GLICLAZIDE MR IN THEMANAGEMENT OF TYPE 2 DMDr. Nazma AkhtarResident phase BDepartment of EndocrinologyBSMMU
3/28/2013 3
3/28/2013 4
SULFONYLUREA: OAD agentMode of action:• Sulfonylureas act directly on the β - cells of the islets ofLangerhans to stimulat...
Classification• Divided into first and second generationagents• In general, the second-generation agents– Are more potent–...
Extended release preparations• Extended-release glipizide and glimepiride arepreferred agents because- they can be given o...
Modified release preparations• A “ modified release ” (MR) formulation ofgliclazide has been introduced for once - dailydo...
Target HbA1c <7% instead of <6.5%Evidence based alternative approachSU as 1st line, irrespective of BMITZD & DPP-4 inhibit...
Which SU to choose-gliclazide 80,glimepiride or the newDiamicron MR 60??
One of the largest clinical studiesever performed in type 2 diabetesN Engl J Med. 2008;358:2560-2572
More than 11,000 type 2 diabeticpatients from 20 countries worldwide4 Asian countries- China, India, Malaysia & Philippine...
Aim of the studyWhat benefits can be gained fromintensive glycemic control (HbA1c≤6.5%) versus standard control?N Engl J M...
Strategy & TimelineMean duration 5 yearsStrategy: treatment initiation with 60 mgDiamicron MR, increase up to 120 mg then ...
Results & OutcomesN Engl J Med. 2008;358:2560-2572. Diabetes Care 32:2068–2074, 2009. Diabetes Res Clin Pract. 2010;89:126...
Reduces HbA1c ≤7% within 6 monthsN Engl J Med. 2008;358:2560-2572
Reduces HbA1c by more than 4%unlike other SUN Engl J Med. 2008;358:2560-2572
Reduces HbA1c ≤7% irrespective ofBMIN Engl J Med. 2008;358:2560-2572
Lowest episodes of hypoglycemiacompared to other large scale clinicaltrials1. N Engl J Med. 2008;358:2560-2572. 2. N Engl ...
Lowest hypoglycemiacompared to DPP4-inhibitorInt J Clin Pract. 2011;65:1132-1140. Curr Med Res Opin 2012; 28:1–8Middle Eas...
Weight neutral unlike other SUN Engl J Med. 2008;358:2560-2572
Significantly reduces combinedmicro & macro vascular complicationsN Engl J Med. 2008;358:2560-2572
Opposite outcome compared toother trials using glimepirideN Engl J Med. 2008;358:2545-2559. N Engl J Med. 2008;358:2560-25...
Better CV protectionthan Metformin & glimepirideEur Heart J. 2011 Aug;32(15):1900-8.
Reduces End-stage Kidney Diseaseunlike any other OADDiabetologia. 2011;54(suppl 1):S23.
Reduces Beta cell apoptosisunlike glimepirideMetabolism. 2008;57:1038-1045.
Prolongs insulin free periodDiabetes Res Clin Pract. 2005;70:291-297.While maintains HbA1c <7% for 14.5 years!!
FACT: EFficacy & tolerAbility of DiamiCronMR60at the dosage of 1.5 to 2 tablets at breakfastoverBangladeshi Type 2 diabeti...
A clinical study conducted by Bangladeshiclinicians over Bangladeshi type 2 diabeticpatients
Objective of the studyTo observe efficacy and tolerabilityof Diamicron MR60 at the dosageof 1.5 to 2 tablets over Banglade...
Findings
Patient characteristicsCharacteristics (N=359)Male (166) 166 (n)Female (193) 193 (n)Mean Age (279) 51 yrs ± 11Mean Height ...
Efficacy: Reduction of HbA1c (Total Patients)55.566.577.588.59Base line After 6 months-1.9% HbA1c reduction within 6 month...
TolerabilityOnly 1.0% hypoglycemia was found!!Baseline After 6monthsChangeWeight (kgs) 63.7 63.3 -0.4
As per the FACT study, Diamicron MR 60reduces HbA1c by -1.9% in 6 months at thedosage of 1.5 to 2 tabletsWith least hypogl...
Clinical Evidences on use ofOAD in Ramadan
 Prof. Hajera MahtabProfessor EmeritusEx-DirectorClinical Services, Research & AcademyDhaka, Bangladesh Prof. Abdul Hami...
Sulphonylureas in the management of type 2 diabetes during the fastingmonth of Ramadan Among the 2nd generation SUs consi...
Among the two once daily Sulphonylureas hypoglycemia is -50% lesswith Diamicron MR60 than glimepirideDiamicron MR Glimepir...
Diamicron MR60 is associated with less hypo andless CV events than glimepiride
Objective:To evaluate the efficacy &safety of Diamicron MR60at the dosage of 1 tabletin RamadanParticipating countries:Ban...
Prof. Hajera Mahtab BIHSProf. Zafar A Latif BIRDEMProf. Tofail Ahmed BIRDEMProf. M A Mannan DMCHProf. Md. Farid Uddin BSMM...
Inclusion Criteria: Newly diagnosed type 2 diabetic patients: start with 60 mg Patients uncontrolled with 1 tablets of D...
Total number of patients:136 fasting type 2 diabetic(35 Bangladeshi+ 50 Indian+ 51 Pakistani)Duration:90 days (45 before R...
Conclusion:Diamicron MR60 maintains tight glycemic control, safely before,during & after Ramadan
Objective:To compare the incidence ofsymptomatic hypoglycemia infasting Muslim patients with type2 diabetes treated with D...
Conclusion:Risk of hypoglycemia is lowest with Diamicron MR60, whereasdouble with glimepiride
IDF guideline (October’12) recommendssulfonylurea to initiate treatment irrespective ofBMIBut all sulfonylureas do not pro...
As per the clinical evidences Diamicron MR 60 provides effective glycemic control irrespectiveof BMI with least risk of ...
Acknowledgement• Prof. Md. Fariduddin• Asso. Prof. M A Hasanat• Dr. Mashfiqul Hasan• Dr. Yasmin Aktar• Sponsoring body
Thank you
Gliclazide MR in the management of Type 2 Diabetes Mellitus
Gliclazide MR in the management of Type 2 Diabetes Mellitus
Gliclazide MR in the management of Type 2 Diabetes Mellitus
Upcoming SlideShare
Loading in …5
×

