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

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Long-Acting Insulin
Type 1 Diabetes Mellitus
Randomized Controlled Trials
Insulin Aspart
Hypoglycemia
Subcutaneous Injections
Insulin
Meals
Fasting
insulin degludec
Insulin Glargine
Glucose

ASJC Scopus subject areas

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

Cite this

Birkeland, K. I., Home, P. D., Wendisch, U., Ratner, R. E., Johansen, T., Endahl, L. A., ... 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

Insulin degludec in type 1 diabetes : A randomized controlled trial of a new-generation ultra-long-acting insulin compared with insulin glargine. / Birkeland, Kåre I.; Home, Philip D.; Wendisch, Ulrich; Ratner, Robert E.; Johansen, Thue; Endahl, Lars A.; Lyby, Karsten; Jendle, Johan H.; Roberts, Anthony P.; Hans DeVries, J.; Meneghini, Luigi F.

In: Diabetes Care, Vol. 34, No. 3, 01.03.2011, p. 661-665.

Research output: Contribution to journalArticle

Birkeland, KI, Home, PD, Wendisch, U, Ratner, RE, Johansen, T, Endahl, LA, Lyby, K, Jendle, JH, Roberts, AP, Hans DeVries, J & Meneghini, LF 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, vol. 34, no. 3, pp. 661-665. https://doi.org/10.2337/dc10-1925
Birkeland, Kåre I. ; Home, Philip D. ; Wendisch, Ulrich ; Ratner, Robert E. ; Johansen, Thue ; Endahl, Lars A. ; Lyby, Karsten ; Jendle, Johan H. ; Roberts, Anthony P. ; Hans DeVries, J. ; Meneghini, Luigi F. / Insulin degludec in type 1 diabetes : A randomized controlled trial of a new-generation ultra-long-acting insulin compared with insulin glargine. In: Diabetes Care. 2011 ; Vol. 34, No. 3. pp. 661-665.
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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.",
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T2 - A randomized controlled trial of a new-generation ultra-long-acting insulin compared with insulin glargine

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AU - Wendisch, Ulrich

AU - Ratner, Robert E.

AU - Johansen, Thue

AU - Endahl, Lars A.

AU - Lyby, Karsten

AU - Jendle, Johan H.

AU - Roberts, Anthony P.

AU - Hans DeVries, J.

AU - Meneghini, Luigi F.

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N2 - 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.

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