Early Diabetes Intervention Trial
ISRCTN | ISRCTN96631607 |
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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
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 |
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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 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(s) | Not provided at time of registration |
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 |
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 |
Overall study end date | 31/12/2003 |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Sex | Both |
Target number of participants | 631 |
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 exclusion criteria | Not provided at time of registration |
Recruitment start date | 01/01/1997 |
Recruitment end date | 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 | |
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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 |