Dapagliflozin monotherapy in drug-naïve patients with diabetes: a randomized-controlled trial of low-dose range.

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  • Author(s): Bailey CJ;Bailey CJ; Iqbal N; T'joen C; List JF
  • Source:
    Diabetes, obesity & metabolism [Diabetes Obes Metab] 2012 Oct; Vol. 14 (10), pp. 951-9. Date of Electronic Publication: 2012 Jul 24.
  • Publication Type:
    Clinical Trial, Phase III; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't
  • Language:
    English
  • 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/*metabolism ; Diabetes Mellitus, Type 2/*drug therapy ; Glucosides/*therapeutic use; Benzhydryl Compounds ; Blood Glucose/drug effects ; Canada/epidemiology ; Diabetes Mellitus, Type 2/blood ; Diabetes Mellitus, Type 2/epidemiology ; Dose-Response Relationship, Drug ; Double-Blind Method ; Drug Administration Schedule ; Female ; Follow-Up Studies ; Glucosides/administration & dosage ; Glycated Hemoglobin/metabolism ; Humans ; India/epidemiology ; Male ; Mexico/epidemiology ; Middle Aged ; Puerto Rico/epidemiology ; Russia/epidemiology ; South Africa/epidemiology ; Treatment Outcome ; United States/epidemiology ; Weight Loss/drug effects
    • Abstract:
      Aims: Many patients with type 2 diabetes are suboptimally managed with currently available therapies. Dapagliflozin, a sodium-glucose co-transporter-2 inhibitor, has shown efficacy in reducing diabetic hyperglycaemia. This study assessed efficacy of three lower doses in recently diagnosed patients.
      Methods: This phase 3, randomized, double-blind, placebo-controlled study assigned treatment-naïve patients to placebo or dapagliflozin monotherapy (1, 2.5 or 5 mg) daily for 24 weeks. Patients were antidiabetic drug-naïve with inadequate glycaemic control [haemoglobin A1c (HbA1c) ≥7.0 and ≤10.0%]. The primary efficacy endpoint was change in HbA1c from baseline. Secondary endpoints included changes in body weight and fasting plasma glucose (FPG), and proportions achieving HbA1c <7%.
      Results: A total of 282 patients with type 2 diabetes were randomly assigned to one of four treatment groups. Baseline characteristics were similar across groups. At week 24, mean HbA1c reduction was significantly greater with dapagliflozin: -0.68% for 1 mg, -0.72% for 2.5 mg, -0.82% for 5 mg, versus 0.02% for placebo (p < 0.0001); compared to mean baseline values of 7.8-8.1%. Mean FPG reduction was significantly greater for all dapagliflozin groups versus placebo (p < 0.02), as was mean weight reduction (p < 0.003). During the treatment period, 19.1% of placebo-treated patients received rescue medication or discontinued because of poor glycaemic control versus 6.9, 4.1 and 5.9% for dapagliflozin 1, 2.5 and 5 mg, respectively. Percentages of patients experiencing ≥1 adverse event were similar across groups.
      Conclusion: Dapagliflozin at doses of 1, 2.5 and 5 mg/day is effective in reducing glycaemic levels and body weight in treatment-naïve patients with type 2 diabetes. Dapagliflozin was generally well tolerated. This insulin-independent mechanism suggests a new treatment for type 2 diabetes.
      (© 2012 Blackwell Publishing Ltd.)
    • Accession Number:
      0 (Benzhydryl Compounds)
      0 (Blood Glucose)
      0 (Glucosides)
      0 (Glycated Hemoglobin A)
      0 (hemoglobin A1c protein, human)
      1ULL0QJ8UC (dapagliflozin)
    • Publication Date:
      Date Created: 20120711 Date Completed: 20130418 Latest Revision: 20221207
    • Publication Date:
      20221213
    • Accession Number:
      10.1111/j.1463-1326.2012.01659.x
    • Accession Number:
      22776824