Glycemic effects of vildagliptin in patients with type 2 diabetes before, during and after the period of fasting in Ramadan

Abstract

Objective: To study the incidence of hypoglycemia, glycemic control and body weight changes in patients with type 2 diabetes treated with vildagliptin and metformin versus another group treated with sulphonylureas and metformin during and after the period of fasting in Ramadan. Patients and methods: This is a randomized open-label clinical trial that recruited 69 patients previously treated with a combination therapy of metformin and sulphonylurea. Patients in the control group were maintained on their usual metformin and sulphonylurea regimen with dose adjustment for the fasting period. Patients in the study group were given vildagliptin 50 mg twice daily (at Suhur and at Iftar). One group remained on the previous background therapy unchanged and the other group was switched from sulphonylurea to vildagliptin in combination with metformin. Four visits were scheduled, one before the beginning of Ramadan (baseline), a second visit at mid Ramadan, a third at the end of Ramadan and a final visit 1 month after the end of Ramadan. At every visit, patients were assessed for hypoglycemic events and patient education was given on lifestyle needs and hypoglycemia monitoring and management. Results: The calculated change in hemoglobin A1c from baseline to last visit was similar for both groups. The incidence of hypoglycemia during Ramadan was higher in the control group (26 episodes versus 19 episodes in the study group); this result was not statistically significant (p = 0.334). However, the number of patients who dropped out from the study because of discomfort due to treatment and fear of hypoglycemia was higher in the control group. Conclusion: For patients who insist on observing the fast, physicians can allow it only with close follow up and monitoring for hypoglycemic events, and vildagliptin may be a better agent than sulphonylurea.

Diabetes and Ramadan: Practical guidelines

“…Four RCTs have examined the effects of switching from SU therapy to either vildagliptin or sitagliptin prior to Ramadan compared with continuing on SUs [31,33,36,42]. The largest of these studies compared the incidence of self-reported hypoglycaemic events in 1066 patients with T2DM treated with sitagliptin or SUs during Ramadan.…”

Comparative studies of dipeptidyl peptidase 4 inhibitor vs sulphonylurea among Muslim Type 2 diabetes patients who fast in the month of Ramadan: A systematic review and meta-analysis

“…Primary outcome for all the nine studies is the number of hypoglycemic events. Six studies compared both the changes in HbA1C and weight pre and post Ramadan in both groups of patients [13,15,[17][18][19]21]. Three studies assessed the treatment compliance during Ramadan [15,17,18].…”

“…All of the included patients were type 2 diabetes mellitus 18 years or older. Seven studies used Vildagliptin as the DPP4 inhibitor of choice [13,15,[17][18][19][20][21] whereas the other two studies used Sitagliptin [14,16]. All of the studies had a control group using sulphonylurea (glipizide, glibenclamide, glimepiride, gliclazide slow release or gliclazide standard formulation) or the other insulin secretagogue -meglitinides.…”

“…Nine papers, with a total of 4276 patients, were included in this meta-analysis [13][14][15][16][17][18][19][20][21]. Sample size ranged between 52 and 1333.…”

Diversity in endocrinology practice: the case of Ramadan

“…antidiabetic choice for Ramadan with practically no hypoglycemia risk. 6 For patients with DM2 on insulin or patients with DM1, a basal-bolus regimen is advised, 2,5 taking, however, into account the paucity of relevant data. 5 A 20% dosing reduction in long-acting insulin analogues, given with Iftar, has been proposed to reduce the risk of hypoglycemia.…”