Effect of Anti-diabetic Drugs on Glycemic Variability (EFFORT)
Diabetes Mellitus, Type 2
About this trial
This is an interventional treatment trial for Diabetes Mellitus, Type 2 focused on measuring Diabetes Mellitus, Type 2, Glycemic Variability, Dapagliflozin, Gliclazide MR, Continuous Glucose Monitoring, Mean Amplitude of Glycemic Excursions, MAGE
Eligibility Criteria
Inclusion Criteria:
A. Informed consent form obtained before any study-related activity. Study-related activities are any procedure that would not be performed during the normal treatment of the patient.
B. All study subjects must be patients diagnosed with type 2 diabetes based on current guidelines of Brazilian Society of Diabetes and/or American Diabetes Association (ADA) and they should have all the following criteria:
- Age ≥40 years old.
- HbA1c ≥7% at randomization.
- Drug naïve or metformin treated with a stable dose for at least 3 months.
Exclusion Criteria:
- Acute vascular event (cardiac, cerebral or peripheral) for at least 2 months of randomization.
- Patient on chronic dialysis and/or renal transplantation and/or serum creatinine >1.5 mg/dL and/or estimated glomerular filtration rate (eGFR) < 45ml/min (MDRD) and/or Creatinine Clearance <60ml/min.
- Patients with HIV, severe autoimmune disease or chronic treatment with oral steroids (>30 consecutive days).
- Current or previous treatment with any SGLT-2 inhibitor within 2 months prior to randomization.
- Current or previous treatment with any type of insulin within 2 months prior to randomization.
- Current or previous treatment with any sulphonylurea and meglitinide within 2 months prior to randomization.
- Current or previous treatment with any DPP-4 inhibitor or glucagon-like peptide-1 (GLP-1) receptor agonist within 2 months prior to randomization.
- Current or previous treatment with acarbose within 2 months prior to randomization.
- Sustained arterial hypertension ≥160/100mm Hg.
- Body mass index (BMI) >50 kg/m².
- HbA1c ≥10.5% at randomization.
- Transaminases (aspartate aminotransferase and/or alanine aminotransferase) >2.5 x upper limit of normal.
- Total bilirubin >2.5 x upper limit of normal
- Chronic liver disease or alcoholic liver disease.
- LDL-cholesterol >250 mg/dL (>6.48 mmol/L).
- Triglycerides >1000 mg/dL (>11.3 mmol/L).
- HDL-cholesterol <25 mg/dL (<0.64 mmol/L).
- Positive haematuria observed in urine sample obtained in the run-in visit.
- Prescription of any investigational medication within 3 months before the screening visit.
- Prescription of any investigational medication within the period between 3 months and one year before the screening visit (visit 1), unless there is a direct benefit to the study subject, at the discretion of the investigator.
- Pregnant or breastfeeding patients.
- Previous participation on this study.
- Individuals at risk for poor adherence to the protocol or medication.
- Any condition that makes the patient unable to complete the study within 3 months.
Sites / Locations
- Centro de Diabetes Curitiba
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Dapagliflozin
Gliclazide MR
The active treatment will include a 10 mg dose of dapagliflozin orally once a day.
As comparator, gliclazide MR will be administered at a dose of 120 mg orally once a day.