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Early Prevention of Diabetes Complications in people with Hyperglycaemia in Europe

Early Prevention of Diabetes Complications in people with Hyperglycaemia in Europe

Objective

"Background: A significant proportion of pre-diabetics, show macro and micro vascular complications associated with hyperglycaemia. Although many trials have demonstrated the efficacy of lifestyle and pharmaceutical interventions in diabetes prevention, no trial has evaluated the extent to which mid- and long-term complications can be prevented by early interventions on hyperglycaemia.

Aims: To assess the long-term effects on multiple complications of hyperglycaemia of early intensive management of hyperglycaemia with linagliptin, metformin or their combination added to lifestyle intervention (LSI) (diet and physical activity), compared with LSI alone in adults with non-diabetic intermediate hyperglycaemia (IFG, IGT or both).

Study Design: Investigator initiated (non-commercial), long-term, multi-centre, randomised, partially double blinded, placebo controlled, phase-IIIb clinical trial with prospective blinded outcome evaluation. Participants will be randomised to four parallel arms: 1) LSI + 2 placebo tablets/day; 2) LSI + 2 Metformin tablets of 850 mg/day; 3) LSI + 1 Linagliptin tablets of 5 mg/day and 1 placebo; 4) LSI + 2 tablets of a fixed-dose combination of Linagliptin 2.5mg and Metformin 850 /day. Active intervention will last for at least 2 years, and additional follow-up up to 4 years.

Setting and population: Males and Females with pre-diabetes (IFG, IGT or both) aged 45 to 74 years selected from primary care screening programs in 15 clinical centres from 12 countries. (N=2000).

Main Outcomes: The primary endpoint is a combined continuous variable: “the microvascular complication índex"" (MCI) composed by a linear combination of the Early Treatment Diabetic Retinopathy Study Scale (ETDRS) score (based on retinograms), the level of urinary albumin to creatinine ratio, and a measure of distal small fibre neuropathy (sudomotor test by SUDOSCAN), measured during baseline visit and at 24th and 48th month visits after randomisation. In addition, this project will include the evaluation of early novel serological biomarkers of systemic inflammation, early micro-vascular damage, non-alcoholic fatty liver disease, insulin sensitivity and insulin secretion, and measures of quality of life, sleep quality (somnograms) and neuropsychological evaluation. Vascular function and structure will be evaluated in a subset of participants (n=1000), including cIMT and microvascular endothelial function measured by EndoPAT.

Expected results: By evaluating the effect of aggressive treatments in pre-diabetes for the early prevention of diabetes complication, this project has the potential of changing the current paradigm of early management of hyperglycaemia. The ultimate goal is the development of a standardized core protocol for the early prevention of microvascular and other complications, impacting social cost as a result not only in health care, but also in disabilities at work."
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Coordinator

EVIDEM CONSULTORES SL

Address

Calle Marroquina 12 Planta 1 Puerta A
28030 Madrid

Spain

Activity type

Private for-profit entities (excluding Higher or Secondary Education Establishments)

EU Contribution

€ 1 721 679,68

Administrative Contact

Eliana Del Aguila (Mrs.)

Participants (35)

