Type 2 diabetes High Albuminuria
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: -Age ≥18 and ≤75 years -Diagnosis of type 2 diabetes mellitus -HbA1c ≥ 6.6% and 100 mg/g -On a stable dose of an ACEi or ARB for at least 4 weeks prior to randomization -On a stable dose of blood glucose lowering medication for at least 4 weeks prior to randomization -eGFR ≥ 45 mL/min/1.73m2 -Willing to sign informed consent
Exclusion criteria
Exclusion criteria: Type 1 diabetes Urinary albumin excretion > 3500 mg/day Active malignancy Pregnancy or breast feeding
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reduction in 24-hr urinary albumin excretion | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess: -To assess the within-patient variability in HbA1c, 24-hr blood pressure, body weight, and albuminuria response to dapagliflozin. -To assess the between-patient variability in HbA1c, 24-hr blood pressure, body weight, and albuminuria response to dapagliflozin. -The variability in HbA1c, blood pressure, body weight, and albuminuria in response to dapagliflozin during the first and second treatment period. | — |
Contacts
University Medical Center Groningen