Long‑term evaluation of patients with type 1 diabetes mellitus treated with insulin glargine
Authors:
I. Haladová; S. Lacigová; D. Čechurová; Z. Jankovec; M. Krčma; Z. Rušavý
Authors‘ workplace:
Diabetologické centrum I. interní kliniky Lékařské fakulty UK a FN Plzeň, přednosta doc. MU Dr. Martin Matějovič, Ph. D.
Published in:
Vnitř Lék 2009; 55(11): 1016-1021
Category:
Original Contributions
Overview
Aims of the study:
To evaluate long‑term effects of treatment with insulin analogue glargine in patients with type 1 diabetes mellitus and to follow up their further course of life. Patient sample and methodology: Retrospective evaluation of 114 patients who, from September 2004, had their basal insulin changed from NPH insulin to insulin glargine. Treatment was changed again in patients in whom a year- long treatment with insulin glargine did not bring improvement in diabetes control. The original sample was divided into 3 groups and the results compared. Compensation of diabetes (HbA1c) after 1, 2 and 3 years and changes to basal and bolus daily insulin dose and body weight were evaluated. Results: The results are presented as median and 25th and 75th percentile. Group A – 75 patients (65%) treated for the entire evaluation period with insulin glargine. Initial HbA1c was 7.3 (6.4– 8.2) %, 6.9 (6.0– 8.4) % after 1 year, 7.1 (5.9– 7.9) % after 2 years and 6.6 (5.5– 7.7) % after 3 years (p < 0.001). We did not identify any statistically significant changes to total, basal or bolus daily dose of insulin or statistically significant body weight increase over the evaluation period. Group B – 19 patients (17%). Switch from insulin glargine to detemir twice daily. Initial HbA1c was 7.3 (6.9– 8.5) %, 7.4 (6.8– 8.7) % after 1 year of treatment with insulin glargine, 7.7 (7.2– 8.1) % before the treatment switch and 7.8 (6.7 – 805) % (NS) after 3 years of treatment. Daily dose of total, basal and bolus insulin did not change and, similarly, no statistically significant change to patients’ body weight was identified. Group C – 17 patients (15%). Switch from insulin glargine to an insulin pump. This group had better initial compensation with HbA1c 6.7 (5.7– 8.6) %, HbA1c after 1 year was 6.2 (5.6– 8.1) %, 7.0 (6.0– 7.4) % before the treatment switch and 6.3 (5.2– 7.7) % after 3 years of treatment. Total daily insulin dose: 48 (34– 60) – 38 (25– 49) IU/ day (NS). Basal daily insulin dose: 17.5 (13– 28) IU/ day – 23 (12– 32) IU/ day (NS). Bolus daily dose decreased significantly: from 25.5 (21– 33) to 15.5 (12– 22) IU/ day (p < 0.01). Body weight: 76 (71– 97) kg – 73 (72– 99) kg (NS). Only 3% of patients went back to NPH insulin. Conclusion: Insulin glargine brings improved control of diabetes. The dose of insulin glargine did not differ from NPH insulin. No statistically significant body weight increase was observed during the evaluation period.
Key words:
type 1 diabetes mellitus – diabetes control – insulin glargine
Sources
1. Green A, Patterson CC. EURODIAB TIGER Study Group. Europe and Diabetes. Trends in the incidence of childhood – onset diabetes in Europe 1989– 1998. Diabetologia 2001; 44: (Suppl 3): B3– B8.
2. The Diabetes Control and Complication Trial (DCCT) Research Group. The effect of intensive treatment on the development and progression of long‑ term comlications in insulin‑ dependent diabetes mellitus. N Engl J Med 1993; 329: 977– 986.
3. Brinchmann‑ Hansen O, Dahl- Jorgensen K, Sandvik L et al. Blood glucose concentrations and progression of diabetic retinopathy: the seven year results of the Oslo study. BMJ 1992; 304: 19– 22.
4. ČDS. Standardy péče o diabetes mellitus 1. typu. DMEV 2007; 10: 185– 188.
5. The Diabetes Control and Complication Trial Research Group (1993). The effects of intensive treatment of diabetes on the development and progression of long‑ term complications in insulin‑dependent diabetes mellitus. N Engl J Med 2006; 329: 977– 986.
6. Ashwell SG, Bradley C, Stephens JW et al. Treatment satisfaction and quality of life with insulin glargine plus insulin lispro compared with NPH insulin plus unmodified human insulin in individuals with type 1 diabetes. Diabetes Care 2008; 31: 1112– 1117.
7. Haladová I, Lacigová S, Jankovec Z et al. Klinické zkušenosti s léčbou dlouhodobým inzulinovým analogem glargin v diabetologickém centru. Vnitř Lék 2007; 53: 632– 636.
8. Brož J, Kožnarová R, Bartášková D et al. Současné možnosti léčby diabetes mellitus pomocí inzulinových pump. DMEV 2006; 9: 179– 186.
9. Hirsch IB, Brownlee M. Should minimal blood glucose variability become the gold standard of glycemic control? J Diabetes Complications 2005; 19: 178– 181.
