Diabetes Mellitus Type 2 (DM type II), Albuminuria
Conditions
Interventions
Dapagliflozine
Exenatide
Sponsors
University Medical Center Groningen (UMCG)
Eligibility
Inclusion criteria
Inclusion criteria: • Type 2 diabetes • HbA1c ≥ 7.5% (58 mmol/mol) and 30 ml/min/1.73m2 • Albumin:creatinine ratio >3.5mg/mmol and ≤100 mg/mmol • Age ≥ 18 years • RAS-blockade either by ACEI or ARB, or willingness to start ACEI or ARB treatment • Written informed consent
Exclusion criteria
Exclusion criteria: • 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) 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 or longer if required by local regulations, and for any other limitation of participation based on local regulations. • 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 or GLP1-RA. • Lithium use • Any medication, surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of medications including, but not limited to any of the following: o Major gastrointestinal tract surgery such as gastrectomy, gastroenterostomy, or bowel resection; o Gastro-intestinal ulcers and/or gastrointestinal or rectal bleeding within last six months; o Pancreatic injury or pancreatitis within the last six months; o Evidence of hepatic disease as determined by any one of the following: ALT or AST values exceeding 3x ULN at inclusion visit, a history of hepatic encephalopathy, a history of esophageal varices, or a history of portocaval shunt; o Evidence of urinary obstruction of difficulty in voiding at screening
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Albuminuria reduction | — |
Secondary
| Measure | Time frame |
|---|---|
| • Correlation in albuminuria response with each intervention • Change from baseline in extracellular volume • Change from baseline in fractional lithium excretion • Correlation between change in albuminuria and extracellular volume • Change in blood pressure • Change in weight • Assessment of pharmacokinetic parameters of each intervention | — |
Contacts
Public ContactH. Lambers Heerspink
University Medical Center Groningen
Outcome results
None listed