To evaluate vildagliptin as compared to gliclazide, given in combination with metformin in Muslim patients with type 2 diabetes fasting during Ramadan.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
557
Patients will be instructed to take Vildagliptin tablets at a fixed dose of 50 mg twice daily (double blind therapy)
Patients will be instructed to take Gliclazide capsules at an equivalent dose to previous sulfonylurea in multiples of 80mg only (double blind therapy)
Patients in both arms will take Metformin at a dose between 1500mg-2500mg per day, in an open label fashion
Percentage of patients experiencing at least one Hypoglycaemic Event (HE) during the Ramadan fasting period to test superiority
Time frame: 1 month
Percentage of patients without an increase in HbA1c (≤ 0.3%) and with no Hypoglycaemic Events (HEs)
Time frame: visit 3 (anytime from week -4 to day -1 before start of Ramadan) to visit 4 (within 4 weeks post-Ramadan fasting period) (minimum 4.5 weeks to maximum 12 weeks) for HbA1c; and during 1 month (Ramadan) for HEs
Change from baseline to endpoint in glycosylated hemoglobin (HbA1c)
Endpoint is defined as the visit 4 (post-Ramadan) measurement or the last observation obtained during or after Ramadan, prior to or at initiation of rescue medication
Time frame: baseline to visit 4 (within 4 weeks post-Ramadan fasting period) (minimum 12.5 weeks to maximum 30 weeks)
Change from visit 3 (pre-Ramadan visit) to endpoint in glycosylated hemoglobin (HbA1c)
Endpoint is defined as the visit 4 (post-Ramadan) measurement or the last observation obtained during or after Ramadan, prior to or at initiation of rescue medication
Time frame: visit 3 (anytime from week-4 to day-1 before start of Ramadan) to visit 4 (within 4 weeks post-Ramadan fasting period) (minimum 4.5 weeks to maximum 12 weeks)
Proportion of patients experiencing severe hypoglycemic events during the Ramadan fasting period
Time frame: 1 month
mean amplitude of glycemic excursions (MAGE) to measure glucose fluctuations during the day
assessed in a selected subgroup of patients
Time frame: 72 hours
Treatment adherence during the Ramadan fasting period
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Patients will be instructed to take the Gliclazide matching placebo capsules at an equivalent dose to previous sulfonylurea in multiples of 80mg only (double blind therapy)
Patients will be instructed to take Vildagliptin matching placebo tablets at a fixed dose of 50 mg twice daily (double blind therapy).
Novartis Investigative Site
Frederiksberg, Denmark
Novartis Investigative Site
Alexandria, Egypt
Novartis Investigative Site
Cairo, Egypt
Novartis Investigative Site
Augsburg, Germany
Novartis Investigative Site
Augsburg, Germany
Novartis Investigative Site
Bad Oeynhausen, Germany
Novartis Investigative Site
Berlin, Germany
Novartis Investigative Site
Dortmund, Germany
Novartis Investigative Site
Einbeck, Germany
Novartis Investigative Site
Löhne, Germany
...and 58 more locations
Time frame: 1 month
Change from visit 3 (pre-Ramadan visit) to endpoint in body weight
Endpoint is defined as the visit 4 (post-Ramadan) measurement or the last observation obtained during or after Ramadan, prior to or at initiation of rescue medication
Time frame: From visit 3 (anytime from week-4 to day-1 before start of Ramadan) to visit 4 (within 4 weeks post-Ramadan fasting period) (minimum 4.5 weeks to maximum 12 weeks)
Number of unscheduled visit to health care professional
Time frame: From visit 3 (anytime from week-4 to day-1 before start of Ramadan) to visit 4 (within 4 weeks post-Ramadan fasting period) (minimum 4.5 weeks to maximum 12 weeks)
Number of days fasted during the Ramadan fasting period
Time frame: 1 month
Number of patients with treatment emergent adverse events (AEs), serious AEs, discontinuation due to AEs, deaths or laboratory abnormalities as assessment of safety and tolerability
Time frame: Baseline to visit 4 (within 4 weeks post-Ramadan fasting period) (minimum 12.5 weeks to maximum 30 weeks)