Abstract
AIM: To assess in real life the rate of hypoglycemia during Ramadan in patients with type 2 diabetes (T2DM) in France, according to their ongoing dual therapy of metformin-vildagliptin or metformin-sulfonylurea/glinide (IS). METHODS: Prospective, non-interventional study with 2 visits (within 8 weeks before and 6 weeks after the end of Ramadan 2012). Study diaries were not used to collect events or record values of glucose monitoring. One hundred and ninety-eight patients on stable oral dual therapy for ≥2 months and with glycosylated hemoglobin (HbA1c) ≤8.0% were recruited by 62 centers: 83 in the IS cohort and 115 in the vildagliptin cohort. RESULTS: Approximately 90% of patients were from Maghreb. The two cohorts were well balanced: 60% men, mean age 59 years, BMI 28 kg/m(2), metformin dose ~2,000 mg/day, and HbA1c 7.2%. Distinct therapeutic management was planned in view of Ramadan with drug-adaptation intended in 61.4% of IS and 18.3% of vildagliptin patients. Hypoglycemia was reported in 37% of IS and 34% of vildagliptin patients; episodes declared as confirmed in 30.8% and 23.5%, respectively, and episodes documented as adverse event (AE) in 17.9% (22 episodes) and 7.5% (13 episodes), respectively (P = 0.025). Severe episodes were reported in 3.9% of IS and 1.7% of vildagliptin patients. 10.4% of IS and 2.6% of vildagliptin patients reported severe episodes and/or unscheduled medical visits due to hypoglycemia (P = 0.029). Glycemic control remained stable in both cohorts. Compliance with fasting was high, as well as adherence to drug with ≥5 missed-dose for 15.4% of IS and 8.5% of vildagliptin patients. CONCLUSION: Although the overall frequency of malaise suggestive of hypoglycemia was high, which would be expected with prolonged fasting in a well-controlled T2DM population during hot summer days, the incidence of more severe and better-documented episodes (AE, severe event, event leading to unscheduled medical visit) were much lower, with consistently less events with vildagliptin therapy.