IMPROVE
- Conditions
- Type 2 diabetesHigh Albuminuria
- Registration Number
- NL-OMON23733
- Lead Sponsor
- niversity Medical Center Groningen
- Brief Summary
n/a
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 36
Inclusion Criteria
Age ≥18 and ≤75 years
-Diagnosis of type 2 diabetes mellitus
-HbA1c ≥ 6.6% and <11.0%
-Urinary albumin excretion > 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
Type 1 diabetes
Urinary albumin excretion > 3500 mg/day
Active malignancy
Pregnancy or breast feeding
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Reduction in 24-hr urinary albumin excretion
- Secondary Outcome Measures
Name Time Method To assess:<br>-To assess the within-patient variability in HbA1c, 24-hr blood pressure, body weight, and albuminuria response to dapagliflozin.<br>-To assess the between-patient variability in HbA1c, 24-hr blood pressure, body weight, and albuminuria response to dapagliflozin.<br>-The variability in HbA1c, blood pressure, body weight, and albuminuria in response to dapagliflozin during the first and second treatment period.