Insulin Degludec in Type 1 Diabetes

A randomized controlled trial of a new-generation ultra-long-acting insulin compared with insulin glargine

  1. Luigi F. Meneghini, MD, MBA9
  1. 1Oslo University Hospital and Faculty of Medicine, Oslo, Norway
  2. 2Newcastle University, Newcastle upon Tyne, U.K.
  3. 3Group Practice in Internal Medicine and Diabetology, Hamburg, Germany
  4. 4MedStar Research Institute, Washington, DC
  5. 5Novo Nordisk A/S, Soeborg, Denmark
  6. 6Örebro University Hospital, Örebro, Sweden
  7. 7Royal Adelaide Hospital, Adelaide, South Australia, Australia
  8. 8University of Amsterdam, Amsterdam, the Netherlands
  9. 9University of Miami Miller School of Medicine, Miami, Florida
  1. Corresponding author: Kåre I. Birkeland, k.i.birkeland{at}medisin.uio.no.

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/m2) received subcutaneous injections of IDeg(A) (600 μmol/L; n = 59), IDeg(B) (900 μmol/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 and well tolerated and provides comparable glycemic control to IGlar at similar doses, with reduced rates of hypoglycemia.

  • Received October 8, 2010.
  • Accepted December 22, 2010.

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  1. Diabetes Care
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