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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.
Diabetes Res Clin Pract. 2015 Jan; 107(1):139-47.DR

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.

Authors+Show Affiliations

Takatsuki Red Cross Hospital, Abuno 1-1-1, Ōsaka, Japan.Department of Medicine & Therapeutics, Prince of Wales Hospital, The Chinese University of Hong Kong, Hong Kong, China.Department of Internal Medicine, Korea University Anam Hospital, 126-1,5-ka,Anam-Dong, Seoul, South Korea.Diabetes Center, Manda Memorial Hospital, 1-1, Minami Nijo, Sapporo, Hokkaido, Japan.Department of Internal Medicine, H.E.C Science Clinic, 4-1-4-102, Yokodai, Yokohama-shi, Kanagawa, Japan.Department of Internal Medicine and Bioengineering, Hanyang University Hospital, Seoul 133-791, South Korea.Global Medical Affairs-Insulin, Novo Nordisk A/S, Vandtårnsvej 114, Søborg, Denmark.Global Development, Novo Nordisk A/S, Vandtårnsvej 114, Søborg, Denmark.Department of Endocrinology MEA, Aarhus University Hospital, Dk-8000 Aarhus C, Denmark. Electronic address: jsc@ki.au.dk.No affiliation info available

Pub Type(s)

Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

25498130

Citation

Kaneko, Shizuka, et al. "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." Diabetes Research and Clinical Practice, vol. 107, no. 1, 2015, pp. 139-47.
Kaneko S, Chow F, Choi DS, et al. 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. Diabetes Res Clin Pract. 2015;107(1):139-47.
Kaneko, S., Chow, F., Choi, D. S., Taneda, S., Hirao, K., Park, Y., Andersen, T. H., Gall, M. A., & Christiansen, J. S. (2015). 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. Diabetes Research and Clinical Practice, 107(1), 139-47. https://doi.org/10.1016/j.diabres.2014.09.026
Kaneko S, et al. 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. Diabetes Res Clin Pract. 2015;107(1):139-47. PubMed PMID: 25498130.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - 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. AU - Kaneko,Shizuka, AU - Chow,Francis, AU - Choi,Dong Seop, AU - Taneda,Shinji, AU - Hirao,Koichi, AU - Park,Yongsoo, AU - Andersen,Thomas Hasseriis, AU - Gall,Mari-Anne, AU - Christiansen,Jens Sandahl, AU - ,, Y1 - 2014/10/14/ PY - 2014/03/27/received PY - 2014/08/19/revised PY - 2014/09/15/accepted PY - 2014/12/16/entrez PY - 2014/12/17/pubmed PY - 2015/8/28/medline KW - HbA(1c) KW - Insulin aspart KW - Insulin degludec KW - Type 2 diabetes SP - 139 EP - 47 JF - Diabetes research and clinical practice JO - Diabetes Res. Clin. Pract. VL - 107 IS - 1 N2 - 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. SN - 1872-8227 UR - https://www.unboundmedicine.com/medline/citation/25498130/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_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0168-8227(14)00426-4 DB - PRIME DP - Unbound Medicine ER -