The PROROK project results after 6 months of intervention (Prospective observation project focusing on the relevance of the difference between fasting blood glucose levels and postprandial blood glucose for estimation of success of type 2 diabetes therapy)

Česká verzia

Authors: Denisa Janíčková-Žďárská ¹; Pavlína Piťhová ¹; Tomáš Pavlík ^2,3; Milan Kvapil
Authors place of work: Interní klinika 2. LF UK a FN Motol, Praha, přednosta prof. MUDr. Milan Kvapil, CSc., MBA ¹; Institut biostatistiky a analýz LF MU Brno, ředitel doc. RNDr. Ladislav Dušek, Ph. D. ²; Ústav zdravotnických informací a statistiky České republiky, Praha, ředitel doc. RNDr. Ladislav Dušek, Ph. D. ³
Published in the journal: Vnitř Lék 2015; 61(Suppl 3): 44-49
Category: Original Contributions

Summary

Introduction:
The PROROK project (Prospective observation project focusing on the relevance of the difference between fasting and postprandial blood glucose levels for the estimation of success of type 2 diabetes therapy) had a character of non-interventional, prospective, multicentric observation study lasting 6 months, whose goal was to quantify the relevance of the difference between fasting and postprandial blood glucose levels to the success of the treatment with GLP1 receptor agonists, resp. the treatment with basal, premixed insulin, or a combination of basal-bolus insulin. Physicians chose a therapy for patients with insufficiently compensated problems as they considered appropriate; 4 972 patients were included.

Goal:
Evaluation of the intervention results for the patients included in the PROROK observation project with a focus on the choice of therapy by the treating diabetologist after 6 months of observation.

Results:
An average improvement of the glycated hemoglobin values in the whole cohort reached 1.6%, the median of the resulting glycated hemoglobin reached 5.9% and 5.8% resp. (basal insulin). Statistically significant was the change in the median weight in the cohort treated with GLP-1 receptor agonists, from 105 kg to 100 kg; this did not significantly change in the other cohorts. The change of waist circumference over time in all patients and in the individual cohorts was consistent with the change of weight. The median change of fasting blood glucose levels in the whole cohort was -1.7 mmol/l after 3 months and -2.4 mmol/l (p < 0.001) after 6 months. The greatest absolute decrease was recorded in the cohort treated with basal insulin (-2.8 mmol/l). The median change of postprandial blood glucose levels was -2.4 mmol/l after 3 months and -3.3 mmol/l (p < 0.001) after 6 months. The greatest absolute decrease was recorded in the branch treated with a combination of prandial and basal insulin (-3.9 mmol/l). All differences p < 0.001.

Conclusion:
The choice of therapy in the PROROK project is in agreement with the basic findings in pathophysiology of type 2 diabetes and with the options of an individually chosen targeted intervention involving antidiabetic therapy. The results of the six-month observation have proven the individual choice of therapy correct. In the cohort of diabetic patients differing at the beginning in weight, waist circumference, fasting blood glucose and the difference between fasting and postprandial glucose levels, an individually chosen therapy led to the same final result, while an absolute change in the followed parameters differed in the individual groups.

Key words:
therapy for type 2 diabetes mellitus – GLP1 receptor agonists – insulin – intensified insulin regimen – basal insulin – premixed insul

Zdroje

1. DeFronzo RA. Lilly lecture 1987. The triumvirate: beta-cell, muscle, liver. A collusion responsible for NIDDM. Diabetes 1988; 37(6): 667–687.

2. Calanna S, Christensen M, Holst JJ et al. Secretion of glucagon-like peptide-1 in patients with type 2 diabetes mellitus: systematic review and meta-analyses of clinical studies. Diabetologia 2013; 56(5): 965–972.

3. Kvapil M, Perušičová J. Postprandiální glykémie. Triton: Praha 2006. ISBN 80–7254–785–2.

4. DeFronzo RA. Current issues in the treatment of type 2 diabetes. Overview of newer agents: where treatment is going. Am J Med 2010; 123(3 Suppl): S38-S48.

5. Niswender KD. Basal insulin: physiology, pharmacology, and clinical implications. Postgrad Med 2011; 123(4): 17–26.

6. Philis-Tsimikas A. Initiating basal insulin therapy in type 2 diabetes: practical steps to optimize glycemic control. Am J Med 2013; 126(9 Suppl 1): S21-S27.

7. Heine RJ, Van Gaal LF, Johns D et al. GWAA Study Group. Exenatide versus insulin glargine in patients with suboptimally controlled type 2 diabetes: a randomized trial. Ann Intern Med 2005; 143(8): 559–569.

8. Roubíček T, Mráz M, Bártlová M et al. Vliv 6měsíčního podávání exenatidu na kompenzaci diabetes mellitus 2. typu, antropometrické a biochemické parametry. Vnitr Lek 2010; 56(1): 15–20.

9. Drucker DJ, Buse JB, Taylor K et al. DURATION-1 Study Group. Exenatide once weekly versus twice daily for the treatment of type 2 diabetes: a randomised, open-label, non-inferiority study. Lancet 2008; 372(9645): 1240–1250.

10. Riddle MC, Aronson R, Home P et al. Adding once-daily lixisenatide for type 2 diabetes inadequately controlled by established basal insulin: a 24-week, randomized, placebo-controlled comparison (GetGoal-L). Diabetes Care 2013; 36(9): 2489–2496.

11. Degn KB, Juhl CB, Sturis J et al. One week‘s treatment with the long-acting glucagon-like peptide 1 derivative liraglutide (NN2211) markedly improves 24-h glycemia and alpha- and beta-cell function and reduces endogenous glucose release in patients with type 2 diabetes. Diabetes 2004; 53(5): 1187–1194.

12. Sun F, Chai S, Li L et al. Effects of Glucagon-Like Peptide-1 Receptor Agonists on Weight Loss in Patients with Type 2 Diabetes: A Systematic Review and Network Meta-Analysis. J Diabetes Res 2015; 2015: 157201. Dostupné z DOI: <http://dx.doi.org/10.1155/2015/157201>.

13. Kvapil M. Premixované inzuliny v léčbě diabetu. Remedia 2013; 23(5): 2–8.

14. Moghissi E, King AB. Individualizing insulin therapy in the management of type 2 diabetes. Am J Med 2014; 127(10 Suppl): S3-S10.

15. Janíčková-Žďárská D, Piťhová P, Pavlík T et al. Volí diabetologové terapii racionálně? Základní výsledky projektu PROROK po 6 měsících intervence (Prospektivní observační projekt významu diference glykémie nalačno a postprandiální glykémie pro odhad úspěšnosti terapie diabetu 2. typu). Vnitř Lék 2015; 61(4): 295–300.

16. Inzucchi SE, Bergenstal RM, Buse JB et al. Management of hyperglycemia in type 2 diabetes, 2015: a patient-centered approach: update to a position statement of the American Diabetes Association and the European Association for the Study of Diabetes. Diabetes Care 2015; 38(1): 140–149.

17. Kvapil M. Klinický význam postprandiální glykemie u diabetu 2. typu. Remedia 2011; 21(5): 14–18.