Comparison of insulin degludec/insulin aspart and biphasic insulin aspart 30 in uncontrolled, insulin-treated type 2 diabetes: a phase 3a, randomized, treat-to-target trial.

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  • Additional Information
    • Corporate Authors:
      BOOST: Intensify Premix I Investigators
    • Source:
      Publisher: American Diabetes Association Country of Publication: United States NLM ID: 7805975 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1935-5548 (Electronic) Linking ISSN: 01495992 NLM ISO Abbreviation: Diabetes Care Subsets: MEDLINE
    • Publication Information:
      Publication: Alexandria Va : American Diabetes Association
      Original Publication: New York, American Diabetes Assn.
    • Subject Terms:
      Biphasic Insulins/*administration & dosage ; Diabetes Mellitus, Type 2/*drug therapy ; Hypoglycemic Agents/*administration & dosage ; Insulin Aspart/*administration & dosage ; Insulin, Isophane/*administration & dosage ; Insulin, Long-Acting/*administration & dosage; Biphasic Insulins/adverse effects ; Blood Glucose/metabolism ; Diabetes Mellitus, Type 2/blood ; Drug Administration Schedule ; Drug Combinations ; Drug Therapy, Combination ; Fasting/blood ; Female ; Glycated Hemoglobin/metabolism ; Humans ; Hypoglycemia/drug therapy ; Hypoglycemic Agents/adverse effects ; Injections ; Insulin Aspart/adverse effects ; Insulin, Isophane/adverse effects ; Insulin, Long-Acting/adverse effects ; Male ; Meals/physiology ; Middle Aged ; Treatment Outcome
    • Abstract:
      Objective: Insulin degludec/insulin aspart (IDegAsp) is the first combination of a basal insulin with an ultralong duration of action, and a rapid-acting insulin in a single injection. This trial compared IDegAsp with biphasic insulin aspart 30 (BIAsp 30) in adults with type 2 diabetes inadequately controlled with once- or twice-daily (OD or BID) pre- or self-mixed insulin with or without oral antidiabetic drugs.
      Research Design and Methods: In this 26-week, randomized, open-label, multinational, treat-to-target trial, participants (mean age 58.7 years, duration of diabetes 13 years, BMI 29.3 kg/m(2), and HbA1c 8.4% [68 mmol/mol]) were exposed (1:1) to BID injections of IDegAsp (n = 224) or BIAsp 30 (n = 222), administered with breakfast and the main evening meal and dose titrated to a self-measured premeal plasma glucose (PG) target of 4.0-5.0 mmol/L.
      Results: After 26 weeks, mean HbA1c was 7.1% (54 mmol/mol) for both groups, with IDegAsp achieving the prespecified noninferiority margin for mean change in HbA1c (estimated treatment difference [ETD] -0.03% points [95% CI -0.18 to 0.13]). Treatment with IDegAsp was superior in lowering fasting PG (ETD -1.14 mmol/L [95% CI -1.53 to -0.76], P < 0.001) and had a significantly lower final mean daily insulin dose (estimated rate ratio 0.89 [95% CI 0.83-0.96], P = 0.002). Fewer confirmed, nocturnal confirmed, and severe hypoglycemia episodes were reported for IDegAsp compared with BIAsp 30.
      Conclusions: IDegAsp BID effectively improves HbA1c and fasting PG levels with fewer hypoglycemia episodes versus BIAsp 30 in patients with uncontrolled type 2 diabetes previously treated with once- or twice-daily pre- or self-mixed insulin.
      (© 2014 by the American Diabetes Association. Readers may use this article as long as the work is properly cited, the use is educational and not for profit, and the work is not altered.)
    • Accession Number:
      0 (Biphasic Insulins)
      0 (Blood Glucose)
      0 (Drug Combinations)
      0 (Glycated Hemoglobin A)
      0 (Hypoglycemic Agents)
      0 (Insulin, Long-Acting)
      0 (insulin aspart, insulin aspart protamine drug combination 30:70)
      0 (insulin degludec, insulin aspart drug combination)
      53027-39-7 (Insulin, Isophane)
      D933668QVX (Insulin Aspart)
    • Publication Date:
      Date Created: 20140510 Date Completed: 20150914 Latest Revision: 20221207
    • Publication Date:
      20221213
    • Accession Number:
      10.2337/dc13-2908
    • Accession Number:
      24812432