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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."

Field of science

  • /medical and health sciences/clinical medicine/ophthalmology/retinopathy
  • /medical and health sciences/clinical medicine/endocrinology/diabetes

Call for proposal

FP7-HEALTH-2011-two-stage
See other projects for this call

Funding Scheme

CP-FP - Small or medium-scale focused research project
Leaflet | Map data © OpenStreetMap contributors, Credit: EC-GISCO, © EuroGeographics for the administrative boundaries

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)

SERVICIO MADRILENO DE SALUD

Participation ended

Spain
Address
Plaza Carlos Trias Bertran 7
28020 Madrid
Activity type
Public bodies (excluding Research Organisations and Secondary or Higher Education Establishments)
Administrative Contact
Ana Coloma Zapatero (Ms.)
TERVEYDEN JA HYVINVOINNIN LAITOS
Finland
EU contribution
€ 254 690,90
Address
Mannerheimintie 166
00271 Helsinki
Activity type
Research Organisations
Administrative Contact
Jaana Lindström (Dr.)
FUNDACION JIMENEZ DIAZ UTE

Participation ended

Spain
Address
Avenida Reyes Catolicos 2
28040 Madrid
Activity type
Research Organisations
Administrative Contact
Antonio González (Mr.)
UNIVERSITA DI PISA
Italy
EU contribution
€ 411 862,20
Address
Lungarno Pacinotti 43/44
56126 Pisa
Activity type
Higher or Secondary Education Establishments
Administrative Contact
Donatella Rossi (Dr.)
UNIVERSIDAD DE VALLADOLID
Spain
EU contribution
€ 200 000
Address
Plaza Santa Cruz 8 Palacio De Santa Cruz
47002 Valladolid
Activity type
Higher or Secondary Education Establishments
Administrative Contact
Yolanda Calvo Conde (Ms.)
UNIVERSITAT FUR WEITERBILDUNG KREMS
Austria
EU contribution
€ 47 000
Address
Dr Karl Dorrek Strasse 30
3500 Krems
Activity type
Higher or Secondary Education Establishments
Administrative Contact
Alexandra Dachenhausen (Ms.)
VASTRA GOTALANDS LANS LANDSTING
Sweden
EU contribution
€ 71 640
Address
Regionens Hus
462 80 Vanersborg
Activity type
Public bodies (excluding Research Organisations and Secondary or Higher Education Establishments)
Administrative Contact
åsa Meijer (Ms.)
FUNDACION DE INVESTIGACION EN RED EN ENFERMEDADES CARDIOVASCULARES

Participation ended

Spain
EU contribution
€ 393 848,02
Address
Almagro 1
28010 Madrid
Activity type
Research Organisations
Administrative Contact
Ana Fernandez Baza (Ms.)
TECHNISCHE UNIVERSITAET DRESDEN
Germany
EU contribution
€ 191 700
Address
Helmholtzstrasse 10
01069 Dresden
Activity type
Higher or Secondary Education Establishments
Administrative Contact
Beate Brenner (Ms.)
FEDERATION INTERNATIONALE DU DIABETE REGION EUROPE AISBL
Belgium
EU contribution
€ 22 500
Address
Chaussee De La Hulpe 166 Bloc C
1170 Bruxelles
Activity type
Other
Administrative Contact
Sophie Peresson (Ms.)
CONSIGLIO NAZIONALE DELLE RICERCHE
Italy
EU contribution
€ 95 685
Address
Piazzale Aldo Moro 7
00185 Roma
Activity type
Research Organisations
Administrative Contact
Ferdinando Grandori (Dr.)
PARACELSUS MEDIZINISCHE PRIVATUNIVERSITAT SALZBURG - PRIVATSTIFTUNG

Participation ended

Austria
Address
Strubergasse 21
5020 Salzburg
Activity type
Higher or Secondary Education Establishments
Administrative Contact
Erik Vossius-Irshaid (Dr.)
LIETUVOS SVEIKATOS MOKSLU UNIVERSITETAS

Participation ended

Lithuania
EU contribution
€ 17 839,75
Address
A Mickeviciaus Gatve 9
44307 Kaunas
Activity type
Higher or Secondary Education Establishments
Administrative Contact
Dzilda Velickiene (Dr.)
ETHNIKO KAI KAPODISTRIAKO PANEPISTIMIO ATHINON
Greece
EU contribution
€ 333 113,60
Address
6 Christou Lada Str
10561 Athina
Activity type
Higher or Secondary Education Establishments
Administrative Contact
Efstathia Kafentzi (Ms.)
FUNDACIO INSTITUT UNIVERSITARI PERA LA RECERCA A L'ATENCIO PRIMARIA DE SALUT JORDI GOL I GURINA
Spain
EU contribution
€ 172 300
Address
Gran Via De Les Corts Catalanes 587
08007 Barcelona
Activity type
Research Organisations
Administrative Contact
Jose M Gallego (Mr.)
FUNDACIO HOSPITAL UNIVERSITARI VALL D'HEBRON - INSTITUT DE RECERCA
Spain
EU contribution
€ 59 359,80
Address
Passeig Vall D Hebron 119-129 Edificio De Recerca
08035 Barcelona
Activity type
Research Organisations
Administrative Contact
Ramon Cosialls (Mr.)
ISTANBUL UNIVERSITESI
Turkey
EU contribution
€ 172 300
Address
Istanbul Universitesi Center Campus Beyazit Eminonu
34452 Istanbul
Activity type
Higher or Secondary Education Establishments
Administrative Contact
Yildiz Tutuncu (Dr.)
DJORDJEVIC SPECIJALISTICKA ORDINACIJA IZ INTERNE MEDICINE PROFESOR DR PREDRAG DORDEVIC DEDINJE PREDUZETNIK