Gliclazide MR in the management of Type 2 Diabetes Mellitus

4,967 views

Published on

Symposium on 10th June, 2013. Presented by Dr. Nazma Akhter (Phase B Resident, Endocrinology)

Published in: Health & Medicine
0 Comments
7 Likes
Statistics
Notes
  • Be the first to comment

No Downloads
Views
Total views
4,967
On SlideShare
0
From Embeds
0
Number of Embeds
18
Actions
Shares
0
Downloads
425
Comments
0
Likes
7
Embeds 0
No embeds

No notes for slide

Gliclazide MR in the management of Type 2 Diabetes Mellitus

  1. 1. GLICLAZIDE MR IN THEMANAGEMENT OF TYPE 2 DMDr. Nazma AkhtarResident phase BDepartment of EndocrinologyBSMMU
  2. 2. 3/28/2013 3
  3. 3. 3/28/2013 4
  4. 4. SULFONYLUREA: OAD agentMode of action:• Sulfonylureas act directly on the β - cells of the islets ofLangerhans to stimulate insulin secretion• They enter the β – cell and bind to the cytosolic surface of thesulfonylurea receptor 1• Binding of a sulfonylurea closes the K + ATP channel, reducingthe efflux of potassium enabling membrane depolarization• Localized membrane depolarization opens adjacent voltage -dependent L - type calcium channels• Increasing calcium influx and raising the cytosolic freecalcium concentration• Mediate the exocytotic release of insulin granules
  5. 5. Classification• Divided into first and second generationagents• In general, the second-generation agents– Are more potent– Have fewer adverse effects and drug-druginteractions
  6. 6. Extended release preparations• Extended-release glipizide and glimepiride arepreferred agents because- they can be given once daily- involve a relatively low risk ofhypoglycemia-low weight gain
  7. 7. Modified release preparations• A “ modified release ” (MR) formulation ofgliclazide has been introduced for once - dailydosing• Interestingly, the 30 mg preparation ofgliclazide MR gives similar efficacy to 80 mg ofunmodified gliclazide and reduces risk ofsevere hypoglycemia
  8. 8. Target HbA1c <7% instead of <6.5%Evidence based alternative approachSU as 1st line, irrespective of BMITZD & DPP-4 inhibitor are 3rd optionWhat’s NEW in the treatmentalgorithm of IDF Guideline 2012?
  9. 9. Which SU to choose-gliclazide 80,glimepiride or the newDiamicron MR 60??
  10. 10. One of the largest clinical studiesever performed in type 2 diabetesN Engl J Med. 2008;358:2560-2572
  11. 11. More than 11,000 type 2 diabeticpatients from 20 countries worldwide4 Asian countries- China, India, Malaysia & PhilippinesN Engl J Med. 2008;358:2560-2572
  12. 12. Aim of the studyWhat benefits can be gained fromintensive glycemic control (HbA1c≤6.5%) versus standard control?N Engl J Med. 2008;358:2560-2572
  13. 13. Strategy & TimelineMean duration 5 yearsStrategy: treatment initiation with 60 mgDiamicron MR, increase up to 120 mg then addother therapyJune2001January2002January2003January2004January2005January2006January2007January2008Blood glucose lowering comparisonRecruitment periodN Engl J Med. 2008;358:2560-2572
