Condition category
Nutritional, Metabolic, Endocrine
Date applied
19/06/2002
Date assigned
19/06/2002
Last edited
06/01/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.dtu.ox.ac.uk/edit/protocol.php

Contact information

Type

Scientific

Primary contact

Dr Rury R Holman

ORCID ID

Contact details

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

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 measures

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

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

Sponsor information

Organisation

Bayer plc and Merck-Lipha (UK)

Sponsor details

-
-
-
United Kingdom

Sponsor type

Industry

Website

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

Results - basic reporting

Publication summary

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

  1. 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.

Additional files

Editorial Notes