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. 2020 Jun 5;2020(6):CD012906. doi: 10.1002/14651858.CD012906.pub2

JPRN‐UMIN000006504.

Methods Type of trial: efficacy trial
Allocation: randomised
Intervention model: parallel assignment
Masking: open‐label
Primary purpose: treatment
Participants Condition: T2DM
Enrollment: estimated 440 participants
Inclusion criteria: T2DM, HbA1c over 6.5%, age between 30 to 75 years old, hypertension (blood pressure less than 140/90 mmHg and stable for at least 1 month. The participants include patients who receive antihypertensive medication. LVEF over 50%), did not receive medication with metformin and pioglitazone for 3 months before enrolment, did not receive insulin therapy for 1 year before enrolment, no renal dysfunction (serum creatinine less than 1.3 mg/dL (male), less than 1.2 mg/dL (female)), informed consent of taking part in clinical research
Exclusion criteria: insulin treatment or secondary diabetes patients, serious hepatic dysfunction/hepatic cirrhosis, unstable angina, AMI, severe CAD patients (Left Main Trunk or triple‐vessel disease), chronic atrial fibrillation or pacemaker patients, prior lactic acidosis, severe dysfunction in cardiovascular system, heart failure, myocardial infarction, pulmonary embolism, likely to develop hypoxaemia, heavy drinker, gastrointestinal disorder such as diarrhoea and vomiting that worried dehydration, severe ketosis, diabetic coma or precoma, severe infection, perioperative, severe injury, malnutrition, starvation, debilitation, pituitary insufficiency or adrenal insufficiency patients, allergic response towards the medication, pregnant or lactating, intent of becoming pregnant, judged inappropriate for the clinical trial
Interventions Intervention(s): metformin (500 1500 mg/day to 1500 mg/day)
Comparator(s): other oral glucose‐lowering drug and pioglitazone
Outcomes Primary outcome(s): left ventricular mass and diastolic function by echocardiography, blood biomarker of heart failure
Secondary outcome(s): left ventricular mass by cardiac MRI, electrocardiogram (assessment of autonomic function by R‐R variation), exploratory analysis, subgroup analyses
Other outcome(s):
Study details Trial identifier:JPRN-UMIN000006504
Publication details Language of protocol: Japanese / English
Funding: ‐
Publication status: unpublished
Stated aim of study Quote: "To assess beneficial effects on left ventricular hypertrophy and diastolic function by metformin in hypertensive patients with type 2 diabetes mellitus using left ventricular mass index of echocardiography and blood biomarkers of heart failure"
Notes Only the protocol is available. Marked as a study awaiting classification due to a lack of data to assess inclusion. Trial authors have been contacted