Participation ended

Serbia
EU contribution
€ 29 824,13
Address
Aleksandra Stamboliskog 10 A
11000 Beograd
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Administrative Contact
Predrag Djordjevic (Prof.)
FACULTY OF MEDICINE, UNIVERSITY OF BELGRADE
Serbia
EU contribution
€ 172 300
Address
Dr Subotica, 8
11000 Belgrade
Activity type
Higher or Secondary Education Establishments
Administrative Contact
Vladimir Bumbasirevic (Prof.)
Jagiellonian University in Krakow
Poland
EU contribution
€ 172 300
Address
Ul. Golebia 24
31007 Krakow
Activity type
Higher or Secondary Education Establishments
Administrative Contact
Katarzyna Gubernat (Ms.)
THE UNIVERSITY OF SYDNEY
Australia
Address
Camperdown Campus Arundel St 71/79
2006 Sydney
Activity type
Higher or Secondary Education Establishments
Administrative Contact
Yamini Sandiran (Ms.)
UNIVERSITY MULTI-PROFILE HOSPITAL FOR ACTIVE TREATMENT ALEXANDROVSKA EAD
Bulgaria
EU contribution
€ 172 201
Address
Georgi Sofiiski Street 1
1431 Sofia
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Administrative Contact
Zdravko Kamenov (Prof.)
HELSINGIN YLIOPISTO
Finland
EU contribution
€ 53 799,40
Address
Yliopistonkatu 3
00014 Helsingin Yliopisto
Activity type
Higher or Secondary Education Establishments
Administrative Contact
Tiina Berg (Dr.)
E-DIAGNOSTIC OFTALMOLOGIA SL
Spain
EU contribution
€ 126 160
Address
Paseo De Belen Campus Miguel Delibes Edificio I+d 11
47011 Valladolid
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Administrative Contact
Diana Bravo García (Ms.)
FONDAZIONE MARIO NEGRI SUD-CENTRO DI RICERCHE FARMACOLOGICHE EB IOMEDICHE

Participation ended

Italy
EU contribution
€ 11 486,40
Address
Via Nazionale 8A
66030 Santa Maria Imbaro
Activity type
Research Organisations
Administrative Contact
Claude Alain Di Menno Di Bucchianico (Mr.)
INSTITUTO DE INVESTIGACION Y ASISTENCIA PSIQUIATRICA SL
Spain
EU contribution
€ 27 810
Address
Calle Serrano 178
28002 Madrid
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Administrative Contact
Laura Ferrando (Dr.)
AARDEX GROUP SA
Switzerland
EU contribution
€ 62 760
Address
Avenue De La Gare 29
1950 Sion
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Administrative Contact
Bernard Vrijens (Dr.)
UNIVERSITE DE GENEVE

Participation ended

Switzerland
EU contribution
€ 1 206,59
Address
Rue Du General Dufour 24
1211 Geneve
Activity type
Higher or Secondary Education Establishments
Administrative Contact
Yvan Seguin (Mr.)
IMPETO MEDICAL
France
EU contribution
€ 62 760
Address
Rue Campagne Premiere 17
75014 Paris
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Administrative Contact
Philippe Brunswick (Dr.)
OIVAUNI OY
Finland
EU contribution
€ 27 500
Address
Kaikukatu 43
70600 Kuopio
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Administrative Contact
Jenni Helena Tuomilehto (Ms.)
QUEEN MARY UNIVERSITY OF LONDON
United Kingdom
EU contribution
€ 25 640
Address
327 Mile End Road
E1 4NS London
Activity type
Higher or Secondary Education Establishments
Administrative Contact
Tanya Szendeffy (Ms.)
GEMEINNUTZIGE SALZBURGER LANDESKLINIKEN BETRIEBSGESELLSCHAFT
Austria
EU contribution
€ 172 300
Address
Mullner Hauptstrasse 48
5020 Salzburg
Activity type
Other
Administrative Contact
Christoph Hutzinger (Mr.)
INSTITUTO INVESTIGACION SANITARIA FUNDACION JIMENEZ DIAZ
Spain
EU contribution
€ 402 860,25
Address
Avenida De Los Reyes Catolicos 2
28040 Madrid
Activity type
Research Organisations
Administrative Contact
Veronica Garcia Martinez (Ms.)
SERVICIO ANDALUZ DE SALUD
Spain
EU contribution
€ 171 093,41
Address
Avenida De La Constitucion 18
41071 Sevilla
Activity type
Public bodies (excluding Research Organisations and Secondary or Higher Education Establishments)
Administrative Contact
Elena Martin-Bautista (Dr.)
ZDRAVSTVENA USTANOVA OPSTA BOLNICA MEDICINSKI SISTEM BEOGRAD MSB
Serbia
EU contribution
€ 142 475,87
Address
Vojvode Stepe 323
11000 Beograd
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Administrative Contact
Aleksandra Pesic (Ms.)