  14. 14. Results & OutcomesN Engl J Med. 2008;358:2560-2572. Diabetes Care 32:2068–2074, 2009. Diabetes Res Clin Pract. 2010;89:126-133.
  15. 15. Reduces HbA1c ≤7% within 6 monthsN Engl J Med. 2008;358:2560-2572
  16. 16. Reduces HbA1c by more than 4%unlike other SUN Engl J Med. 2008;358:2560-2572
  17. 17. Reduces HbA1c ≤7% irrespective ofBMIN Engl J Med. 2008;358:2560-2572
  18. 18. Lowest episodes of hypoglycemiacompared to other large scale clinicaltrials1. N Engl J Med. 2008;358:2560-2572. 2. N Engl J Med. 2008;358:2545-2559. 3. Lancet. 1998;352:837-853.
  19. 19. Lowest hypoglycemiacompared to DPP4-inhibitorInt J Clin Pract. 2011;65:1132-1140. Curr Med Res Opin 2012; 28:1–8Middle EastIndia & Malaysia
  20. 20. Weight neutral unlike other SUN Engl J Med. 2008;358:2560-2572
  21. 21. Significantly reduces combinedmicro & macro vascular complicationsN Engl J Med. 2008;358:2560-2572
  22. 22. Opposite outcome compared toother trials using glimepirideN Engl J Med. 2008;358:2545-2559. N Engl J Med. 2008;358:2560-2572. N Engl J Med. 2009;360.
  23. 23. Better CV protectionthan Metformin & glimepirideEur Heart J. 2011 Aug;32(15):1900-8.
  24. 24. Reduces End-stage Kidney Diseaseunlike any other OADDiabetologia. 2011;54(suppl 1):S23.
  25. 25. Reduces Beta cell apoptosisunlike glimepirideMetabolism. 2008;57:1038-1045.
  26. 26. Prolongs insulin free periodDiabetes Res Clin Pract. 2005;70:291-297.While maintains HbA1c <7% for 14.5 years!!
  27. 27. FACT: EFficacy & tolerAbility of DiamiCronMR60at the dosage of 1.5 to 2 tablets at breakfastoverBangladeshi Type 2 diabetic patients
  28. 28. A clinical study conducted by Bangladeshiclinicians over Bangladeshi type 2 diabeticpatients
  29. 29. Objective of the studyTo observe efficacy and tolerabilityof Diamicron MR60 at the dosageof 1.5 to 2 tablets over Bangladeshitype 2 diabetic patients
  30. 30. Findings
  31. 31. Patient characteristicsCharacteristics (N=359)Male (166) 166 (n)Female (193) 193 (n)Mean Age (279) 51 yrs ± 11Mean Height (75) 1.5 m ± 0.6Mean Weight (219) 64 kgs ± 9Mean BMI (96) 26 ± 3
  32. 32. Efficacy: Reduction of HbA1c (Total Patients)55.566.577.588.59Base line After 6 months-1.9% HbA1c reduction within 6 months-1.9%n= 3598.9%7.0%
  33. 33. TolerabilityOnly 1.0% hypoglycemia was found!!Baseline After 6monthsChangeWeight (kgs) 63.7 63.3 -0.4
  34. 34. As per the FACT study, Diamicron MR 60reduces HbA1c by -1.9% in 6 months at thedosage of 1.5 to 2 tabletsWith least hypoglycemia as well as noweight gainFindings of FACT study
  35. 35. Clinical Evidences on use ofOAD in Ramadan
  36. 36.  Prof. Hajera MahtabProfessor EmeritusEx-DirectorClinical Services, Research & AcademyDhaka, Bangladesh Prof. Abdul Hamid ZargarProfessor & HeadDepartment of EndocrinologySK Institute of Medical SciencesSrinagar, India Prof. Abdul BasitDirector & Head of the DepartmentBaqai Institute of Diabetology & EndocrinologyBaqai Medical UniversityKarachi, PakistanRESEARCH ANALYSIS
