ISRCTN ISRCTN96631607
DOI https://doi.org/10.1186/ISRCTN96631607
Secondary identifying numbers Study Numbers:Bay g 5421/0740 and Bay g 5421/200031
Submission date
19/06/2002
Registration date
19/06/2002
Last edited
06/01/2011
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English Summary

Not provided at time of registration

Study website

Contact information

Dr Rury R Holman
Scientific

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

Study information

Study designProspective, randomised, double-blind, placebo-controlled study
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeNot Specified
Scientific title
Study acronymEDIT Study
Study hypothesisThe 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
ConditionImpaired glucose tolerance
InterventionSubjects valid for inclusion were randomly assigned to acarbose 50 mg tds, metformin 500 mg tds, a combination of the two, or matching placebo.
Intervention typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)acarbose, metformin
Primary outcome measureNot provided at time of registration
Secondary outcome measuresNot provided at time of registration
Overall study start date01/01/1997
Overall study end date31/12/2003

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants631
Participant inclusion criteriaSubjects 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 exclusion criteriaNot provided at time of registration
Recruitment start date01/01/1997
Recruitment end date31/12/2003

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Diabetes Trials Unit
Oxford
OX3 7LJ
United Kingdom

Sponsor information

Bayer plc and Merck-Lipha (UK)
Industry

-
-
-
United Kingdom

Funders

Funder type

Industry

Educational grants were provided by Bayer plc and Merck-Lipha (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

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