Shizuka Kaneko1, Francis Chow2, Dong Seop Choi3, Shinji Taneda4, Koichi Hirao5, Yongsoo Park6, Thomas Hasseriis Andersen7, Mari-Anne Gall8, Jens Sandahl Christiansen9. 1. Takatsuki Red Cross Hospital, Abuno 1-1-1, Ōsaka, Japan. 2. Department of Medicine & Therapeutics, Prince of Wales Hospital, The Chinese University of Hong Kong, Hong Kong, China. 3. Department of Internal Medicine, Korea University Anam Hospital, 126-1,5-ka,Anam-Dong, Seoul, South Korea. 4. Diabetes Center, Manda Memorial Hospital, 1-1, Minami Nijo, Sapporo, Hokkaido, Japan. 5. Department of Internal Medicine, H.E.C Science Clinic, 4-1-4-102, Yokodai, Yokohama-shi, Kanagawa, Japan. 6. Department of Internal Medicine and Bioengineering, Hanyang University Hospital, Seoul 133-791, South Korea. 7. Global Medical Affairs-Insulin, Novo Nordisk A/S, Vandtårnsvej 114, Søborg, Denmark. 8. Global Development, Novo Nordisk A/S, Vandtårnsvej 114, Søborg, Denmark. 9. Department of Endocrinology MEA, Aarhus University Hospital, Dk-8000 Aarhus C, Denmark. Electronic address: jsc@ki.au.dk.
Abstract
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/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 HbA₁c (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). Rates of overall confirmed and severe hypoglycaemia were similar between treatments, while rate of nocturnal confirmed hypoglycaemia was numerically (p=ns) lower with IDegAsp. During the maintenance period there was a trend (p=ns) towards lower hypoglycaemia rates for IDegAsp. CONCLUSION: 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.
RCT Entities:
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/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 HbA₁c (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). Rates of overall confirmed and severe hypoglycaemia were similar between treatments, while rate of nocturnal confirmed hypoglycaemia was numerically (p=ns) lower with IDegAsp. During the maintenance period there was a trend (p=ns) towards lower hypoglycaemia rates for IDegAsp. CONCLUSION: 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.
Authors: C E Onder; S M Kuşkonmaz; G Koc; S Firat; T Omma; I Taskaldiran; P Gokbulut; C Culha Journal: Acta Endocrinol (Buchar) Date: 2020 Oct-Dec Impact factor: 0.877
Authors: Ajay Kumar; Edward Franek; Jonathan Wise; Marcus Niemeyer; Henriette Mersebach; Rafael Simó Journal: PLoS One Date: 2016-10-19 Impact factor: 3.240