An open-label randomised cross-over study to evaluate the albuminuria lowering effect of dapagliflozin, exenatide and their combination in patients with type 2 diabetes
- Conditions
- Diabetes Mellitus Type 2 (DM type II), Albuminuria
- Registration Number
- NL-OMON24855
- Lead Sponsor
- niversity Medical Center Groningen (UMCG)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 17
Inclusion Criteria
•Type 2 diabetes
•HbA1c ≥ 7.5% (58 mmol/mol) and <10% (86 mmol/mol)
Exclusion Criteria
•Pregnant women and women of child-bearing potential who are not using
reliable contraception
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Albuminuria reduction
- Secondary Outcome Measures
Name Time Method •Correlation in albuminuria response with each intervention<br /><br>•Change from baseline in extracellular volume<br /><br>•Change from baseline in fractional lithium excretion<br /><br>•Correlation between change in albuminuria and extracellular volume<br /><br>•Change in blood pressure<br /><br>•Change in weight<br /><br>•Assessment of pharmacokinetic parameters of each intervention<br /><br>