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Results of the PREDICTIVE project in the Czech Republic


Authors: MUDr. Marek Honka
Authors‘ workplace: Interní klinika FN Ostrava, přednosta doc. MUDr. Arnošt Martínek, CSc.
Published in: Vnitř Lék 2008; 54(4): 361-367
Category: Original Contributions

Overview

Introduction:
The PREDICTIVE project was an international multicentric, open observation study evaluating the safety and efficiency of insulin detemir in clinical practice. 1,695 type 1 or 2 diabetes mellitus (DM) patients were enrolled in the study in the Czech Republic. The patients were treated by insulin detemir for the period of 26 weeks in accordance with the standard scheme implemented by the treating doctor.

The primary objective of the study was to monitor the incidence of serious adverse events including severe hypoglycaemias. The secondary objective of the study (the number of adverse events, the incidence of all and nocturnal hypoglycaemic episodes, the variability of fasting glycaemia, the change in HbA1c at the end of the study, the change in the patients’ weight) focused on the safety and efficiency of diabetes treatment.

Results:
Insulin detemir therapy resulted in a statistically significant decrease in all nocturnal episodes (from 26.8 to 10.4 episodes/patient/year in type 1 DM; from 9.2 to 2.6 in persons with type 2 DM), in severe nocturnal episodes (from 2.5 to 0.1 episode/patient/year in type 1 DM, and from 0.6 to 0 in type 2 DM), and also in hypoglycaemic nocturnal episodes (from 7.2 to 1.8 episode/patient/year in type 1 DM and from 1.7 to 0.3 in type 2 DM) as compared with the period preceding the therapy. In addition, detemir therapy resulted in a statistically significant improvement of diabetes compensation characterised by a decrease in the average HbA1c from 7.6% to 6.7% in type 1 DM patients, and from 7.9% to 7.0% in type 2 DM patients. Average fasting glycaemia recorded a significant decrease by 2.4 mmol/l in type 1 DM patients, and by 2.3 mmol/l in type 2 DM patients. Also the variability of fasting glycaemia recorded a significant decrease at the end of the study in both patient groups. No major change in weight was recorded in the course of the study in persons with type 1 DM, while a significant decrease in weight was recorded for type 2 DM patients.

Conclusion:
The results of the study PREDICTIVE confirmed the data from randomised studies on the safety and efficiency of insulin detemir treatment in the conditions of standard clinical practice in the Czech Republic.

Key words:
diabetes mellitus – insulin detemir – hypoglycaemia – HbA1c


Sources

1. The Diabetes Control and Complications Trial Research Group. The effect of intensive treatment of diabetes on the development and progression of long-term complications in insulin-dependent diabetes mellitus. N Engl J Med 1993; 329: 977-986.

2. The 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). Lancet 1998; 352: 837-853.

3. The UK Prospective Diabetes Study (UKPDS) Group. Effect of intensive blood-glucose control with metformin on complications in overweight patients with type 2 diabetes (UKPDS 34). Lancet 1998; 352: 854-865.

4. Stratton IM, Adler AI, Neil HA et al. Association of glycaemia with macrovascular and microvascular complications of type 2 diabetes (UKPDS 35): prospective observational study. BMJ 2000; 321: 405-412.

5. American Diabetes Association. Standards of medical care in diabetes. Diabetes Care 2007; 30(Suppl 1): S4-S41.

6. Česká diabetologická společnost http://www.diab.cz/modules.php?name=NDP.

7. Peterson GE. Intermediate and long-acting insulins: a review of NPH insulin, insulin glargine and insulin detemir. Curr Med Res Opin 2006; 22: 2613-2619.

8. Davies M. The reality of glycaemic control in insulin treated diabetes: defining the clinical challenges. Int J Obes 2004; 28(Suppl 2): S14-S22.

9. Korytkowski M. When oral agents fail: practical barriers to starting insulin. Int J Obes Relat Metab Disord 2002; 26 (Suppl. 3): S18-S24.

10. 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.

11. Lindholm A. New insulins in the treatment of diabetes mellitus. Best Pract Res Clin Gastroenterol 2002; 16: 475-492.

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. 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.

14. 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.

15. Home P, Bartley P, Russell-Jones D et al. Insulin detemir offers improved glycemic control compared with NPH insulin in people with type 1 diabetes; a randomised clinical trial. Diabetes Care 2004; 27: 1081-1087.

16. 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.

17. 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.

18. 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.

19. Raslova K, Tamer SC, Clauson P et al. Insulin detemir results in less weight gain than NPH insulin when used in basal-bolus therapy for type 2 diabetes mellitus, and this advantage increases with baseline body mass index. Clin Drug Investig 2007; 27: 279-285.

20. 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.

21. Luddeke HJ, Sreenan S, Aczel S et al. PREDICTIVE Study Group. PREDICTIVE - a global, prospective observational study to evaluate insulin detemir treatment in types 1 and 2 diabetes: baseline characteristics and predictors of hypoglycaemia from the European cohort. Diabetes Obes Metab 2007; 9: 428-434.

22. Dornhorst A, Luddeke HJ, Sreenan S et al. Safety and efficacy of insulin detemir in clinical practice: 14-week follow-up data from type 1 and type 2 diabetes patients in the PREDICTIVE European cohort. Int J Clin Pract 2007; 61: 523-528.

23. 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.

24. Mann CJ. Observational research methods. Research design II cohort, cross sectional, and case-control studies. Emerg Med J 2003; 20: 54-60.

25. Ligthelm RJ, Borzi V, Gumprecht J et al. Importance of observational studies in clinical practice. Clin Ther 2007; 29: 1284-1292.

26. Gough S. Post-marketing surveillance: a UK/European perspective. Curr Med Res and Opin 2005; 21: 565-570.

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