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Gliclazide Study observational study GREET

A
ameet rathod

This study aims to evaluate the glycemic outcomes of treating type 2 diabetes patients in India with gliclazide alone or in combination with other antidiabetic agents. The study will be a prospective, multicenter, observational trial conducted at 15 sites across India. Approximately 700 sulphonylurea-naive patients aged 30-65 years with HbA1c levels between 7-10% and fasting plasma glucose between 126-250 mg/dl will be enrolled. The primary endpoint is the mean change in HbA1c levels at 12 and 24 weeks. Secondary endpoints include changes in fasting plasma glucose, body weight, number achieving HbA1c target of <7%, and safety and tolerability measures. Patient

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GLICLAZIDE STUDY
Study Title A Real-World study on Glycaemic outcomes in Type 2 Diabetes mellitus patients treated with Gliclazide alone and in combination with other Anti-diabetic agents. (Gliclazide Study)
STUDY OBJECTIVE To evaluate glycemic outcomes Gliclazide alone and in combination with other Anti- diabetic agents in Sulphonyl urea na誰ve patients with type 2 diabetes mellitus in Indian population Pilot study
Study Design Prospective, Multicenter, Observational, Real- WorldEvidenceStudy. Study Sites Atotalofupto15sites inIndiawillbe involvedintheStudy. Sample Size Approximately700 patientswhoqualify basedonstudy selectioncriteriawill beenrolledinthe study.
INCLUSION CRITERIA
INCLUSIONCRITERIA Male or Female between 30 years to 65 years of age. Sulphonylureas na誰ve patients of type 2 diabetes mellitus (defined as never receiving Sulphonylureas treatment for diabetes since original diagnosis) and also patients who are on other OHAs but not initiated on SUs. Fasting Plasma glucose (FPG) between 126 mg/dl and 250 mg/dl. Patients with Body Mass Index (BMI) between 18 kg/m2 to 30 kg/m2. Patients with HbA1c between 7% to 10% both inclusive.
INCLUSION CRITERIACONT Patients If on anti-hypertensive, lipid-lowering, or thyroid medications or hormone therapy, has been on constant dosage for at least 3 months prior to screening visit Patients those have voluntarily given written informed consent. Women with childbearing potential, willing to use effective contraceptive measures (other than oral contraceptive pills) such mechanical or barrier contraceptives, postmenopausal will be included. In the opinion of the investigator, patients who are able to comply with the requirements of the protocol. Patients who received counseling on diet and exercise consistent with ADA recommendations
Exclusion Criteria Patients with Type 1 diabetes Female patients who were pregnant or breast feeding Presence of any other clinically significant disease or laboratory findings that in the Investigator's opinion may affect the study outcomes or continued participation of patient in the study. Participation in another study concurrently or within 4 weeks prior to initiation of treatment with Gliclazide.
Study Follow-up Duration/Visits Once enrolled into the study the patient will be instructed to return to the study investigators clinic to evaluate the study outcomes after a period of 12 weeks and 24 weeks. The duration of the study for the participants is 24 weeks
Study Endpoints Primary Endpoint Mean change in HbA1c levels at 12 weeks and 24 weeks after initiation of Gliclazide alone and in combination with other anti-diabetic agents.
Secondary Endpoint: Mean change in Fasting and Postprandial Plasma Glucose at 12 weeks, and 24 weeks after initiation of Gliclazide alone and in combination with other Anti-diabetic agents. Mean change in body weight and BMI at 12 weeks and 24 weeks after initiation of Gliclazide alone and in combination with other Anti-diabetic agents. Number of patients achieving the target HbA1c level (<7%) at 12 and 24 weeks after initiation of Gliclazide alone and in combination with other Anti-diabetic agents. Mean Change in Renal Function tests (eGFR, Serum Creatinine, Serum Urea, Serum uric acid, Blood urea nitrogen (BUN), Serum Sodium, Potassium & chloride) as compared to baseline. Mean Change in Liver Function Tests (Total Bilirubin, SGOT, SGPT, Alkaline Phosphate, Total Protein and Albumin) as compared to baseline. Mean Change in Lipid profile (Total Cholesterol, LDL, VLDL, HDL, and Triglycerides) as compared to the baseline. Assessment of comorbidities experienced by patients on Gliclazide alone and in combination with other Anti-diabetic agents. Assessment of concomitant medications prescribed along with Gliclazide alone and in combination with other Anti-diabetic agents. Assessment of safety of Gliclazide alone and in combination with other Anti-diabetic agents
Study Methodology This is a multicenter, prospective, observational study collecting data from prescription of each patient for a duration of 6 months from the timepoint when the patient was initiated on Gliclazide alone and in combination with other anti-diabetic drugs as part of routine clinical practice. The patient recruitment and prospective data collection in the study will be initiated only after obtaining approval from the ethics committee. The prescriptions and clinical laboratory data of qualified patients will be collected and uploaded into a secure electronic database by the study investigator or qualified site personnel at each study site. Each study investigator will be provided a unique user ID and password to the database. The data will be stored in a secured database with access to authorized personnel only. All necessary measures will be undertaken to protect privacy and confidentiality of patient data. The collected data will be analyzed prospectively and study outcome results will be presented.
Statistical Analysis .. Continuous data like age, weight etc. will be summarized with n, mean, SD and range. Categorical data like sex etc. will be depicted with count (%). Demographic Characteristics: Efficacy parameters such as change in HbA1c, FPG, PPG, and other laboratory parameters (Renal function tests, Liver function tests, and lipid profile) will be summarized with n, mean, SD, range and change from baseline will be evaluated. Number of patients achieving the HbA1c level of <7% will be summarized with count (%). Efficacy Analysis Incidence of adverse events will be summarized with count (%). Other safety measures such as physical examination and vital signs will be summarized using descriptive statistics and change from baseline, if applicable Safety Analysis
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Gliclazide Study observational study GREET

