| Source of record | UK Trials |
| ISRCTN | ISRCTN96631607 |
| Date ISRCTN assigned | 19/06/2002 |
| Local reference number(s) | Study Numbers:Bay g 5421/0740 and Bay g 5421/200031 |
| Public title | Early Diabetes Intervention Trial |
| Scientific title |
|
| Acronym | EDIT Study |
| Disease/condition/study domain | Impaired glucose tolerance |
| 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. |
| Design/methodology | Prospective, randomised, double-blind, placebo-controlled study |
| Research ethics review | Not provided at time of registration |
| Countries of trial | United Kingdom |
| Participants - 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 |
| Participants - exclusion criteria | Not provided at time of registration |
| Patient information material |
|
| Anticipated start date | 01/01/1997 |
| Anticipated end date | 31/12/2003 |
| Status of trial | Completed |
| Target number of participants | 631 |
| Interventions | Subjects valid for inclusion were randomly assigned to acarbose 50 mg tds, metformin 500 mg tds, a combination of the two, or matching placebo |
| Primary outcome measure(s) | Not available at time of registration |
| Secondary outcome measure(s) | Not available at time of registration |
| Trial website | http://www.dtu.ox.ac.uk/index.html?maindoc=/4-T/ |
| Publications | 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 |
| Sources of funding | Educational grants were provided by Bayer plc and Merck-Lipha |
| Sponsor name | Bayer plc and Merck-Lipha (UK) |
| Sponsor details | -
-
United Kingdom
- |
| Contact name | Professor Rury R Holman |
| Contact details | Diabetes Trials Unit
Block 11-2
Radcliffe Infirmary
Woodstock Road
Oxford
United Kingdom
OX2 6HE |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN96631607 |
| Date last extracted from ISRCTN register | 17/04/2008 |
