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Original Research
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
Gregory R. Fulcher, Jens Sandahl Christiansen, Ganapathi Bantwal, Miroslawa Polaszewska-Muszynska, Henriette Mersebach, Thomas H. Andersen, Leo K. Niskanen and on behalf of the BOOST: Intensify Premix I investigators
Diabetes Care 2014 May; DC_132908. https://doi.org/10.2337/dc13-2908
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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/m2, 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 FPG (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.

  • Received December 16, 2013.
  • Accepted March 20, 2014.
  • © 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. See http://creativecommons.org/licenses/by-nc-nd/3.0/ for details.

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Diabetes Care: 42 (3)

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March 2019
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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
Gregory R. Fulcher, Jens Sandahl Christiansen, Ganapathi Bantwal, Miroslawa Polaszewska-Muszynska, Henriette Mersebach, Thomas H. Andersen, Leo K. Niskanen, on behalf of the BOOST: Intensify Premix I investigators
Diabetes Care May 2014, DC_132908; DOI: 10.2337/dc13-2908

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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
Gregory R. Fulcher, Jens Sandahl Christiansen, Ganapathi Bantwal, Miroslawa Polaszewska-Muszynska, Henriette Mersebach, Thomas H. Andersen, Leo K. Niskanen, on behalf of the BOOST: Intensify Premix I investigators
Diabetes Care May 2014, DC_132908; DOI: 10.2337/dc13-2908
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© 2019 by the American Diabetes Association. Diabetes Care Print ISSN: 0149-5992, Online ISSN: 1935-5548.