Efficacy and safety of biphasic insulin aspart 30 combined with pioglitazone in type 2 diabetes poorly controlled on glibenclamide (glyburide) monotherapy or combination therapy: An 18-week, randomized, open-label study

Clinical Therapeutics

Volumn 27, Issue 9, 2005, Pages 1432-1443

  Raz, Itamar ^a   Stranks, Stephen ^b   Filipczak, Robert ^c   Joshi, Pankaj ^d   Lertoft, Benedikte ^e   Rastam, Jacob ^e   Chow, Chun Chung ^f   Shaban, Joseph ^g  

^a HADASSAH HEBREW UNIVERSITY MEDICAL CENTER   (Israel)

^b REPATRIATION GENERAL HOSPITAL   (Australia)

^c Diabetes Unit   (Poland)

^d Louis Pasteur Medical Centre   (South Africa)

^e NOVO NORDISK A S   (Denmark)

^f CHINESE UNIVERSITY OF HONG KONG   (Hong Kong)

^g WINDSOR REGIONAL HOSPITAL   (Canada)

Author keywords

Biphasic insulin aspart; Glibenclamide; Glyburide; Glycemic control; Pioglitazone; Sulfonylurea; Type 2 diabetes

Indexed keywords

BIPHASIC INSULIN; GLIBENCLAMIDE; HEMOGLOBIN A1C; NEUTRAL INSULIN; PIOGLITAZONE; PLASMINOGEN ACTIVATOR INHIBITOR;

ADULT; ARTICLE; BODY MASS; CELLULITIS; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DIET RESTRICTION; DRUG DELIVERY SYSTEM; DRUG EFFICACY; DRUG SAFETY; EDEMA; FEMALE; GLUCOSE BLOOD LEVEL; GLYCEMIC INDEX; HEADACHE; HEART INFARCTION; HUMAN; HYPOGLYCEMIA; LIPID BLOOD LEVEL; LOW DRUG DOSE; MAJOR CLINICAL STUDY; MALE; MONOTHERAPY; MULTICENTER STUDY; NON INSULIN DEPENDENT DIABETES MELLITUS; PERIPHERAL EDEMA; PROSTATE HYPERTROPHY; PROTEIN BLOOD LEVEL; RANDOMIZED CONTROLLED TRIAL; SIDE EFFECT; UPPER RESPIRATORY TRACT INFECTION; WEIGHT GAIN;

BLOOD GLUCOSE; DIABETES MELLITUS, TYPE 2; DRUG THERAPY, COMBINATION; FEMALE; GLYBURIDE; HEMOGLOBIN A, GLYCOSYLATED; HUMANS; HYPOGLYCEMIC AGENTS; INSULIN; MALE; THIAZOLIDINEDIONES; TIME FACTORS; TRIGLYCERIDES; WEIGHT GAIN;

EID: 27744500426     PISSN: 01492918     EISSN: 1879114X     Source Type: Journal    
DOI: 10.1016/j.clinthera.2005.09.001     Document Type: Article

References (35)

