This study will examine whether the incidence of hypoglycemia in patients fasting for Ramadan is lower when treated with sitagliptin as compared to sulfonylurea treatment.
This study and NCT01340768 (MK-0431-262) have the same design but are conducted under separate protocols, in different countries, according to local guidelines.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
1,147
Sitagliptin 100 mg tablet administered orally once daily over the Ramadan period.
Sulfonylurea (glibenclamide, glimepiride, or gliclazide) administered orally daily over the Ramadan period as per physician's prescription
Participants could continue pre-study metformin as concomitant therapy during the study.
Proportion of Participants With at Least One Symptomatic Hypoglycemic Event
Symptomatic hypoglycemic event was determined based on the participant's self-reported symptoms including faintness, headache, confusion, anxiety, sweating, tremor, palpitation, nausea, pallor, dizziness, hunger, and sudden behavioral change.
Time frame: 30 days: first day of Ramadan (August 11) to last day of Ramadan (September 10)
Proportion of Participants With at Least One Symptomatic or Asymptomatic Hypoglycemic Event
Hypoglycemic event was based on the participant's self-report and/or finger-stick blood glucose level. Symptomatic hypoglycemic symptoms included faintness, headache, confusion, anxiety, sweating, tremor, palpitation, nausea, pallor, dizziness, hunger, and sudden behavioral change.
Time frame: 30 days: first day of Ramadan (August 11) to last day of Ramadan (September 10)
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