Ignite Creation Date:
2025-12-24 @ 9:34 PM
Ignite Modification Date:
2025-12-27 @ 2:49 AM
Study NCT ID:
NCT01039532
Status:
COMPLETED
Last Update Posted:
2015-10-26
First Post:
2009-12-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Thrice Daily Biphasic Human Insulin With Basal Bolus Regimen in Type 2 Diabetes Mellitus Patients
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': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-10', 'completionDateStruct': {'date': '2010-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-10-23', 'studyFirstSubmitDate': '2009-12-24', 'studyFirstSubmitQcDate': '2009-12-24', 'lastUpdatePostDateStruct': {'date': '2015-10-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-12-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Glycaemic control', 'timeFrame': '3months'}], 'secondaryOutcomes': [{'measure': 'Weight gain Hypoglycaemic episodes Adverse effects Cost effectiveness', 'timeFrame': '3 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Type 2 diabetes mellitus', 'Biphasic human insulin thrice a day', 'Basal bolus insulin'], 'conditions': ['Diabetes Mellitus, Type 2']}, 'descriptionModule': {'briefSummary': "It is a proven fact that Basal Bolus insulin regimen is the near- physiological regimen \\& Thrice daily Biphasic Insulin Aspart is a comparable alternative for glycemic control in type 2 diabetes mellitus patients. In this study the investigators evaluated whether Biphasic Human Insulin can be used in a thrice daily regimen in place of BIAsp.\n\nAs the regimen is less expensive and one prick less than the basal-bolus regimen, it can be a good alternative for a diabetics in India.\n\nThis is a 12 week Open labelled parallel-Randomised controlled pilot study - 50 patients with type 2 Diabetes mellitus was selected after satisfying the inclusion and exclusion criteria's .Metformin and pioglitazone were continued and they are randomised into 2 groups at base line and was allotted into any of the two regimens.\n\n1. Basal detemir + bolus aspart or\n2. Thrice Daily Biphasic Human Insulin Regimen.\n\nThe two regimens were compared by the following variables:\n\nPrimary endpoint:\n\nGlycaemic control\n\nSecondary endpoint:\n\nWeight gain, Hypoglycaemic episodes, Adverse effects and Cost effectiveness", 'detailedDescription': 'It is a proven fact that Basal Bolus insulin regimen is the near- physiological regimen \\& Thrice daily Biphasic Insulin Aspart is a comparable alternative for glycemic control in type 2 diabetes mellitus patients. In this study the investigators evaluated whether Biphasic Human Insulin can be used in a thrice daily regimen in place of BIAsp.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '50 type 2 diabetes mellitus patients inadequately controlled patients treated with human premixed insulin twice daily for at least 3months along with metformin 2g/d and pioglitazone 30mg/d.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Type 2 Diabetics \\>/= 18 yrs of age Diabetic for \\>/= 6months\n* Inadequately controlled patients treated with human premixed insulin twice daily for at least 3months along with metformin 2g/d and pio30mg/d\n\n * Single dose of insulin exceeding 25 units or total insulin dose is more than 0.7u/kg/day with\n * If post lunch blood glucose is not controlled\n * If HbA1c ≥7%\n* No major cardiac events in the preceding 6 months.\n* NYHA \\<= Class II.\n\nExclusion Criteria:\n\n* Deranged LFT's- AST,ALT or ALP values \\>= 2 times.\n* Deranged RFT Sr. Creatinine \\>=1.5\n* Allergy to Insulin or its products.\n* Recent intake of any new medications for sugar control.\n* Illiterate to the level that she/he cannot understand the study.\n* Any other acute co morbid illness.\n* Pregnancy.\n* Decompensated heart failure/UsA/MI all within last 12month\n* Untreated proliferative retinopathy/ maculopathy\n* Drug or alcohol dependence"}, 'identificationModule': {'nctId': 'NCT01039532', 'briefTitle': 'Comparison of Thrice Daily Biphasic Human Insulin With Basal Bolus Regimen in Type 2 Diabetes Mellitus Patients', 'organization': {'class': 'UNKNOWN', 'fullName': 'PIMERIndia'}, 'officialTitle': 'Comparison of Thrice Daily Biphasic Human Insulin Versus Basal Detemir and Bolus Aspart in Patients With Poorly Controlled Type 2 Diabetes Mellitus', 'orgStudyIdInfo': {'id': 'BHI3'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Basal Bolus regimen', 'description': 'Basal Bolus regimen'}, {'label': 'Biphasic human insulin', 'description': 'Biphasic human insulin'}]}, 'contactsLocationsModule': {'locations': [{'zip': '160012', 'city': 'Chandigarh', 'state': 'Chandigarh', 'country': 'India', 'facility': 'AnilBhansali', 'geoPoint': {'lat': 30.73629, 'lon': 76.7884}}], 'overallOfficials': [{'name': 'Anil Bhansali, DM', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Post Graduate Institute of Medical Education and Research, Chandigarh'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Post Graduate Institute of Medical Education and Research, Chandigarh', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'prof and head', 'investigatorFullName': 'Anil Bhansali', 'investigatorAffiliation': 'Post Graduate Institute of Medical Education and Research, Chandigarh'}}}}