10. Gough S A. review of human and analogue insulin trials. Diabetes Res Clin Pract 2007; 77: 1– 15.
11. 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.
12. Gallen I, Carter C. Prospective audit of the introduction of insulin glargine (Lantus) into clinical practice in type 1 diabetes. Pract Diab Int 2004; 21: 110– 114.
13. Kudva YC, Basu A, Jenkins GD al. Randomized controlled clinical trial of glargin versus ultralente insulin in the fragment of type 1 diabetes. Diabetes Care 2005; 28: 10– 14.
14. Hirsch IB. Insulin analogues. N Engl J Med 2005; 352: 174– 183.
15. Rosenstock J, Park G, Zimmerman J et al. Basal insulin glargine (HOE 901) versus NPH insulin in patients with type 1 diabetes on multiple daily insulin regimens. Diabetes Care 2000; 23: 1137– 1142.
16. Alemzadeh R, Berhe T, Wyatt DT. Flexible insulin therapy with glargine insulin improved glycemic control and reduced severe hypoglycemia among preschool- aged children with type 1 diabetes mellitus. Pediatrics 2005; 115: 1320– 1324.
17. 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.
18. Ruhnau KJ, Schneider K, Schweitzer MA. Introduction of insulin glargin to basal- bolus therapy improves metabolic control in patients with type 1 diabetes in every day clinical practice. Diabetologia 2005; 48 (Suppl 1): A303.
19. Chase HP, Arslanian S, White NH et al. Insulin glargine versus intermediate‑ acting insulin as the basal component of multiple daily injection regimens for adolescents with type 1 diabetes mellitus. J Pediatr 2008; 153: 547– 553.
20. Schütt M, Kern W, Krause U et al. Is the freguency of self-monitoring of blood glucose related to long‑term metabolic control? Multicenter analysis including 24,500 patients from 191 centers in Germany and Austria. Exp Clin Endocrinol Diabetes 2006; 114: 384– 388.
21. Schreiber SA, Russmann A. Long‑term efficacy of insulin glargine therapy with an educational programme in type 1 diabetes patients in clinical practice. Curr Med Res Opin 2007; 23: 3131– 3136.
22. Perušičová J. Statistické zpracování průběhu a výsledků léčby inzulinem glargine v ordinaci šesti českých diabetologů. Medicína po promoci 2004; 10– 12.
23. Chase HP, Dixon B, Pearson J et al. Reduced hypoglycaemic episodes and improved glycaemic control in children with type 1 diabetes using insulin glargine and neutral protamine Hagedorn insulin. J Pediatr 2003; 143: 737– 740.
24. Owens DR, Griffiths S. Insulin glargine (Lantus). Int J Clin Pract 2002; 56: 460– 466.
25. Hamann A, Matthaei S, Rosak C et al. A randomized clinical trial comparing breakfast, dinner, or bedtime administration of insulin glargine in patients with type 1 diabetes. Diabetes Care 2003; 6: 1738– 1744.
26. 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.
27. Pieber TR, Treichel HC, Hompesch B et al. Comparison of insulin detemir and insulin glargine in subjects with Type 1 diabetes using intensive insulin therapy. Diabet Med 2007; 24: 635– 642.
28. Kabadi UM. Deleterious outcomes after abrupt transition from insulin glargine to insulin detemir in patients with type 1 diabetes mellitus. Clin Drug Investig 2008; 28: 697– 701.
29. Pickup J, Mattock M, Kerry S. Glycaemic control with continuous subcutaneous insulin infusion compared with intensive insulin injections in patients with type 1 diabetes: meta‑analysis of randomised controlled trials. Br Med J 2002; 324: 705.
30. Jeitler K, Horvath K, Berghold A et al. Continuous subcutaneous insulin infusion versus multiple daily insulin injections in patients with diabetes mellitus: systematic review and meta‑analysis. Diabetologia 2008; 51: 941– 951.
31. Jankovec Z, Krcma M, Lacigova S et al. National Registry of Patients Treated with Continuous Subcutaneous Insulin Infusion (CSII) in the Czech Republic: Long‑term results. Infusystem International 2005; 4: 21– 24.
32. Jankovec Z, Čechurová D, Krčma M et al. Dlouhodobý efekt léčby inzulínovou pumpou (CSII) – výsledky Registru pacientů léčených CSII v České republice. DMEV 2006; 9 (Suppl 2): 26.
33. Nicolucci A, Maione A, Franciosi M et al. EQuality1 Study Group- Evaluation of QUALITY of Life and Costs in Diabetes Type 1. Quality of life and treatment satisfaction in adults with Type 1 diabetes: a comparison between continuous subcutaneous insulin infusion and multiple daily injections. Diabet Med 2008; 25: 213– 220.
34. 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.
35. Bartley PC, Bogoev M, Larsen J et al. Long‑term efficacy and safety of insulin detemir compared to Neutral Protamine Hagedorn insulin in patients with Type 1 diabetes using a treat- to- target basal-bolus regimen with insulin aspart at meals: a 2‑year, randomized, controlled trial. Diabetic Med 2008; 25: 442– 449.
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