Effect of short-term treatment with sitagliptin or glibenclamide on daily glucose fluctuation in drug-naïve Japanese patients with type 2 diabetes mellitus.

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  • Additional Information
    • Source:
      Publisher: Wiley-Blackwell Country of Publication: England NLM ID: 100883645 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1463-1326 (Electronic) Linking ISSN: 14628902 NLM ISO Abbreviation: Diabetes Obes Metab Subsets: MEDLINE
    • Publication Information:
      Original Publication: Oxford : Wiley-Blackwell, c1999-
    • Subject Terms:
      Blood Glucose/*analysis ; Diabetes Mellitus, Type 2/*drug therapy ; Glyburide/*administration & dosage ; Hypoglycemic Agents/*administration & dosage ; Sitagliptin Phosphate/*administration & dosage; Aged ; Blood Glucose Self-Monitoring ; Diabetes Mellitus, Type 2/blood ; Dipeptidyl-Peptidase IV Inhibitors/administration & dosage ; Drug Administration Schedule ; Fasting/blood ; Female ; Humans ; Japan ; Male ; Middle Aged ; Sulfonylurea Compounds/administration & dosage ; Treatment Outcome
    • Abstract:
      Aims: To compare the effect of a dipeptidyl peptidase-4 inhibitor (DPP4-i) and a sulfonylurea (SU) on daily glucose fluctuation in drug-naïve Japanese patients with type 2 diabetes mellitus (T2DM).
      Materials and Methods: A total of 53 drug-naïve Japanese patients with T2DM (HbA1c, 7.0%-9.0%; fasting plasma glucose, 6.1 mmol/L or higher) were randomly assigned to either sitagliptin 50 mg qd or glibenclamide 2.5 mg per day (given in divided doses) in a 1:1 ratio. A continuous glucose monitoring (CGM) device was used to obtain 24-hour glucose profiles for each patient at baseline and at Week 2. The primary study endpoint was change from baseline in mean amplitude of glucose excursion (MAGE) during a 24-hour period. A key secondary endpoint was change from baseline in the standard deviation (SD) of 24-hour glucose levels.
      Results: After 2 weeks of treatment, a numerically greater reduction in MAGE from baseline was observed in the sitagliptin group compared with the glibenclamide group, but the between-treatment difference was not statistically significant (LS mean difference [95% CI]: -0.48 mmol/L [-1.31, 0.34]; P = .245). However, a significantly greater reduction in the change from baseline in SD was observed in the sitagliptin group compared with the glibenclamide group (LS mean difference [95% CI]: -0.33 mmol/L [-0.62, -0.03]; P = .029).
      Conclusions: This study suggests that the DPP4 inhibitor sitagliptin has a greater ability to reduce daily glucose fluctuation than the SU glibenclamide in drug-naïve Japanese patients with T2DM. ClinicalTrials.gov: NCT02318693.
      (© 2018 John Wiley & Sons Ltd.)
    • Contributed Indexing:
      Keywords: continuous glucose monitoring; daily glucose fluctuation; glibenclamide; sitagliptin; type 2 diabetes mellitus
    • Molecular Sequence:
      ClinicalTrials.gov NCT02318693
    • Accession Number:
      0 (Blood Glucose)
      0 (Dipeptidyl-Peptidase IV Inhibitors)
      0 (Hypoglycemic Agents)
      0 (Sulfonylurea Compounds)
      SX6K58TVWC (Glyburide)
      TS63EW8X6F (Sitagliptin Phosphate)
    • Publication Date:
      Date Created: 20180518 Date Completed: 20190205 Latest Revision: 20190730
    • Publication Date:
      20221213
    • Accession Number:
      10.1111/dom.13364
    • Accession Number:
      29770541