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

Volumn 107, Issue 1, 2015, Pages 139-147

  Kaneko, Shizuka ^a   Chow, Francis ^b   Choi, Dong Seop ^c   Taneda, Shinji ^d   Hirao, Koichi ^d   Park, Yongsoo ^e   Andersen, Thomas Hasseriis ^f   Gall, Mari Anne ^f   Christiansen, Jens Sandahl ^g  

^a TAKATSUKI RED CROSS HOSPITAL   (Japan)

^b CHINESE UNIVERSITY OF HONG KONG   (Hong Kong)

^c Korea University College of Medicine   (South Korea)

^d Diabetes Center Manda Memorial Hospital ^*  (Japan)

^e Hanyang University College of Medicine   (South Korea)

^f NOVO NORDISK A S   (Denmark)

^g AARHUS UNIVERSITY HOSPITAL   (Denmark)

Author keywords

HbA1c< inf>; Insulin aspart; Insulin degludec; Type 2 diabetes

Indexed keywords

GLUCOSE; HEMOGLOBIN A1C; INSULIN; INSULIN ASPART; INSULIN ASPART PLUS INSULIN DEGLUDEC; METFORMIN; BIPHASIC INSULINS; BLOOD GLUCOSE; DRUG COMBINATIONS; HEMOGLOBIN A, GLYCOSYLATED; HYPOGLYCEMIC AGENTS; INSULIN ASPART, INSULIN ASPART PROTAMINE DRUG COMBINATION 30:70; INSULIN DEGLUDEC, INSULIN ASPART DRUG COMBINATION; INSULIN DETEMIR; INSULIN, ISOPHANE; INSULIN, LONG-ACTING;

ADULT; ARTICLE; ASIAN; BODY MASS; CLINICAL EFFECTIVENESS; CONTROLLED STUDY; DIABETES CONTROL; DIABETIC RETINOPATHY; DISEASE SEVERITY; DRUG EFFICACY; DRUG SAFETY; FEMALE; GLUCOSE BLOOD LEVEL; GLYCEMIC CONTROL; HEMOGLOBIN BLOOD LEVEL; HUMAN; HYPOGLYCEMIA; MAJOR CLINICAL STUDY; MALE; MEAL; MULTICENTER STUDY; NON INSULIN DEPENDENT DIABETES MELLITUS; RANDOMIZED CONTROLLED TRIAL; RHINOPHARYNGITIS; TREATMENT DURATION; TREATMENT OUTCOME; UPPER RESPIRATORY TRACT INFECTION; AGED; ASIAN CONTINENTAL ANCESTRY GROUP; BLOOD; BLOOD GLUCOSE; CLINICAL TRIAL; DIABETES MELLITUS, TYPE 2; DRUG COMBINATIONS; DRUG EFFECTS; ETHNOLOGY; HUMANS; METABOLISM; MIDDLE AGED; STATISTICS AND NUMERICAL DATA; TREATMENT FAILURE;

ADULT; AGED; ASIAN CONTINENTAL ANCESTRY GROUP; BIPHASIC INSULINS; BLOOD GLUCOSE; DIABETES MELLITUS, TYPE 2; DRUG COMBINATIONS; FEMALE; HEMOGLOBIN A, GLYCOSYLATED; HUMANS; HYPOGLYCEMIA; HYPOGLYCEMIC AGENTS; INSULIN; INSULIN ASPART; INSULIN, ISOPHANE; INSULIN, LONG-ACTING; MALE; METFORMIN; MIDDLE AGED; TREATMENT FAILURE;

EID: 84922809906     PISSN: 01688227     EISSN: 18728227     Source Type: Journal    
DOI: 10.1016/j.diabres.2014.09.026     Document Type: Article

References (21)

