<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02208921</url>
  </required_header>
  <id_info>
    <org_study_id>D1843R00050</org_study_id>
    <secondary_id>NIS-DIN-XXX-2014/1</secondary_id>
    <nct_id>NCT02208921</nct_id>
  </id_info>
  <brief_title>An Observational, Cross Sectional Study to Assess the Prevalence of Chronic Kidney Disease (CKD) in Type 2 Diabetes Patients</brief_title>
  <acronym>START-INDIA</acronym>
  <official_title>An Observational, Cross Sectional Study to Assess the Prevalence of Chronic Kidney Disease in Type 2 Diabetes Patients in India</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>AstraZeneca</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>AstraZeneca</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This non-interventional, multi-centric, cross-sectional study is aimed to determine the&#xD;
      prevalence of Chronic Kidney Disease in Indian patients with Type 2 Diabetes (T2DM). 3000&#xD;
      patients will be enrolled from 30 investigative sites all over the country. Each&#xD;
      investigative site will be expected to enrol 100 subjects. All the procedures will be&#xD;
      completed in a single day.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is an observational, multicenter, cross-sectional study to be conducted at 30 sites in&#xD;
      India. Endocrinologist/ Diabetologist from multiple private clinics will evaluate the Type 2&#xD;
      Diabetes patients. The study will be conducted over 9-10 months and will be started after&#xD;
      obtaining written approval of Independent Ethics Committee (IEC) and written Informed consent&#xD;
      of the patient. . Each investigative site will be expected to enrol 100 subjects. All the&#xD;
      procedures will be completed in a single day.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2014</start_date>
  <completion_date type="Actual">May 2015</completion_date>
  <primary_completion_date type="Actual">May 2015</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <target_duration>1 Day</target_duration>
  <primary_outcome>
    <measure>The proportion of T2DM patients with Chronic Kidney Disease (CKD)</measure>
    <time_frame>1 day</time_frame>
    <description>The proportion of T2DM patients with CKD as per GFR (Glomerular Filtration Rate)criteria. GFR below 90 ml/min/1.73 m2 is defined as CKD. we will also classify CKD into various groups as per the KDIGO 2013.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Frequency of T2DM patients in various stages of CKD</measure>
    <time_frame>1 day</time_frame>
    <description>The proportion of T2DM patients with CKD as per GFR (Glomerular Filtration Rate)criteria. We will also classify CKD into various groups as per the KDIGO (KIDNEY DISEASE IMPROVING GLOBAL OUTCOMES) 2013.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Frequency of T2DM patients with CKD in patients with different duration of T2DM</measure>
    <time_frame>1 day</time_frame>
    <description>The proportion of T2DM patients with CKD as per GFR (Glomerular Filtration Rate)criteria.we will also classify CKD into various groups as per the KDIGO 2013.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Frequency of patients with HbA1C less than 7% in T2DM patients with and without CKD</measure>
    <time_frame>1 day</time_frame>
    <description>Frequency of patients with HbA1C (Glycated Haemoglobin) less than 7% in T2DM patients with and without CKD. we will correlate prevalence of CKD with HbA1C level.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">3000</enrollment>
  <condition>Diabetes</condition>
  <arm_group>
    <arm_group_label>T2DM patients with Chronic Kidney Disease</arm_group_label>
    <description>T2DM patients with Chronic Kidney Disease</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        A total of 3000 T2DM patients of either gender with age of 18 years and more will be&#xD;
        enrolled in the study after the Informed Consent Process.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Known cases of T2DM.&#xD;
&#xD;
          2. Male and female patients aged 18 years and above.&#xD;
&#xD;
          3. Must provide written Informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients with known type-1 diabetes.&#xD;
&#xD;
          2. Patients with any form of acute kidney injury based on investigator's discretion.&#xD;
&#xD;
          3. Patients on maintenance dialysis or known renal transplant patients.&#xD;
&#xD;
          4. Patients who have participated in any interventional study within past 3 months prior&#xD;
             to entry in this study.&#xD;
&#xD;
          5. Pregnant women.&#xD;
&#xD;
          6. Patients with symptomatic Urinary Tract Infection (UTI) or with history of hematuria.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Dr. Prasanna Kumar K.M, DM</last_name>
    <role>Study Chair</role>
