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 (HbA_1c) 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 HbA_1c 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 HbA_1c, 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.

Key words::

• Diabetes mellitus, type 2
• Dipeptidyl-peptidase 4 inhibitors
• Fasting hypoglycaemia
• Muslims
• Vildagliptin

Transparency

Declaration of funding

This study was funded by Novartis Pharmaceuticals UK Ltd, who helped in the study design, and in the collection, analysis and interpretation of data. The co-authors from Novartis were also involved in writing the manuscript and in the decision to submit for publication.

Declaration of financial/other relationships

M.H. has no conflict of interests with the study sponsors, but has received honoraria for lectures and Advisory Boards with Eli-Lilly, and honoraria for lectures with Takeda, Novo-Nordisk, Merck Sharpe & Dohme Limited, Boehringer Ingelheim and Sanofi-Aventis. W.H. has received research grants and honoraria from, and acted as a consultant for Novartis Pharmaceuticals Corporation, Novo-Nordisk and Bristol-Myers Squibb. W.M. has received educational grant sponsorship to attend scientific meetings and honoraria for lectures from Novartis Pharmaceuticals Corporation, Novo Nordisk A/S, Eli Lily and Company, AstraZeneca LP and Merck Sharpe & Dohme Limited. A.K. has no conflicts of interest to declare. P.G., C.A. and N.L. are employees of Novartis Pharmaceuticals UK Ltd. A.B. has received honoraria for lectures and advisory work from Novartis Pharmaceuticals Corporation, Merck Sharpe & Dohme Limited, Bristol-Myers Squibb Company, AstraZeneca LP, Boehringer Ingelheim, Takeda, Eli Lilly and Company, Novo Nordisk A/S, and Sanofi-Aventis.

Acknowledgements

The authors gratefully acknowledge the work and contributions of the clinical project manager Jocelyn Cannon, of Sue Hunt for carrying out the data management for the study, and of Sailesh Sankar for assistance with recruitment. Writing and editorial support to the authors was provided by Dr Abi Woollard and Dr Jeremy Bright from Oxford PharmaGenesis^TM Ltd and was funded by Novartis Pharmaceuticals UK Ltd. The authors had full access to the data at all times and take full responsibility for the analysis of the data and content of the manuscript.

CMRO peer reviewers may have received honoraria for their review work. The peer reviewers on this manuscript have disclosed that they have no relevant financial relationships.