4.3 Article

Comparison of glycemic control and β-cell function in new onset T2DM patients with PCOS of metformin and saxagliptin monotherapy or combination treatment

Journal

BMC ENDOCRINE DISORDERS
Volume 18, Issue -, Pages -

Publisher

BIOMED CENTRAL LTD
DOI: 10.1186/s12902-018-0243-5

Keywords

Polycystic ovary syndrome; Type 2 diabetes mellitus; Saxagliptin; Metformin

Funding

  1. National Natural Science Foundation of China [81200628]
  2. Chinese Medical Association Clinical Research and Special Funds - Squibb Endocrinology Diabetes Research projects
  3. Natural Science Foundation of Shanghai, China [12ZR1417800]
  4. Shanghai Science and Technology Development Fund [08411953000]

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Background: Impaired insulin activity in women with polycystic ovary syndrome might differ from that seen in type 2 diabetes mellitus without polycystic ovary syndrome. This study was designed to compare the effects of treatment with metformin, saxagliptin, and their combination in newly diagnosed women with type 2 diabetes mellitus and polycystic ovary syndrome in China. Methods: A total of 75 newly diagnosed patients from Shanghai, China with type 2 diabetes mellitus and polycystic ovary syndrome were included in this randomized, parallel, open-label study. All patients received treatment for 24 weeks with metformin, saxagliptin, or their combination. Patients were allocated to one of three treatment groups by a computer-generated code that facilitated equal patient distribution of 25 patients per group. The primary outcome was a change in glycemic control and beta-cell function. Results: A total of 63 patients completed the study (n = 21, for each group). The reduction in hemoglobin A1c was significant in the combination group, compared to the monotherapy groups (saxagliptin vs. combination treatment vs. metformin: -1.1 vs. -1.3 vs. -1.1%, P = 0.016), whereas it was comparable between the metformin and saxagliptin groups (P > 0.05). Saxagliptin, metformin, and the combination treatment significantly reduced the homeostasis model assessment-insulin resistance index and increased the deposition index (P < 0.01 for all). However, no significant change was observed in the homeostasis model assessment-beta-cell function among the metformin and combination groups, and no significant changes were observed in the insulinogenic index among all three groups (P > 0.05 for all). In addition, saxagliptin and metformin treatments significantly reduced body mass index and high-sensitivity C-reactive protein levels (P < 0.01 for both). Conclusions: Saxagliptin and metformin were comparably effective in regulating weight loss, glycemic control, and beta-cell function, improving lipid profiles, and reducing inflammation in newly diagnosed type 2 diabetes mellitus patients with polycystic ovary syndrome.

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