  37. 37. Sulphonylureas in the management of type 2 diabetes during the fastingmonth of Ramadan Among the 2nd generation SUs considering efficacy and safety,which one is more suitable during Ramadan Sulfonylureas as a first line used by majority of patients Many of Muslim type 2 diabetic patients fast in Ramadan Alteration of energy intake, physical activity & drug patternassociated with greater risk of hypoglycemia & ketoacidosis
  38. 38. Among the two once daily Sulphonylureas hypoglycemia is -50% lesswith Diamicron MR60 than glimepirideDiamicron MR Glimepiride
  39. 39. Diamicron MR60 is associated with less hypo andless CV events than glimepiride
  40. 40. Objective:To evaluate the efficacy &safety of Diamicron MR60at the dosage of 1 tabletin RamadanParticipating countries:Bangladesh, India &Pakistan
  41. 41. Prof. Hajera Mahtab BIHSProf. Zafar A Latif BIRDEMProf. Tofail Ahmed BIRDEMProf. M A Mannan DMCHProf. Md. Farid Uddin BSMMUDr. Saghir Abdur Rahim BIRDEMDr. Sarker M Saiful Islam MEDINOVADr. ABM Rahmatullah HCDP- JurainDr. Sufia Khatun NHN- Mirpur 10Dr. Umme Sadia Mili NHN- Darus SalamDr. Md. Wahiduzzaman NHN- Darus SalamDr. MA Sabur DAB- KhulnaTHE RAMADAN STUDY GROUP- BANGLADESH
  42. 42. Inclusion Criteria: Newly diagnosed type 2 diabetic patients: start with 60 mg Patients uncontrolled with 1 tablets of Diamicron MR/Gliclazide 80/MR or 1 mg of Glimepiride: up-titrate to 60 mgDiamicron MR60 Patients well controlled on 60 mg of Diamicron MR60 Patients well controlled on 2 tablets of Gliclazide 80/MR or 2mg of Glimepiride: switched to 60 mg of Diamicron MR60THE RAMADAN STUDY
  43. 43. Total number of patients:136 fasting type 2 diabetic(35 Bangladeshi+ 50 Indian+ 51 Pakistani)Duration:90 days (45 before Ramadan+ 30 Ramadan+ 15 afterRamadan)Result:- Around 1% (0.8%) HbA1c reduction within 3 months- 3.7% hypoglycemia before, 2.2% during & 1.5% afterRamadanTHE RAMADAN STUDY
  44. 44. Conclusion:Diamicron MR60 maintains tight glycemic control, safely before,during & after Ramadan
  45. 45. Objective:To compare the incidence ofsymptomatic hypoglycemia infasting Muslim patients with type2 diabetes treated with DPP-4inhibitor or SU during Ramadan.
  46. 46. Conclusion:Risk of hypoglycemia is lowest with Diamicron MR60, whereasdouble with glimepiride
  47. 47. IDF guideline (October’12) recommendssulfonylurea to initiate treatment irrespective ofBMIBut all sulfonylureas do not provide sameoutcomeTherefore, selection of sulfonylurea is a majorissue to be considered before initiating treatmentTake home messages
  48. 48. As per the clinical evidences Diamicron MR 60 provides effective glycemic control irrespectiveof BMI with least risk of hypo & without weight gain significantly reduces vascular complications ensures cardiovascular protection unlikeglimepiride,also better than metformin preserves beta cell through anti-oxidantpropertiesTake home messages
  49. 49. Acknowledgement• Prof. Md. Fariduddin• Asso. Prof. M A Hasanat• Dr. Mashfiqul Hasan• Dr. Yasmin Aktar• Sponsoring body
  50. 50. Thank you

×