Glucose Lowering in Non-diabetic hyperglycaemia Trial
GLINT (Glucose Lowering in Non-diabetic Hyperglycaemia Trial) is a pragmatic study which aims to compare the impact of adding metformin versus placebo to the usual care of patients who have high modelled cardiovascular risk (≥20% over 10 years) and blood glucose levels that are raised but below the diagnostic threshold for diabetes on a composite endpoint of death due to cardiovascular disease, nonfatal heart attack and nonfatal stroke. The study is a double-blinded, placebo controlled primary prevention trial which will randomise participants with non-diabetic hyperglycaemia (HbA1c 5.5-6.4%, 37-47mmol/mol) to metformin (Glucophage XR®) versus a matched placebo. Currently, funding is available for the feasibility phase of 500 participants which we estimate will run for eighteen months. This may be extended into the full study which will then run for a further 5 years to recruit an additional 12,500 participants.
Participants will be required to take 500mg metformin prolonged release (Glucophage XR)/placebo with a starting dose of 1 tablet/day (500mg Metformin/placebo) for 4 weeks, titrating up to 2 tablets/day (1000mg Metformin/placebo) for weeks 5 to 8 and then up to the maximum dose of 3 tablets/day (1500mg Metformin/placebo) for the remainder of the study. Study participants who develop diabetes after being randomised to GLINT study medication (metformin prolonged release or placebo) may be prescribed additional metformin at your discretion. If study participants begin open-label metformin, the GLINT study medication assignment will not be unblinded except in exceptional situations or clinical emergencies. Therefore, you should assume that your patient is receiving active metformin in the study medication and use the table below to determine the maximum amount of additional metformin to prescribe.
|GLINT study edication daily dose||Maximum additional daily amount of
standard release metformin permitted
|Maximum additional daily amount of
prolonged release metformin permitted
|500 mg (1 tablet)||2000 mg||1500 mg|
|1000 mg (2 tablets)||1500 mg||1000 mg|
|1500 mg (3 tablets)||1000 mg||500 mg|
If your patient’s glycaemic control is sub-optimal despite prescription of the maximum additional dose of metformin, you may prescribe additional antidiabetic medications and the patient may continue in GLINT.
Participant information leaflets for each region can be found below. They are provided to all people who consider joining the study and contain a copy of the Informed consent form.
We will send a postal questionnaire to you at 4 months post enrolment and annually thereafter. We wish to gather information on events of cardiovascular disease (CVD), cancer and diabetes, and current prescribed medication. We have a streamlined data collection process and do not anticipate this will take up too much of your time. Your efforts will assist the study in obtaining important outcomes information to determine whether metformin reduces the number of cardiovascular or cancer events.