title: 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.
authors.affiliation: a The First Affiliated Hospital of Guangzhou Medical University , Endocrinology Department , Guangzhou , China.
authors.forename: Chen
authors.initials: C
authors.lastname: Xiaoyan
authors.affiliation: a The First Affiliated Hospital of Guangzhou Medical University , Endocrinology Department , Guangzhou , China.
authors.forename: Wang
authors.initials: W
authors.lastname: Jing
authors.affiliation: a The First Affiliated Hospital of Guangzhou Medical University , Endocrinology Department , Guangzhou , China.
authors.forename: Huang
authors.initials: H
authors.lastname: Xiaochun
authors.affiliation: a The First Affiliated Hospital of Guangzhou Medical University , Endocrinology Department , Guangzhou , China.
authors.forename: Tan
authors.initials: T
authors.lastname: Yuyu
authors.affiliation: a The First Affiliated Hospital of Guangzhou Medical University , Endocrinology Department , Guangzhou , China.
authors.forename: Deng
authors.initials: D
authors.lastname: Shunyou
authors.affiliation: a The First Affiliated Hospital of Guangzhou Medical University , Endocrinology Department , Guangzhou , China.
authors.forename: Fu
authors.initials: F
authors.lastname: Yingyu
mesh_terms: D000218:Adamantane / Q000031:analogs & derivatives* / Q000627:therapeutic use; D000368:Aged; D044466:Asian People; D001786:Blood Glucose / Q000378:metabolism; D002681:China; D003924:Diabetes Mellitus, Type 2 / Q000097:blood* / Q000188:drug therapy*; D004151:Dipeptides / Q000627:therapeutic use*; D054873:Dipeptidyl-Peptidase IV Inhibitors / Q000627:therapeutic use*; D004359:Drug Therapy, Combination; D005260:Female; D005907:Gliclazide / Q000627:therapeutic use; D006442:Glycated Hemoglobin / Q000378:metabolism; D006801:Humans; D007004:Hypoglycemic Agents / Q000627:therapeutic use*; D008297:Male; D008687:Metformin / Q000627:therapeutic use; D008875:Middle Aged; D009570:Nitriles / Q000627:therapeutic use*; D011446:Prospective Studies; D011759:Pyrrolidines / Q000627:therapeutic use*; D013453:Sulfonylurea Compounds / Q000627:therapeutic use; D000077597:Vildagliptin
chemical_list: D000218:Adamantane; D001786:Blood Glucose; D004151:Dipeptides; D054873:Dipeptidyl-Peptidase IV Inhibitors; D005907:Gliclazide; D006442:Glycated Hemoglobin; D007004:Hypoglycemic Agents; D008687:Metformin; D009570:Nitriles; D011759:Pyrrolidines; D013453:Sulfonylurea Compounds; D000077597:Vildagliptin; C502994:saxagliptin
keywords: Acute glucose fluctuation; CGMS; Chinese type 2 diabetes mellitus; DPP-4 inhibitors