacy of JY09 Compared With Dulaglutide in Combination Therapy Diabetes Mellitus Type · Phase 3 · active not recruiting
NCT03647306 — Behavioral Chronotype: Impact on Sleep and Metabolism · NA · active not recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03151343 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Caroline M Kistorp
Last refreshed: 18 August 2022

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03151343.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing