Comparison of biphasic insulin aspart 30 given three times daily or twice daily in combination with metformin versus oral antidiabetic drugs alone in patients with poorly controlled type 2 diabetes: A 16-week, randomized, open-label, parallel-group trial conducted in russia

Clinical Therapeutics

Volumn 29, Issue 11, 2007, Pages 2374-2384

  Ushakova, Olga ^a   Sokolovskaya, Vera ^b   Morozova, Alla ^c   Valeeva, Farida ^d   Zanozina, Olga ^e   Sazonova, Olga ^f   Zhadanova, Elena ^g   Starceva, Maria ^h   Kazakova, Elena ⁱ   Saifullina, Marina ^j   Shapiro, Irina ^a   Tarasov, Alexander ^k   Al Tayar, Bassam ^b   Starkova, Ninella ^b  

^a Department of Prophylactic Medicine   (Russian Federation)

^b NOVO NORDISK A S   (Denmark)

^c PACIFIC STATE MEDICAL UNIVERSITY   (Russian Federation)

^d KAZAN STATE MEDICAL UNIVERSITY   (Russian Federation)

^e Nizhni Novgorod Academy ^*  (Russian Federation)

^f NOVOSIBIRSK STATE MEDICAL UNIVERSITY   (Russian Federation)

^g Municipal Out patient Clinic No 4   (Russian Federation)

^h Regional Hospital   (Russian Federation)

ⁱ Municipal Clinical Hospital No 1   (Russian Federation)

^j Omsk Diagnostic Centre   (Russian Federation)

^k Regional Endocrinology Dispensary   (Russian Federation)

more..

Author keywords

intensification; oral antidiabetic drugs; premixed insulin; therapy; type 2 diabetes

Indexed keywords

2,4 THIAZOLIDINEDIONE DERIVATIVE; ALPHA GLUCOSIDASE INHIBITOR; HEMOGLOBIN A1C; INSULIN ASPART; MEGLITINIDE; METFORMIN; ORAL ANTIDIABETIC AGENT; SULFONYLUREA;

ADULT; ARTICLE; ASTHMA; BODY MASS; BODY WEIGHT; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DOSAGE SCHEDULE COMPARISON; DRUG DOSE TITRATION; DRUG EFFICACY; DRUG ERUPTION; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; FEMALE; GLUCOSE BLOOD LEVEL; GLYCEMIC CONTROL; HEMOGLOBIN BLOOD LEVEL; HUMAN; HYPOGLYCEMIA; MAJOR CLINICAL STUDY; MALE; MONOTHERAPY; MULTICENTER STUDY; NON INSULIN DEPENDENT DIABETES MELLITUS; OPEN STUDY; PATIENT COMPLIANCE; PATIENT SATISFACTION; QUALITY OF LIFE; QUESTIONNAIRE; RANDOMIZED CONTROLLED TRIAL; RASH; RUSSIAN FEDERATION; SELF MONITORING; SIDE EFFECT; WEIGHT CHANGE; WEIGHT GAIN;

BIOLOGICAL MARKERS; BLOOD GLUCOSE; DIABETES MELLITUS, TYPE 2; DRUG THERAPY, COMBINATION; ENDPOINT DETERMINATION; FEMALE; HEMOGLOBIN A, GLYCOSYLATED; HUMANS; HYPOGLYCEMIA; HYPOGLYCEMIC AGENTS; INSULIN; MALE; METFORMIN; MIDDLE AGED; QUALITY OF LIFE; RUSSIA; WEIGHT GAIN;

EID: 37449027138     PISSN: 01492918     EISSN: 1879114X     Source Type: Journal    
DOI: 10.1016/j.clinthera.2007.11.017     Document Type: Article

References (32)

