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

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.

Conditions

• Diabetic Nephropathy
• Diabetic Retinopathy

Interventions

DRUG

Spironolactone

DRUG

Placebo

DRUG

Standard care

Standard diabetes care

Sponsors & Collaborators

• Mosaiques Diagnostics GmbH

  collaborator UNKNOWN

• University Medical Center Groningen

  collaborator OTHER

• University of Glasgow

  collaborator OTHER

• Istituto Di Ricerche Farmacologiche Mario Negri

  collaborator OTHER

• Univerzita Karlova v Praze

  collaborator OTHER

• Geniko Nosokomeio Athinas Ippokrateio

  collaborator UNKNOWN

• Institut Klinické a Experimentální Mediciny Praze

  collaborator UNKNOWN

• Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz

  collaborator OTHER

• Klinikum St. Georg Leipzig

  collaborator UNKNOWN

• Cyril and Methodius University in Skopje

  collaborator UNKNOWN

• Hannover Clinical Trial Center

  collaborator UNKNOWN

• European Commission

  collaborator OTHER

• Diabetes Vascular Research Foundation Hoogeveen

  collaborator UNKNOWN

• University Ghent

  collaborator OTHER

• Universitätsklinikum Carl Gustav Carus an der Technischen Universität Dresden

  collaborator UNKNOWN

• Stichting VUMC

  collaborator UNKNOWN

• Diabetologen Hessen

  collaborator UNKNOWN

• Peter Rossing

  lead OTHER

Principal Investigators

• Peter Rossing, Prof. MD · Steno Diabetes Center Copenhagen

• Matias Trillini, MD · Istituto de Ricerche Farmacologiche Mario Negri

• Alberto Ortiz, MD · Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz

• Christian Delles, MD · University of Glasgow

• Gerjan Navis, MD · University Medical Center Groningen

• Ivan Rychlik, MD · Univerzita Karlova v Praze

• Joachim Beige, MD · Klinikum St. Georg gGmbH

• Marina Noutsou, MD · Geniko Nosikomeico Athinas Ippokrateio, Hospital Diabetes Center

• Peter Girman, MD · Institut Klinické a Experimentální Mediciny

• Goce Spasovski, MD · Department of Nephrology, University of Skopje

• Adriaan Kooy, MD · Diabetes Vascular Research Foundation Hoogeveen

• Marjin Speeckaert, MD · University Ghent

• Joline Beulens, MD · Stichting VUMC

• Rüdiger Göke, MD · Diabetologen Hessen

• Andreas Birkenfeld, MD · Universitätsklinikum Carl Gustav Carus, Technischen Universität Dresden

Study Design

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2014-03-31

Primary Completion

2018-11-30

Completion

2018-11-30

Countries

• Belgium
• Czechia
• Denmark
• Germany
• Greece
• Italy
• Netherlands
• North Macedonia
• Spain
• United Kingdom

Study Locations