Insulin degludec in type 1 diabetes: A randomized controlled trial of a new-generation ultra-long-acting insulin compared with insulin glargine

Kåre I. Birkeland, Philip D. Home, Ulrich Wendisch, Robert E. Ratner, Thue Johansen, Lars A. Endahl, Karsten Lyby, Johan H. Jendle, Anthony P. Roberts, J. Hans DeVries, Luigi F. Meneghini

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140 Scopus citations

Abstract

OBJECTIVE - Insulin degludec (IDeg) is a basal insulin that forms soluble multihexamers after subcutaneous injection, resulting in an ultra-long action profile. We assessed the efficacy and safety of IDeg formulations administered once daily in combination with mealtime insulin aspart in people with type 1 diabetes. RESEARCH DESIGN AND METHODS - In this 16-week, randomized, open-label trial, participants (mean: 45.8 years old, A1C 8.4%, fasting plasma glucose [FPG] 9.9 mmol/L, BMI 26.9 kg/m 2) received subcutaneous injections of IDeg(A) (600 μmol/L; n = 59), IDeg(B) (900 mmol/L; n = 60), or insulin glargine (IGlar; n = 59), all given once daily in the evening. Insulin aspart was administered at mealtimes. RESULTS - At 16 weeks, mean A1C was comparable for IDeg(A) (7.8±0.8%), IDeg(B) (8.0±1.0%), and IGlar (7.6 ± 0.8%), as was FPG (8.3 ± 4.0, 8.3 ± 2.8, and 8.9 ± 3.5 mmol/L, respectively). Estimated mean rates of confirmed hypoglycemia were 28% lower for IDeg(A) compared with IGlar (rate ratio [RR]: 0.72 [95% CI 0.52-1.00]) and 10% lower for IDeg(B) compared with IGlar (RR: 0.90 [0.65-1.24]); rates of nocturnal hypoglycemia were 58% lower for IDeg(A) (RR: 0.42 [0.25-0.69]) and 29% lower for IDeg(B) (RR: 0.71 [0.44-1.16]). Mean total daily insulin dose was similar to baseline. The frequency and pattern of adverse events was similar between insulin treatments. CONCLUSIONS - In this clinical exploratory phase 2 trial in people with type 1 diabetes, IDeg is safe andwell tolerated and provides comparable glycemic control to IGlar at similar doses, with reduced rates of hypoglycemia.

Original languageEnglish (US)
Pages (from-to)661-665
Number of pages5
JournalDiabetes care
Volume34
Issue number3
DOIs
StatePublished - Mar 1 2011

ASJC Scopus subject areas

  • Internal Medicine
  • Endocrinology, Diabetes and Metabolism
  • Advanced and Specialized Nursing

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    Birkeland, K. I., Home, P. D., Wendisch, U., Ratner, R. E., Johansen, T., Endahl, L. A., Lyby, K., Jendle, J. H., Roberts, A. P., Hans DeVries, J., & Meneghini, L. F. (2011). Insulin degludec in type 1 diabetes: A randomized controlled trial of a new-generation ultra-long-acting insulin compared with insulin glargine. Diabetes care, 34(3), 661-665. https://doi.org/10.2337/dc10-1925