Effects of vildagliptin versus saxagliptin on daily acute glucose fluctuations in Chinese patients with T2DM inadequately controlled with a combination of metformin and sulfonylurea

Abstract

Objective The present study aimed to compare the effects of the dipeptidyl peptidase-4 (DPP-4) inhibitors vildagliptin and saxagliptin on 24 hour acute glucose fluctuations in Chinese patients with type 2 diabetes mellitus (T2DM) inadequately controlled with a combination of metformin and sulfonylurea.

Research design and methods This was a 24 week, prospective, randomized, open-label, active-controlled study. Patients (N = 73) with T2DM who had inadequate glycemic control (HbA1c 7.0%–10.0%) with a stable dosage of metformin plus gliclazide for more than 3 months were randomized to receive either vildagliptin 50 mg twice daily (BID, n = 37) or saxagliptin 5 mg once daily (QD, n = 36). Change in mean amplitude of glycemic excursions (MAGE) was assessed at the end of 24 weeks.

Results At baseline, the mean (±SD) age was 62.9 ± 6.55 years, disease duration was 7.0 ± 2.33 years, and HbA1c was 8.4 ± 0.68%. After 24 weeks of treatment, the MAGE decreased from 5.81 ± 1.16 mmol/L to 4.06 ± 0.86 mmol/L (p<0.001) in the vildagliptin group and from 5.66 ± 1.14 mmol/L to 4.79 ± 1.25 mmol/L (p = 0.003) in the saxagliptin group. The mean change in MAGE in the vildagliptin group was significantly greater than that in the saxagliptin group (1.74 ± 0.48 mmol/L vs. 0.87 ± 0.40 mmol/L, p<0.001). The mean change in HbA1c, from baseline to the study endpoint, in the vildagliptin and saxagliptin groups, was 1.22 ± 0.40% and 1.07 ± 0.36%, respectively, with no significant difference between the groups (p = 0.091). The overall safety and tolerability of vildagliptin and saxagliptin were similar. The limitations of the study were a small number of patients and open-label administration of the study drug.

Conclusion Vildagliptin produced a significantly greater reduction in acute glucose fluctuations compared with saxagliptin when added to a dual combination of metformin and sulfonylurea in Chinese patients with T2DM.

Chinese clinical trial registration number ChiCTR-TRC-13003858.

Keywords:

• Acute glucose fluctuation
• CGMS
• Chinese type 2 diabetes mellitus
• DPP-4 inhibitors

Declaration of funding

This study was not funded.

Author contributions: C.X. designed the study. C.X. and W.J. wrote the manuscript and researched data. W.J. conducted CGMS and followed up with the patients. H.X., T.Y., D.S. and F.Y. screened the patients and collected the data. C.X. reviewed and edited the manuscript and researched data, and also participated in the study as an investigator. All authors read and approved the final manuscript for submission. C.X. is guarantor of this work and, as such, had full access to all the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis.

Declaration of financial/other relationships

C.X., W.J., H.X., T.Y., D.S., and F.Y. have disclosed that they have no significant relationships with or financial interests in any commercial companies related to this study or article.

CMRO peer reviewer 1 has disclosed that he is the recipient of research/grant funding from GlaxoSmithKline, Novartis, Novo-Nordisk, Takeda, Astra-Zeneca, NIH, sanofi-aventis, Eli Lilly and Daiichi-Sankyo; is a consultant to, and lecturer for, GlaxoSmithKline, Novartis, Takeda, sanofi-aventis, Eli Lilly and Daiichi Sankyo; and is on the speakers bureau for Novo Nordisk and sanofi-aventis. CMRO peer reviewers 2 and 3 have no relevant financial or other relationships to disclose.

Acknowledgments

The authors gratefully acknowledge all the investigators, staff and patients at the participating sites and Anil Dandu (Novartis Healthcare Pvt. Ltd) for editorial assistance.