Greater fear of hypoglycaemia with premixed insulin than with basal-bolus insulin glargine and glulisine: patient-reported outcomes from a 60-week randomised study.

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  • Author(s): Polonsky WH;Polonsky WH; Thompson S; Wei W; Riddle MC; Chaudhari S; Jackson J; Bruno AS
  • Source:
    Diabetes, obesity & metabolism [Diabetes Obes Metab] 2014 Nov; Vol. 16 (11), pp. 1121-7. Date of Electronic Publication: 2014 Jul 12.
  • Publication Type:
    Clinical Trial, Phase IV; 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/*drug effects ; Diabetes Mellitus, Type 2/*drug therapy ; Hypoglycemia/*chemically induced ; Hypoglycemic Agents/*administration & dosage ; Insulin/*analogs & derivatives ; Insulin, Long-Acting/*administration & dosage ; Quality of Life/*psychology; Adult ; Aged ; Aged, 80 and over ; Anxiety ; Body Mass Index ; Diabetes Mellitus, Type 2/blood ; Diabetes Mellitus, Type 2/psychology ; Drug Administration Schedule ; Drug Therapy, Combination ; Female ; Humans ; Hypoglycemia/psychology ; Insulin/administration & dosage ; Insulin Glargine ; Male ; Middle Aged ; Patient Outcome Assessment ; Surveys and Questionnaires ; United States/epidemiology
    • Abstract:
      Aim: To assess the effect of initiating insulin treatment on quality of life of patients with type 2 diabetes (T2DM) in the 60-week All-to-Target trial (NCT00384085).
      Methods: Patient-reported outcomes from a phase IV, multicentre, randomised, open-label, parallel-group study were analysed. Participants were randomised to: insulin glargine with up to one insulin glulisine injection (G + 1); insulin glargine with stepwise addition of up to three insulin glulisine injections (G + 3); or twice-daily premixed 70/30 insulin protamine-aspart/aspart (PM-2). Patient-reported outcome questionnaires were administered at weeks 0, 6, 12, 24, 36, 48 and 60.
      Results: There were no between-group differences in the Psychosocial Adjustment to Illness State-Self Report (PAIS-SR) or in the EuroQoL Group Five-Dimension Self-Report Index Questionnaire (EQ-5D) from baseline to week 60; however, PAIS-SR scores improved significantly over this period in the G + 3 group (p = 0.0016) and EQ-5D scores worsened significantly in the PM-2 group (p = 0.02). Hypoglycemia Fear Survey Behaviour and Worry subscales worsened significantly for all groups, with greater deterioration being observed in the PM-2 group than in the G + 1 group (Behaviour, p = 0.0050; Worry, p = 0.0017) and G + 3 groups (Behaviour, p = 0.0105; Worry, p = 0.0016). Total scores on the Diabetes Quality of Life (DQoL) questionnaire improved more in the G + 3 group than in the PM-2 group over the study period (p = 0.0284), with all groups showing a significant improvement in DQoL score over time.
      Conclusion: Insulin glargine-based regimens showed advantages over premixed insulin in a number of patient-reported outcome measures. The potential impact on fear of hypoglycaemia may be of particular relevance when addressing the major barriers to early insulin treatment.
      (© 2014 John Wiley & Sons Ltd.)
    • Contributed Indexing:
      Keywords: clinical trial; diabetes mellitus; insulin analogues; insulin therapy; randomised trial; type 2 diabetes
    • Molecular Sequence:
      ClinicalTrials.gov NCT00384085
    • Accession Number:
      0 (Blood Glucose)
      0 (Hypoglycemic Agents)
      0 (Insulin)
      0 (Insulin, Long-Acting)
      2ZM8CX04RZ (Insulin Glargine)
      7XIY785AZD (insulin glulisine)
    • Publication Date:
      Date Created: 20140613 Date Completed: 20150707 Latest Revision: 20170203
    • Publication Date:
      20231215
    • Accession Number:
      10.1111/dom.12328
    • Accession Number:
      24919603