Refining basal insulin therapy: What have we learned in the age of analogues?

Diabetes/Metabolism Research and Reviews

Volumn 23, Issue 6, 2007, Pages 441-454

  DeVries, J H ^a   Nattrass, M ^b   Pieber, T R ^c  

^a ACADEMIC MEDICAL CENTER   (Netherlands)

^b SELLY OAK HOSPITAL   (United Kingdom)

^c MEDICAL UNIVERSITY OF GRAZ   (Austria)

Author keywords

Basal bolus therapy; Basal insulin; Insulin analogue; Insulin detemir; Insulin glargine; NPH insulin

Indexed keywords

GLIMEPIRIDE; GLUCOSE; HEMOGLOBIN A1C; HUMAN INSULIN; INSULIN; INSULIN ASPART; INSULIN DERIVATIVE; INSULIN DETEMIR; INSULIN GLARGINE; INSULIN GLULISINE; INSULIN LISPRO; ISOPHANE INSULIN; METFORMIN; NATEGLINIDE; ORAL ANTIDIABETIC AGENT; PLACEBO;

BLOOD GLUCOSE MONITORING; BOLUS INJECTION; CLINICAL TRIAL; DIABETES MELLITUS; DOSAGE SCHEDULE COMPARISON; DOSE RESPONSE; DOSE TIME EFFECT RELATION; DRUG ABSORPTION; DRUG DISTRIBUTION; DRUG DOSE COMPARISON; DRUG DOSE ESCALATION; DRUG DOSE INCREASE; DRUG DOSE REDUCTION; DRUG DOSE REGIMEN; DRUG DOSE TITRATION; DRUG EFFICACY; DRUG SUBSTITUTION; DRUG TOLERABILITY; DRUG WITHDRAWAL; EVIDENCE BASED MEDICINE; GLYCEMIC CONTROL; HEMOGLOBIN BLOOD LEVEL; HUMAN; HYPOGLYCEMIA; INSULIN DEPENDENT DIABETES MELLITUS; INSULIN HYPOGLYCEMIA; MEDLINE; NON INSULIN DEPENDENT DIABETES MELLITUS; PATIENT SATISFACTION; PHARMACODYNAMICS; PRIORITY JOURNAL; QUALITY OF LIFE; REVIEW; RISK REDUCTION; SIDE EFFECT; WEIGHT GAIN;

CONTROLLED CLINICAL TRIALS; DIABETES MELLITUS, TYPE 1; DIABETES MELLITUS, TYPE 2; DOSE-RESPONSE RELATIONSHIP, DRUG; DRUG ADMINISTRATION SCHEDULE; HUMANS; HYPOGLYCEMIC AGENTS; INSULIN;

EID: 34948861041     PISSN: 15207552     EISSN: 15207560     Source Type: Journal    
DOI: 10.1002/dmrr.762     Document Type: Review

References (58)

