Lower rates of hypoglycemia during maintenance treatment with insulin degludec/insulin aspart versus biphasic insulin aspart 30 : a combined analysis of two Phase 3a studies in type 2 diabetes

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Christiansen , J S , Niskanen , L , Rasmussen , S , Johansen , T & Fulcher , G 2016 , ' Lower rates of hypoglycemia during maintenance treatment with insulin degludec/insulin aspart versus biphasic insulin aspart 30 : a combined analysis of two Phase 3a studies in type 2 diabetes ' , Journal of Diabetes , vol. 8 , no. 5 , pp. 720-728 . https://doi.org/10.1111/1753-0407.12355

Title: Lower rates of hypoglycemia during maintenance treatment with insulin degludec/insulin aspart versus biphasic insulin aspart 30 : a combined analysis of two Phase 3a studies in type 2 diabetes
Author: Christiansen, Jens Sandahl; Niskanen, Leo; Rasmussen, Soeren; Johansen, Thue; Fulcher, Greg
Contributor: University of Helsinki, Department of Medicine
Date: 2016-09
Language: eng
Number of pages: 9
Belongs to series: Journal of Diabetes
ISSN: 1753-0393
URI: http://hdl.handle.net/10138/167945
Abstract: BackgroundInsulin degludec/insulin aspart (IDegAsp) is a soluble coformulation of the basal analog insulin degludec and the rapid-acting prandial insulin aspart in a single injection. The present combined analysis of two Phase 3a trials compared the incidence of hypoglycemia in participants treated twice daily with IDegAsp or biphasic insulin aspart 30 (BIAsp 30). MethodsHypoglycemia data were analyzed from two similarly designed randomized controlled open-label treat-to-target Phase 3a clinical trials of adults with type 2 diabetes (T2D). Participants were treated twice daily with IDegAsp or BIAsp 30, with breakfast and their main evening meal. ResultsOver 26 weeks, the rates of overall confirmed, nocturnal confirmed and severe hypoglycemic events were 19%, 57%, and 39% lower, respectively, with IDegAsp (n = 504) than BIAsp 30 (n = 364); estimated rate ratios were 0.81 (95% confidence interval [CI] 0.67, 0.98; P = 0.0341), 0.43 (95% CI 0.31, 0.59; P = 0.0001), and 0.61 (95% CI 0.26, 1.45; P = NS). The between-treatment differences were more pronounced during the maintenance period (16 weeks); compared with BIAsp 30, rates of overall confirmed, nocturnal confirmed and severe hypoglycemic events with IDegAsp were 0.69 (95% CI 0.55, 0.87; -31%; P = 0.0015); 0.38 (95% CI 0.25, 0.58; -62%; P <0.0001), and 0.16 (95% CI 0.04, 0.59; -84%; P = 0.0061), respectively. ConclusionsCompared with BIAsp 30 twice daily, IDegAsp twice daily provided similar improvements in glycemic control with a lower risk of hypoglycemia, particularly nocturnal hypoglycemia, in subjects with T2D previously treated with insulin.
Subject: bid
treatment
biphasic insulin aspart 30
hypoglycemia
insulin degludec
insulin aspart
type 2 diabetes
b i d
TO-TARGET TRIAL
STEADY-STATE
THERAPY
MANAGEMENT
GLARGINE
IDEGASP
PEOPLE
BASAL
RISK
3121 General medicine, internal medicine and other clinical medicine
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