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

Current Medical Research and Opinion

Volumn 25, Issue 12, 2009, Pages 2887-2894

  Strojek, Krzysztof ^a,h   Bebakar, Wan M W ^b   Khutsoane, Duma T ^c   Pesic, Milica ^d   Šmahelova, Alena ^e   Thomsen, Henrik F ^f   Kalra, Sanjay ^g  

^a MEDICAL UNIVERSITY OF SILESIA   (Poland)

^b SCHOOL OF MEDICAL SCIENCES   (Malaysia)

^c Bloemfontein Medi Clinic   (South Africa)

^d Clinical Centre Nis   (Serbia)

^e UNIVERSITY HOSPITAL HRADEC KRALOVE   (Czech Republic)

^f NOVO NORDISK A S   (Denmark)

^g Bharti Research Institute of Diabetes and Endocrinology   (India)

^h NONE   (Poland)

Author keywords

Biphasic insulin aspart; Glycemic control; Hypoglycemia; Insulin glargine; Once daily; Type 2 diabetes

Indexed keywords

GLIMEPIRIDE; GLUCOSE; HEMOGLOBIN A1C; INSULIN ASPART; INSULIN GLARGINE; METFORMIN; ORAL ANTIDIABETIC AGENT;

ADULT; AGED; ARTICLE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DIABETES CONTROL; DRUG DOSE TITRATION; DRUG EFFICACY; DRUG INDUCED HEADACHE; DRUG SAFETY; DRUG TREATMENT FAILURE; EVENING DOSAGE; FEMALE; GLUCOSE BLOOD LEVEL; HEMOGLOBIN BLOOD LEVEL; HUMAN; HYPOGLYCEMIA; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; NON INSULIN DEPENDENT DIABETES MELLITUS; PATIENT SATISFACTION; RANDOMIZED CONTROLLED TRIAL; RHINOPHARYNGITIS; RISK FACTOR; UPPER RESPIRATORY TRACT INFECTION;

ADMINISTRATION, ORAL; AGED; BLOOD GLUCOSE; DIABETES MELLITUS, TYPE 2; DOSAGE FORMS; DOSE-RESPONSE RELATIONSHIP, DRUG; DRUG ADMINISTRATION SCHEDULE; FEMALE; HUMANS; HYPOGLYCEMIA; HYPOGLYCEMIC AGENTS; INSULIN; MALE; MIDDLE AGED; TREATMENT FAILURE;

EID: 72549114224     PISSN: 03007995     EISSN: 14734877     Source Type: Journal    
DOI: 10.1185/03007990903354674     Document Type: Article

References (17)

1. American Association of Clinical Endocrinologists medical guidelines for clinical practice for the management of diabetes mellitus. Endocr Pract 2007; 13(Suppl. 1):1-68
2. Nathan DM, Buse JB, Davidson MB, et al. Medical management of hyperglycemia in type 2 diabetes: a consensus algorithm for the initiation and adjustment of therapy: a consensus statement of the American Diabetes Association and the European Association for the Study of Diabetes. Diabetes Care 2009;32(1):193-203
3. Heinemann L, Linkeschova R, Rave K, et al. Time-action profile of the long-acting insulin analog insulin glargine (HOE901) in comparison with those of NPH insulin and placebo. Diabetes Care 2000;23(5):644-649 (Pubitemid 30321545)
4. Lepore M, Pampanelli S, Fanelli C, et al. Pharmacokinetics and pharmacodynamics of subcutaneous injection of long-acting human insulin analog glargine, NPH insulin, and ultralente human insulin and continuous subcutaneous infusion of insulin lispro. Diabetes 2000; 49(12):2142-2148
5. Kilo C, Mezitis N, Jain R, et al. Starting patients with type 2 diabetes on insulin therapy using once-daily injections of biphasic insulin aspart 70/30, biphasic human insulin 70/30, or NPH insulin in combination with metformin. J Diabetes Complications 2003;17(6):307-313 (Pubitemid 37315939)
6. 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(1):58-66
7. World Medical Association Declaration of Helsinki. Ethical principles for medical research involving human subjects. JAMA 2000;284(23):3043-3045
8. International Conference on Harmonisation. ICH Harmonised Tripartite Guideline: Guideline for Good Clinical Practice E6(R1) 1996
9. Brod M, Skovlund SE, Wittrup-Jensen KU. Measuring the impact of diabetes through patient report of treatment satisfaction, productivity and symptom experience. Qual Life Res 2006;15(3):481-491
10. Stratton IM, Adler AI, Neil HA, et al. Association of glycaemia with macrovascular and microvascular complications of type 2 diabetes (UKPDS 35): prospective observational study. BMJ 2000;321(7258):405-412 (Pubitemid 30609442)
11. Kann PH, Wascher T, Zackova V, et al. Starting insulin therapy in type 2 diabetes: twice-daily biphasic insulin Aspart 30 plus metformin versus oncedaily insulin glargine plus glimepiride. Exp Clin Endocrinol Diabetes 2006;114(9):527-532 (Pubitemid 44870902)
12. Raskin P, Allen E, Hollander P, et al. Initiating insulin therapy in type 2 Diabetes: a comparison of biphasic and basal insulin analogs. Diabetes Care 2005;28(2):260-265 (Pubitemid 40170923)
13. Chan JC, Malik V, Jia W, et al. Diabetes in Asia: epidemiology, risk factors, and pathophysiology. JAMA 2009;301(20):2129-2140
14. Cryer PE, Davis SN, Shamoon H. Hypoglycemia in diabetes. Diabetes Care 2003;26(6):1902-1912
15. Rosenstock J, Davies M, Home PD, et al. A randomised, 52-week, treat-totarget trial comparing insulin detemir with insulin glargine when administered as add-on to glucose-lowering drugs in insulin-naive people with type 2 diabetes. Diabetologia 2008;51(3):408-416
16. Riddle MC, Rosenstock J, Gerich J. The treat-to-target trial: randomized addition of glargine or human NPH insulin to oral therapy of type 2 diabetic patients. Diabetes Care 2003;26(11):3080-3086 (Pubitemid 37339502)
17. Pramming S, Thorsteinsson B, Bendtson I, et al. Nocturnal hypoglycaemia in patients receiving conventional treatment with insulin. Br Med J (Clin Res Ed) 1985;291(6492):376-379 (Pubitemid 15012998)