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

Phase 1

• Conditions: Type 1 diabetes with albuminuria; Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

• Registration Number: EUCTR2015-005691-26-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: 8 August 2016

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 26

Inclusion Criteria

• Type 1 diabetes or Type 2 diabetes
• eGFR > 45ml/min/1.73m2
• Albumin:creatinine ratio >50mg/g and =2000 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 26
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0

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: 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

Study & Design

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