A Non-Interventional Study To Evaluate Diabetes Related Quality Of Life, Frequency And Impact Of Hypoglycemia In T2DM (INSIGHT)

September 5, 2014 updated by: AstraZeneca

A Non-Interventional Study To Evaluate Diabetes Related Quality Of Life, Frequency And Impact Of Hypoglycemia In Type 2 Diabetes Patients On Pharmacotherapy (INSIGHT)

This is a non-interventional, cross sectional, multicentric study in T2DM patients which will involve a single visit for study related procedures. This study will be conducted in approximately 5,000 patients at around 300 hospitals/primary care clinics across India. Approximately 18-20 patients per site will be enrolled. This study has been designed to evaluate diabetes related quality of life (DQoL), frequency and impact of hypoglycaemia in relation to HbA1c control and to assess disease modifying variables-BMI and BP in T2DM patients on oral / injectable anti-diabetic drugs with/without insulin therapy.

Study Overview

Status

Completed

Conditions

Detailed Description

A Non-Interventional Study To Evaluate Diabetes Related Quality Of Life, Frequency And Impact Of Hypoglycemia In Type 2 Diabetes Patients On Pharmacotherapy (INSIGHT)

Study Type

Observational

Enrollment (Actual)

4911

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
      • Delhi, India
        • Research Site
      • New Delhi, India
        • Research Site
    • Andhara Pradesh
      • Vijayawada, Andhara Pradesh, India
        • Research Site
    • Andhra Pradesh
      • Hyderabad, Andhra Pradesh, India
        • Research Site
      • Khammam, Andhra Pradesh, India
        • Research Site
      • Kurnool, Andhra Pradesh, India
        • Research Site
      • Nellore, Andhra Pradesh, India
        • Research Site
      • Vijayawada, Andhra Pradesh, India
        • Research Site
      • Visakhapatnam, Andhra Pradesh, India
        • Research Site
    • Andhra Pradesh,
      • Hanamkoda, Andhra Pradesh,, India
        • Research Site
      • Kammam, Andhra Pradesh,, India
        • Research Site
      • Khammam, Andhra Pradesh,, India
        • Research Site
      • Vijayawada, Andhra Pradesh,, India
        • Research Site
    • Assam
      • Guwahati, Assam, India
        • Research Site
    • Bangalore
      • Mysore, Bangalore, India
        • Research Site
    • Chhattisgarh
      • Bilaspur, Chhattisgarh, India
        • Research Site
      • Raipur, Chhattisgarh, India
        • Research Site
    • Goa
      • Mapusa, Goa, India
        • Research Site
    • Gujarat
      • Ahemdabad, Gujarat, India
        • Research Site
      • Ahmadabad, Gujarat, India
        • Research Site
      • Anand, Gujarat, India
        • Research Site
      • Chennai, Gujarat, India
        • Research Site
      • Nadiad, Gujarat, India
        • Research Site
      • Vadodara, Gujarat, India
        • Research Site
    • Haryana
      • Karnal, Haryana, India
        • Research Site
    • Haryana-
      • Panchkula, Haryana-, India
        • Research Site
    • Jharkhand
      • Dhanbad, Jharkhand, India
        • Research Site
      • Ranchi, Jharkhand, India
        • Research Site
    • Karnataka
      • Bangalore, Karnataka, India
        • Research Site
      • Kanpur, Karnataka, India
        • Research Site
      • Mangalore, Karnataka, India
        • Research Site
      • Mysore, Karnataka, India
        • Research Site
      • Trichy, Karnataka, India
        • Research Site
    • Karnatka
      • Hubli, Karnatka, India
        • Research Site
      • Mangalore, Karnatka, India
        • Research Site
      • Mysore, Karnatka, India
        • Research Site
    • Kerala
      • Kannur, Kerala, India
        • Research Site
    • MP
      • Indore, MP, India
        • Research Site
    • Madhya Pradesh
      • Bhopal, Madhya Pradesh, India
        • Research Site
      • Gwalior, Madhya Pradesh, India
        • Research Site
      • Indore(MP), Madhya Pradesh, India
        • Research Site
      • Ujain, Madhya Pradesh, India
        • Research Site
    • Maharastra
      • Mumbai, Maharastra, India
        • Research Site
      • Pune, Maharastra, India
        • Research Site
    • Mahrastra
      • Pune, Mahrastra, India
        • Research Site
    • New Delhi
      • Delhi, New Delhi, India
        • Research Site
      • New Delh, New Delhi, India
        • Research Site
    • Orissa
      • Bhubaneswar, Orissa, India
        • Research Site
    • Pondicherry
      • Puducherry, Pondicherry, India
        • Research Site
    • Punjab
      • Ludhiana, Punjab, India
        • Research Site
    • Rajasthan
      • Jaipur, Rajasthan, India
        • Research Site
      • Jodhpur, Rajasthan, India
        • Research Site
      • Kota, Rajasthan, India
        • Research Site
      • Pushkar, Rajasthan, India
        • Research Site
    • Tamil Nadu
      • Chennai, Tamil Nadu, India
        • Research Site
      • Chennai., Tamil Nadu, India
        • Research Site
      • Madurai, Tamil Nadu, India
        • Research Site
    • Tamilnadu
      • Chennai, Tamilnadu, India
        • Research Site
      • Coimbatore, Tamilnadu, India
        • Research Site
      • Cuddlore, Tamilnadu, India
        • Research Site
      • Kanchipuram, Tamilnadu, India
        • Research Site
      • Karaikal, Tamilnadu, India
        • Research Site
      • Thuckalay, Tamilnadu, India
        • Research Site
      • Trichy, Tamilnadu, India
        • Research Site
      • Vellore, Tamilnadu, India
        • Research Site
    • UP
      • Bhilai, UP, India
        • Research Site
      • Fatepur, UP, India
        • Research Site
      • Ghaziabad, UP, India
        • Research Site
      • Kanpur, UP, India
        • Research Site
      • Noida, UP, India
        • Research Site
    • Uttar Pradesh
      • Gorakhpur, Uttar Pradesh, India
        • Research Site
      • Lucknow, Uttar Pradesh, India
        • Research Site
      • Noida, Uttar Pradesh, India
        • Research Site
    • West Bangal
      • Kolkata, West Bangal, India
        • Research Site
    • West Bengal
      • Kolkata, West Bengal, India
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Approximately 5,000 adult patients (≥ 18 years) diagnosed with T2DM will be randomly selected from around 300 hospitals/primary care clinics across India to participate in this study.

