Glucose lowering for prevention of heart attack and stroke in participants at risk of developing diabetes
- Conditions
- on-diabetic hyperglycaemia (elevated blood glucose levels below the diagnostic threshold for diabetes) and high risk of cardiovascular disease (>20% risk over 10 years)Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]
- Registration Number
- EUCTR2012-005570-56-GB
- Lead Sponsor
- Cambridge University Hospitals NHS Foundation Trust and the University of Cambridge
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 249
Participants must meet all of the following criteria to participate in the study:
•Age = 40 years
•HbA1c =36.6mmol/mol but <47.5mmol/mol, measured within 12 months prior to enrolment
•Estimated 10-year CVD risk =20% as assessed by the Framingham or QRISK2 scores, measured within 12 months prior to involvement (laboratory values used for the risk calculators should be collected no more than one year prior enrolment)
•Estimated glomerular filtration rate (eGFR) =45ml/min as determined by the MDRD-4 method and measured within 6 months prior to enrollment
•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
•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 (including recording of NHS number and access to Health Episode Statistics (HES))
• Participant agrees to be tagged for mortality with the Office for National Statistics and to be tagged for:
• time to first non-melanoma cancer diagnosis (supplied by the National Cancer Registry
• 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)
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 6449
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 6449
The participant may not enter the study if ANY of the following apply:
•Unable to provide written consent
•Prior history of physician-diagnosed Type 2 diabetes.
NOTE: Participants with a history of gestational diabetes which resolved after pregnancy are permitted to enrol.
•Prior history of CVD, defined as:
omyocardial infarction, surgical or percutaneous coronary revascularization procedure
oStroke (hemorrhagic or ischemic)
NOTE: Participants with prior transient ischemic attack or unstable angina are NOT excluded and may be enrolled
•Participant has a planned or anticipated revascularization procedure within 6 months following enrolment
NOTE: Participants with previous peripheral revascularisation procedure are NOT excluded and may be enrolled
•Participant is pregnant
• Participant is breastfeeding
• Participant is currently taking metformin (for any reason) or they have taken metformin in the last 3 months
•History of cirrhosis of the liver or other significant hepatic impairment, as assessed by medical history
•End-stage renal disease (CKD stage 3b, eGFR <45ml/min)
•In the investigator’s 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
•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.
•Participant is enrolled 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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method