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SERVICIO MADRILENO DE SALUD

Spain

TERVEYDEN JA HYVINVOINNIN LAITOS

Finland

EU Contribution

€ 254 690,90

FUNDACION JIMENEZ DIAZ UTE

Spain

UNIVERSITA DI PISA

Italy

EU Contribution

€ 411 862,20

UNIVERSIDAD DE VALLADOLID

Spain

EU Contribution

€ 200 000

UNIVERSITAT FUR WEITERBILDUNG KREMS

Austria

EU Contribution

€ 47 000

VASTRA GOTALANDS LANS LANDSTING

Sweden

EU Contribution

€ 71 640

FUNDACION DE INVESTIGACION EN RED EN ENFERMEDADES CARDIOVASCULARES

Spain

EU Contribution

€ 393 848,02

TECHNISCHE UNIVERSITAET DRESDEN

Germany

EU Contribution

€ 191 700

FEDERATION INTERNATIONALE DU DIABETE REGION EUROPE AISBL

Belgium

EU Contribution

€ 22 500

CONSIGLIO NAZIONALE DELLE RICERCHE

Italy

EU Contribution

€ 95 685

PARACELSUS MEDIZINISCHE PRIVATUNIVERSITAT SALZBURG - PRIVATSTIFTUNG

Austria

LIETUVOS SVEIKATOS MOKSLU UNIVERSITETAS

Lithuania

EU Contribution

€ 17 839,75

ETHNIKO KAI KAPODISTRIAKO PANEPISTIMIO ATHINON

Greece

EU Contribution

€ 333 113,60

FUNDACIO INSTITUT UNIVERSITARI PERA LA RECERCA A L'ATENCIO PRIMARIA DE SALUT JORDI GOL I GURINA

Spain

EU Contribution

€ 172 300

FUNDACIO HOSPITAL UNIVERSITARI VALL D'HEBRON - INSTITUT DE RECERCA

Spain

EU Contribution

€ 59 359,80

ISTANBUL UNIVERSITESI

Turkey

EU Contribution

€ 172 300

DJORDJEVIC SPECIJALISTICKA ORDINACIJA IZ INTERNE MEDICINE PROFESOR DR PREDRAG DORDEVIC DEDINJE PREDUZETNIK

Serbia

EU Contribution

€ 29 824,13

FACULTY OF MEDICINE, UNIVERSITY OF BELGRADE

Serbia

EU Contribution

€ 172 300

UNIWERSYTET JAGIELLONSKI

Poland

EU Contribution

€ 172 300

THE UNIVERSITY OF SYDNEY

Australia

UNIVERSITY MULTI-PROFILE HOSPITAL FOR ACTIVE TREATMENT ALEXANDROVSKA EAD

Bulgaria

EU Contribution

€ 172 201

HELSINGIN YLIOPISTO

Finland

EU Contribution

€ 53 799,40

E-DIAGNOSTIC OFTALMOLOGIA SL

Spain

EU Contribution

€ 126 160

FONDAZIONE MARIO NEGRI SUD-CENTRO DI RICERCHE FARMACOLOGICHE EB IOMEDICHE

Italy

EU Contribution

€ 11 486,40

INSTITUTO DE INVESTIGACION Y ASISTENCIA PSIQUIATRICA SL

Spain

EU Contribution

€ 27 810

AARDEX GROUP SA

Switzerland

EU Contribution

€ 62 760

UNIVERSITE DE GENEVE

Switzerland

EU Contribution

€ 1 206,59

IMPETO MEDICAL

France

EU Contribution

€ 62 760

OIVAUNI OY

Finland

EU Contribution

€ 27 500

QUEEN MARY UNIVERSITY OF LONDON

United Kingdom

EU Contribution

€ 25 640

GEMEINNUTZIGE SALZBURGER LANDESKLINIKEN BETRIEBSGESELLSCHAFT

Austria

EU Contribution

€ 172 300

INSTITUTO INVESTIGACION SANITARIA FUNDACION JIMENEZ DIAZ

Spain

EU Contribution

€ 402 860,25

SERVICIO ANDALUZ DE SALUD

Spain

EU Contribution

€ 171 093,41

ZDRAVSTVENA USTANOVA OPSTA BOLNICA MEDICINSKI SISTEM BEOGRAD MSB

Serbia

EU Contribution

€ 142 475,87

Project information

Grant agreement ID: 279074

Status

Closed project

  • Start date

    1 January 2012

  • End date

    31 December 2017

Funded under:

FP7-HEALTH

  • Overall budget:

    € 8 332 258,96

  • EU contribution

    € 5 999 996

Coordinated by:

EVIDEM CONSULTORES SL

Spain