1. Yoon K.H., Lee J.H., Kim J.W., Cho J.H., Choi Y.H., Ko S.H., et al. Epidemic obesity and type 2 diabetes in Asia. Lancet 2006, 368:1681-1688.
2. Heianza Y., Arase Y., Fujihara K., Tsuji H., Saito K., Hsieh S.D., et al. High normal HbA(1c) levels were associated with impaired insulin secretion without escalating insulin resistance in Japanese individuals: the Toranomon Hospital Health Management Center Study 8 (TOPICS 8). Diabet Med 2012, 29:1285-1290.
3. Chan J.C., Gagliardino J.J., Baik S.H., Chantelot J.M., Ferreira S.R., Hancu N., et al. Multifaceted determinants for achieving glycemic control: the International Diabetes Management Practice Study (IDMPS). Diabetes Care 2009, 32:227-233.
4. Chen M.L. Ethnic or racial differences revisited: impact of dosage regimen and dosage form on pharmacokinetics and pharmacodynamics. Clin Pharmacokinet 2006, 45:957-964.
5. Davidson J.A., Lacaya L.B., Jiang H., Heilmann C.R., Scism-Bacon J.L., Gates J.R., et al. Impact of race/ethnicity on the efficacy and safety of commonly used insulin regimens: a post hoc analysis of clinical trials in type 2 diabetes mellitus. Endocr Pract 2010, 16:818-828.
6. Home P., Naggar N.E., Khamseh M., Gonzalex-Galvez G., Shen C., Chakkarwar P., et al. An observational non-interventional study of people with diabetes beginning or changed to insulin analogue therapy in non-Western countries: the A1chieve study. Diabetes Res Clin Pract 2011, 94:352-363.
7. Heise T., Nosek L., Bottcher S.G., Hastrup H., Haahr H. Ultra-long-acting insulin degludec has a flat and stable glucose-lowering effect in type 2 diabetes. Diabetes Obes Metab 2012, 14:944-950.
8. Heise T., Hermanski L., Nosek L., Feldman A., Rasmussen S., Haahr H. Insulin degludec: four times lower pharmacodynamic variability than insulin glargine under steady-state conditions in type 1 diabetes. Diabetes Obes Metab 2012, 14:859-864.
9. Ratner R.E., Gough S.C., Mathieu C., Del Prato S., Bode B., Mersebach H., et al. Hypoglycaemia risk with insulin degludec compared with insulin glargine in type 2 and type 1 diabetes: a pre-planned meta-analysis of phase 3 trials. Diabetes Obes Metab 2013, 15:175-184.
10. Meneghini L., Atkin S.L., Gough S.C., Raz I., Blonde L., Shestacova M., et al. The efficacy and safety of insulin degludec given in variable once-daily dosing intervals compared with insulin glargine and insulin degludec dosed at the same time daily: a 26-week, randomized, open-label, parallel-group, treat-to-target trial in individuals with type 2 diabetes. Diabetes Care 2013, 36:858-864.
11. Havelund S., Ribel U., Hubalek F., Hoeg-Jensen T., Jonassen I.B. Insulin degludec (IDeg) and insulin aspart (IAsp) can be co-formulated such that the formulation of IDeg multi-hexamers and IAsp monomers is retained upon S.C. injection. Diabetes 2013, 62(Suppl 1):A241.
12. Niskanen L., Leiter L.A., Franek E., Weng J., Damci T., Muñoz-Torres M., et al. Comparison of a soluble co-formulation of insulin degludec/insulin aspart vs biphasic insulin aspart 30 in type 2 diabetes: a randomised trial. Eur J Endocrinol 2012, 167:287-294.
13. Onishi Y., Ono Y., Rabol R., Endahl L., Nakamura S. Superior glycaemic control with once-daily insulin degludec/insulin aspart versus insulin glargine in Japanese adults with type 2 diabetes inadequately controlled with oral drugs: a randomized, controlled phase 3 trial. Diabetes Obes Metab 2013, 15:826-832.
14. Fulcher G.R., Christiansen J.S., Bantwal G., Polaszewska-Muszynska M., Mersebach H., Andersen T.H., et al. Comparison of insulin degludec/insulin aspart and biphasic insulin aspart 30 in uncontrolled, insulin-treated type 2 diabetes: a phase 3a, randomized, treat-to-target trial. Diabetes Care 2014, 37:2084-2090.
15. Lindholm A., Jensen L.B., Home P.D., Raskin P., Boehm B.O., Rastam J. Immune responses to insulin aspart and biphasic insulin aspart in people with type 1 and type 2 diabetes. Diabetes Care 2002, 25:876-882.
16. Mire-Sluis A.R., Barrett Y.C., Devanarayan V., Koren E., Liu H., Maia M., et al. Recommendations for the design and optimization of immunoassays used in the detection of host antibodies against biotechnology products. J Immunol Methods 2004, 289:1-16.
17. American Diabetes Association Defining and reporting hypoglycemia in diabetes: a report from the American Diabetes Association Workgroup on Hypoglycemia. Diabetes Care 2005, 28:1245-1249.
18. American Diabetes Association Standards of medical care in diabetes - 2012. Diabetes Care 2012, 35(Suppl 1):S11-S63.
19. International Diabetes Federation Global Guideline for Type 2 Diabetes. Diabetes Res Clin Pract 2014, 104(1):1-52.
20. Heise T., Nosek L., Klein O., Hastrup H., Chenji S., Haahr H. Insulin degludec/insulin aspart has distinct prandial and basal glucose-lowering effects at steady state in subjects with type 1 diabetes. Diabetes 2013, 62(suppl 1):A235.
21. Heise T., Nosek L., Klein O., Coester H.V., Roepstorff C., Svendsen A.L., et al. Insulin degludec/insulin aspart produces a dose-proportional glucose-lowering effect in subjects with type 1 diabetes. Diabetes 2013, 62(suppl 1):A241.