New treatments to reduce cardiovascular disease in type 1 diabetes

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Steno Diabetes Center Copenhagen

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Hormonal diseases [C19], Diseases [C] - Cardiovascular Diseases [C14]

Trial duration

5 Jul 2024 → ongoing

Decision date (initial)

2024-05-13

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Efficacy

The aim of the Steno 1 study is to test a strategy of intensified care based on MFI in individuals with T1D at high risk of CVD with ambitious treatment targets compared to standard of care, while simultaneously investigating the safety and efficacy of 40 mg finerenone in individuals with T1D in risk of CV death and hospitalization for heart failure (HHF )

Secondary objectives 5

1. To determine whether a multifactorial intervention is superior to standard care with respect to a composite endpoint of renal function (end-stage kidney disease (ESKD) (dialysis, renal death, transplantation) a sustained eGFR <15 ml/min/1.73 m2 or >50% sustained decline in eGFR) compared to standard of care (sustained means change in eGFR sustained for at least 30 days).
2. To determine the effect of multifactorial intervention is superior to standard of care with respect to the individual components of the composite endpoints.
3. To determine whether a multifactorial intervention is superior to standard care with respect to all-cause mortality.
4. To determine the effect of the multifactorial intervention on the development and progression of painful and painless diabetic peripheral neuropathy
5. To determine the effect of MFI on the composite endpoint CV death and HHF

Conditions and MedDRA coding

Type 1 diabetes

Regulatory references

Plan to share IPD

No

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 6

1. 1. Given written informed consent
2. Male or female patients ≥40 years old with type 1 diabetes (diagnosis before age 30 with insulin from onset or if diagnosis after 30 years of age insulin from onset and DKA or positive autoantibodies ( in accordance with local guidelines)), or confirmed, at the investigator discretion by the available medical records) during >10 years
3. Presence of chronic kidney disease (UACR >30 mg/g or eGFR < 60 ml/min/1.73 m2) OR history of ischemic heart disease (previous myocardial infarction, stroke or angina) OR history of heart failure OR obesity grade 2 and 3 (BMI>35 kg/m2) OR 10-year CVD risk >10% according to Steno Type 1 Risk Engine
4. Fertile females must use highly efficient chemical, hormonal and mechanical contraceptives during the whole study and at least 2 months after cessation of study drug. The following contraceptive methods are approved: IUD or hormonal contraception that inhibits ovulation, i.e. pills, implantations, transdermal patches, vaginal ring or depot injection. Alternatively, be in menopause (i.e. must not have had regular menstrual bleeding for at least one year), have undergone bilateral oophorectomy or have been surgically sterilized or hysterectomised at least 12 months prior to screening. Fertile participants will be pregnancy tested every six months with urine HCG
5. Ability to communicate with the investigator and understand informed consent
6. For the CGM sub-study: Using CGM at inclusion, as part of their usual diabetes treatment.

Exclusion criteria 8

1. Type 2 diabetes, MODY, secondary diabetes.
2. History of pancreatitis
3. Body mass index < 18.5 kg/m2
4. Females of childbearing potential who are pregnant, breast-feeding, intend to become pregnant or are not using adequate contraceptive methods
5. Known or suspected abuse of alcohol or recreational drugs.
6. CKD stage 5
7. Participant in another drug-intervention study
8. For the sub-study on CGM if for some reason the participant chooses no longer to use CGM

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. • First major adverse cardiovascular events (MACE), and first hospitalization for heart failure (HHF). The primary efficacy analysis will analyse if a multifactorial intervention strategy is superior to standard care with respect to time to first event of the composite endpoint of first non-fatal myocardial infarction, first non-fatal stroke, cardiovascular death or first hospitalization for heart failure five years after inclusion of the first patient.

Secondary endpoints 3

1. Will determine whether a multifactorial intervention is superior to standard care with respect time to a composite endpoint of renal function (end-stage kidney disease (ESKD) (dialysis, renal death, transplantation) a sustained eGFR <15 ml/min/1.73 m2 or >50% sustained decline in eGFR from baseline) compared to standard of care (sustained means change in eGFR sustained for at least 30 days).
2. To determine the effect of multifactorial intervention is superior to standard of care with respect to the individual components of the composite endpoints.
3. To determine whether a multifactorial intervention is superior to standard care with respect to all-cause mortality.

Investigational products

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

Test 7

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Steno Diabetes Center Copenhagen

Sponsor organisation

Steno Diabetes Center Copenhagen

Address

Borgmester Ib Juuls Vej 83

City

Herlev

Postcode

2730

Country

Denmark

Scientific contact point

Organisation

Steno Diabetes Center Copenhagen

Contact name

Frederik Persson

Public contact point

Organisation

Steno Diabetes Center Copenhagen

Contact name

Frederik Persson

Third parties 1

Locations

1 EU/EEA country · 19 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 28 files

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

Application history

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