  • 2. Study Title A Real-World study on Glycaemic outcomes in Type 2 Diabetes mellitus patients treated with Gliclazide alone and in combination with other Anti-diabetic agents. (Gliclazide Study)
  • 3. STUDY OBJECTIVE To evaluate glycemic outcomes Gliclazide alone and in combination with other Anti- diabetic agents in Sulphonyl urea na誰ve patients with type 2 diabetes mellitus in Indian population Pilot study
  • 4. Study Design Prospective, Multicenter, Observational, Real- WorldEvidenceStudy. Study Sites Atotalofupto15sites inIndiawillbe involvedintheStudy. Sample Size Approximately700 patientswhoqualify basedonstudy selectioncriteriawill beenrolledinthe study.
  • 6. INCLUSIONCRITERIA Male or Female between 30 years to 65 years of age. Sulphonylureas na誰ve patients of type 2 diabetes mellitus (defined as never receiving Sulphonylureas treatment for diabetes since original diagnosis) and also patients who are on other OHAs but not initiated on SUs. Fasting Plasma glucose (FPG) between 126 mg/dl and 250 mg/dl. Patients with Body Mass Index (BMI) between 18 kg/m2 to 30 kg/m2. Patients with HbA1c between 7% to 10% both inclusive.
  • 7. INCLUSION CRITERIACONT Patients If on anti-hypertensive, lipid-lowering, or thyroid medications or hormone therapy, has been on constant dosage for at least 3 months prior to screening visit Patients those have voluntarily given written informed consent. Women with childbearing potential, willing to use effective contraceptive measures (other than oral contraceptive pills) such mechanical or barrier contraceptives, postmenopausal will be included. In the opinion of the investigator, patients who are able to comply with the requirements of the protocol. Patients who received counseling on diet and exercise consistent with ADA recommendations
  • 8. Exclusion Criteria Patients with Type 1 diabetes Female patients who were pregnant or breast feeding Presence of any other clinically significant disease or laboratory findings that in the Investigator's opinion may affect the study outcomes or continued participation of patient in the study. Participation in another study concurrently or within 4 weeks prior to initiation of treatment with Gliclazide.
  • 9. Study Follow-up Duration/Visits Once enrolled into the study the patient will be instructed to return to the study investigators clinic to evaluate the study outcomes after a period of 12 weeks and 24 weeks. The duration of the study for the participants is 24 weeks
  • 10. Study Endpoints Primary Endpoint Mean change in HbA1c levels at 12 weeks and 24 weeks after initiation of Gliclazide alone and in combination with other anti-diabetic agents.
  • 11. Secondary Endpoint: Mean change in Fasting and Postprandial Plasma Glucose at 12 weeks, and 24 weeks after initiation of Gliclazide alone and in combination with other Anti-diabetic agents. Mean change in body weight and BMI at 12 weeks and 24 weeks after initiation of Gliclazide alone and in combination with other Anti-diabetic agents. Number of patients achieving the target HbA1c level (<7%) at 12 and 24 weeks after initiation of Gliclazide alone and in combination with other Anti-diabetic agents. Mean Change in Renal Function tests (eGFR, Serum Creatinine, Serum Urea, Serum uric acid, Blood urea nitrogen (BUN), Serum Sodium, Potassium & chloride) as compared to baseline. Mean Change in Liver Function Tests (Total Bilirubin, SGOT, SGPT, Alkaline Phosphate, Total Protein and Albumin) as compared to baseline. Mean Change in Lipid profile (Total Cholesterol, LDL, VLDL, HDL, and Triglycerides) as compared to the baseline. Assessment of comorbidities experienced by patients on Gliclazide alone and in combination with other Anti-diabetic agents. Assessment of concomitant medications prescribed along with Gliclazide alone and in combination with other Anti-diabetic agents. Assessment of safety of Gliclazide alone and in combination with other Anti-diabetic agents
  • 12. Study Methodology This is a multicenter, prospective, observational study collecting data from prescription of each patient for a duration of 6 months from the timepoint when the patient was initiated on Gliclazide alone and in combination with other anti-diabetic drugs as part of routine clinical practice. The patient recruitment and prospective data collection in the study will be initiated only after obtaining approval from the ethics committee. The prescriptions and clinical laboratory data of qualified patients will be collected and uploaded into a secure electronic database by the study investigator or qualified site personnel at each study site. Each study investigator will be provided a unique user ID and password to the database. The data will be stored in a secured database with access to authorized personnel only. All necessary measures will be undertaken to protect privacy and confidentiality of patient data. The collected data will be analyzed prospectively and study outcome results will be presented.
  • 13. Statistical Analysis .. Continuous data like age, weight etc. will be summarized with n, mean, SD and range. Categorical data like sex etc. will be depicted with count (%). Demographic Characteristics: Efficacy parameters such as change in HbA1c, FPG, PPG, and other laboratory parameters (Renal function tests, Liver function tests, and lipid profile) will be summarized with n, mean, SD, range and change from baseline will be evaluated. Number of patients achieving the HbA1c level of <7% will be summarized with count (%). Efficacy Analysis Incidence of adverse events will be summarized with count (%). Other safety measures such as physical examination and vital signs will be summarized using descriptive statistics and change from baseline, if applicable Safety Analysis