Plain English Summary
Not provided at time of registration
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
Study Numbers:Bay g 5421/0740 and Bay g 5421/200031
Study information
Scientific title
Acronym
EDIT Study
Study hypothesis
The Early Diabetes Intervention Trial (EDIT) was a six-year, prospective, randomised, double-blind, placebo-controlled study in subjects thought to be at increased risk of developing diabetes, and who had two consecutive fasting plasma glucose levels in the range 5.5 to 7.7 mmol/L. The primary aim of the trial was to determine whether deterioration in glycaemic tolerance towards diabetes could be delayed or prevented using an alpha-glucosidase inhibitor (acarbose) or a biguanide (metformin). The trial results were presented at the 2003 Diabetes UK meeting.
Ethics approval
Not provided at time of registration
Study design
Prospective, randomised, double-blind, placebo-controlled study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Not Specified
Patient information sheet
Condition
Impaired glucose tolerance
Intervention
Subjects valid for inclusion were randomly assigned to acarbose 50 mg tds, metformin 500 mg tds, a combination of the two, or matching placebo.
Intervention type
Drug
Phase
Not Specified
Drug names
acarbose, metformin
Primary outcome measure
Not provided at time of registration
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/01/1997
Overall trial end date
31/12/2003
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Subjects aged 30 to 70 years inclusive, with fasting hyperglycaemia; defined as a fasting plasma glucose (FPG) level ≥5.5 mmol/l and <7.8 mmol/l on two occasions at least 1 week apart
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
631
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
01/01/1997
Recruitment end date
31/12/2003
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Diabetes Trials Unit
Oxford
OX3 7LJ
United Kingdom
Funders
Funder type
Industry
Funder name
Educational grants were provided by Bayer plc and Merck-Lipha (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
1. 2000 results in: Possible prevention of type 2 diabetes with acarbose or metformin
R R Holman, et al. Diabetes. (2000); 49: Supplement (1): 450-P
http://www.dtu.ox.ac.uk/Abstracts/DTU_MtgAbs092_Abstract.pdf
2. 2003 results: Six-year results from the Early Diabetes Intervention Trial R. R. Holman, et al. Diabetic Medicine (2003); 20: Supplement (2): 15
http://www.dtu.ox.ac.uk/edit/edit2003.pdf
3. 2009 Hyper Glycaemia results in http://www.ncbi.nlm.nih.gov/pubmed/19002431
Publication citations
-
Hyper Glycaemia results
Gloyn AL, van de Bunt M, Stratton IM, Lonie L, Tucker L, Ellard S, Holman RR, Prevalence of GCK mutations in individuals screened for fasting hyperglycaemia., Diabetologia, 2009, 52, 1, 172-174, doi: 10.1007/s00125-008-1188-4.