A rotation study of different albuminuria lowering drug classes to study individual drug response in diabetes

Phase 1

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

• Registration Number: EUCTR2015-005113-73-NL
• Lead Sponsor: niversity Medical Center Groningen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-06-14
• Last Update Posted: 4 July 2016

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 52

Inclusion Criteria

•Type 2 diabetes
•eGFR > 45ml/min/1.73m2
•Albumin:creatinine ratio >50mg/g and =500 mg/g
•Age = 18 years
•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 52
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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) < 6 months before inclusion
•Uncontrolled blood pressure (office bp > 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.
•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:
oMajor gastrointestinal tract surgery such as gastrectomy, gastroenterostomy, or bowel resection;
oGastro-intestinal ulcers and/or gastrointestinal or rectal bleeding within last six months;
oPancreatic injury or pancreatitis within the last six months;
oEvidence 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;
oEvidence of urinary obstruction of difficulty in voiding at screening

Study & Design

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