Early Diabetes Intervention Trial
| 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 of protocol
Not provided at time of registration
Contact information
Dr Rury R Holman
Scientific
Scientific
Diabetes Trials Unit
OCDEM, Churchill Hospital
Old Road, Headington
Oxford
OX3 7LJ
United Kingdom
Study information
| Study design | Prospective, randomised, double-blind, placebo-controlled study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Not Specified |
| 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | acarbose, metformin |
| Primary outcome measure | Not provided at time of registration |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 01/01/1997 |
| Completion date | 31/12/2003 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 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 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Diabetes Trials Unit
Oxford
OX3 7LJ
United Kingdom
OX3 7LJ
United Kingdom
Sponsor information
Bayer plc and Merck-Lipha (UK)
Industry
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 share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not 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 |
