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

NCT01523405 | Completed

• 1 other identifier: NIS-CIN-XXX-2011/3
• Study Type: observational
• Target: 4,911
• Locations: 1 country
• Sites: 70

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.

Conditions

Type II Diabetes Mellitus

Keywords

Non Interventional Study, Type II Diabetes Mellitus, Quality of Life

Outcome Measures

Primary Outcomes (1)

• Diabetic Quality of Life using Modified 15 item DQoL (MDQoL) questionnaire

  2nd February 2012 - 2nd August 2012

Secondary Outcomes (3)

• HbA1c and its correlation with frequency of hypoglycemia

  2nd February 2012 - 2nd August 2012

• Frequency and impact of hypoglycemia using HFS-II (worry subscale)

  2nd February 2012 - 2nd August 2012

• Disease modifying variables Body Mass Index (BMI) and Blood Pressure (BP)

  2nd February 2012 - 2nd August 2012

Study Arms (1)

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (70)

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Vijayawada, Andhara Pradesh, India

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Hanamkoda, Andhra Pradesh, India

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Hyderabad, Andhra Pradesh, India

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Kammam, Andhra Pradesh, India

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Khammam, Andhra Pradesh, India

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Kurnool, Andhra Pradesh, India

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Nellore, Andhra Pradesh, India

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Vijayawada, Andhra Pradesh, India

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Visakhapatnam, Andhra Pradesh, India

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Guwahati, Assam, India

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Mysore, Bangalore, India

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Bilāspur, Chhattisgarh, India

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Raipur, Chhattisgarh, India

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Mapusa, Goa, India

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Ahemdabad, Gujarat, India

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Ahmedabad, Gujarat, India

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Anand, Gujarat, India

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Chennai, Gujarat, India

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Nadiād, Gujarat, India

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Vadodara, Gujarat, India

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Karnāl, Haryana, India

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Panchkula, Haryana, India

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Dhanbad, Jharkhand, India

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Ranchi, Jharkhand, India

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Bangalore, Karnataka, India

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Kanpur, Karnataka, India

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Mangalore, Karnataka, India

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Mysore, Karnataka, India

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Trichy, Karnataka, India

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Hubli, Karnatka, India

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Mangalore, Karnatka, India

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Mysore, Karnatka, India

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Kannur, Kerala, India

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Bhopal, Madhya Pradesh, India

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Gwalior, Madhya Pradesh, India

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Indore, Madhya Pradesh, India

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Indore(MP), Madhya Pradesh, India

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Ujjain, Madhya Pradesh, India

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Mumbai, Maharashtra, India

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Pune, Maharashtra, India

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Pune, Mahrastra, India

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Delhi, National Capital Territory of Delhi, India

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Delhi, New Delhi, India

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New Delhi, New Delhi, India

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New Delh, New Delhi, India

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Bhubaneswar, Odisha, India

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Puducherry, Puducherry, India

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Ludhiana, Punjab, India

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Jaipur, Rajasthan, India

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Jodhpur, Rajasthan, India

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Kota, Rajasthan, India

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Pushkar, Rajasthan, India

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Chennai, Tamil Nadu, India

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Coimbatore, Tamil Nadu, India

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Cuddlore, Tamil Nadu, India

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Kanchipuram, Tamil Nadu, India

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Karaikal, Tamil Nadu, India

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Madurai, Tamil Nadu, India

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Thuckalay, Tamil Nadu, India

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Trichy, Tamil Nadu, India

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Vellore, Tamil Nadu, India

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Bhilāi, Uttar Pradesh, India

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Fatepur, Uttar Pradesh, India

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Ghaziabad, Uttar Pradesh, India

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Gorakhpur, Uttar Pradesh, India

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Kanpur, Uttar Pradesh, India

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Lucknow, Uttar Pradesh, India

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Noida, Uttar Pradesh, India

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Kolkata, West Bangal, India

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Kolkata, West Bengal, India

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MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• 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,

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 30, 2012
• First Posted: February 1, 2012
• Study Start: March 1, 2012
• Primary Completion: February 1, 2013
• Study Completion: February 1, 2013
• Last Updated: September 8, 2014

Record last verified: 2014-09

Locations

IN (70)