Sitagliptin added to stable insulin therapy with or without metformin in Chinese patients with type 2 diabetes.

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  • Additional Information
    • Source:
      Publisher: Asian Association for the Study of Diabetes and Blackwell Pub. Asia Country of Publication: Japan NLM ID: 101520702 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 2040-1124 (Electronic) Linking ISSN: 20401116 NLM ISO Abbreviation: J Diabetes Investig Subsets: MEDLINE
    • Publication Information:
      Original Publication: Tokyo : Asian Association for the Study of Diabetes and Blackwell Pub. Asia
    • Subject Terms:
      Diabetes Mellitus, Type 2/*drug therapy ; Hypoglycemic Agents/*therapeutic use ; Insulin/*therapeutic use ; Metformin/*therapeutic use ; Sitagliptin Phosphate/*therapeutic use; Asian People ; China ; Diabetes Mellitus, Type 2/blood ; Female ; Glycated Hemoglobin/analysis ; Humans ; Hypoglycemic Agents/adverse effects ; Male ; Middle Aged ; Sitagliptin Phosphate/adverse effects ; Treatment Outcome
    • Abstract:
      Introduction: We evaluated the tolerability and efficacy of the addition of sitagliptin in Chinese patients with type 2 diabetes mellitus receiving stable insulin therapy alone or in combination with metformin.
      Materials and Methods: A total of 467 patients with inadequate glycemic control on insulin (glycated hemoglobin [HbA1c] ≥7.5% and ≤11%) were randomized 1:1 to receive sitagliptin 100 mg once daily or a matching placebo for 24 weeks. Randomization was stratified based on metformin use (on or not on metformin) and type of insulin (pre-mixed vs intermediate-/long-acting) at screening. The primary end-point was the change from baseline at week 24 in HbA1c.
      Results: The addition of sitagliptin led to a significantly (P < 0.001) greater week 24 HbA1c reduction (0.7%) compared with the reduction (0.3%) with placebo. A significantly (P = 0.013) greater proportion of patients taking sitagliptin (16%) had an HbA1c of <7.0% at week 24 compared with placebo (8%). The addition of sitagliptin significantly (P < 0.001) reduced 2-h post-meal glucose by 26.5 mg/dL (1.5 mmol/L) relative to placebo. Reductions from baseline in fasting plasma glucose were observed in both the sitagliptin (14.4 mg/dL reduction) and placebo (10.7 mg/dL reduction) groups; the between-group difference was not significant. A total of 64 (27.4%) patients taking sitagliptin and 51 (21.9%) taking placebo experienced adverse events of hypoglycemia (symptomatic or asymptomatic). Neither group had a significant change from baseline in bodyweight.
      Conclusions: After 24 weeks, sitagliptin added to stable insulin therapy (±metformin) was generally well tolerated and improved glycemic control in Chinese patients with type 2 diabetes mellitus.
      (© 2016 Merck Sharp & Dohme Corp. Journal of Diabetes Investigation published by Asian Association for the Study of Diabetes (AASD) and John Wiley & Sons Australia, Ltd.)
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    • Contributed Indexing:
      Keywords: Insulin; Sitagliptin; Type 2 diabetes mellitus
    • Accession Number:
      0 (Glycated Hemoglobin A)
      0 (Hypoglycemic Agents)
      0 (Insulin)
      0 (hemoglobin A1c protein, human)
      9100L32L2N (Metformin)
      TS63EW8X6F (Sitagliptin Phosphate)
    • Publication Date:
      Date Created: 20161015 Date Completed: 20180305 Latest Revision: 20221207
    • Publication Date:
      20240829
    • Accession Number:
      PMC5415484
    • Accession Number:
      10.1111/jdi.12585
    • Accession Number:
      27740719