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

Completed

• Conditions: Type II Diabetes Mellitus

• Registration Number: NCT01523405
• Lead Sponsor: AstraZeneca

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)

Study Timeline

• Study First Submitted: 2012-01-30
• Study First Submitted QC: 2012-01-30
• Study First Posted: 2012-02-01
• Study Start: 2012-03
• Primary Completion: 2013-02
• Study Completion: 2013-02
• Status Verified: 2014-09
• Last Update Submitted: 2014-09-05
• Last Update Posted: 2014-09-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 4911

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Diabetic Quality of Life using Modified 15 item DQoL (MDQoL) questionnaire	2nd February 2012 - 2nd August 2012

Secondary Outcome Measures

Name	Time	Method
HbA1c and its correlation with frequency of hypoglycemia	2nd February 2012 - 2nd August 2012
Frequency and impact of hypoglycemia using HFS-II (worry subscale)	2nd February 2012 - 2nd August 2012
Disease modifying variables Body Mass Index (BMI) and Blood Pressure (BP)	2nd February 2012 - 2nd August 2012

Trial Locations

Locations (1)

Research Site; 🇮🇳 New Delhi, India