Effect of Anti-diabetic Drugs on Glycemic Variability
Status:
Completed
Trial end date:
2019-01-01
Target enrollment:
Participant gender:
Summary
Objectives
Primary objective:
To access the change from baseline to week 12 in MAGE index of glycemic variability measured
by CGMS for dapagliflozin versus. gliclazide MR.
Secondary objectives:
1. Change from baseline to week 12 in glycated hemoglobin A1c (HbA1c), fasting plasma
glucose, postprandial glucose and achievement of HbA1c ≤6.5% and <7% at the end of the
study) for dapagliflozin versus gliclazide MR.
2. Change from baseline to week 12 in glycemic variability defined by the interquartile
range (IQR - interval between 25th and 75th percentiles) measured by CGMS for
dapagliflozin versus gliclazide MR.
3. Change from baseline to week 12 in glycemic variability measured by the Standard
Deviation of the mean glycemia (SD) measured by CGMS for dapagliflozin versus gliclazide
MR.
4. Change from baseline to week 12 in glycemic variability measured by the Coefficient of
Variation (CV) measured by CGMS for dapagliflozin versus gliclazide MR.
5. Change from baseline to week 12 in the time spent on hypoglycemic range (glycemia
<70mg/dL) measured by CGMS for dapagliflozin versus gliclazide MR.
Study design This is a single-center, prospective, randomized, open-label, comparative, phase
IV study to compare the effects of gliclazide MR and dapagliflozin on Glycemic Variability in
patients with Type 2 Diabetes Mellitus (T2DM). All patients should be treatment naïve or
receive standard of care therapy for T2DM as well as for co-morbidities based on accepted
guidelines and local best practices.
Target patient population Approximately 120 patients with T2DM will be randomized from study
site. Patients who were treated with metformin only and had inadequate glycemic control at
the time of enrollment as well as treatment naïve or non-medically treated (e.g., diet)
patients, will be enrolled and receive either dapagliflozin 10mg qd or comparator gliclazide
MR 120mg qd in addition to standard of care treatment for T2DM and co-morbidities.
Investigational product, dosage and mode of administration Dapagliflozin 10mg tablets
administered orally once daily for 12 weeks.
Comparator, dosage and mode of administration Gliclazide MR 60mg tablets administered orally,
2 tablets once daily for 12 weeks.
Duration of treatment The treatment with study medication or comparator will have a total
duration of 15 weeks.