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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01523405
First received: January 30, 2012
Last updated: September 5, 2014
Last verified: September 2014

January 30, 2012
September 5, 2014
March 2012
February 2013   (final data collection date for primary outcome measure)
Diabetic Quality of Life using Modified 15 item DQoL (MDQoL) questionnaire [ Time Frame: 2nd February 2012 - 2nd August 2012 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01523405 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
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Not Provided
 
A Non-Interventional Study To Evaluate Diabetes Related Quality Of Life, Frequency And Impact Of Hypoglycemia In T2DM
A Non-Interventional Study To Evaluate Diabetes Related Quality Of Life, Frequency And Impact Of Hypoglycemia In Type 2 Diabetes Patients On Pharmacotherapy (INSIGHT)

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.

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

Observational
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Not Provided
Not Provided
Non-Probability Sample

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.

Type II Diabetes Mellitus
Not Provided
1
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
4911
February 2013
February 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
India
 
NCT01523405
NIS-CIN-XXX-2011/3
No
AstraZeneca
AstraZeneca
Not Provided
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,
AstraZeneca
September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP