diabites line up protocal trial only on....

1. PROTOCoL DESIGN Presented by: RUCHIR JAIN ANKIT DESAI PGDCTM-2009

3. Protocol is the most important of all clinical trial documents

6. Open Label,

7. Treatment (Glimepiride)

8. Active Control,

10. blood glucose levels rise due to 1) Lack of insulin production 2) Insufficient insulin action

12. Extra-pancreatic effect

13. Pancreatic effect:

14. Increase insulin release from pancreas

15. Suppress secretions of Glucagon

16. Extra pancreatic effect:

17. Increases the number of insulin receptors

18. Increases post-receptor insulin sensitivity

19. Increases glucolysis

20. Increases glycogen storage in muscle and liver

22. Subjects already taking medication for type-2 diabetes mellitus:-No

23. Age eligible for study:-18Years to 40 Years

24. Genders eligible for study:-Both

25. Accepts healthy volunteers:-No

26. Inclusion criteria

27. Exclusion criteria

29. Diet control

30. All diabetic patients should be on diet control.

31. Diet control is a must either the patient is taking insulin or oral therapy.

32. Over weight should be reduced .

33. Exercise

34. Smoking cessation

35. Insulin

36. Oral agents

37. Mechanism of action:

38. Pancreatic effect

39. Extra-pancreatic effect

40. Glimepiride 2mg per day

42. Therapeutic Lifestyle Change Lab Test Oral Drugs Only After 12 Week check Treatment of Type 2 Diabetes Diagnosis

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. EC/IRB Notification by Investigator

47. Reports of all adverse events (including follow-up information) must be submitted to the EC/IRB within 10 working days.

48. FDA Notification by Sponsor

50. Quality control and assurance(QC/QA)procedures

51. Ethics( IDMC process, EC, Confidentiality)

52. Monitoring/ Direct access to data

53. Data Handling and record keeping

54. Financing and Insurance

56. Any Questions