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

Phase 1

• Conditions: Type 2 diabetes and albuminuria; MedDRA version: 20.1Level: LLTClassification code 10045242Term: Type II diabetes mellitusSystem Organ Class: 100000004861; Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

• Registration Number: EUCTR2017-001977-18-DK
• Lead Sponsor: niversity Medical Center Groningen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-05-08
• Last Update Posted: 5 April 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

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, percutaneous 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)

Study & Design

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