Prevention of Microvascular Complications in Prediabetes e-PREDICE Study
Status:
Unknown status
Trial end date:
2019-12-31
Target enrollment:
Participant gender:
Summary
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.
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 14 clinical centres from 10 countries:
Australia, Austria, Bulgaria, Greece, Italy, Kuwait, Poland, Serbia, Spain and Turkey and .
(N=1000)
Main Outcomes: The primary endpoint is a combined continous 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, serological biomarkers of inflammation, vascular damage,
non-alcoholic fatty liver disease, insulin secretion, measures of quality of life, sleep
quality, neuropsychological evaluation and endothelial function will be also evaluated in a
subset of participants.
Phase:
N/A
Details
Lead Sponsor:
Evidem Consultores SL
Collaborators:
Boehringer Ingelheim European Commission Merck Serono International SA