A 32-Week Randomized Comparison of Stepwise Insulin Intensification of Biphasic Insulin Aspart (BIAsp 30) Versus Basal–Bolus Therapy in Insulin-Naïve Patients with Type 2 Diabetes

Diabetes Therapy

Volumn 9, Issue 1, 2018, Pages 1-11

  Linjawi, Sultan ^a   Lee, Byung Wan ^b   Tabak, Ömür ^c   Lövdahl, Susanna ^d   Werther, Shanti ^d   Abusnana, Salahedeen ^e  

^a Coffs Endocrine and Diabetes Service ^*  (Australia)

^b Yonsei University College of Medicine   (South Korea)

^c Istanbul Kanuni Sultan Suleyman Research and Teaching Hospital   (Turkey)

^d NOVO NORDISK A S   (Denmark)

^e Rashid Center for Diabetes and Research   (United Arab Emirates)

Author keywords

Basal bolus; BIAsp 30; Stepwise insulin intensification; Type 2 diabetes

Indexed keywords

BIPHASIC INSULIN; HEMOGLOBIN A1C; INSULIN; INSULIN ASPART; INSULIN GLARGINE; METFORMIN; SODIUM GLUCOSE COTRANSPORTER 2; SULFONYLUREA;

ADULT; AGED; ARTHRALGIA; ARTICLE; BACKACHE; BLOOD PRESSURE MONITORING; BODY MASS; BODY WEIGHT; BODY WEIGHT GAIN; BOLUS INJECTION; COMPARATIVE STUDY; CONTROLLED STUDY; DIABETES TREATMENT SATISFACTION QUESTIONNAIRE; DIARRHEA; DRUG DOSE INTENSIFICATION; DRUG DOSE TITRATION; DRUG EFFICACY; DRUG SAFETY; FEMALE; GLUCOSE BLOOD LEVEL; GLYCEMIC CONTROL; HEADACHE; HUMAN; HYPOGLYCEMIA; LIVER FUNCTION; LOGISTIC REGRESSION ANALYSIS; MAJOR CLINICAL STUDY; MALE; MEDICAL SOCIETY; MIDDLE AGED; NON INSULIN DEPENDENT DIABETES MELLITUS; POST HOC ANALYSIS; PRIORITY JOURNAL; PROBABILITY; PROLIFERATIVE RETINOPATHY; QUESTIONNAIRE; RANDOMIZED CONTROLLED TRIAL; RETINA MACULOPATHY; RETROSPECTIVE STUDY; RHINOPHARYNGITIS; UPPER RESPIRATORY TRACT INFECTION;

EID: 85041493580     PISSN: 18696953     EISSN: 18696961     Source Type: Journal    
DOI: 10.1007/s13300-017-0334-8     Document Type: Article

References (25)

