Metabolic, Cardiovascular, Cancer, Type 2 diabetes. Nutritional, Metabolic, Endocrine Non-insulin-dependent diabetes mellitus
Conditions
Interventions
Slow-release metformin (Glucophage®) 1500mg (3 x 500mg tablet/day) or Placebo (3 x 500mg tablet/day).
Participants will receive study medication until a median of five years of follow-up has been re
Sponsors
Cambridge University Hospitals NHS Foundation Trust and the University of Cambridge
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Participants must meet all of the following criteria to participate in the study: 1. Men and women with non-diabetic hyperglycaemia (HbA1c equal to or greater than 5.5% but 45ml/min as determined by the MDRD-4 method and measured within 6 months prior to enrolment 4. Participant understands the study procedures, alternative treatments available, and the risks involved with the study, and voluntarily agrees to participate by providing written informed consent 5. Participant agrees to allow study staff to contact his or her General Practitioner and/or consultant to notify them of study participation and to obtain all medical records necessary for complete data ascertainment during the follow-up period.
Exclusion criteria
Exclusion criteria: The participant may not enter the study if ANY of the following apply: 1. Prior history of physician-diagnosed diabetes. Note: Participants with a history of gestational diabetes which resolved after pregnancy are permitted to enrol. 2. Prior history of CVD, defined as: 2.1. Myocardial infarction, surgical or percutaneous coronary revascularisation procedure 2.2. Stroke (haemorrhagic or ischemic) Note: Participants with prior transient ischemic attack or unstable angina are NOT excluded and may be enrolled 3. Participant has a planned or anticipated revascularisation procedure within 6 months following enrolment Note: Participants with previous peripheral revascularisation procedure are NOT excluded and may be enrolled 4. Participant is pregnant 5. History of cirrhosis of the liver or other significant hepatic impairment, as assessed by medical history 6. End-stage renal disease 7. In the investigators opinion, participant has a medical history that indicates a life expectancy of <2 years or might limit the individual's ability to take the trial treatments for the duration of the study 8. Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participant at risk because of participation in the study, or may influence the result of the study, or the participant's ability to participate in the study. 9. Participant is enroled in or has participated within 12 weeks prior to enrolment in another experimental protocol involving the use of an investigational drug or device or an intervention that would interfere with the conduct of the trial.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| 1. Time to event for each of the components of the primary composite endpoint (e.g. cardiovascular mortality, nonfatal myocardial infarction, nonfatal stroke) 2. All-cause mortality (supplied by Office of National Statistics) 3. Time to first non-melanoma cancer (supplied by the National Cancer Registry) 4. Death due to a non-melanoma cancer cause according to primary/underlying cause of death on death certificate (supplied by the Office of National Statistics) 5. Incident diabetes (physician diagnosed) 6. Patient satisfaction with treatment (adapted DTSQ) 7. Functional status (SF-8) 8. Health utility (EuroQol EQ-5D) | — |
Primary
| Measure | Time frame |
|---|---|
| Time to first confirmed event in the primary composite macrovascular endpoint (cardiovascular mortality, nonfatal myocardial infarction, and nonfatal stroke) | — |
Countries
England, United Kingdom
Outcome results
None listed