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PROTOCoL DESIGN Powered By Docstoc

 Protocol is the most important of all clinical trial documents

 It is also the first to be prepared and discussed with the

“ It is a confidential document since it contains information on drug “


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.

To study the effect of oral sulfonylurea in patient with type -2 diabetes
mellitus not previously treated with drug therapy.

   Study Objectives

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.

    Study Design

      Open Label,
      Treatment (Glimepiride)
      Active Control,
      Safety/Efficacy Study
                             Diabetes Mellitus :
    a group of diseases characterized by high levels of blood glucose
    resulting from defects in insulin production, insulin action, or both
2 Types:
           1) Type 1 diabetes
 Insulin dependent diabetes
           2) Type 2 diabetes
 Non insulin dependent diabetes
 blood glucose levels rise due to
                   1) Lack of insulin production
                   2) Insufficient insulin action
         Sample Introduction
Glimepiride is a medium-to-long acting sulfonylurea anti-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.
It is sometimes classified as third-generation, and sometimes classified as second-
Mechanism of action:
      Pancreatic effect
      Extra-pancreatic effect
      Pancreatic effect:
           Increase insulin release from pancreas
           Suppress secretions of Glucagon
      Extra pancreatic effect:
           Increases the number of insulin receptors
           Increases post-receptor insulin sensitivity
           Increases glucolysis
           Increases glycogen storage in muscle and liver
           Decreases the hepatic output of glucose
Selection Criteria

  Subjects already taking medication for type-2 diabetes mellitus:-No
  Age eligible for study:-18Years to 40 Years
  Genders eligible for study:-Both
  Accepts healthy volunteers:-No
  Inclusion criteria
  Exclusion criteria
  Withdrawal Criteria
Study Treatment
 Life style modification
           Diet control
                All diabetic patients should be on diet control.
                Diet control is a must either the patient is taking insulin
              or oral therapy.
                Over weight should be reduced .
           Smoking cessation
 Oral agents
           Mechanism of action:
                Pancreatic effect
                Extra-pancreatic effect
   Glimepiride 2mg per day
       Once daily. Half-life 9 hours, peak action for 4 hours.
             Phase 2/Open Study
Patient    Patients with type 2 diabetes not previously treated
Type       with diet or oral drug
Trial Size Multicenter trial

Design      Active control & openly treated with orally Glimepiride
Dosing      2mg. Once Daily Glimepiride

Endpoints   HbA1c, body weight, fasting plasma glucose, safety
Treatment of Type 2 Diabetes

    Therapeutic Lifestyle Change

             Lab Test

          Oral Drugs Only

        After 12 Week check
                              Flow Chat
             Lab Test                          Para Meter
Laboratory Examination             Safety (Hepatic, CVD,
  Glucose (Fasting)              Hypoglycemia – While realizing that
Not lass than 120 mg/dl
                                 diabetes is a serious disease!)
  Glucose (PP)
Not lass than 160 mg/dl            Efficacy (glycemic control, risk
  Glucose Torrance Test (GTT)    factor reduction)

 Hemoglobin (In Blood)             Side Effects (weight gain)
Not less than 8.0 gms/dl
                                   Patient acceptability
 HbA1C(Glycocyated                 Preventing Diabetes
 Laboratory Examination           Glucose control
Urine(Rotten, Microscope)RM
                                  Blood pressure control
                                  Blood lipid control
                                  Preventive care practices for eyes,
                                 kidneys, feet, teeth and gums
 Study Sponsor Notification by Investigator
     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
 EC/IRB Notification by Investigator
     Reports of all adverse events (including follow-up information) must be
   submitted to the EC/IRB within 10 working days.
 FDA Notification by Sponsor
     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.
Other Components

Quality control and assurance(QC/QA)procedures

Ethics( IDMC process, EC, Confidentiality)

Monitoring/ Direct access to data

Data Handling and record keeping

Financing and Insurance

Publication policy
Comparative approach

Regulatory Guidelines@

     Indian GCP
               Sch Y

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