Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The aim of this clinical trial is investigate the comparative effectiveness of empagliflozin and dapagliflozin for the treatment of diabetes, chronic kidney disease, and heart failure.
Patients who are prescribed either empagliflozin or dapagliflozin, as part of daily clinical practice at the participating sites, will be included in the study. Treatment will be randomized automatically through the electronic health record software in clusters defined by time of day.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Empagliflozin 10 MG | Other | Head-to-head comparator |
|
| Dapagliflozin 10 MG | Other | Head-to-head comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Empagliflozin 10 MG | Drug | Once daily |
| |
| Dapagliflozin 10 MG |
| Measure | Description | Time Frame |
|---|---|---|
| Time to the first occurrence of any of the components of the composite: all-cause mortality, hospitalization for heart failure, hospitalization for myocardial infarction, hospitalization for ischemic stroke, and incident or worsening nephropathy. | Incident or worsening nephropathy is defined as:
| Up to 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| All-cause mortality | Up to 24 months | |
| Hospitalization for heart failure | Up to 24 months | |
| Hospitalization for myocardial infarction |
| Measure | Description | Time Frame |
|---|---|---|
| Hospitalization for ketoacidosis | Safety outcome | Up to 24 months |
| Hospitalization for limb amputation | Safety outcome | Up to 24 months |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Morten Schou, Professor | Contact | 004540523920 | morten.schou.04@regionh.dk | |
| Daniel M. Christensen, MD, PhD | Contact | 004526248546 | dmc@dadlnet.dk |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bispebjerg Hospital | Recruiting | Copenhagen | Denmark | |||
| Rigshospitalet |
Not provided
Not provided
Not provided
Not provided
Treatment assignment will be blinded to the statistician analysing the trial data.
Not provided
| Drug |
Once daily |
|
| Up to 24 months |
| Hospitalization for ischemic stroke | Up to 24 months |
| Incident or worsening nephropathy | Defined as a sustained decrease in estimated glomerular filtration rate (eGFR) of ≥40% from baseline, a sustained decrease in eGFR of ≤10 per minute per 1.73 m2, initiation of dialysis, or kidney transplantation | Up to 24 months |
| Hospitalization for coronary revascularization | Up to 24 months |
| Hospitalization for unstable angina | Up to 24 months |
| Hospitalization for genitourinary infection | Safety outcome | Up to 24 months |
| Hospitalization for fracture | Safety outcome | Up to 24 months |
| Recruiting |
| Copenhagen |
| Denmark |
| Herlev and Gentofte Hospital | Recruiting | Herlev | Denmark |
|
| Steno Diabetes Center Copenhagen | Recruiting | Herlev | Denmark |
| Nordsjællands Hospital | Recruiting | Hillerød | Denmark |
| Holbæk Sygehus | Recruiting | Holbæk | Denmark |
| Hvidovre Hospital | Recruiting | Hvidovre | Denmark |
| Sjællands Universitetshospital | Recruiting | Køge | Denmark |
| Nykøbing F. Sygehus | Recruiting | Nykøbing Falster | Denmark |
| Sjællands Universitetshospital | Recruiting | Roskilde | Denmark |
| Bornholms Hospital | Recruiting | Rønne | Denmark |
| Slagelse Sygehus | Recruiting | Slagelse | Denmark |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D006333 | Heart Failure |
| D051436 | Renal Insufficiency, Chronic |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| C570240 | empagliflozin |
| C529054 | dapagliflozin |
Not provided
Not provided
Not provided