Early Diabetes Intervention Trial

ISRCTN	ISRCTN96631607
DOI	https://doi.org/10.1186/ISRCTN96631607
Protocol serial number	Study Numbers:Bay g 5421/0740 and Bay g 5421/200031
Sponsor	Bayer plc and Merck-Lipha (UK)
Funder	Educational grants were provided by Bayer plc and Merck-Lipha (UK)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr Rury R Holman
Scientific

Diabetes Trials Unit
OCDEM, Churchill Hospital
Old Road, Headington
Oxford
OX3 7LJ
United Kingdom

Primary study design	Interventional
Study design	Prospective, randomised, double-blind, placebo-controlled study
Secondary study design	Randomised controlled trial
Scientific title
Study acronym	EDIT Study
Study objectives	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(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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 / device / biological / vaccine name(s)	acarbose, metformin
Primary outcome measure(s)	Not provided at time of registration
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	31/12/2003

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	631
Key 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
Key exclusion criteria	Not provided at time of registration
Date of first enrolment	01/01/1997
Date of final enrolment	31/12/2003

Diabetes Trials Unit

Oxford
OX3 7LJ
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/06/2003		Yes	No
Results article	Hyper Glycaemia results	01/01/2009		Yes	No
Abstract results				No	No
Abstract results				No	No
Abstract results	abstract 450-P	01/06/2000		No	No
Study website	Study website	11/11/2025	11/11/2025	No	Yes