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

NCT ID: NCT01523405

Last Updated: 2014-09-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

4911 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-03-31

Study Completion Date

2013-02-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Type II Diabetes Mellitus

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Abhay Raut, MD

Role: PRINCIPAL_INVESTIGATOR

Prashanti Clinic,

Sashi Kumar, MBBS

Role: PRINCIPAL_INVESTIGATOR

Dianova Diabetes Centre

Subodh Chandra, MD

Role: PRINCIPAL_INVESTIGATOR

Chandra Medicals Pvt. Ltd

Debashish Maji, MD, DM

Role: PRINCIPAL_INVESTIGATOR

Calcutta Diabetes and endocrine Foundation,

Mayur Patel, MD

Role: PRINCIPAL_INVESTIGATOR

Swasthya (All India Institute of Diabetes and Research)

Nallaperumal Sivagnam, MBBS

Role: PRINCIPAL_INVESTIGATOR

Swamy Diabetes Centre,

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Research Site

Vijayawada, Andhara Pradesh, India

Site Status

Research Site

Hanamkoda, Andhra Pradesh, India

Site Status

Research Site

Hyderabad, Andhra Pradesh, India

Site Status

Research Site

Kammam, Andhra Pradesh, India

Site Status

Research Site

Khammam, Andhra Pradesh, India

Site Status

Research Site

Kurnool, Andhra Pradesh, India

Site Status

Research Site

Nellore, Andhra Pradesh, India

Site Status

Research Site

Vijayawada, Andhra Pradesh, India

Site Status

Research Site

Visakhapatnam, Andhra Pradesh, India

Site Status

Research Site

Guwahati, Assam, India

Site Status

Research Site

Mysore, Bangalore, India

Site Status

Research Site

Bilāspur, Chhattisgarh, India

Site Status

Research Site

Raipur, Chhattisgarh, India

Site Status

Research Site

Mapusa, Goa, India

Site Status

Research Site

Ahemdabad, Gujarat, India

Site Status

Research Site

Ahmedabad, Gujarat, India

Site Status

Research Site

Anand, Gujarat, India

Site Status

Research Site

Chennai, Gujarat, India

Site Status

Research Site

Nadiād, Gujarat, India

Site Status

Research Site

Vadodara, Gujarat, India

Site Status

Research Site

Karnāl, Haryana, India

Site Status

Research Site

Panchkula, Haryana, India

Site Status

Research Site

Dhanbad, Jharkhand, India

Site Status

Research Site

Ranchi, Jharkhand, India

Site Status

Research Site

Bangalore, Karnataka, India

Site Status

Research Site

Kanpur, Karnataka, India

Site Status

Research Site

Mangalore, Karnataka, India

Site Status

Research Site

Mysore, Karnataka, India

Site Status

Research Site

Trichy, Karnataka, India

Site Status

Research Site

Hubli, Karnatka, India

Site Status

Research Site

Mangalore, Karnatka, India

Site Status

Research Site

Mysore, Karnatka, India

Site Status

Research Site

Kannur, Kerala, India

Site Status

Research Site

Bhopal, Madhya Pradesh, India

Site Status

Research Site

Gwalior, Madhya Pradesh, India

Site Status

Research Site

Indore, Madhya Pradesh, India

Site Status

Research Site

Indore(MP), Madhya Pradesh, India

Site Status

Research Site

Ujjain, Madhya Pradesh, India

Site Status

Research Site

Mumbai, Maharashtra, India

Site Status

Research Site

Pune, Maharashtra, India

Site Status

Research Site

Pune, Mahrastra, India

Site Status

Research Site

Delhi, National Capital Territory of Delhi, India

Site Status

Research Site

Delhi, New Delhi, India

Site Status

Research Site

New Delhi, New Delhi, India

Site Status

Research Site

New Delh, New Delhi, India

Site Status

Research Site

Bhubaneswar, Odisha, India

Site Status

Research Site

Puducherry, Puducherry, India

Site Status

Research Site

Ludhiana, Punjab, India

Site Status

Research Site

Jaipur, Rajasthan, India

Site Status

Research Site

Jodhpur, Rajasthan, India

Site Status

Research Site

Kota, Rajasthan, India

Site Status

Research Site

Pushkar, Rajasthan, India

Site Status

Research Site

Chennai, Tamil Nadu, India

Site Status

Research Site

Coimbatore, Tamil Nadu, India

Site Status

Research Site

Cuddlore, Tamil Nadu, India

Site Status

Research Site

Kanchipuram, Tamil Nadu, India

Site Status

Research Site

Karaikal, Tamil Nadu, India

Site Status

Research Site

Madurai, Tamil Nadu, India

Site Status

Research Site

Thuckalay, Tamil Nadu, India

Site Status

Research Site

Trichy, Tamil Nadu, India

Site Status

Research Site

Vellore, Tamil Nadu, India

Site Status

Research Site

Bhilāi, Uttar Pradesh, India

Site Status

Research Site

Fatepur, Uttar Pradesh, India

Site Status

Research Site

Ghaziabad, Uttar Pradesh, India

Site Status

Research Site

Gorakhpur, Uttar Pradesh, India

Site Status

Research Site

Kanpur, Uttar Pradesh, India

Site Status

Research Site

Lucknow, Uttar Pradesh, India

Site Status

Research Site

Noida, Uttar Pradesh, India

Site Status

Research Site

Kolkata, West Bangal, India

Site Status

Research Site

Kolkata, West Bengal, India

Site Status

Countries

Review the countries where the study has at least one active or historical site.

India

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

NIS-CIN-XXX-2011/3

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.