Comparison of the dipeptidyl peptidase-4 inhibitor vildagliptin and the sulphonylurea gliclazide in combination with metformin, in Muslim patients with type 2 diabetes mellitus fasting during Ramadan: results of the VECTOR study

Abstract

Objective:To compare the incidence of hypoglycaemic events (HEs) in a real-world setting in Muslim patients with type 2 diabetes mellitus fasting during Ramadan.Research design and methods:We performed a ≤16-week prospective, non-interventional, two-cohort study. Data were collected 1–6 weeks before and ≤6 weeks after fasting. Patients were enrolled who had been receiving vildagliptin (50 mg twice daily) or sulphonylurea (SU) as add-on to metformin at least 4 weeks prior to fasting.Main outcome measures:The primary efficacy endpoint was incidence of HEs during the Ramadan fast. Changes in glycated haemoglobin (HbA1c) and body weight, as well as adherence to treatment, were also assessed.Results:Seventy-two patients were enrolled (vildagliptin, n = 30; SU, n = 41; no treatment, n = 1), of whom 23 (76.7%) and 36 (87.8%), respectively, completed the study. With vildagliptin, there were no HEs or severe HEs, compared with 34 HEs (15 patients, 41.7%) and one severe (grade 2) HE with SU. The mean between-group difference in the proportion who experienced at least one HE was −41.7% (95%CI −57.8%, −25.6%), p = 0.0002. Vildagliptin lowered mean HbA1c from 7.6% (SD 0.9%) at baseline to 7.2% (SD 0.7%) post-Ramadan, whereas SU had no effect (7.2% [SD 0.6%] vs 7.3% [SD 0.7%]; mean between-group difference −0.5% [95% CI −0.9%, −0.1%], p = 0.0262). The mean number of missed doses was markedly lower with vildagliptin (0.2 [SD 0.8] vs 7.6 [SD 14.9]; mean between-group difference −7.4 [95% CI −13.7, −1.20] doses; p = 0.0204). Body weight remained unchanged in both groups.Conclusion:Vildagliptin caused no hypoglycaemia, was well adhered to and improved HbA1c, making it a suitable treatment option for managing fasting. Study limitations are the sample size and the lack of diet and exercise data. When extrapolated to the global Muslim population with a similar clinical background, these findings could have considerable public health and clinical implications.