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 Shizuka Kaneko a , Francis Chow b , Dong Seop Choi c , Shinji Taneda d , Koichi Hirao e , Yongsoo Park f , Thomas Hasseriis Andersen g , Mari-Anne Gall h , Jens Sandahl Christiansen i, * on behalf of the BOOST 1 : Intensify All Trial Investigators a Takatsuki Red Cross Hospital, Abuno 1-1-1, O - saka, Japan b Department of Medicine & Therapeutics, Prince of Wales Hospital, The Chinese University of Hong Kong, Hong Kong, China c Department of Internal Medicine, Korea University Anam Hospital, 126-1,5-ka,Anam-Dong, Seoul, South Korea d Diabetes Center, Manda Memorial Hospital, 1-1, Minami Nijo, Sapporo, Hokkaido, Japan e Department of Internal Medicine, H.E.C Science Clinic, 4-1-4-102, Yokodai, Yokohama-shi, Kanagawa, Japan f Department of Internal Medicine and Bioengineering, Hanyang University Hospital, Seoul 133-791, South Korea g Global Medical Affairs–Insulin, Novo Nordisk A/S, Vandta ˚ rnsvej 114, Søborg, Denmark h Global Development, Novo Nordisk A/S, Vandta ˚ rnsvej 114, Søborg, Denmark i Department of Endocrinology MEA, Aarhus University Hospital, Dk-8000 Aarhus C, Denmark d i a b e t e s r e s e a r c h a n d c l i n i c a l p r a c t i c e 1 0 7 ( 2 0 1 5 ) 1 3 9 – 1 4 7 a r t i c l e i n f o Article history: Received 27 March 2014 Received in revised form 19 August 2014 Accepted 15 September 2014 Available online 14 October 2014 Keywords: Insulin degludec Insulin aspart Type 2 diabetes HbA 1c a b s t r a c t Aims: 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. Methods: Participants (mean age 59.8 years, HbA 1c 8.4%, FPG 7.9 mmol/L, BMI 25.4 kg/m 2 ) were randomised 2:1 to BID IDegAsp (n = 282) or BIAsp 30 (n = 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. Results: IDegAsp achieved the primary endpoint of non-inferiority to BIAsp 30 for mean change in HbA 1c (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, p < 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, p < 0.0001). * Corresponding author. Tel.: +45 78462013; fax: +45 7846 2010. E-mail address: [email protected](J.S. Christiansen). Contents available at ScienceDirect Diabetes Research and Clinical Practice journal homepage: www.elsevier.com/locate/diabres http://dx.doi.org/10.1016/j.diabres.2014.09.026 0168-8227/# 2014 The Authors. Published by Elsevier Ireland Ltd. This is an open access article under the CC BY-NC-ND license (http:// creativecommons.org/licenses/by-nc-nd/3.0/).
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Insulin degludec/insulin aspart versus biphasicinsulin aspart 30 in Asian patients with type 2diabetes inadequately controlled on basal orpre-/self-mixed insulin: A 26-week, randomised,treat-to-target trial
Shizuka Kaneko a, Francis Chow b, Dong Seop Choi c, Shinji Taneda d,Koichi Hirao e, Yongsoo Park f, Thomas Hasseriis Andersen g,Mari-Anne Gall h, Jens Sandahl Christiansen i,* on behalf of the BOOST1:Intensify All Trial InvestigatorsaTakatsuki Red Cross Hospital, Abuno 1-1-1, O
-saka, Japan
bDepartment of Medicine & Therapeutics, Prince of Wales Hospital, The Chinese University of Hong Kong, Hong Kong,
ChinacDepartment of Internal Medicine, Korea University Anam Hospital, 126-1,5-ka,Anam-Dong, Seoul, South KoreadDiabetes Center, Manda Memorial Hospital, 1-1, Minami Nijo, Sapporo, Hokkaido, JapaneDepartment of Internal Medicine, H.E.C Science Clinic, 4-1-4-102, Yokodai, Yokohama-shi, Kanagawa, JapanfDepartment of Internal Medicine and Bioengineering, Hanyang University Hospital, Seoul 133-791, South KoreagGlobal Medical Affairs–Insulin, Novo Nordisk A/S, Vandtarnsvej 114, Søborg, DenmarkhGlobal Development, Novo Nordisk A/S, Vandtarnsvej 114, Søborg, DenmarkiDepartment of Endocrinology MEA, Aarhus University Hospital, Dk-8000 Aarhus C, Denmark
d i a b e t e s r e s e a r c h a n d c l i n i c a l p r a c t i c e 1 0 7 ( 2 0 1 5 ) 1 3 9 – 1 4 7
a r t i c l e i n f o
Article history:
Received 27 March 2014
Received in revised form
19 August 2014
Accepted 15 September 2014
Available online 14 October 2014
Keywords:
Insulin degludec
Insulin aspart
Type 2 diabetes
HbA1c
a b s t r a c t
Aims: 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.
Methods: Participants (mean age 59.8 years, HbA1c 8.4%, FPG 7.9 mmol/L, BMI 25.4 kg/m2)
were randomised 2:1 to BID IDegAsp (n = 282) or BIAsp 30 (n = 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.
Results: IDegAsp achieved the primary endpoint of non-inferiority to BIAsp 30 for mean
http://dx.doi.org/10.1016/j.diabres.2014.09.0260168-8227/# 2014 The Authors. Published by Elsevier Ireland Ltd. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/3.0/).
Supplementary data associated with this article can be
found, in the online version, at http://dx.doi.org/10.1016/
j.diabres.2014.09.026.
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