Insulin degludec/insulin aspart versus biphasic insulin aspart 30 in Asian patients with type 2 diabetes inadequately controlled on basal or pre-/self-mixed insulin: A 26-week, randomised, treat-to-target trial. Issue 1 (January 2015)

• Record Type: Journal Article
• Authors: Kaneko, Shizuka; Chow, Francis; Choi, Dong Seop; Taneda, Shinji; Hirao, Koichi; Park, Yongsoo; Andersen, Thomas Hasseriis; Gall, Mari-Anne; Christiansen, Jens Sandahl; on behalf of the BOOST®: Intensify All Trial Investigators
• Is Part Of: Diabetes research and clinical practice. Volume 107:Issue 1(2015)
• Page Start: 139
• Page End: 147
• Publication Date: 2015-01
• Subjects: Diabetes -- Periodicals; Diabetes Mellitus -- Periodicals; 616.462
• DOI: 10.1016/j.diabres.2014.09.026
• Languages: English
• ISSNs: 0168-8227

Abstract

<abstract abstract-type="author" id="abs0005"> <title id="sect0005">Abstract</title> <sec> <title id="sect0010"> <bold>Aims</bold> </title> <p id="spar0005">Insulin degludec/insulin aspart (IDegAsp) is a soluble co-formulation of IDeg and IAsp. This pan-Asian, 26-week trial investigated efficacy and safety of IDegAsp vs biphasic insulin aspart 30 (BIAsp 30) in Asian adults with type 2 diabetes (T2DM), inadequately controlled on once- or twice-daily (BID) basal, premixed or self-mixed insulin.</p> </sec> <sec> <title id="sect0015"> <bold>Methods</bold> </title> <p id="spar0010">Participants (mean age 59.8 years, HbA<sub>1c</sub> 8.4%, FPG 7.9 mmol/L, BMI 25.4 kg/m<sup>2</sup>) were randomised 2:1 to BID IDegAsp (<italic>n</italic> = 282) or BIAsp 30 (<italic>n</italic> = 142) and continued existing metformin treatment. Insulins were administered with breakfast and main evening meal, titrated to a pre-breakfast and pre-main evening meal self-measured plasma glucose target of 4–5 mmol/L.</p> </sec> <sec> <title id="sect0020"> <bold>Results</bold> </title> <p id="spar0015">IDegAsp achieved the primary endpoint of non-inferiority to BIAsp 30 for mean change in HbA<sub>1c</sub> (estimated treatment difference [ETD] IDegAsp–BIAsp 30: 0.05% points [95% CI −0.10; 0.20]). IDegAsp was superior in lowering fasting plasma glucose (FPG) (ETD −1.06 mmol/L, 95% CI −1.43; −0.70, <italic>p</italic> < 0.001), and resulted in a lower final mean daily insulin dose (0.79 U/kg vs 0.99 U/kg, estimated rate ratio [RR] 0.79, 95% CI 0.73; 0.85, <italic>p</italic> < 0.0001).</p> <p id="spar0020">Rates of overall confirmed and severe hypoglycaemia were similar between treatments, while rate of nocturnal confirmed hypoglycaemia was numerically (<italic>p</italic> = ns) lower with IDegAsp. During the maintenance period there was a trend (<italic>p</italic> = ns) towards lower hypoglycaemia rates for IDegAsp.</p> </sec> <sec> <title id="sect0025"> <bold>Conclusion</bold> </title> <p id="spar0025">In Asian adults with T2DM, IDegAsp BID effectively improves long-term glycaemic control, and compared to BIAsp 30, provides superior reductions in FPG with a lower dose, and numerically less nocturnal hypoglycaemia.</p> </sec> </abstract>