The overall aim of this study is to examine the feasibility of a 12-month, two-arm lifestyle intervention to induce and maintain remission of type 2 diabetes (T2D). The findings from the feasibility study will inform the recruitment, design and delivery of the interventions in a 5-arm, 24-month randomised controlled trial.
Diagnosis of T2D. Treatment lifestyle changes, oral anti-diabetic medication including metformin, and/or sulfonylureas and/or DPP-4 inhibitors and/or SGLT2 inhibitors and/or incretin-based medication
HbA1c between 36-86 mmol/mol
T2D duration of ≤6 years
BMI ≥27 kg/m2
Insulin treatment within 6 months prior to screening (any type)
Heart failure (ejection fraction ≤40%) and treated with SGLT-2i (current or planned)
Cardiovascular disease, including previous heart attack or stroke, for which incretin-based therapy and/or an SGLT-2i has been prescribed.
Kidney disease (eGFR <60 ml/min/1,73m² and/or albuminuria (≥30 mg/g) for at least three months) and treated with SGLT-2i (current or planned)
Steno Diabetes Center Copenhagen
Lead sponsor
Aarhus University Hospital
Collaborator
Steno Diabetes Center Odense
Collaborator
University of Copenhagen
Collaborator
The Novo Nordisk Foundation Center for Basic Metabolic Research
Collaborator
Bispebjerg Hospital
Collaborator