Clinical trial NCT01523405: A Non-Interventional Study To Evaluate Diabetes Related Quality Of Life, Frequency And Impact Of Hypoglycemia In T2DM
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 type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type II Diabetes Mellitus
Keywords: Non Interventional Study, Type II Diabetes Mellitus, Quality of Life
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2012-02-01
Enrollment: 4911
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
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.

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.

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 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

Primary outcomes:
measure: Diabetic Quality of Life using Modified 15 item DQoL (MDQoL) questionnaire
timeFrame: 2nd February 2012 - 2nd August 2012
Secondary outcomes:
measure: HbA1c and its correlation with frequency of hypoglycemia
timeFrame: 2nd February 2012 - 2nd August 2012
measure: Frequency and impact of hypoglycemia using HFS-II (worry subscale)
timeFrame: 2nd February 2012 - 2nd August 2012
measure: Disease modifying variables Body Mass Index (BMI) and Blood Pressure (BP)
timeFrame: 2nd February 2012 - 2nd August 2012
Other outcomes:
Locations:
city: Vijayawada
country: India
facility: Research Site
state: Andhara Pradesh
city: Hanamkoda
country: India
facility: Research Site
state: Andhra Pradesh,
city: Kammam
country: India
facility: Research Site
state: Andhra Pradesh,
city: Khammam
country: India
facility: Research Site
state: Andhra Pradesh,
city: Vijayawada
country: India
facility: Research Site
state: Andhra Pradesh,
city: Hyderabad
country: India
facility: Research Site
state: Andhra Pradesh
city: Khammam
country: India
facility: Research Site
state: Andhra Pradesh
city: Kurnool
country: India
facility: Research Site
state: Andhra Pradesh
city: Nellore
country: India
facility: Research Site
state: Andhra Pradesh
city: Vijayawada
country: India
facility: Research Site
state: Andhra Pradesh
city: Visakhapatnam
country: India
facility: Research Site
state: Andhra Pradesh
city: Guwahati
country: India
facility: Research Site
state: Assam
city: Mysore
country: India
facility: Research Site
state: Bangalore
city: Bilaspur
country: India
facility: Research Site
state: Chhattisgarh
city: Raipur
country: India
facility: Research Site
state: Chhattisgarh
city: Mapusa
country: India
facility: Research Site
state: Goa
city: Ahemdabad
country: India
facility: Research Site
state: Gujarat
city: Ahmadabad
country: India
facility: Research Site
state: Gujarat
city: Anand
country: India
facility: Research Site
state: Gujarat
city: Chennai
country: India
facility: Research Site
state: Gujarat
city: Nadiad
country: India
facility: Research Site
state: Gujarat
city: Vadodara
country: India
facility: Research Site
state: Gujarat
city: Panchkula
country: India
facility: Research Site
state: Haryana-
city: Karnal
country: India
facility: Research Site
state: Haryana
city: Dhanbad
country: India
facility: Research Site
state: Jharkhand
city: Ranchi
country: India
facility: Research Site
state: Jharkhand
city: Bangalore
country: India
facility: Research Site
state: Karnataka
city: Kanpur
country: India
facility: Research Site
state: Karnataka
city: Mangalore
country: India
facility: Research Site
state: Karnataka
city: Mysore
country: India
facility: Research Site
state: Karnataka
city: Trichy
country: India
facility: Research Site
state: Karnataka
city: Hubli
country: India
facility: Research Site
state: Karnatka
city: Mangalore
country: India
facility: Research Site
state: Karnatka
city: Mysore
country: India
facility: Research Site
state: Karnatka
city: Kannur
country: India
facility: Research Site
state: Kerala
city: Bhopal
country: India
facility: Research Site
state: Madhya Pradesh
city: Gwalior
country: India
facility: Research Site
state: Madhya Pradesh
city: Indore(MP)
country: India
facility: Research Site
state: Madhya Pradesh
city: Ujain
country: India
facility: Research Site
state: Madhya Pradesh
city: Mumbai
country: India
facility: Research Site
state: Maharastra
city: Pune
country: India
facility: Research Site
state: Maharastra
city: Pune
country: India
facility: Research Site
state: Mahrastra
city: Indore
country: India
facility: Research Site
state: MP
city: Delhi
country: India
facility: Research Site
state: New Delhi
city: New Delh
country: India
facility: Research Site
state: New Delhi
city: Bhubaneswar
country: India
facility: Research Site
state: Orissa
city: Puducherry
country: India
facility: Research Site
state: Pondicherry
city: Ludhiana
country: India
facility: Research Site
state: Punjab
city: Jaipur
country: India
facility: Research Site
state: Rajasthan
city: Jodhpur
country: India
facility: Research Site
state: Rajasthan
city: Kota
country: India
facility: Research Site
state: Rajasthan
city: Pushkar
country: India
facility: Research Site
state: Rajasthan
city: Chennai.
country: India
facility: Research Site
state: Tamil Nadu
city: Chennai
country: India
facility: Research Site
state: Tamil Nadu
city: Madurai
country: India
facility: Research Site
state: Tamil Nadu
city: Chennai
country: India
facility: Research Site
state: Tamilnadu
city: Coimbatore
country: India
facility: Research Site
state: Tamilnadu
city: Cuddlore
country: India
facility: Research Site
state: Tamilnadu
city: Kanchipuram
country: India
facility: Research Site
state: Tamilnadu
city: Karaikal
country: India
facility: Research Site
state: Tamilnadu
city: Thuckalay
country: India
facility: Research Site
state: Tamilnadu
city: Trichy
country: India
facility: Research Site
state: Tamilnadu
city: Vellore
country: India
facility: Research Site
state: Tamilnadu
city: Bhilai
country: India
facility: Research Site
state: UP
city: Fatepur
country: India
facility: Research Site
state: UP
city: Ghaziabad
country: India
facility: Research Site
state: UP
city: Kanpur
country: India
facility: Research Site
state: UP
city: Noida
country: India
facility: Research Site
state: UP
city: Gorakhpur
country: India
facility: Research Site
state: Uttar Pradesh
city: Lucknow
country: India
facility: Research Site
state: Uttar Pradesh
city: Noida
country: India
facility: Research Site
state: Uttar Pradesh
city: Kolkata
country: India
facility: Research Site
state: West Bangal
city: Kolkata
country: India
facility: Research Site
state: West Bengal
city: Delhi
country: India
facility: Research Site
city: New Delhi
country: India
facility: Research Site
Study officials:
affiliation: Prashanti Clinic,
name: Abhay Raut, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Dianova Diabetes Centre
name: Sashi Kumar, MBBS
role: PRINCIPAL_INVESTIGATOR
affiliation: Chandra Medicals Pvt. Ltd
name: Subodh Chandra, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Calcutta Diabetes and endocrine Foundation,
name: Debashish Maji, MD, DM
role: PRINCIPAL_INVESTIGATOR
affiliation: Swasthya (All India Institute of Diabetes and Research)
name: Mayur Patel, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Swamy Diabetes Centre,
name: Nallaperumal Sivagnam, MBBS
role: PRINCIPAL_INVESTIGATOR
References: