Multifactorial Intervention to Reduce Cardiovascular Disease in Type 1 Diabetes

Recruiting Phase 3 Interventional Study
Cardiovascular Diseases Heart Failure Type 1 Diabetes Kidney Failure
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
40 – 90
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
2,000 (estimated)
Sponsor
Steno Diabetes Center Copenhagen · Other
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About This Trial

A prospective, randomised, open-labelled, multi-center study. The aim of the Steno 1 study is to test multifactorial intervention in individuals with type 1 diabetes at high risk of CVD with ambitious treatment targets. We will include 2000 participants. Follow-up is 5 years.

Trial Locations
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Eligibility Criteria
Inclusion Criteria: 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)) du…
Contacts

Frederik Persson, MD, DMSc

+4521623779

frederik.persson@regionh.dk

CONTACT

Elisabeth Stougaard, MD

+4522436292

elisabeth.buur.stougaard@regionh.dk

CONTACT