Comparison of glycemic control and β-cell function in new onset T2DM patients with PCOS of metformin and saxagliptin monotherapy or combination treatment
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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 β-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- β-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 β-cell function, improving lipid profiles, and reducing inflammation in newly diagnosed type 2 diabetes mellitus patients with polycystic ovary syndrome. TRIAL REGISTRATION: ChiCTR-IPR-17011120 (retrospectively registered on 2017-04-12).
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The arm with saxagliptin plus metformin demonstrated superiority versus metformin in fasting glucose and oral glucose tolerance test normalization (p = 0.007).
“The arm with saxagliptin plus metformin demonstrated superiority versus metformin in fasting glucose and OGTT normalization (p = 0.007).”
From From Prediabetes to Type 2 Diabetes Mellitus in Women with Polycystic Ovary Syndrome: Lifestyle and Pharmacological Management (2020) · cites this paper as [69]
In a study of premenopausal patients with PCOS and impaired fasting glucose or impaired glucose tolerance randomly assigned to metformin extended release, saxagliptin, or combination, 56% of patients had glucose tolerance normalization (25% in the metformin group, 55% in the saxagliptin, and 91% in the combination).
“At the end of the study, 56% of patients had a glucose tolerance normalization (25% in the metformin group, 55% in the saxagliptin, and 91% in the combination).”
From From Prediabetes to Type 2 Diabetes Mellitus in Women with Polycystic Ovary Syndrome: Lifestyle and Pharmacological Management (2020) · cites this paper as [69]
In a study of 75 patients diagnosed with both T2D and PCOS randomly assigned to metformin, saxagliptin, or both over 24 weeks, there was significant reduction of glycated haemoglobin in all groups, but no differences were detected between groups.
“The study showed significant reduction of glycated haemoglobin in all groups, but no differences were detected between groups (saxagliptin vs. combination vs. metformin: −1.1% vs. −1.3% vs. −1.1%, respectively, p = 0.016; saxagliptin vs. metformin, p = 0.890).”
From From Prediabetes to Type 2 Diabetes Mellitus in Women with Polycystic Ovary Syndrome: Lifestyle and Pharmacological Management (2020) · cites this paper as [69]
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- Authors
- Tao, T., Wu, P., Wang, Y., & Liu, W.
- Affiliations
- Shanghai Jiao Tong University (CN)
- Corresponding author
- Tao, Tao
- Liu, Wei
- Venue
- BMC Endocrine Disorders
- Published
- 2018-02-27
- Volume
- 18
- Issue
- 1
- Pages
- 14-14
- ISSN
- 1472-6823 (ISSN-L)
- PMC
- PMC5828487
- OpenAlex
- W2794726686
- Cited by
- 38
- References
- 23
- Citations by year
- 2026: 1 · 2025: 1 · 2024: 3 · 2023: 6 · 2022: 7 · 2021: 11 · 2020: 5 · 2019: 2 · 2018: 2
- FWCI
- 5.36
- Type
- journal article
- Language
- en
- Open access
- gold
- doi.org
- Licence
- cc-by
- Locations
- BMC Endocrine Disorders (publishedVersion, cc-by)
- PubMed Central (publishedVersion, cc-by)
- PubMed (publishedVersion)
- DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion, cc-by-sa)
- Funders
- National Natural Science Foundation of China (81200628)
- Chinese Medical Association Clinical Research and Special Funds - Squibb Endocrinology Diabetes Research projects (2012)
- Natural Science Foundation of Shanghai (12ZR1417800)
- Shanghai Science and Technology Development Fund (08411953000)
- Topics
- Health Sciences › Medicine › Reproductive Medicine › Ovarian function and disorders
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Treatment and Management
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes, Cardiovascular Risks, and Lipoproteins
- Keywords
- type 2 diabetes, polycystic ovary syndrome, metformin, saxagliptin, combination therapy, glycemic control, beta-cell function, insulin resistance, HOMA-IR, HOMA-β, insulinogenic index, HbA1c, body mass index, C-reactive protein, newly diagnosed diabetes, women, lipid profile, inflammation
- MeSH terms
- Adamantane, Adult, Blood Glucose, Diabetes Mellitus, Type 2, Dipeptides, Drug Therapy, Combination, Female, Follow-Up Studies, Glycated Hemoglobin, Humans, Hypoglycemic Agents, Metformin, Polycystic Ovary Syndrome, Prognosis, Prospective Studies, Biomarkers, Age of Onset, Glycemic Index, Insulin-Secreting Cells, Dipeptidyl-Peptidase IV Inhibitors
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