The results of open observational trial DIAMOND
https://doi.org/10.14341/2072-0351-6232
Abstract
Aim.
DIAMOND (DIAMicrON in Daily practice) is an open non-randomized observational trial aimed to estimate the efficacy and safety of gliclazide(Diamicron MB) in routine clinical practice.
Materials and methods.
394 patients with poor control of type 2 diabetes mellitus (T2 DM), previously treated with diet or one of oral antidiabeticdrug (OAD), were switched to Diamicron MB. Previous therapy was left unchanged, except for a sulfonylurea or glinide that were canceled.
Results.
After 6 months of Diamicron MB therapy (30% monotherapy, 70% combined therapy) target HbA1c<7% was reached in 64,7% of patients,HbA1c<6,5% in 30,71% patients. Statistically significant reduction of body weight, systolic and diastolic blood pressure, microalbuminuria ratewas reached. The number of patients with microalbuminuria decreased from 29,19% to 22,59%, with proteinuria from 5,08% to 3,30%. No severehypoglycemia was registered, light hypoglycemia was seen in 2,28% of patients.Conclusions. Diamicron MB was effective and well-tolerated and showed low risk of hypoglycemia with no severe adverse effects in daily routinepractice. Diamicron MB demonstrated nephroprotective features as a result of better glycemic control.
DIAMOND (DIAMicrON in Daily practice) is an open non-randomized observational trial aimed to estimate the efficacy and safety of gliclazide(Diamicron MB) in routine clinical practice.
Materials and methods.
394 patients with poor control of type 2 diabetes mellitus (T2 DM), previously treated with diet or one of oral antidiabeticdrug (OAD), were switched to Diamicron MB. Previous therapy was left unchanged, except for a sulfonylurea or glinide that were canceled.
Results.
After 6 months of Diamicron MB therapy (30% monotherapy, 70% combined therapy) target HbA1c<7% was reached in 64,7% of patients,HbA1c<6,5% in 30,71% patients. Statistically significant reduction of body weight, systolic and diastolic blood pressure, microalbuminuria ratewas reached. The number of patients with microalbuminuria decreased from 29,19% to 22,59%, with proteinuria from 5,08% to 3,30%. No severehypoglycemia was registered, light hypoglycemia was seen in 2,28% of patients.Conclusions. Diamicron MB was effective and well-tolerated and showed low risk of hypoglycemia with no severe adverse effects in daily routinepractice. Diamicron MB demonstrated nephroprotective features as a result of better glycemic control.
About the Authors
Marina Vladimirovna Shestakova
Endocrinology Research Centre, Moscow
Olga Konstantinovna Vikulova
Endocrinology Research Centre, Moscow
References
1. Шестакова М.В. Из доклада «Новые рекомендации по терапии СД2 в России». Обучающий курс Joslin Diabetes Center и ЭНЦ МЗРФ. - М., 25 мая 2011 г.
2. Gribble F.M., Reimann F. Differential selectivity of insulin secretagogues: mechanisms, clinical implications, and drug interactions // J. Diabetes Complications. - 2003. - № 17. - Р. 11-15.
3. Schernthaner G., Grimaldi A., Di Mario U., Drzewoski J., Kem - pler P., Kvapil M., Novials A., Rottiers R., Rutten G. E. H. M. and Shaw K. M. GUIDE study: double-blind comparison of once-daily gliclazide MR and glimepiride in type 2 diabetic patients // European Journal of Clinical Investigation. - 2004. - № 34. - Р. 535-542.
4. Tessier D., Dawson K., Tetrault J.P., Bravo G., Meneilly G.S. Glibenclamide vs gliclazide in type 2 diabetes of the elderly // Diabet Med. - 1994. - № 11. - Р. 974-980.
5. Veitch P.C., Clifton-Bligh R.J. Long-acting sulfonylureas - long-acting gypoglycaemia // Med. J. Aust. - 2004. - № 180. - Р. 84-85.
6. Patel A., MacMahon S., Chalmers J., Neal B. et al. The ADVANCE Collaborative GrouP. Intensive blood glucose control and vascular outcomes in patients with type 2 diabetes // N. Engl. J. Med. - 2008. - № 358. - Р. 2560-2572.
7. Drouin1 P., Standl E. for the Diamicron MR Study GrouP. Gliclazide modified release*: results of a 2-year study in patients with type 2 diabetes // Diabetes, Obesity and Metabolism. - 2004. - № 6. - Р. 414-421.
