Study to evaluate the effect of dapagliflozin, exenatide and their combination on the loss of protein in urine in patients with type 2 diabetes

Phase 1

• Conditions: Type 2 diabetes; Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

• Registration Number: EUCTR2017-004709-42-NL
• Lead Sponsor: Martini Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-03-28
• Last Update Posted: 7 May 2018

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 17

Inclusion Criteria

•Type 2 diabetes
•HbA1c = 7.5% (58 mmol/mol) and <10% (86 mmol/mol)
•eGFR > 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

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 4
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 13

Exclusion Criteria

•Pregnant women and women of child-bearing potential who are not using reliable contraception
•Cardiovascular disease
•Uncontrolled blood pressure (office bp > 160/ 100 mmHg)
•Active malignancy
•History of autonomic dysfunction (e.g. history of fainting or clinically significant orthostatic hypotension)
•Use of SGLT-2 inhibitor, GLP1-RA or DPP-4 inhibitor.
•Lithium use

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified