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ISRCTN
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ISRCTN96631607
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ClinicalTrials.gov identifier
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Public title
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Early Diabetes Intervention Trial
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Scientific title
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Acronym
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EDIT Study
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Serial number at source
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Study Numbers:Bay g 5421/0740 and Bay g 5421/200031
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Study hypothesis
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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.
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Ethics approval
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Not provided at time of registration
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Study design
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Prospective, randomised, double-blind, placebo-controlled study
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Impaired glucose tolerance
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Participants - inclusion criteria
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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
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Participants - exclusion criteria
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Not provided at time of registration
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Anticipated start date
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01/01/1997
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Anticipated end date
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31/12/2003
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Status of trial
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Completed
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Patient information material
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Target number of participants
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631
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Interventions
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Subjects valid for inclusion were randomly assigned to acarbose 50 mg tds, metformin 500 mg tds, a combination of the two, or matching placebo.
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Primary outcome measure(s)
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Not provided at time of registration
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Secondary outcome measure(s)
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Not provided at time of registration
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Sources of funding
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Educational grants were provided by Bayer plc and Merck-Lipha (UK)
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Trial website
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http://www.dtu.ox.ac.uk
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Publications
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1. Possible prevention of type 2 diabetes with acarbose or metformin
Rury R Holman, Bernard V North, Felicity K Tunbridge Diabetes (2000); 49: Supplement (1): 450-P
2. Six-year results from the Early Diabetes Intervention Trial R. R. Holman, L. Blackwell, I. M. Stratton, S. E. Manley, L. Tucker and
V. Frighi Diabetic Medicine (2003); 20: Supplement (2): 15
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Contact name
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Dr
Rury R
Holman
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Address
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Diabetes Trials Unit
OCDEM, Churchill Hospital
Old Road, Headington
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City/town
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Oxford
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Zip/Postcode
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OX3 7LJ
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Country
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United Kingdom
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Sponsor
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Bayer plc and Merck-Lipha (UK)
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Address
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-
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City/town
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-
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Zip/Postcode
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-
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Country
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United Kingdom
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Date applied
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19/06/2002
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Last edited
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14/07/2008
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Date ISRCTN assigned
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19/06/2002
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