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PROTOCoL DESIGN<br />Presented by:<br />RUCHIR JAIN<br />ANKIT DESAI<br />PGDCTM-2009<br />
<ul><li>Importance
Protocol is the most important of all clinical trial documents
It is also the first to be prepared and discussed with the investigators.</li></ul>“ It is a confidential document since i...
<ul><li>Background</li></ul>To study the effect of oral sulfonylurea in patient with type -2 diabetes mellitus not previou...
 Open Label,
Treatment (Glimepiride)
Active Control,
Safety/Efficacy Study</li></li></ul><li>Diabetes Mellitus: a group of diseases characterized by high levels of blood gluco...
blood glucose levels rise due to </li></ul>		1) Lack of insulin 	production<br />		2) Insufficient insulin action <br />
<ul><li>Sample Introduction</li></ul>Glimepiride is a medium-to-long acting sulfonylureaanti-diabetic drug. It is marketed...
Extra-pancreatic effect
Pancreatic effect:
Increase insulin release from pancreas
Suppress secretions of Glucagon
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Protocal Ppt Ruchir

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Transcript of "Protocal Ppt Ruchir"

  1. 1. PROTOCoL DESIGN<br />Presented by:<br />RUCHIR JAIN<br />ANKIT DESAI<br />PGDCTM-2009<br />
  2. 2. <ul><li>Importance
  3. 3. Protocol is the most important of all clinical trial documents
  4. 4. It is also the first to be prepared and discussed with the investigators.</li></ul>“ It is a confidential document since it contains information on drug “<br /><ul><li>Definition</li></ul>A document that states the background, objectives, rationale, design, methodology (including the methods for dealing with AEs,withdrawals etc) and statistical considerations of the study. It also states the conditions under which the study shall be performed and managed.<br />“ ICH GCP E-6 1.44 ”<br />
  5. 5. <ul><li>Background</li></ul>To study the effect of oral sulfonylurea in patient with type -2 diabetes mellitus not previously treated with drug therapy.<br /><ul><li>Study Objectives</li></ul>To assess the effectiveness of oral sulfonylurea in patients with type-2 diabetes diagnosed keeping in view that the patient is receiving medication for the first time.<br /><ul><li>Study Design
  6. 6. Open Label,
  7. 7. Treatment (Glimepiride)
  8. 8. Active Control,
  9. 9. Safety/Efficacy Study</li></li></ul><li>Diabetes Mellitus: a group of diseases characterized by high levels of blood glucose resulting from defects in insulin production, insulin action, or both<br />2 Types:<br /> 1) Type 1 diabetes<br /><ul><li>Insulin dependent diabetes</li></ul> 2) Type 2 diabetes<br /><ul><li>Non insulin dependent diabetes
  10. 10. blood glucose levels rise due to </li></ul> 1) Lack of insulin production<br /> 2) Insufficient insulin action <br />
  11. 11. <ul><li>Sample Introduction</li></ul>Glimepiride is a medium-to-long acting sulfonylureaanti-diabetic drug. It is marketed as Amaryl by Sanofi-Aventis and Glyree by Ipca. Glimepiride is the first third-generation sulfonylurea, and is very potent.<br />It is sometimes classified as third-generation, and sometimes classified as second-generation.<br />Mechanism of action:<br /><ul><li>Pancreatic effect
  12. 12. Extra-pancreatic effect
  13. 13. Pancreatic effect:
  14. 14. Increase insulin release from pancreas
  15. 15. Suppress secretions of Glucagon
  16. 16. Extra pancreatic effect:
  17. 17. Increases the number of insulin receptors
  18. 18. Increases post-receptor insulin sensitivity
  19. 19. Increases glucolysis
  20. 20. Increases glycogen storage in muscle and liver
  21. 21. Decreases the hepatic output of glucose</li></li></ul><li><ul><li>Selection Criteria
  22. 22. Subjects already taking medication for type-2 diabetes mellitus:-No
  23. 23. Age eligible for study:-18Years to 40 Years
  24. 24. Genders eligible for study:-Both
  25. 25. Accepts healthy volunteers:-No
  26. 26. Inclusion criteria
  27. 27. Exclusion criteria
  28. 28. Withdrawal Criteria</li></li></ul><li>Study Treatment<br /><ul><li>Life style modification
  29. 29. Diet control
  30. 30. All diabetic patients should be on diet control.
  31. 31. Diet control is a must either the patient is taking insulin or oral therapy.
  32. 32. Over weight should be reduced .
  33. 33. Exercise
  34. 34. Smoking cessation
  35. 35. Insulin
  36. 36. Oral agents
  37. 37. Mechanism of action:
  38. 38. Pancreatic effect
  39. 39. Extra-pancreatic effect
  40. 40. Glimepiride 2mg per day
  41. 41. Once daily. Half-life 9 hours, peak action for 4 hours.</li></li></ul><li>
  42. 42. Therapeutic Lifestyle Change<br />Lab Test<br />Oral Drugs Only<br />After 12 Week check <br />Treatment of Type 2 Diabetes<br />Diagnosis<br />
  43. 43.
  44. 44.  <br />ADVERSE EVENTS (AE) REPORTING<br /><ul><li>Study Sponsor Notification by Investigator
  45. 45. A adverse event must be reported to the study sponsor by telephone within 24 hours of the event. A Serious Adverse Event (SAE) form must be completed by the investigator and faxed to the study sponsor within 24 hours
  46. 46. EC/IRB Notification by Investigator
  47. 47. Reports of all adverse events (including follow-up information) must be submitted to the EC/IRB within 10 working days.
  48. 48. FDA Notification by Sponsor
  49. 49. The study sponsor shall notify the FDA by telephone or by facsimile transmission of any unexpected fatal or life-threatening experience associated with the use of the drug as soon as possible but no later than 7 calendar days from the sponsor’s original receipt of the information.</li></li></ul><li><ul><li>Other Components
  50. 50. Quality control and assurance(QC/QA)procedures
  51. 51. Ethics( IDMC process, EC, Confidentiality)
  52. 52. Monitoring/ Direct access to data
  53. 53. Data Handling and record keeping
  54. 54. Financing and Insurance
  55. 55. Publication policy </li></li></ul><li>Comparative approach<br />Regulatory Guidelines@<br />ICH-GCP<br /> Indian GCP<br /> Sch Y<br />
  56. 56. Any Questions<br />
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