PROTOCOL DESIGN-

SYNOPSIS
• TITLE OF THE STUDY- TEAM DETAILS
• AIMS AND OBJECTIVES
• DESIGN OF THE STUDY
• INCLUSION AND EXCLUSION CRITERIA
• METHODOLOGY/STUDY POINTS
• END POINTS(SAFETY AND EFFICACY)
• ASSESMENT OF EFFICACY AS SAFETY
PARAMETERS
• REFERENCES
 PHASE 3 MULTICENTRIC RANDOMISED TRIAL
FOR EVALUATING ORAL HYPOGLYCEMIC
DRUG-REPAGLINIDE

• DESIGNED BY:
SAVITHA RAMAKRISHNAN
VIJAYA LAKSHMI I.
ALAGU PRIYA S.
ARUNA KUMARI
ANANTHA LAKSHMI G.
AASHIYANA KHAN
 AIMS AND OBJECTIVES

• AIM:
-COMPARE THE EFFECT OF
REPAGLINIDE WITH GLIPIZIDE.
-TO EVALUATE LONG TERM
EFFECTIVENESS AND SAFETY OF
REPAGLINIDE AS A NOVEL PRANDIAL
GLUCOSE REGULATOR.
• OBJECTIVES:
-EFFICACY AND TOLERABILITY.
-QOL
 DESIGN OF THE STUDY

• MULTI CENTRIC
• RANDOMISED
• DOUBLE BLIND
• COMPARATIVE
• PARALLEL GROUP STUDY OF MILD TO
MODERATE TYPE 2 DIABETES MELLITUS
TRIAL ON ORAL HYPO GLYCEMIC AGENTS
• ID:REPAGLINIDE Vs GLIPIZIDE
 INCLUSION AND EXCLUSION CRITERIA

• INCLUSION CRITERIA:
-PATIENTS AGE:40 TO 75 YEARS -HAVING TYPE 2
DIABETES MELLITUS
-FBG LEVEL>140mg/dl and <270mg/dl.
-BMI -22 TO 40Kg/m2 INCLUSIVE.
• EXCLUSION CRITERIA:
-PREVIOUS PARTICIPATION
-PREVIOUS TREATMENT WITH THE CURRENT ANTI
DIABETIC AGENTS
-HISTORY OF MI/TACHY CARDIA/VENTRICULAR
FIBRILLATIONS IN THE PAST 6 MONTHS
 METHODOLOGY /STUDY PLAN

• ADVERTISING/PUBLICATION
• PARALLEL GROUP SUBJECTS WITH ID/STD DRUG
• GROUPING-RANDOMIZATION
• SCREENING/SELECTION OF PATIENTS
• ENROLLING THE PATIENTS
• INFORMED CONSENT
• LAB INVESTIGATIONS
• INCLUSION/EXCLUSION CRITERIA
• GP-DONE ON RANDOMIZATION BASIS
• TREATMENT:TOTAL PATIENTS-375;TOTAL CENTRES-25
DOSAGE REGIMEN: SOLID DOSAGE FORMS
REPAGLINIDE:1.0 TO4.0mg
GLIPIZIDE:5.0 TO15mg
DURATION:ONE YEAR
• FOLLOW UP:FIRST 2 MONTHS ONCE IN 12 DAYS & AFTER 2
MONTHS MONTHLY ONCE
 PRIMARY AND SECONDARY END POINTS

• PRIMARY END POINTS:

REPAGLINIDE: FBG:decreases 2.4mmol/l
BGL>140
Hba1c-decreases 1.5%
GLIPIZIDE: FBG:decreases 1.4mmol/l
Hba1c- decreases 0.3%
• SECONDARY END POINTS: weight gain
depends upon the conditions of the patients/varies from
patients to patients.
 ASSESMENT OF SAFETY AND EFFICACY
PARAMETERS

• EFFICACY PARAMETERS:
BGL:decreases
HbA1c:decreases 1.5%
IGT-decrease 2.4%
• SAFETY PARAMETERS:
BMI-20 to 35Kg/m2
HbA1c-4.2 to 12.8%
No micro or macro vascular complications
No effect on kidney & liver
 REFERENCES

• LITERATURE:
MEDICAL PHARAMACOLOGY
TRIPATI & CRC MONITORING
• WWW.irwingoldsteinmd.com
• www.zafes.de/institute/ gynaekologie-
geburtshilfe/index-kaufmann.html - 59k
• www.pennysylvania.com
• www.clinicaltrials.gov.com