8. Gerstein H.C., Miller M.E., Byington R.P., Goff D.C. et al. The Action to Control Cardiovascular Risk in Diabetes Study Group: effects of intensive glucose lowering in type 2 diabetes // N. Engl. J. Med. - 2008. - № 358. - Р. 2545-2559.
9. Duckworth W., Abraira C., Mortiz T., Reda D. et al. VADT Investigators. Glucose control and vascular complications in veterans with type 2 diabetes // N. Engl. J. Med. - 2009. - № 360. - Р. 129-139.
10. Zoungas S., Chalmers J., Kengne A.P., Pillai A., Billot L., de Galan B., Marre M., Neal B., Harrap S., Poulter N., Patel A. The efficacy of lowering glycated haemoglobin with a gliclazide modified release-based intensive glucose lowering regimen in the ADVANCE trial // Diab. Res. Clin. Pract. - 2010. - № 89. - Р. 126-133. doi:10.1016/j.diabres. 2010.05.012.
11. Desouza C.V., Bolli G.B., Fonseca V. Hypoglycemia, diabetes, and cardiovascular events // Diabetes Care. - 2010. - № 33(6). - Р. 1389-1394.
12. Skyler J.S., Bergenstal R., Bonow R.O., Buse J. et al. Intensive glycaemic control and the prevention of cardiovascular events: implications of the ACCORD, ADVANCE, and VA Diabetes Tials: A Position Statement of the American Diabetes Association and a Scientific Statement of the American College of Cardiology Foundation and the American Heart Association // Circulation. - 2009. - № 119. - Р. 351-357.
13. Klepzig H., Kober G., Matter C. et al. Sulfonylureas and ischemic preconditioning: a double-blind, placebo-controlled evaluation of glimepiride and glibenclamide // Eur. Heart J. - 1999. - № 20. - Р. 439-446.
14. Maddock H.L., Siedlecka S.M., Yellon D.M. Myocardial protection from either ischemic preconditioning or nicorandil is not blocked by gliclazide // Cardiovasc Drugs Ther. - 2004. - № 18. - Р. 113-119.
15. Thisted H., Johnsen S.P., Rungby J. Sulfonylureas and the risk of myocardial infarction // Metabolism. - 2006. - № 55. - S16-S19.
16. Johnsen S.P., Monster T.B., Olsen M.L. et al. Risk and short-term prognosis of myocardial infarction among users of antidibetic drugs // Am. J. Ther. - 2006. - № 13. - Р. 134-140.
17. Monami M., Balzi D., Lamanna C., Barchielli et al. Are sulfonylureas all the same? A cohort study on cardiovascular and cancer related mortality // Diabetes Metab. Res. Rev. - 2007. - № 23. - Р. 479-484.
18. Monami M., Luzzzi C., Lamanna C. et al. Three-year mortality in diabetic patients treated with different combinations of insulin secretagogues and metformin // Diabetes Metab. Res. Rev. - 2006. - № 22. - Р. 477-482.
19. Khalangot M., Tronko M., Kravchenko V., Kovtun V. Glibenclamiderelated excess in total and ardiovascular mortality risks: data from large Ukrainian observational cohort study // Diabetes Res. Clin. Pract. - 2009. - № 86. - Р. 247-253.
20. Schramm T.K., Gislason G.H., Vaag A., Rasmussen J.N. et al. Mortality and cardiovascular risk associated with different insulin secretagogues compared with metformin in type 2 diabetes, with or without a previous myocardial infarction: a nationwide study // European Heart Journal. - 2011. - doi:10.1093/eurheartj/ehr077.
21. Gram J., Jespersen J. Increased fibrinolytic potential induced by gliclazide in types I and II diabetic patients // Am. J. Med. - 1991. - № 90. - P. 62S-66S.
22. Zoungas S., Chalmers J., Patel A., et al. Intensive glucose control is renoprotective in type 2 diabetes: new analyses from ADVANCE. Abstracts of 46th annual meeting of the European Association for the Study of Diabetes, 2010 // Diabetologia. - 2010. - № 53(Suppl1). - S98.
Review
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Shestakova M.V., Vikulova O.K. The results of open observational trial DIAMOND. Diabetes mellitus. 2011;14(3):96-102. (In Russ.) https://doi.org/10.14341/2072-0351-6232
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