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

Purpose

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
Type II Diabetes Mellitus

Study Type:	Observational
Study Design:	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)

Resource links provided by NLM:

MedlinePlus related topics: Diabetes Diabetes Medicines Diabetes Type 2 Hypoglycemia

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

Diabetic Quality of Life using Modified 15 item DQoL (MDQoL) questionnaire [ Time Frame: 2nd February 2012 - 2nd August 2012 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

HbA1c and its correlation with frequency of hypoglycemia [ Time Frame: 2nd February 2012 - 2nd August 2012 ] [ Designated as safety issue: No ]
Frequency and impact of hypoglycemia using HFS-II (worry subscale) [ Time Frame: 2nd February 2012 - 2nd August 2012 ] [ Designated as safety issue: No ]
Disease modifying variables Body Mass Index (BMI) and Blood Pressure (BP) [ Time Frame: 2nd February 2012 - 2nd August 2012 ] [ Designated as safety issue: No ]

Estimated Enrollment:	5000
Study Start Date:	March 2012
Estimated Study Completion Date:	January 2013
Estimated Primary Completion Date:	January 2013 (Final data collection date for primary outcome measure)

Groups/Cohorts
1

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)

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
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.

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT01523405

Contacts

Contact: AstraZeneca Pharma India Limited Clinical Study Information

+918067748632

jayakumar.gurunathan@astrazeneca.com

Hide Study Locations

Locations

India
Research Site	Active, not recruiting
Hanamkoda, Andhra Pradesh,, India
Research Site	Completed
Hyderabad, Andhra Pradesh, India
Research Site	Recruiting
Khammam, Andhra Pradesh, India
Research Site	Completed
Kurnool, Andhra Pradesh, India
Research Site	Completed
Nellore, Andhra Pradesh, India
Research Site	Completed
Vijayawada, Andhra Pradesh, India
Research Site	Completed
Visakhapatnam, Andhra Pradesh, India
Research Site	Completed
Guwahati, Assam, India
Research Site	Completed
Mysore, Bangalore, India
Research Site	Completed
Bilaspur, Chhattisgarh, India
Research Site	Recruiting
Raipur, Chhattisgarh, India
Research Site	Completed
Mapusa, Goa, India
Research Site	Completed
Ahemdabad, Gujarat, India
Research Site	Completed
Anand, Gujarat, India
Research Site	Completed
Chennai, Gujarat, India
Research Site	Completed
Nadiad, Gujarat, India
Research Site	Completed
Vadodara, Gujarat, India
Research Site	Recruiting
Chandigarh, Hariyana, India
Research Site	Completed
Panchkula, Haryana-, India
Research Site	Recruiting
Karnal, Haryana, India
Research Site	Completed
Dhanbad, Jharkhand, India
Research Site	Active, not recruiting
Ranchi, Jharkhand, India
Research Site	Recruiting
Bangalore, Karnataka, India
Research Site	Completed
Kanpur, Karnataka, India
Research Site	Completed
Mangalore, Karnataka, India
Research Site	Completed
Trichy, Karnataka, India
Research Site	Completed
Hubli, Karnatka, India
Research Site	Completed
Mysore, Karnatka, India
Research Site	Completed
Kannur, Kerala, India
Research Site	Completed
Bhopal, Madhya Pradesh, India
Research Site	Completed
Gwalior, Madhya Pradesh, India
Research Site	Completed
Ujain, Madhya Pradesh, India
Research Site	Completed
Mumbai, Maharastra, India
Research Site	Active, not recruiting
Pune, Mahrastra, India
Research Site	Completed
Indore, MP, India
Research Site	Completed
Bhubaneswar, Orissa, India
Research Site	Completed
Puducherry, Pondicherry, India
Research Site	Completed
Ludhiana, Punjab, India
Research Site	Recruiting
Jaipur, Rajasthan, India
Research Site	Completed
Jaipur, Rajasthan, India
Research Site	Completed
Jodhpur, Rajasthan, India
Research Site	Completed
Kota, Rajasthan, India
Research Site	Completed
Pushkar, Rajasthan, India
Research Site	Recruiting
Chennai, Tamil Nadu, India
Research Site	Completed
Madurai, Tamil Nadu, India
Research Site	Completed
Coimbatore, Tamilnadu, India
Research Site	Completed
Cuddlore, Tamilnadu, India
Research Site	Not yet recruiting
Kanchipuram, Tamilnadu, India
Research Site	Recruiting
Karaikal, Tamilnadu, India
Research Site	Recruiting
Thuckalay, Tamilnadu, India
Research Site	Completed
Trichy, Tamilnadu, India
Research Site	Completed
Vellore, Tamilnadu, India
Research Site	Recruiting
Bhilai, UP, India
Research Site	Recruiting
Fatepur, UP, India
Research Site	Recruiting
Ghaziabad, UP, India
Research Site	Recruiting
Kanpur, UP, India
Research Site	Recruiting
Noida, UP, India
Research Site	Completed
Gorakhpur, Uttar Pradesh, India
Research Site	Completed
Lucknow, Uttar Pradesh, India
Research Site	Completed
Noida, Uttar Pradesh, India
Research Site	Completed
Kolkata, West Bengal, India
Research Site	Recruiting
Delhi, India
Research Site	Completed
New Delhi, India
Research Site	Recruiting
Pondicherry, 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,

More Information

No publications provided

Responsible Party:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT01523405 History of Changes
Other Study ID Numbers:	NIS-CIN-XXX-2011/3
Study First Received:	January 30, 2012
Last Updated:	December 28, 2012
Health Authority:	INDIA: DCGI and Ethics Committee

Keywords provided by AstraZeneca:

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

Additional relevant MeSH terms:

Diabetes Mellitus
Diabetes Mellitus, Type 2
Hypoglycemia

Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on May 22, 2013

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