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: 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 ]


Enrollment:	4911
Study Start Date:	March 2012
Study Completion Date:	February 2013
Primary Completion Date:	February 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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Show 75 Study Locations

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:	September 5, 2014
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, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases

ClinicalTrials.gov processed this record on March 03, 2015

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