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

Sponsor
AstraZeneca (Industry)
Overall Status
Completed
CT.gov ID
NCT01523405
Collaborator
(none)
4,911
Enrollment
75
Locations
11.1
Duration (Months)
65.5
Patients Per Site
5.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Actual Enrollment :
    4911 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Cross-Sectional
    Official Title:
    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 Start Date :
    Mar 1, 2012
    Actual Primary Completion Date :
    Feb 1, 2013
    Actual Study Completion Date :
    Feb 1, 2013

    Arms and Interventions

    Arm Intervention/Treatment
    1

    Outcome Measures

    Primary Outcome Measures

    1. Diabetic Quality of Life using Modified 15 item DQoL (MDQoL) questionnaire [2nd February 2012 - 2nd August 2012]

    Secondary Outcome Measures

    1. HbA1c and its correlation with frequency of hypoglycemia [2nd February 2012 - 2nd August 2012]

    2. Frequency and impact of hypoglycemia using HFS-II (worry subscale) [2nd February 2012 - 2nd August 2012]

    3. Disease modifying variables Body Mass Index (BMI) and Blood Pressure (BP) [2nd February 2012 - 2nd August 2012]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Research Site Vijayawada Andhara Pradesh India
    2 Research Site Hanamkoda Andhra Pradesh, India
    3 Research Site Kammam Andhra Pradesh, India
    4 Research Site Khammam Andhra Pradesh, India
    5 Research Site Vijayawada Andhra Pradesh, India
    6 Research Site Hyderabad Andhra Pradesh India
    7 Research Site Khammam Andhra Pradesh India
    8 Research Site Kurnool Andhra Pradesh India
    9 Research Site Nellore Andhra Pradesh India
    10 Research Site Vijayawada Andhra Pradesh India
    11 Research Site Visakhapatnam Andhra Pradesh India
    12 Research Site Guwahati Assam India
    13 Research Site Mysore Bangalore India
    14 Research Site Bilaspur Chhattisgarh India
    15 Research Site Raipur Chhattisgarh India
    16 Research Site Mapusa Goa India
    17 Research Site Ahemdabad Gujarat India
    18 Research Site Ahmadabad Gujarat India
    19 Research Site Anand Gujarat India
    20 Research Site Chennai Gujarat India
    21 Research Site Nadiad Gujarat India
    22 Research Site Vadodara Gujarat India
    23 Research Site Panchkula Haryana- India
    24 Research Site Karnal Haryana India
    25 Research Site Dhanbad Jharkhand India
    26 Research Site Ranchi Jharkhand India
    27 Research Site Bangalore Karnataka India
    28 Research Site Kanpur Karnataka India
    29 Research Site Mangalore Karnataka India
    30 Research Site Mysore Karnataka India
    31 Research Site Trichy Karnataka India
    32 Research Site Hubli Karnatka India
    33 Research Site Mangalore Karnatka India
    34 Research Site Mysore Karnatka India
    35 Research Site Kannur Kerala India
    36 Research Site Bhopal Madhya Pradesh India
    37 Research Site Gwalior Madhya Pradesh India
    38 Research Site Indore(MP) Madhya Pradesh India
    39 Research Site Ujain Madhya Pradesh India
    40 Research Site Mumbai Maharastra India
    41 Research Site Pune Maharastra India
    42 Research Site Pune Mahrastra India
    43 Research Site Indore MP India
    44 Research Site Delhi New Delhi India
    45 Research Site New Delh New Delhi India
    46 Research Site Bhubaneswar Orissa India
    47 Research Site Puducherry Pondicherry India
    48 Research Site Ludhiana Punjab India
    49 Research Site Jaipur Rajasthan India
    50 Research Site Jodhpur Rajasthan India
    51 Research Site Kota Rajasthan India
    52 Research Site Pushkar Rajasthan India
    53 Research Site Chennai. Tamil Nadu India
    54 Research Site Chennai Tamil Nadu India
    55 Research Site Madurai Tamil Nadu India
    56 Research Site Chennai Tamilnadu India
    57 Research Site Coimbatore Tamilnadu India
    58 Research Site Cuddlore Tamilnadu India
    59 Research Site Kanchipuram Tamilnadu India
    60 Research Site Karaikal Tamilnadu India
    61 Research Site Thuckalay Tamilnadu India
    62 Research Site Trichy Tamilnadu India
    63 Research Site Vellore Tamilnadu India
    64 Research Site Bhilai UP India
    65 Research Site Fatepur UP India
    66 Research Site Ghaziabad UP India
    67 Research Site Kanpur UP India
    68 Research Site Noida UP India
    69 Research Site Gorakhpur Uttar Pradesh India
    70 Research Site Lucknow Uttar Pradesh India
    71 Research Site Noida Uttar Pradesh India
    72 Research Site Kolkata West Bangal India
    73 Research Site Kolkata West Bengal India
    74 Research Site Delhi India
    75 Research Site New Delhi India

    Sponsors and Collaborators

    • 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 Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    AstraZeneca
    ClinicalTrials.gov Identifier:
    NCT01523405
    Other Study ID Numbers:
    • NIS-CIN-XXX-2011/3
    First Posted:
    Feb 1, 2012
    Last Update Posted:
    Sep 8, 2014
    Last Verified:
    Sep 1, 2014
    Keywords provided by AstraZeneca
    Non Interventional Study, Type II Diabetes Mellitus, Quality of Life
    Additional relevant MeSH terms:
    Diabetes Mellitus
    Hypoglycemia
    Diabetes Mellitus, Type 2

    Study Results

    No Results Posted as of Sep 8, 2014