Description

Inclusion Criteria:

  • Patients with diagnosis of T2DM for > 1 year prior to entry in the study willing and able to complete the questionnaire and on pharmacotherapy
  • Patients who are currently treated with a single or combination of injectable/oral antidiabetic drugs with or without insulin therapy
  • Treatment type must be unchanged in the previous 3 months. However, dose modifications are allowed
  • Patients who agree to participate in the study and give their written informed consent

Exclusion Criteria:

  • Patients with type 1 diabetes
  • Patients with diabetic ketoacidosis and/or hyperosmolar hyperglycaemic state
  • Patients with secondary diabetes (including disease of the exocrine pancreas, endocrinopathies)
  • Patients with concurrent treatment involving systemic glucocorticoids. However, inhaled, locally injected and topical use of glucocorticoids is allowed
  • Patients suffering from severe cardiac, hepatic, renal diseases as judged by the investigator
  • Any condition of the patient which may have an impact on objective and outcome of the trial example: patients currently undergoing major/ minor surgical

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
1

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Diabetic Quality of Life using Modified 15 item DQoL (MDQoL) questionnaire
Time Frame: 2nd February 2012 - 2nd August 2012
2nd February 2012 - 2nd August 2012

Secondary Outcome Measures

Outcome Measure
Time Frame
HbA1c and its correlation with frequency of hypoglycemia
Time Frame: 2nd February 2012 - 2nd August 2012
2nd February 2012 - 2nd August 2012
Frequency and impact of hypoglycemia using HFS-II (worry subscale)
Time Frame: 2nd February 2012 - 2nd August 2012
2nd February 2012 - 2nd August 2012
Disease modifying variables Body Mass Index (BMI) and Blood Pressure (BP)
Time Frame: 2nd February 2012 - 2nd August 2012
2nd February 2012 - 2nd August 2012

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Investigators

  • Principal Investigator: Abhay Raut, MD, Prashanti Clinic,
  • Principal Investigator: Sashi Kumar, MBBS, Dianova Diabetes Centre
  • Principal Investigator: Subodh Chandra, MD, Chandra Medicals Pvt. Ltd
  • Principal Investigator: Debashish Maji, MD, DM, Calcutta Diabetes and endocrine Foundation,
  • Principal Investigator: Mayur Patel, MD, Swasthya (All India Institute of Diabetes and Research)
  • Principal Investigator: Nallaperumal Sivagnam, MBBS, Swamy Diabetes Centre,

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2012

Primary Completion (Actual)

February 1, 2013

Study Completion (Actual)

February 1, 2013

Study Registration Dates

First Submitted

January 30, 2012

First Submitted That Met QC Criteria

January 30, 2012

First Posted (Estimate)

February 1, 2012

Study Record Updates

Last Update Posted (Estimate)

September 8, 2014

Last Update Submitted That Met QC Criteria

September 5, 2014

Last Verified

September 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NIS-CIN-XXX-2011/3

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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