Ignite Creation Date:
2025-12-25 @ 3:20 AM
Ignite Modification Date:
2025-12-26 @ 1:58 AM
Study NCT ID:
NCT01523405
Status:
COMPLETED
Last Update Posted:
2014-09-08
First Post:
2012-01-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Non-Interventional Study To Evaluate Diabetes Related Quality Of Life, Frequency And Impact Of Hypoglycemia In T2DM
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 4911}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-09', 'completionDateStruct': {'date': '2013-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-09-05', 'studyFirstSubmitDate': '2012-01-30', 'studyFirstSubmitQcDate': '2012-01-30', 'lastUpdatePostDateStruct': {'date': '2014-09-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-02-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Diabetic Quality of Life using Modified 15 item DQoL (MDQoL) questionnaire', 'timeFrame': '2nd February 2012 - 2nd August 2012'}], 'secondaryOutcomes': [{'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'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Non Interventional Study, Type II Diabetes Mellitus, Quality of Life'], 'conditions': ['Type II Diabetes Mellitus']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': 'A Non-Interventional Study To Evaluate Diabetes Related Quality Of Life, Frequency And Impact Of Hypoglycemia In Type 2 Diabetes Patients On Pharmacotherapy (INSIGHT)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with diagnosis of T2DM for \\> 1 year prior to entry in the study willing and able to complete the questionnaire and on pharmacotherapy\n* Patients who are currently treated with a single or combination of injectable/oral antidiabetic drugs with or without insulin therapy\n* Treatment type must be unchanged in the previous 3 months. However, dose modifications are allowed\n* Patients who agree to participate in the study and give their written informed consent\n\nExclusion Criteria:\n\n* Patients with type 1 diabetes\n* Patients with diabetic ketoacidosis and/or hyperosmolar hyperglycaemic state\n* Patients with secondary diabetes (including disease of the exocrine pancreas, endocrinopathies)\n* Patients with concurrent treatment involving systemic glucocorticoids. However, inhaled, locally injected and topical use of glucocorticoids is allowed\n* Patients suffering from severe cardiac, hepatic, renal diseases as judged by the investigator\n* Any condition of the patient which may have an impact on objective and outcome of the trial example: patients currently undergoing major/ minor surgical'}, 'identificationModule': {'nctId': 'NCT01523405', 'acronym': 'INSIGHT', 'briefTitle': 'A Non-Interventional Study To Evaluate Diabetes Related Quality Of Life, Frequency And Impact Of Hypoglycemia In T2DM', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'A Non-Interventional Study To Evaluate Diabetes Related Quality Of Life, Frequency And Impact Of Hypoglycemia In Type 2 Diabetes Patients On Pharmacotherapy (INSIGHT)', 'orgStudyIdInfo': {'id': 'NIS-CIN-XXX-2011/3'}}, 'armsInterventionsModule': {'armGroups': [{'label': '1'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Vijayawada', 'state': 'Andhara Pradesh', 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Ltd'}, {'name': 'Debashish Maji, MD, DM', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Calcutta Diabetes and endocrine Foundation,'}, {'name': 'Mayur Patel, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Swasthya (All India Institute of Diabetes and Research)'}, {'name': 'Nallaperumal Sivagnam, MBBS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Swamy Diabetes Centre,'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AstraZeneca', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}