Proteomic Prediction and Renin Angiotensin Aldosterone System Inhibition Prevention Of Early Diabetic nephRopathy In TYpe 2 Diabetic Patients With Normoalbuminuria

• Status: Completed
• Trial end date: 2018-11-01

Summary

This is a prospective, multicenter, randomized, double blind, placebo-controlled and a prospective observational study.

This study will be conducted at 15 study centers in various European countries. 1777 participant between 18 to 75 years old with Type 2 diabetes mellitus and normoalbuminuria participate in the study. The study period is 2 - 4.5 years (excluding the 6 week screening period). Depending on the risk score of the urinary protein pattern, participants have been stratified into an observational group or an interventional group. Participants with the low risk pattern (observational group) attend visits annually after screening and baseline. Participants with the high risk pattern (interventional group) attend study visits every 13 weeks after screening and baseline.

The interventional group has been allocated into one treatment group either receiving spironolactone or placebo. A placebo is a medicine without a pharmaceutical substance. The allocation to one of the two treatment groups has been done by a random distribution procedure established before the study start.

The results of the urine sample from the Screening visit has been analysed and the urine proteomic pattern is determined to be either low- or high risk pattern and will determine the further study program.

Participants with a low-risk pattern (observational group):

During the study period, participants attend an annual project visit, were regular diabetes care is performed and three urine samples are analysed for albuminuria.

Participants with a high-risk pattern (intervention group):

Participants with a high-risk pattern have been randomized to either spironolactone treatment or placebo. The treatment is one tablet for oral use to be taken once a day for the entire study period. Four times each year (every 13th week) a study visit is conducted including examination of three urine samples for albuminuria.

This study aims to:

1. Confirm in a prospective multicenter study of normoalbuminuric type 2 DM patients that the urinary proteome test identifies patients with a high risk for development of microalbuminuria.

2. Demonstrate the clinical utility of the test by showing that aldosterone blockade in high-risk patients can reduce progression to microalbuminuria in comparison to placebo, on the top of standard treatment in a randomized double-blind, placebo-controlled multicenter study.

• Phase: Phase 2/Phase 3

Details

• Lead Sponsor: Peter Rossing
• Collaborators: Charite University, Berlin, Germany; Cyril and Methodius University in Skopje; Diabetes Vascular Research Foundation Hoogeveen; Diabetologen Hessen; European Commission; Geniko Nosokomeio Athinas Ippokrateio; Hannover Clinical Trial Center; Institut Klinické a Experimentální Mediciny Praze; Institut Universitaire de Recherche Clinique Montpellier; Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz; Istituto Di Ricerche Farmacologiche Mario Negri; Klinikum St. Georg Leipzig; Mosaiques Diagnostics GmbH; Stichting VUMC; Universitaet Zürich; Universitair Ziekenhuis Gent; Universitätsklinikum Carl Gustav Carus an der Technischen Universität Dresden; University Medical Center Groningen; University of Glasgow; Univerzita Karlova v Praze
• Treatments: Mineralocorticoid Receptor Antagonists; Spironolactone