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
- diabetesDiabetes Mellitus10012653
- Registration Number
- NL-OMON46820
- Lead Sponsor
- Martini Ziekenhuis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 20
* Type 2 diabetes
* HbA1c * 6.5% (48 mmol/mol)
* eGFR > 30 ml/min/1.73m2
* Albumin:creatinine ratio >3.5mg/mmol and *100 mg/mmol
* Age * 18 years
* Written informed consent
* Pregnant women and women of child-bearing potential who are not using reliable contraception
* Cardiovascular disease: myocardial infarction, angina pectoris, percutanous transluminal coronary angioplasty, coronary artery bypass grafting, stroke, heart failure (NYHA I-IV) < 6 months before inclusion
* Uncontrolled blood pressure (> 160/ 100 mmHg)
* Active malignancy
* History of autonomic dysfunction (e.g. history of fainting or clinically significant orthostatic hypotension)
* Participation in any clinical investigation within 3 months prior to initial dosing.
* Donation or loss of 400 ml or more of blood within 8 weeks prior to initial dosing
* History of drug or alcohol abuse within the 12 months prior to dosing, or evidence of such abuse as indicated by the laboratory assays conducted during the screening.
* Use of SGLT-2 inhibitor, GLP1-RA or DPP-4 inhibitor.
* Lithium use
* Any medication, surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of medications
* Any condition when MRI is contraindicated
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The main study endpoint is the change in albuminuria from baseline at the end<br /><br>of each treatment period.</p><br>
- Secondary Outcome Measures
Name Time Method