    <affiliation>Endocrinology Center for Diabetes and Endocrine Care</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Ahmedabad</city>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Bangalore</city>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Chandigarh</city>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Chennai</city>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Coimbatore</city>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Delhi</city>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Ghaziabad</city>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Hyderabad</city>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Jaipur</city>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Kanpur</city>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Karnal</city>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Kolkata</city>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Ludhiana</city>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Mumbai</city>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Noida</city>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Pune</city>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Rohtak</city>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Trivandrum</city>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>India</country>
  </location_countries>
  <link>
    <url>http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&amp;studyid=3100&amp;filename=Synopsis.pdf</url>
    <description>CSR_Synopsis</description>
  </link>
  <verification_date>March 2016</verification_date>
  <study_first_submitted>August 4, 2014</study_first_submitted>
  <study_first_submitted_qc>August 4, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 5, 2014</study_first_posted>
  <last_update_submitted>March 24, 2016</last_update_submitted>
  <last_update_submitted_qc>March 24, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">March 25, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Type 2 Diabetes</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Kidney Diseases</mesh_term>
    <mesh_term>Renal Insufficiency, Chronic</mesh_term>
    <mesh_term>Diabetes Mellitus</mesh_term>
    <mesh_term>Diabetes Mellitus, Type 2</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02208921
org study id: D1843R00050
secondary id: NIS-DIN-XXX-2014/1
nct id: NCT02208921
lead sponsor: 
has dmc: Yes
This non-interventional, multi-centric, cross-sectional study is aimed to determine the
      prevalence of Chronic Kidney Disease in Indian patients with Type 2 Diabetes (T2DM). 3000
      patients will be enrolled from 30 investigative sites all over the country. Each
      investigative site will be expected to enrol 100 subjects. All the procedures will be
      completed in a single day.
This is an observational, multicenter, cross-sectional study to be conducted at 30 sites in
      India. Endocrinologist/ Diabetologist from multiple private clinics will evaluate the Type 2
      Diabetes patients. The study will be conducted over 9-10 months and will be started after
      obtaining written approval of Independent Ethics Committee (IEC) and written Informed consent
      of the patient. . Each investigative site will be expected to enrol 100 subjects. All the
      procedures will be completed in a single day.
time perspective: Cross-Sectional
measure: The proportion of T2DM patients with Chronic Kidney Disease (CKD)
time frame: 1 day
description: The proportion of T2DM patients with CKD as per GFR (Glomerular Filtration Rate)criteria. GFR below 90 ml/min/1.73 m2 is defined as CKD. we will also classify CKD into various groups as per the KDIGO 2013.
measure: Frequency of T2DM patients in various stages of CKD
time frame: 1 day
description: The proportion of T2DM patients with CKD as per GFR (Glomerular Filtration Rate)criteria. We will also classify CKD into various groups as per the KDIGO (KIDNEY DISEASE IMPROVING GLOBAL OUTCOMES) 2013.
measure: Frequency of T2DM patients with CKD in patients with different duration of T2DM
time frame: 1 day
description: The proportion of T2DM patients with CKD as per GFR (Glomerular Filtration Rate)criteria.we will also classify CKD into various groups as per the KDIGO 2013.
measure: Frequency of patients with HbA1C less than 7% in T2DM patients with and without CKD
time frame: 1 day
description: Frequency of patients with HbA1C (Glycated Haemoglobin) less than 7% in T2DM patients with and without CKD. we will correlate prevalence of CKD with HbA1C level.
arm group label: T2DM patients with Chronic Kidney Disease
description: T2DM patients with Chronic Kidney Disease
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Dr. Prasanna Kumar K.M, DM
role: Study Chair
affiliation: Endocrinology Center for Diabetes and Endocrine Care
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: India
url: http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=3100&filename=Synopsis.pdf
description: CSR_Synopsis
responsible party type: Sponsor
mesh term: Kidney Diseases
mesh term: Renal Insufficiency, Chronic
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 2