1. Hirsch IB. Insulin analogues. N Engl J Med 2005; 352: 174-183.
2. Heise T, Nosek L, Ronn BB, et al. Lower within-subject variability of insulin detemir in comparison to NPH insulin and insulin glargine in people with type 1 diabetes. Diabetes 2004; 53: 1614-1620.
3. Davis S, Alonso MD. Hypoglycaemia as a barrier to glucose control. J Diabetes Complicat 2004; 18: 60-68.
4. Cryer PE, Childs BP. Negotiating the barrier of hypoglycaemia in diabetes. Diab Spec 2002; 15: 20-27.
5. Lindholm A. New insulins in the treatment of diabetes mellitus. Best Pract Res Clin Gastroenterol 2003; 16: 475-492.
6. Bolli GB, Owens DR. Insulin glargine. Lancet 2000; 356(9228): 443-445.
7. Havelund S, Plum A, Ribel U, et al. The mechanism of protraction of insulin detemir, a long-acting, acylated analog of human insulin. Pharm Res 2004; 21: 1498-1504.
8. Kurtzhals P. Engineering predictability and protraction in a basal insulin analogue: the pharmacology of insulin detemir. Int J Obes Relat Metab Disord 2004; 28(Suppl. 2): S23-S28.
9. 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: 644-649.
10. Rave K, Nosek L, Heinemann L, et al. Time-action profile of the long-acting insulin analogue insulin glargine in comparison to NPH insulin in Japanese volunteers. Diabetes Metab 2003; 29: 430-431.
11. 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: 2142-2148.
12. Plank J, Bodenlenz M, Sinner F, et al. A double-blind, randomized, dose-response study investigating the pharmacodynamic and pharmacokinetic properties of the long-acting insulin analog detemir. Diabetes Care 2005; 28: 1107-1112.
13. Klein O, Lynge J, Endahl L, et al. Albumin-bound basal insulin analogues (insulin detemir and NN344): comparable time-action profiles but less variability than insulin glargine in type 2 diabetes. Diabetes Obes Metab 2007; 9: 290-299.
14. Hermansen K, Fontaine P, Kukolja KK, et al. Insulin analogues (insulin detemir and insulin aspart) versus traditional human insulins (NPH insulin and regular human insulin) in basal-bolus therapy for patients with type 1 diabetes. Diabetologia 2004; 47: 622-629.
15. Murphy NP, Keane SM, Ong KK, et al. Randomized cross-over trial of insulin glargine plus lispro or NPH insulin plus regular human insulin in adolescents with type 1 diabetes on intensive insulin regimens. Diabetes Care 2003; 26: 799-804.
16. Ashwell SG, Amiel SA, Bilous RW, et al. Improved glycaemic control with insulin glargine plus insulin lispro: a multicentre, randomized, cross-over trial in people with Type 1 diabetes. Diabet Med 2006; 23: 285-292.
17. Porcellati F, Rossetti P, Pampanelli S, et al. Better long-term glycaemic control with the basal insulin glargine as compared with NPH in patients with Type 1 diabetes mellitus given meal-time lispro insulin. Diabet Med 2004; 21: 1213-1220.
18. Hermansen K, Davies M. Does insulin detemir have a role in reducing risk of insulin-associated weight gain? Diabetes Obes Metab 2007; 9: 209-217.
19. Wagner J, Malchoff C, Abbott G. Invasiveness as a barrier to self-monitoring of blood glucose in diabetes. Diabetes Technol Ther 2005; 7: 612-619.
20. Chatterjee S, Jarvis-Kay J, Rengarajan T, Lawrence IG, McNally PG, Davies MJ. Glargine versus NPH insulin: Efficacy in comparison with insulin aspart in a basal bolus regimen in type 1 diabetes-The glargine and aspart study (GLASS) A randomised cross-over study. Diabetes Res Clin Pract 2007; 77: 215-222.
21. Pieber TR, Draeger E, Kristensen A, et al. Comparison of three multiple injection regimens for Type 1 diabetes: morning plus dinner or bedtime administration of insulin detemir vs. morning plus bedtime NPH insulin. Diabet Med 2005; 22: 850-857.
22. Raskin P, Klaff L, Bergenstal R, et al. A 16-week comparison of the novel insulin analog insulin glargine (HOE 901) and NPH human insulin used with insulin lispro in patients with type 1 diabetes. Diabetes Care 2000; 23: 1666-1671.
23. Ratner RE, Hirsch IB, Neifing JL, et al. Less hypoglycemia with insulin glargine in intensive insulin therapy for type 1 diabetes. U.S. Study Group of Insulin Glargine in Type 1 Diabetes. Diabetes Care 2000; 23: 639-643.