1. Korytkowski M. When oral agents fail: Practical barriers to starting insulin. Int J Obes Relat Metab Disord 26 Suppl 3 (2002) S18-S24
2. Riddle M., Rosenstock J., Gerich J., and for the Insulin Glargine 4002 Study Investigators. The treat-to-target trial: Randomized addition of glargine or human NPH insulin to oral therapy of type 2 diabetic patients. Diabetes Care 26 (2003) 3080-3086
3. Riddle M. Timely initiation of basal insulin. Am J Med 116 Suppl 3A (2004) 3S-9S
4. Rosenstock J. Basal insulin supplementation in type 2 diabetes: Refining the tactics. Am J Med 116 Suppl 3A (2004) 10S-16S
5. Ceriello A. The possible role of postprandial hyperglycaemia in the pathogenesis of diabetic complications. Diabetologia 46 Suppl 1 (2003) M9-M16
6. Monnier L., Lapinski H., and Colette C. Contributions of fasting and postprandial glucose increments to the overall di-urnal hyperglycemia of type 2 diabetic patients: Variations with increasing levels of HbA(lc). Diabetes Care 26 (2003) 881-885
7. 1c. Diab Metab Res Rev 20 Suppl 2 (2004) S9-S12
8. Ceriello A. Postprandial hyperglycemia and diabetes complications: Is it time to treat?. Diabetes 54 (2005) 1-7
9. Gerich J. Clinical significance, pathogenesis, and management of postprandial hyperglycemia. Arch Intern Med 163 (2003) 1306-1316
10. Abrahamson M. Optimal glycemic control in type 2 diabetes mellitus: Fasting and postprandial glucose in context. Arch Intern Med 164 (2003) 486-491
11. Hanefeld M., and Temelkova-Kurktschiev T. Control of post-prandial hyperglycemia-an essential part of good diabetes treatment and prevention of cardiovascular complications. Nutr Metab Cardiovasc Dis 12 (2002) 98-107
12. Owens D., Zinman B., and Bolli G. Insulins today and beyond. Lancet 358 (2001) 739-746
13. Weyer C., Heise T., and Heinemann T. Insulin aspart in a 30/70 premixed formulation. Pharmacodynamic properties of a rapid-acting insulin analog in stable mixture. Diabetes Care 20 (1997) 1612-1614
14. Boehm B., Home P., Behrend C., et al. Premixed insulin aspart 30 vs. premixed human insulin 30/70 twice daily: A randomized trial in Type 1 and Type 2 diabetic patients. [published correction appears in Diabet Med. 2002;19:797]. Diabet Med 19 (2002) 393-399
15. Boehm B., Vaz J., Bronsted L., and Home P. Long-term efficacy and safety of biphasic insulin aspart 30 in patients with type 2 diabetes. Eur J Intern Med 15 (2004) 496-502
16. Inzucchi S. Oral antihyperglycemic therapy for type 2 diabetes: Scientific review. JAMA 287 (2002) 360-372
17. Lebovitz H. Oral antidiabetic agents: 2004. Med Clin North Am 88 (2004) 847-863
18. Kvapil M., Swatko A., Hilberg C., and Shestakova M. Biphasic insulin aspart 30 plus metformin: An effective combination in type 2 diabetes. Diabetes Obes Metab 8 (2006) 39-48
19. McSorley P., Bell P., Jacobsen L., et al. Twice-daily biphasic insulin aspart 30 versus biphasic human insulin 30: A double-blind crossover study in adults with type 2 diabetes mellitus. Clin Ther 24 (2002) 530-539
20. Christiansen J., Vaz J., Bogoev M., and Dedov I. Twice daily biphasic insulin aspart improves postprandial glycaemic control more effectively than twice daily NPH insulin, with low risk of hypoglycaemia, in patients with type 2 diabetes. Diabetes Obes Metab 5 (2003) 446-454
21. Meadows K., Abrams C., and Sandbaek A. Adaptation of the Diabetes Health Profile (DH P-1 ) for use with patients with Type 2 diabetes mellitus: Psychometric evaluation and cross-cultural comparison. DiabetMed 17 (2000) 572-580
22. Bradley C., and Gamsu D. Guidelines for encouraging psychological well-being: Report of a Working Group of the World Health Organization Regional Office for Europe and International Diabetes Federation European Region St Vincent Declaration Action Programme for Diabetes. Diabet Med 11 (1994) 510-516
23. 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 Diabet Complications 17 (2003) 307-313
24. McNally P., Dean J., Morris A., et al. Using continuous glucose monitoring to measure the frequency of low glucose values when using biphasic insulin aspart 30 compared with biphasic human insulin 30: A double-blind crossover study in individuals with type 2 diabetes. Diabetes Care 30 (2007) 1044-1048
25. Raskin P., Allen E., Hollander P., et al., for the INITIATE Study Group. Initiating insulin therapy in type 2 diabetes: A comparison of biphasic and basal insulin analogs. Diabetes Care 28 (2005) 260-265
26. Garber A., Wahlen J., Wahl T., et al. Attainment ofglycaemic 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 8 (2006) 58-66
27. Heise T., Tusek C., Bott S., et al. Investigating the drug accumulation of two premixed insulins. Diabetes 52 Suppl 1 (2003) A121 Abstract 519-P
28. Chen J., Lauritzen T., Christiansen J., et al. Pharmacokinetic profiles of biphasic insulin aspart 30/70 and 70/30 in patients with Type 1 diabetes: A randomized double-blinded crossover study. Diabet Med 22 (2005) 273-277
29. Rubin R., and Peyrot M. Quality of life, treatment satisfaction, and treatment preference associated with use of a pen device delivering a premixed 70/30 insulin aspart suspension (aspart protamine suspension/soluble aspart) versus alternative treatment strategies. [published correction appears in Diabetes Care. 2004;27: 3032]. Diabetes Care 27 (2004) 2495-2497
30. de Grauw W., van de Lisdonk E., van Gerwen W., et al. Insulin therapy in poorly controlled type 2 diabetic patients: Does it affect quality of life?. Br J Gen Pract 51 (2001) 527-532
31. Wilson M., Moore M., and Lunt H. Treatment satisfaction after commencement of-insulin in Type 2 diabetes. Diabetes Res Clin Pract 66 (2004) 263-267
32. Brod M., Lammert M., and Raskin P. omparison of-treatment satisfaction of twice-daily BIAsp 70/30 with once- daily insulin glargine in patients with type 2 diabetes. Diabetes 54 Suppl 1 (2005) A114 Abstract 461-P