Mid- and high-ratio premix insulin analogues: Potential treatment options for patients with type 2 diabetes in need of greater postprandial blood glucose control

Diabetes, Obesity and Metabolism

Volumn 12, Issue 2, 2010, Pages 105-114

  Christiansen, J S ^a   Liebl, A ^b   Davidson, J A ^c   Ligthelm, R J ^d   Halimi, S ^e  

^a AARHUS UNIVERSITY HOSPITAL   (Denmark)

^b Department for Internal Medicine Center for Diabetes and Metabolism M and i Fachklinik Bad Heilbrunn   (Germany)

^c UNIVERSITY OF TEXAS SOUTHWESTERN MEDICAL CENTER   (United States)

^d EHM Clinic   (Netherlands)

^e GRENOBLE UNIVERSITY HOSPITAL   (France)

Author keywords

High ratio premix; Insulin analogue; Intensification; Mid ratio premix; Postprandial hyperglycaemia; Type 2 diabetes

Indexed keywords

BIPHASIC INSULIN; GLUCOSE; HEMOGLOBIN A1C; INSULIN ASPART; INSULIN DERIVATIVE; INSULIN GLARGINE; INSULIN LISPRO; ISOPHANE INSULIN; METFORMIN;

AREA UNDER THE CURVE; BLOOD GLUCOSE MONITORING; CLINICAL TRIAL; DRUG BIOAVAILABILITY; DRUG BLOOD LEVEL; DRUG DOSAGE FORM COMPARISON; DRUG FORMULATION; DRUG SAFETY; DRUG TOLERABILITY; GLUCOSE BLOOD LEVEL; GLYCEMIC CONTROL; HUMAN; HYPERGLYCEMIA; HYPOGLYCEMIA; INSULIN DEPENDENT DIABETES MELLITUS; INSULIN TREATMENT; MAXIMUM PLASMA CONCENTRATION; NON INSULIN DEPENDENT DIABETES MELLITUS; POSTPRANDIAL STATE; REVIEW; SINGLE DRUG DOSE; TIME TO MAXIMUM PLASMA CONCENTRATION; TREATMENT OUTCOME;

EID: 73349128766     PISSN: 14628902     EISSN: 14631326     Source Type: Journal    
DOI: 10.1111/j.1463-1326.2009.01144.x     Document Type: Review

References (42)

