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, MD1,
- Philip D. Home, DM, DPHIL2,
- Ulrich Wendisch, MD3,
- Robert E. Ratner, MD4,
- Thue Johansen, MD, PHD5,
- Lars A. Endahl, PHD5,
- Karsten Lyby, MSC5,
- Johan H. Jendle, MD, PHD6,
- Anthony P. Roberts, MD7,
- J. Hans DeVries, MD8 and
- Luigi F. Meneghini, MD, MBA9
- 1Oslo University Hospital and Faculty of Medicine, Oslo, Norway
- 2Newcastle University, Newcastle upon Tyne, U.K.
- 3Group Practice in Internal Medicine and Diabetology, Hamburg, Germany
- 4MedStar Research Institute, Washington, DC
- 5Novo Nordisk A/S, Soeborg, Denmark
- 6Örebro University Hospital, Örebro, Sweden
- 7Royal Adelaide Hospital, Adelaide, South Australia, Australia
- 8University of Amsterdam, Amsterdam, the Netherlands
- 9University of Miami Miller School of Medicine, Miami, Florida
- Corresponding author: Kåre I. Birkeland, .
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.
- © 2011 by the American Diabetes Association.
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