1. Meneghini LF. Intensifying insulin therapy: what options are available to patients with type 2 diabetes? Am J Med. 2013;126:S28–37.
2. Holman RR, Paul SK, Bethel MA, Matthews DR, Neil HA. 10-year follow-up of intensive glucose control in type 2 diabetes. N Engl J Med. 2008;359:1577–89.
3. American Diabetes Association. Standards of medical care in diabetes—2017. Diabetes Care. 2017;40:S1–135.
4. Garber AJ, Abrahamson MJ, Barzilay JI, et al. Consensus statement by the American Association of Clinical Endocrinologists and American College of Endocrinology on the comprehensive type 2 diabetes management algorithm–2016 executive summary. Endocr Pract. 2016;22:84–113.
5. IDF Clinical Guidelines Task Force. Global guideline for type 2 diabetes. 2012. www.idf.org/sites/default/files/IDF-Guideline-for-Type-2-Diabetes.pdf. Accessed July 2017.
6. Royal Australian College of General Practitioners and Diabetes (RAGCP). General practice management of type 2 diabetes, 2016–18. https://static.diabetesaustralia.com.au/s/fileassets/diabetes-australia/5d3298b2-abf3-487e-9d5e-0558566fc242.pdf. Accessed July 2017.
7. ® 30.2010. http://www.ema.europa.eu/docs/en_GB/document_908library/EPAR_-_Product_Information/human/000390908/WC500029441.pdf. Accessed June 2017.
8. Giugliano D, Chiodini P, Maiorino MI, Bellastella G, Esposito K. Intensification of insulin therapy with basal-bolus or premixed insulin regimens in type 2 diabetes: a systematic review and meta-analysis of randomized controlled trials. Endocrine. 2016;51:417–28.
9. Raskin P, Allen E, Hollander P, et al. INITIATE Study Group. Initiating insulin therapy in type 2 diabetes: a comparison of biphasic and basal insulin analogs. Diabetes Care. 2005;28:260–5.
10. Rys P, Wojciechowski P, Siejka S, Małecki P, Hak L, Malecki MT. A comparison of biphasic insulin aspart and insulin glargine administered with oral antidiabetic drugs in type 2 diabetes mellitus–a systematic review and meta-analysis. Int J Clin Pract. 2014;68:304–13.
11. Strojek K, Bebakar WM, Khutsoane DT, et al. Once-daily initiation with biphasic insulin aspart 30 versus insulin glargine in patients with type 2 diabetes inadequately controlled with oral drugs: an open-label, multinational RCT. Curr Med Res Opin. 2009;25:2887–94.
12. Qayyum R, Bolen S, Maruthur N, et al. Systematic review: comparative effectiveness and safety of premixed insulin analogues in type 2 diabetes. Ann Intern Med. 2008;149:549–59.
13. Owens DR. Stepwise intensification of insulin therapy in type 2 diabetes management—exploring the concept of the basal-plus approach in clinical practice. Diabet Med. 2013;30:276–88.
14. Rodbard HW, Visco VE, Andersen H, Hiort LC, Shu DH. Treatment intensification with stepwise addition of prandial insulin aspart boluses compared with full basal-bolus therapy (FullSTEP Study): a randomised, treat-to-target clinical trial. Lancet Diabetes Endocrinol. 2014;2:30–7.
15. Garber AJ, Wahlen J, Wahl T, et al. Attainment of glycaemic goals in type 2 diabetes with once-, twice-, or thrice-daily dosing with biphasic insulin aspart 70/30 (The 1-2-3 study). Diabetes Obes Metab. 2006;8:58–66.
16. Jin SM, Kim JH, Min KW, et al. Basal-prandial versus premixed insulin in patients with type 2 diabetes requiring insulin intensification after basal insulin optimization: a 24-week randomized non-inferiority trial. J Diabetes. 2016;8:405–13.
17. Tinahones FJ, Gross JL, Onaca A, Cleall S, Rodríguez A. Insulin lispro low mixture twice daily versus basal insulin glargine once daily and prandial insulin lispro once daily in patients with type 2 diabetes requiring insulin intensification: a randomized phase IV trial. Diabetes Obes Metab. 2014;16:963–70.
18. Vora J, Cohen N, Evans M, Hockey A, Speight J, Whately-Smith C. Intensifying insulin regimen after basal insulin optimization in adults with type 2 diabetes: a 24-week, randomized, open-label trial comparing insulin glargine plus insulin glulisine with biphasic insulin aspart (LanScape). Diabetes Obes Metab. 2015;17:1133–41.
19. Downie M, Kilov G, Wong J. Initiation and intensification strategies in type 2 diabetes management: a comparison of basal plus and premix regimens. Diabetes Ther. 2016;7:641–57.
20. Bowering K, Reed VA, Felicio JS, Landry J, Ji L, Oliveira J. A study comparing insulin lispro mix 25 with glargine plus lispro therapy in patients with type 2 diabetes who have inadequate glycaemic control on oral anti-hyperglycaemic medication: results of the PARADIGM study. Diabet Med. 2012;29:e263–72.
21. 1chieve study. Diabetes Res Clin Pract. 2011;94:352–63.
22. Bradley C. Diabetes treatment satisfaction questionnaire. In: Bradley C, editor. Handbook of psychology and diabetes: a guide to psychological measurement in diabetes research and practice. Chur: Harwood Academic; 1994. p. 111–32.
23. Brod M, Pohlman B, Wolden M, Christensen T. Non-severe nocturnal hypoglycemic events: experience and impacts on patient functioning and well-being. Qual Life Res. 2013;22:997–1004.
24. Cryer PE, Davis SN, Shamoon H. Hypoglycemia in diabetes. Diabetes Care. 2003;26:1902–12.
25. Wu T, Betty B, Downie M, et al. Practical guidance on the use of premix insulin analogs in initiating, intensifying, or switching insulin regimens in type 2 diabetes. Diabetes Ther. 2015;6:273–87.