A Non-Interventional Study To Evaluate Diabetes Related Quality Of Life, Frequency And Impact Of Hypoglycemia In T2DM (INSIGHT)
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ClinicalTrials.gov Identifier: NCT01523405 |
Recruitment Status
:
Completed
First Posted
: February 1, 2012
Last Update Posted
: September 8, 2014
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Condition or disease |
---|
Type II Diabetes Mellitus |
Study Type : | Observational |
Actual Enrollment : | 4911 participants |
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) |
Study Start Date : | March 2012 |
Actual Primary Completion Date : | February 2013 |
Actual Study Completion Date : | February 2013 |

Group/Cohort |
---|
1 |
- Diabetic Quality of Life using Modified 15 item DQoL (MDQoL) questionnaire [ Time Frame: 2nd February 2012 - 2nd August 2012 ]
- HbA1c and its correlation with frequency of hypoglycemia [ Time Frame: 2nd February 2012 - 2nd August 2012 ]
- Frequency and impact of hypoglycemia using HFS-II (worry subscale) [ Time Frame: 2nd February 2012 - 2nd August 2012 ]
- Disease modifying variables Body Mass Index (BMI) and Blood Pressure (BP) [ Time Frame: 2nd February 2012 - 2nd August 2012 ]

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01523405

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, |
Responsible Party: | AstraZeneca |
ClinicalTrials.gov Identifier: | NCT01523405 History of Changes |
Other Study ID Numbers: |
NIS-CIN-XXX-2011/3 |
First Posted: | February 1, 2012 Key Record Dates |
Last Update Posted: | September 8, 2014 |
Last Verified: | September 2014 |
Keywords provided by AstraZeneca:
Non Interventional Study, Type II Diabetes Mellitus, Quality of Life |
Additional relevant MeSH terms:
Diabetes Mellitus Hypoglycemia Diabetes Mellitus, Type 2 |
Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases |