Ignite Creation Date:
2025-12-25 @ 4:32 AM
Ignite Modification Date:
2025-12-26 @ 3:34 AM
Study NCT ID:
NCT01292018
Status:
COMPLETED
Last Update Posted:
2013-02-21
First Post:
2011-01-31
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Management of Dyslipidemia in Adult Type 2 Diabetes Patients in India
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D050171', 'term': 'Dyslipidemias'}, {'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], 'ancestors': [{'id': 'D052439', 'term': 'Lipid Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Lipid profile ( Low Density Lipoproteins(LDL), High Density Lipoprotein (HDL), Triglycerides \\& Total cholesterol) Blood Glucose Measurements (Fasting Plasma Glucose)'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 5400}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-02', 'completionDateStruct': {'date': '2012-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-02-20', 'studyFirstSubmitDate': '2011-01-31', 'studyFirstSubmitQcDate': '2011-02-08', 'lastUpdatePostDateStruct': {'date': '2013-02-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-02-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of type 2 diabetic dyslipidemia patients achieving the target LDL goal according to ADA 2010. These patients should be on stable dose of Lipid Lowering Drugs(LDL) for at least 3 months'}], 'secondaryOutcomes': [{'measure': 'Proportion of dyslipidemia control rate according to american diabetes Association (ADA) 2010 criteria by age and gender'}, {'measure': 'Control of dyslipidemia by Lipid Lowering Drugs (LLDs) drugs alone or combination'}, {'measure': 'Control of dyslipidemia by all commercial available brands hypolipidemics drugs'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Management of dyslipidemia in Type 2 Diabetes Mellitus adult patients in India', 'Dyslipidemia control rates in Type 2 diabetic Mellitus patients'], 'conditions': ['Dyslipidemia', 'Type 2 Diabetes Mellitus']}, 'descriptionModule': {'briefSummary': 'The purpose of study to assess the control of dyslipidemia in the Indian diabetic population treated with any hypolipidemic agent.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Type 2 Diabetics with dyslipidemia on stable dose of Lipid Lowering Drugs(LLDs).', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult who is a known Type 2 diabetic as per the ADA 2010 criteria OR controlled diabetic (taking any antidiabetic medication)\n* Patients in the study will have been on lipid lowering drugs at a stable dose for the last three months before the designated study visit.\n\nExclusion Criteria:\n\n* Type 1 diabetic patients\n* Patients with a history of hepatic or renal diseases\n* Hypertension due to organic diseases'}, 'identificationModule': {'nctId': 'NCT01292018', 'acronym': 'SOLID', 'briefTitle': 'Management of Dyslipidemia in Adult Type 2 Diabetes Patients in India', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'A Non Interventional, Cross Sectional, Epidemiological Study on the Management of Dyslipidemia in Type 2 DM Adult Patients in India', 'orgStudyIdInfo': {'id': 'NIS-CIN-DUM-2010/1'}}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AstraZeneca', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}