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Insulin degludec in...
Insulin degludec in type 1 diabetes : a randomized controlled trial of a new-generation ultra-long-acting insulin compared with insulin glargine
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Birkeland, Kare I. (författare)
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Home, Philip D. (författare)
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Wendisch, Ulrich (författare)
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Ratner, Robert E. (författare)
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Johansen, Thue (författare)
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Endahl, Lars A. (författare)
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Lyby, Karsten (författare)
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- Jendle, Johan (författare)
- Örebro universitet,Hälsoakademin
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Roberts, Anthony P. (författare)
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DeVries, J. Hans (författare)
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Meneghini, Luigi F. (författare)
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(creator_code:org_t)
- 2011-02-17
- 2011
- Engelska.
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Ingår i: Diabetes Care. - : American Diabetes Association. - 0149-5992 .- 1935-5548. ; 34:3, s. 661-665
- Relaterad länk:
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https://care.diabete...
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https://urn.kb.se/re...
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https://doi.org/10.2...
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Abstract
Ämnesord
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- 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 mu mol/L; n = 59), IDeg(B) (900 mu mol/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.
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- MEDICINE
- MEDICIN
- Medicin
- Medicine
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Till lärosätets databas
- Av författaren/redakt...
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Birkeland, Kare ...
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Home, Philip D.
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Wendisch, Ulrich
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Ratner, Robert E ...
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Johansen, Thue
-
Endahl, Lars A.
-
visa fler...
-
Lyby, Karsten
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Jendle, Johan
-
Roberts, Anthony ...
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DeVries, J. Hans
-
Meneghini, Luigi ...
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visa färre...
- Artiklar i publikationen
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Diabetes Care
- Av lärosätet
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Örebro universitet