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

Type II Diabetes Mellitus Clinical Trial

— INSIGHT  

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01523405
• Other study ID #: NIS-CIN-XXX-2011/3
• Status: Completed
• Phase: N/A
• First received: January 30, 2012
• Last updated: September 5, 2014
• Start date: March 2012
• Est. completion date: February 2013

Study information

• Verified date: September 2014
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: INDIA: DCGI and Ethics Committee
• Study type: Observational

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4911
• Est. completion date: February 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Case-Only, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Hypoglycemia
• Type II Diabetes Mellitus

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diabetic Quality of Life using Modified 15 item DQoL (MDQoL) questionnaire		2nd February 2012 - 2nd August 2012	No
Secondary	HbA1c and its correlation with frequency of hypoglycemia		2nd February 2012 - 2nd August 2012	No
Secondary	Frequency and impact of hypoglycemia using HFS-II (worry subscale)		2nd February 2012 - 2nd August 2012	No
Secondary	Disease modifying variables Body Mass Index (BMI) and Blood Pressure (BP)		2nd February 2012 - 2nd August 2012	No