1. 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, 359:1577-1589.
2. Stratton IM, Adler AI, Neil HAW. Association of glycaemia with macrovascular and microvascular complications of type 2 diabetes (UKPDS 35): prospective observational study. BMJ 2000, 321:405-412. on behalf of the UK Prospective Diabetes Study Group
3. Monnier L, Lapinski H, Colette C. Contributions of fasting and postprandial plasma glucose increments to the overall diurnal hyperglycemia of type 2 diabetic patients: variations with increasing levels of HbA(1c). Diabetes Care 2003, 26:881-885.
4. Crandall JP, Shamoon H, Cohen HW. Postchallenge hyperglycemia in older adults is associated with increased cardiovascular risk profile. J Clin Endocrinol Metab 2009, 94:1595-1601.
5. Bibra H, Siegmund T, Ceriello A, Volozhyna M, Schumm-Draeger PM. Optimized postprandial glucose control is associated with improved cardiac/vascular function - comparison of three insulin regimens in well-controlled type 2 diabetes. Horm Metab Res 2009, 41:109-115.
6. Ceriello A, Bortolotti N, Motz E. Meal-induced oxidative stress and low-density lipoprotein oxidation in diabetes: the possible role of hyperglycemia. Metabolism 1999, 48:1503-1508.
7. Raz I, Wilson PW, Strojek K. Effects of prandial versus fasting glycemia on cardiovascular outcomes in type 2 diabetes: the HEART2D trial. Diabetes Care 2009, 32:381-386.
8. UK prospective diabetes study 16. Overview of 6 years' therapy of type II diabetes: a progressive disease. Diabetes 1995, 44:1249-1258. UK Prospective Diabetes Study (UKPDS) Group
9. Turner RC, Cull CA, Frighi V, Holman RR. Glycaemic control with diet, sulfonylurea, metformin, or insulin in patients with type 2 diabetes mellitus: progressive requirement for multiple therapies (UKPDS 49). UK Prospective Diabetes Study (UKPDS) Group. JAMA 1999, 281:2005-2012.
10. Wright A, Felix Burden AC, Paisey RB, Cull CA, Holman RR. Sulfonylurea inadequacy. Efficacy of addition of insulin over 6 years in patients with type 2 diabetes in the UK Prospective Diabetes Study (UKPDS 57). Diabetes Care 2002, 25:330-336. for the UK Prospective Diabetes Study Group
11. Velojic-Golubovic M, Mikic D, Pesic M, Dimic D, Radenkovic S, Antic S. Biphasic insulin aspart 30: better glycaemic control than with premixed human insulin 30 in obese patients with type 2 diabetes. J Endocrinol Invest 2009, 32:23-27.
12. Boehm B, Home P, Behrend C, Kamp NM, Lindholm A. Premixed insulin aspart 30 vs. premixed human insulin 30/70 twice daily: a randomized trial in type 1 and type 2 diabetic patients. Diabet Med 2002, 19:393-399.
13. McSorley P, Bell P, Jacobsen L, Kristensen A, Lindholm A. Twice-daily biphasic insulin aspart 30 vs biphasic human insulin 30: a double-blind crossover study in adults with type 2 diabetes mellitus. Clin Ther 2002, 24:530-539.
14. Roach P, Yue L, Arora V. Improved postprandial glycaemic control during treatment with Humalog Mix25, a novel protamine-based insulin lispro formulation. Diabetes Care 1999, 22:1258-1261. The Humalog Mix25 Study Group
15. Rosenfalck AM, Thorsby P, Kjems L. Improved postprandial glycaemic control with insulin Aspart in type 2 diabetic patients treated with insulin. Acta Diabetol 2000, 37:41-46.
16. Brange J, Owens DR, Kang S, Volund A. Monomeric insulins and their experimental and clinical implications. Diabetes Care 1990, 13:923-954.
17. Bolli GB. Physiological insulin replacement in type 1 diabetes mellitus. Exp Clin Endocrinol Diabetes 2001, 109((Suppl. 2)):S317-S332.
18. Brange J, Volund A. Insulin analogs with improved pharmacokinetic profiles. Adv Drug Deliv Rev 1999, 35:307-335.
19. Home PD, Barriocanal L, Lindholm A. Comparative pharmacokinetics of the novel rapid-acting insulin analogue, insulin aspart, in healthy volunteers. Eur J Clin Pharmacol 1999, 55:199-203.
20. Howey DC, Bowsher RR, Brunelle RL, Woodworth JR. (Lys(B28), Pro(B29))-human insulin. A rapidly absorbed analogue of human insulin. Diabetes 1994, 43:396-402.
21. Jacobsen LV, Sogaard B, Riis A. Pharmacokinetics and pharmacodynamics of a premixed formulation of soluble and protamine-retarded insulin aspart. Eur J Clin Pharmacol 2000, 56:399-403.
22. Heise T, Weyer C, Serwas A. Time-action profiles of novel premixed preparations of insulin lispro and NPL insulin. Diabetes Care 1998, 21:800-803.
23. Heise T, Eckers U, Kanc K, Nielsen JN, Nosek L. The pharmacokinetic and pharmacodynamic properties of different formulations of biphasic insulin aspart: a randomized, glucose clamp, crossover study. Diabetes Technol Ther 2008, 10:479-485.
24. Chen J-W, Lauritzen T, Christiansen JJ, Jensen LH, Clausen WH, Christiansen JS. 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 2005, 22:273-277.
25. Thorisdottir RL, Parkner T, Chen JW, Ejskjaer N, Christiansen JS. A comparison of pharmacokinetics and pharmacodynamics of biphasic insulin aspart 30, 50, 70 and pure insulin aspart: a randomized, quadruple crossover study. Basic Clin Pharmacol Toxicol 2009, 104:216-221.
26. Bott S, Tusek C, Heinemann L, Friberg HH, Heise T. The pharmacokinetic and pharmacodynamic properties of biphasic insulin aspart 70 (BIAsp 70) are significantly different from those of biphasic insulin aspart 30 (BIAsp 30). Exp Clin Endocrinol Diabetes 2005, 113:545-550.
27. Malone JK, Kerr LF, Campaigne BN, Sachson RA, Holcombe JH. Combined therapy with insulin lispro Mix 75/25 plus metformin or insulin glargine plus metformin: a 16-week, randomized, open-label, crossover study in patients with type 2 diabetes beginning insulin therapy. Clin Ther 2004, 26:2034-2044. Lispro Mixture-Glargine Study Group
28. Malone JK, Bai S, Campaigne BN, Reviriego J, Augendre-Ferrante B. Twice-daily premixed insulin rather than basal insulin therapy alone results in better overall glycaemic control in patients with type 2 diabetes. Diabet Med 2005, 22:374-381.
29. Liebl A, Prager R, Binz K, Kaiser M, Bergenstal R, Gallwitz B. Comparison of insulin analogue regimens in people with type 2 diabetes mellitus in the PREFER Study: a randomized controlled trial. Diabetes Obes Metab 2009, 11:45-52. PREFER Study Group
30. Garber A, Wahlen J, Wahl T. 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.
31. Robbins DC, Beisswenger PJ, Ceriello A. Mealtime 50/50 basal + prandial insulin analogue mixture with a basal insulin analogue, both plus metformin, in the achievement of target HbA1c and pre- and postprandial blood glucose levels in patients with type 2 diabetes: a multinational, 24-week, randomized, open-label, parallel-group comparison. Clin Ther 2007, 29:2349-2364.
32. Schwartz S, Zagar AJ, Althouse SK, Pinaire JA, Holcombe JH. A single-center, randomized, double-blind, three-way crossover study examining postchallenge glucose responses to human insulin 70/30 and insulin lispro fixed mixtures 75/25 and 50/50 in patients with type 2 diabetes mellitus. Clin Ther 2006, 28:1649-1657.
33. Roach P, Arora V, Campaigne BN, Mattoo V, Rangwala S. Humalog® Mix50™ before carbohydrate-rich meals in type 2 diabetes mellitus. Diabetes Obes Metab 2003, 5:311-316. The India Mix25/Mix50 Study Group
34. Cucinotta D, Smirnova O, Christiansen JS. Three different premixed combinations of biphasic insulin aspart - comparison of the efficacy and safety in a randomized controlled clinical trial in subjects with type 2 diabetes. Diabetes Obes Metab 2009, 11:700-708.
35. Schernthaner G, Kopp H-P, Ristic S, Muzyka B, Peter L, Mitteregger G. Metabolic control in patients with type 2 diabetes using Humalog® Mix50™ injected three times daily: crossover comparison with human insulin 30/70. Horm Metab Res 2004, 36:188-193.
36. Dashora U, Ashwell S, Home P. An exploratory study of the effect of using high-mix biphasic insulin aspart in people with type 2 diabetes. Diabetes Obes Metab 2009, 11:680-687.
37. Clements MR, Tits J, Kinsley BT, Råstam J, Friberg HH, Ligthelm RJ. Improved glycaemic control of thrice-daily biphasic insulin aspart compared with twice-daily biphasic human insulin; a randomized, open-label trial in patients with type 1 or type 2 diabetes. Diabetes Obes Metab 2008, 10:229-237.
38. Standards of medical care in diabetes - 2009. Diabetes Care 2009, 32((Suppl. 1)):S13-S61. American Diabetes Association
39. Ligthelm RJ, Mouritzen U, Lynggaard H. Biphasic insulin aspart given thrice daily is as efficacious as a conventional basal-bolus insulin regimen with four daily injections; a randomised open-label parallel group four months comparison in patients with type 2 diabetes. Exp Clin Endocrinol Diabetes 2006, 114:511-519.
40. Ejskjaer N, Rasmussen M, Kamp N, Lindholm A, Christiansen JS. Comparison of thrice daily 'high' vs. 'medium' premixed insulin aspart with respect to evening and overnight glycaemic control in patients with type 2 diabetes. Diabetes Obes Metab 2003, 5:438-445.
41. Henderson JN, Allen KV, Deary IJ, Frier BM. Hypoglycaemia in insulin-treated type 2 diabetes: frequency, symptoms and impaired awareness. Diabet Med 2003, 20:1016-1021.
42. Christiansen JS, Parkner T, Dyrskog SEU. Clinical pharmacological aspects of biphasic insulin aspart 50 and biphasic insulin aspart 70 in non-obese and obese patients with type 2 diabetes. Diabetologia 2005, 48((Suppl. 1)):A838.