A study to assess the anti-albuminuric effects and variability in response to dapagliflozin in subjects with type 2 diabetes
Phase 4
Completed
- Conditions
- Albuminuria in patients with type 2 diabetes1001265310029149
- Registration Number
- NL-OMON40930
- Lead Sponsor
- niversitair Medisch Centrum Groningen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- 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 <p>Primary study goal is to assess the change from baseline in 24-hr albuminuria<br /><br>with dapagliflozin for six weeks relative to placebo treatment in patients with<br /><br>diabetes and albuminuria > 100 mg/day on stable ACEi or ARB treatment.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary Objective(s):<br /><br>To assess:<br /><br>• To assess the within-patient variability in HbA1c, 24-hr blood pressure, body<br /><br>weight, and albuminuria response to dapagliflozin.<br /><br>• To assess the between-patient variability in HbA1c, 24-hr blood pressure,<br /><br>body weight, and albuminuria response to dapagliflozin.<br /><br>• The variability in HbA1c, blood pressure, body weight, and albuminuria in<br /><br>response to dapagliflozin during the first and second treatment period.</p><br>