24. Rosenstock J, Schwartz SL, Clark CM Jr, et al. Basal insulin therapy in type 2 diabetes: 28-week comparison of insulin glargine (HOE 901) and NPH insulin. Diabetes Care 2001; 24: 631-636.
25. Schober E, Schoenle E, Van Dyk J, et al., Pediatric Study Group of Insulin Glargine. Comparative trial between insulin glargine and NPH insulin in children and adolescents with type 1 diabetes mellitus. J Pediatr Endocrinol Metab 2002; 15: 369-376.
26. Hershon KS, Blevins TC, May CA, Rosskamp R. Once-daily insulin glargine compared with twice-daily NPH insulin in patients with type 1 diabetes. Endocr Pract 2004; 10: 10-17.
27. Home PD, Rosskamp R, Forjanic-Klapproth J, et al., European Insulin Glargine Study Group. A randomized multicentre trial of insulin glargine compared with NPH insulin in people with type 1 diabetes. Diabetes Metab Res Rev 2005; 21: 545-553.
28. Hamann A, Matthaei S, Rosak C, et al., HOE901/4007 Study Group. A randomized clinical trial comparing breakfast, dinner, or bedtime administration of insulin glargine in patients with type 1 diabetes. Diabetes Care 2003; 26: 1738-1744.
29. Ashwell SG, Gebbie J, Home PD. Twice-daily compared with once-daily insulin glargine in people with Type 1 diabetes using meal-time insulin aspart. Diabet Med 2006; 23: 879-886.
30. Albright ES, Desmond R, Bell DS. Efficacy of conversion from bedtime NPH insulin injection to once- or twice-daily injections of insulin glargine in type 1 diabetic patients using basal/bolus therapy. Diabetes Care 2004; 27: 632-633.
31. Garg SK, Gottlieb PA, Hisatomi ME, et al. Improved glycemic control without an increase in severe hypoglycemic episodes in intensively treated patients with type 1 diabetes receiving morning, evening, or split dose insulin glargine. Diabetes Res Ciin Pract 2004; 66: 49-56.
32. Russell-Jones D, Simpson R, Hylleberg B, et al. Effects of QD insulin detemir or neutral protamine Hagedorn on blood glucose control in patients with type I diabetes mellitus using a basal-bolus regimen. Clin Ther 2004; 26: 724-736.
33. Pieber T, Treichel HC, Robertson L, Mordhorst L, Gall MA. Insulin detemir plus insulin aspart is associated with less risk of major as well as nocturnal hypoglycaemia than insulin glargine plus insulin aspart at comparable levels of glycaemic control in type 1 diabetes. Diabetologia 2005; 48(Suppl. 1): A92.
34. Garg SK, Rosenstock J, Ways K. Optimized Basal-bolus insulin regimens in type 1 diabetes: insulin glulisine versus regular human insulin in combination with Basal insulin glargine. Endocr Pract 2005; 11: 11-17.
35. Yki-Jarvinen H, Dressler A, Ziemen M, The HOE 901/3002 Study Group. Less nocturnal hypoglycaemia and better post-dinner glucose control with bedtime insulin glargine compared with bedtime NPH insulin during insulin combination therapy in type 2 diabetes. Diabetes Care 2000; 23: 1130-1136.
36. Riddle MC, Rosenstock J, Gerich J, on behalf of 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 2003; 26: 3080-3086.
37. Fritsche A, Schweitzer MA, Haring HU, 4001 Study Group. Glimepiride combined with morning insulin glargine, bedtime neutral protamine Hagedorn insulin, or bedtime insulin glargine in patients with type 2 diabetes. A randomized, controlled trial. Ann Intern Med 2003; 138: 952-959.
38. Massi Benedetti M, Humburg E, Dressler A, et al., for the 3002 Study Group. A one-year, randomised, multicentre trial comparing insulin glargine with NPH insulin in combination with oral agents in patients with type 2 diabetes. Horm Metab Res 2003; 35: 189-196.
39. Standl E, Maxeiner S, Raptis S, HOE901/4009 Study Group. Once-daily insulin glargine administration in the morning compared to bedtime in combination with morning glimepiride in patients with type 2 diabetes: an assessment of treatment flexibility. Horm Metab Res 2006; 38: 172-177.
