The REVERT-PREDIABETES trial

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Region Midtjylland

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Cardiovascular Diseases [C14], Diseases [C] - Nutritional and Metabolic Diseases [C18]

Trial duration

3 Mar 2026 → ongoing

Decision date (initial)

2025-11-23

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

Novo Nordisk Foundation

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy

To examine the proportion of patients with angiographically documented coronary artery disease that can be reverted from prediabetes to normoglycemia by using cardioprotective glucose-lowering drugs.

Secondary objectives 2

1. To compare the prevalence of retinopathy, nephropathy, neuropathy, and MASLD in patients with chronic coronary syndrome and prediabetes versus normoglycemia.
2. To examine the 2-year incidence of recurrence of prediabetes or progression to type 2 diabetes in patients with chronic coronary syndrome and initial prediabetes treated with glucose-lowering medications for one year.

Conditions and MedDRA coding

Coronary artery disease

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 3

1. Chronic coronary syndrome with documented coronary artery disease. In the case of previous myocardial infarction, at least 30 days between the event and randomization is required.
2. Prediabetes defined as HbA1c 42-47 mmol/mol OR normoglycemia defined as HbA1c <39 mmol/mol
3. Age 18 to 80 years

Exclusion criteria 10

1. eGFR <30 mL/min/1.73 m2
2. Previous diabetes diagnosis, previous HbA1c >47 mmol/mol, or current/previous usage of diabetes medication
3. Anemia, recent bleeding or blood transfusion (<3 months)
4. Previous pancreatitis
5. Pregnancy, breastfeeding, or fertile women who do not use highly effective birth control
6. Strongly reduced liver function
7. Chronic alcohol abuse
8. Known hemoglobinopathy and other conditions with effect on erythrocyte lifespan
9. Intake of medications with known effect on HbA1c validity
10. Heart failure with NYHA class III or IV

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 2

1. Presence of a composite of retinopathy, nephropathy, neuropathy, and MASLD in patients with chronic coronary syndrome and prediabetes versus normoglycemia.
2. Incidence of normoglycemia defined as HbA1c <39 mmol/mol after 1 year in the interventional therapy arm compared with conventional therapy.

Secondary endpoints 21

1. To examine the 2-year incidence of recurrence of prediabetes or progression to type 2 diabetes in patients with chronic coronary syndrome and initial prediabetes treated with glucose-lowering medications for one year compared with conventional therapy.
2. Baseline presence of a composite of retinopathy, nephropathy, and neuropathy in patients with chronic coronary syndrome and prediabetes versus normoglycemia..
3. Baseline presence of retinopathy, nephropathy, neuropathy or MASLD, respectively, in patients with chronic coronary syndrome and prediabetes versus normoglycemia.
4. 1-year incidence of normoglycemia defined as HbA1c <42 mmol/mol
5. Change in HbA1c
6. Change in eGFR
7. Change in cystatin-C
8. Change in hs-CRP
9. Change in lipid parameters
10. Change in c-peptide
11. Change in HOMA-IR
12. Change in Fib-4
13. Change in CD163
14. Change in PRO-C3
15. Change in MASLD severity
16. Change in urine albumin-creatinine ratio
17. Change in weight
18. Change in waist circumference
19. 2-year incidence of type 2 diabetes in the interventional therapy arm compared with conventional therapy.
20. Prevalence of prediabetes defined as HbA1c 42-47 mmol/mol in the interventional therapy arm compared with conventional therapy.
21. Prevalence of prediabetes defined as HbA1c 39-47 mmol/mol in the interventional therapy arm compared with conventional therapy.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 2

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Region Midtjylland

Sponsor organisation

Region Midtjylland

Address

Palle Juul-Jensens Boulevard 99

City

Aarhus N

Postcode

8200

Country

Denmark

Scientific contact point

Organisation

Region Midtjylland

Contact name

Hjertesygdomme AUH

Public contact point

Organisation

Region Midtjylland

Contact name

Hjertesygdomme AUH

Third parties 1

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 8 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications