The effect of vildagliptin relative to sulfonylurea as dual therapy with metformin (or as monotherapy) in Muslim patients with type 2 diabetes fasting during Ramadan in the Middle East: the VIRTUE study

Abstract

Objective: To assess the effect of vildagliptin relative to sulfonylurea (SU) on hypoglycemic events, in Muslim patients from the Middle East with type 2 diabetes who fast during Ramadan. The primary endpoint was the proportion of patients with at least one hypoglycemic event (HE) during the fasting period. Secondary endpoints included change in weight, HbA1c levels, treatment adherence and overall safety.

Design and methods: This multicenter, prospective, observational cohort study enrolled Muslim adult T2DM patients from Middle Eastern countries who received treatment with vildagliptin or SU as add on to metformin or monotherapy. During a ∼16 week observation period, data was collected up to 6 weeks before and 6 weeks after Ramadan fasting.

Results: A total of 584 patients from the Middle East enrolled in the study; 308 patients received vildagliptin and 265 received SU. Significantly fewer vildagliptin patients reported at least one HE (3.7% vildagliptin vs. 25.5% SU; p < .001). No grade 2 HEs were reported in vildagliptin patients versus two in SU patients (p = .128). Mean change in HbA1c at the end of study showed −0.18% between treatment difference in favor of vildagliptin, p = .001. Mean body weight change at the end of study showed −0.68 kg between treatment difference in favor of vildagliptin, p < .001. Treatment exposure and adherence were high and similar in both cohorts. There were 4.3% adverse events reported in vildagliptin compared to 25.3% in the SU cohort, with hypoglycemia being the most experienced event in both cohorts.

Limitations: Being observational and not mandating HE confirmation with blood glucose measurement (though it was done in a large number of patients) were key limitations.

Conclusion: Anti-hyperglycemic treatment with vildagliptin led to significantly fewer hypoglycemia events compared to sulfonylurea treatment among Muslim diabetic patients who fast during Ramadan. Good glycemic control, weight control and safety results supported this outcome.

Keywords:

• Fasting
• hypoglycemic events
• Ramadan
• sulfonylurea
• type 2 diabetes
• vildagliptin
• VIRTUE

Transparency

Declaration of funding

This study was funded by Novartis Pharma services AG and its respective affiliates.

Author contributions

M.A. and A.A.K.H. have both contributed to the conduct of the study and reviewed and approved the manuscript for submission. M.I. was involved in data interpretation, drafting, critical review and approval of the manuscript for submission.

Declaration of financial/other relationships

M.A. has disclosed that she has received investigator fees related to conduct of the VIRTUE study; and has received consultancy fees for advisory/speaker engagements for Novartis and its affiliates. A.A.K.H. has disclosed that he has received investigator fees related to conduct of the VIRTUE study; and has received consultancy fees for advisory/speaker engagements for Novartis and its affiliates. M.I. has disclosed that he is a Novartis employee and shareholder.

Acknowledgments

The authors gratefully acknowledge the efforts of all investigators and sub-investigators from the countries of the Middle East. The authors would like to acknowledge Kreara Solutions Private Ltd for medical writing support and collation and incorporation of comments from authors.

Previous presentation

Results of this study were presented, in part, at the First Clinical Congress and Gulf Chapter of the American Association of Clinical Endocrinologists, 3–5 October 2013, Abu Dhabi, UAE. Hassoun A, Al-Arouj M, Ibrahim M. The effect of vildagliptin relative to sulfonylurea as dual therapy with metformin (or as monotherapy) in Muslim patients with type 2 diabetes fasting during Ramadan in the Middle East: the VIRTUE study. Ibnosina J Med BS 2013;5:363-402.