40. Kennedy L, Herman WH, Strange P, Harris A, GOAL AIC Team. Impact of active versus usual algorithmic titration of basal insulin and point-of-care versus laboratory measurement of HbA1c on glycemic control in patients with type 2 diabetes: the Glycemic Optimization with Algorithms and Labs at Point of Care (GOAL A1C) trial. Diabetes Care 2006; 29: 1-8.
41. Philis-Tsimikas A, Charpentier G, Clauson P, et al. Comparison of once-daily insulin detemir with NPH insulin added to a regimen of oral antidiabetic drugs in poorly controlled type 2 diabetes. Clin Ther 2006; 28: 1569-1581.
42. Hermansen K, Davies M, Derezinski T, et al. A 26-week, randomized, parallel, treat-to-target trial comparing insulin detemir with NPH insulin as add-on therapy to oral glucose-lowering drugs in insulin-naive people with type 2 diabetes. Diabetes Care 2006; 29: 1269-1274.
43. Riddle MC. Evening insulin strategy. Diabetes Care 1990; 13: 676-686.
44. 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.
45. Monnier L, Colette C, Monnier L, Colette C. Contributions of fasting and postprandial glucose to hemoglobin A1c. Endocr Pract 2006; 12(Suppl. 1): 42-46.
46. Yki-Jarvinen H, Kauppinen-Makelin R, Tiikkainen M, et al. Insulin glargine or NPH combined with metformin in type 2 diabetes: the LANMET study. Diabetologia 2006; 49: 442-451.
47. Dashora UK, Sibal L, Ashwell SG, Home PD. Insulin glargine in combination with nateglinide in people with Type 2 diabetes: a randomized placebo-controlled trial. Diabet Med 2007; 24: 344-349.
48. Ashwell SG, Gebbie J, Home PD. Optimal timing of injection of once-daily insulin glargine in people with Type 1 diabetes using insulin lispro at meal-times. Diabet Med 2006; 23: 46-52.
49. Fulcher GR, Gilbert RE, Yue DK. Glargine is superior to neutral protamine Hagedorn for improving glycated haemoglobin and fasting blood glucose levels during intensive insulin therapy. Intern Med J 2005; 35: 536-542.
50. Standl E, Lang H, Roberts A. The 12-month efficacy and safety of insulin detemir and NPH insulin in basal-bolus therapy for the treatment of type 1 diabetes. Diabetes Technol Ther 2004; 6: 579-588.
51. Kolendorf K, Ross GP, Pavlic-Renar I, et al. Insulin detemir lowers the risk of hypoglycaemia and provides more consistent plasma glucose levels compared with NPH insulin in Type 1 diabetes. Diabet Med 2006; 23: 729-735.
52. De Leeuw I, Vague P, Selam JL, et al. Insulin detemir used in basal-bolus therapy in people with type 1 diabetes is associated with a lower risk of nocturnal hypoglycaemia and less weight gain over 12 months in comparison to NPH insulin. Diabetes Obes Metab 2005; 7: 73-82.
53. Vague P, Selam JL, Skeie S, et al. Insulin detemir is associated with more predictable glycemic control and reduced risk of hypoglycemia than NPH insulin in patients with type 1 diabetes on a basal-bolus regimen with premeal insulin aspart. Diabetes Care 2003; 26: 590-596.
54. Home P, Bartley P, Russell-Jones D, et al., Study to Evaluate the Administration of Detemir Insulin Efficacy, Safety and Suitability (STEADINESS) Study Group. Insulin detemir offers improved glycemic control compared with NPH insulin in people with type 1 diabetes: a randomized clinical trial. Diabetes Care 2004; 27: 1081-1087.
55. Fonseca V, Bell DS, Berger S, et al. A comparison of bedtime insulin glargine with bedtime neutral protamine hagedorn insulin in patients with type 2 diabetes: subgroup analysis of patients taking once-daily insulin in a multicenter, randomized, parallel group study. Am J Med Sci 2004; 328: 274-280.
56. Haak T, Tiengo A, Draeger E, et al. Lower within-subject variability of fasting blood glucose and reduced weight gain with insulin detemir compared to NPH insulin in patients with type 2 diabetes. Diabetes Obes Metab 2005; 7: 56-64.
57. Raslova K, Bogoev M, Raz I, et al. Insulin detemir and insulin aspart: a promising basal-bolus regimen for type 2 diabetes. Diabetes Res Clin Pract 2004; 66: 193-201, Erratum Diabetes Res Clin Pract. 2006; 72: 112.
58. Eliaschewitz FG, Calvo C, Valbuena H, et al., HOE 901/4013 LA Study Group. Therapy in type 2 diabetes: insulin glargine vs. NPH insulin both in combination with glimepiride. Arch Med Res 2006; 37: 495-501.