1. UK Prospective Diabetes Study Group UK Prospective Diabetes Study 16. Overview of 6 years' therapy of type II diabetes: A progressive disease [published correction appears in Diabetes. 1996;45:1655] Diabetes 44 1995 1249 1258
2. Van Gaal LF, and De Leeuw IH Rationale and options for combination therapy in the treatment of type 2 diabetes Diabetologia 46 Suppl 1 2003 M44 M50
3. Basu AK, Bandyopadhyay D, and Bandyopadhyay R Insulin in type 2 diabetes: Promises to keep J Indian Med Assoc 102 2004 438
4. Basu AK, Bandyopadhyay D, and Bandyopadhyay R Insulin in type 2 diabetes: Promises to keep J Indian Med Assoc 102 2004 440
5. Basu AK, Bandyopadhyay D, and Bandyopadhyay R Insulin in type 2 diabetes: Promises to keep J Indian Med Assoc 102 2004 442
6. UK Prospective Diabetes Study (UKPDS) Group Intensive blood-glucose control with sulphonylureas or insulin compared with conventional treatment and risk of complications in patients with type 2 diabetes (UKPDS 33) [published correction appears in Lancet. 1999;354:602] Lancet 352 1998 837 853
7. for the INS-2061 Study Team Schwartz S, Sievers R, and Strange P Insulin 70/30 mix plus metformin versus triple oral therapy in the treatment of type 2 diabetes after failure of two oral drugs: Efficacy, safety, and cost analysis Diabetes Care 26 2003 2238 2243
8. European Diabetes Policy Group A desktop guide to type 2 diabetes mellitus Diabet Med 16 1999 716 730
9. for the UK Insulin Aspart Study Group Home PD, Lindholm A, Hylleberg B, and Round P Improved glycemic control with insulin aspart: A multicenter randomized double-blind crossover trial in type 1 diabetic patients Diabetes Care 21 1998 1904 1909
10. Lindholm A, McEwen J, and Riis AP Improved postprandial glycemic control with insulin aspart. A randomized double-blind cross-over trial in type 1 diabetes Diabetes Care 22 1999 801 805
11. for the European Insulin Aspart Study Group Home PD, Lindholm A, and Riis A Insulin aspart vs. human insulin in the management of long-term blood glucose control in type 1 diabetes mellitus: A randomized controlled trial Diabet Med 17 2000 762 770
12. Rosenfalck AM, Thorsby P, and Kjems L Improved postprandial glycaemic control with insulin aspart in type 2 diabetic patients treated with insulin Acta Diabetol 37 2000 41 46
13. Jacobsen LV, Sogaard B, and Riis A Pharmacokinetics and pharmacodynamics of a premixed formulation of soluble and protamine-retarded insulin aspart Eur J Clin Pharmacol 56 2000 399 403
14. Boehm BO, Home PD, and Behrend C 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. Hermansen K, Colombo M, and Storgaard H Improved postprandial glycemic control with biphasic insulin aspart relative to biphasic insulin lispro and biphasic human insulin in patients with type 2 diabetes Diabetes Care 25 2002 883 888
16. McSorley PT, Bell PM, and Jacobsen LV 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
17. Owens DR, Zinman B, and Bolli GB Insulins today and beyond [published correction appears in Lancet. 2001;358:1374] Lancet 358 2001 739 746
18. Buse J Combining insulin and oral agents Am J Med 108 Suppl 6a 2000 23S 32S
19. Yki-Jarvinen H, Ryysy L, and Nikkila K Comparison of bedtime insulin regimens in patients with type 2 diabetes mellitus. A randomized, controlled trial Ann Intern Med 130 1999 389 396
20. Kilo C, Mezitis N, and Jain R 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 17 2003 307 313
21. Raz I, Mouritzen U, and Vaz J Addition of biphasic insulin aspart 30 to rosiglitazone in type 2 diabetes mellitus that is poorly controlled with glibenclamide monotherapy Clin Ther 25 2003 3109 3123
22. Strowig SM, Aviles-Santa ML, and Raskin P Improved glycemic control without weight gain using triple therapy in type 2 diabetes Diabetes Care 27 2004 1577 1583
23. for the INITIATE Study Group Raskin P, Allen E, and Hollander P Initiating insulin therapy in type 2 diabetes: A comparison of biphasic and basal insulin analogs Diabetes Care 28 2005 260 265
24. World Medical Association Declaration of Helsinki: Ethical principles for medical research involving human subjects JAMA 284 2000 3043 3045
25. Yki-Jarvinen H Thiazolidinediones N Engl J Med 351 2004 1106 1118
26. Stratton IM, Adler AI, and Neil HA Association of glycaemia with macrovascular and microvascular complications of type 2 diabetes (UKPDS 35): Prospective observational study BMJ 321 2000 405 412
27. Boyle PJ, King AB, and Olansky L Effects of pioglitazone and rosiglitazone on blood lipid levels and glycemic control in patients with type 2 diabetes mellitus: A retrospective review of randomly selected medical records Clin Ther 24 2002 378 396
28. Staels B The clinical significance of PPARalpha and gamma agonism Br J Diabetes Vasc Dis 2 Suppl 1 2002 S28 S31
29. Juhan-Vague I, and Alessi MC PAI-1, obesity, insulin resistance and risk of cardiovascular events Thromb Haemost 78 1997 656 660
30. Buch HN, Baskar V, and Barton DM Combination of insulin and thiazolidinedione therapy in massively obese patients with type 2 diabetes Diabet Med 19 2002 572 574
31. Kermani A, and Garg A Thiazolidinedione-associated congestive heart failure and pulmonary edema Mayo Clin Proc 78 2003 1088 1091
32. Tolman KG, and Chandramouli J Hepatotoxicity of the thiazolidinediones Clin Liver Dis 7 2003 369 379
33. Gerich JE Contributions of insulin-resistance and insulin-secretory defects to the pathogenesis of type 2 diabetes mellitus Mayo Clin Proc 78 2003 447 456
34. Smith SR, De Jonge L, and Volaufova J Effect of pioglitazone on body composition and energy expenditure: A randomized controlled trial Metabolism 54 2005 24 32
35. Meriden T Progress with thiazolidinediones in the management of type 2 diabetes mellitus Clin Ther 26 2004 177 190