Ignite Creation Date:
2025-12-24 @ 11:42 PM
Ignite Modification Date:
2026-02-18 @ 8:43 AM
Study NCT ID:
NCT02212951
Status:
COMPLETED
Last Update Posted:
2016-02-08
First Post:
2014-08-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Postprandial Glucose Control Associated With BIOD-531 vs. Humalog Mix 75/25 vs. Humulin R U-500
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': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-01', 'dispFirstSubmitDate': '2016-01-15', 'lastUpdateSubmitDate': '2016-01-15', 'studyFirstSubmitDate': '2014-08-07', 'dispFirstSubmitQcDate': '2016-01-15', 'studyFirstSubmitQcDate': '2014-08-08', 'dispFirstPostDateStruct': {'date': '2016-02-08', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2016-02-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-08-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Post-standardized meal glucose exposure (AUC)', 'timeFrame': '0-120 minutes after meal'}], 'secondaryOutcomes': [{'measure': 'Speed of insulin absorption (Times to 50%, 90%, maximal insulin concentrations)', 'timeFrame': '0-720 minutes'}, {'measure': 'Insulin exposure (AUC)', 'timeFrame': 'Various time frames over 720 minutes'}, {'measure': 'Maximal insulin concentration', 'timeFrame': '0-720 minutes'}, {'measure': 'Post breakfast and post-lunch glucose exposure (AUC)', 'timeFrame': 'Various times frames over 720 minutes'}, {'measure': 'Post-breakfast and post-lunch maximal glucose concentrations', 'timeFrame': '0-720 minutes'}, {'measure': 'Injection site toleration (VAS and severity scales)', 'timeFrame': '30 minutes post injection'}, {'measure': 'Draize injection site erythema and edema scoring', 'timeFrame': '0-720 minutes'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Type 2 Diabetes Mellitus']}, 'descriptionModule': {'briefSummary': 'The study is to compare meal time glucose control associated with BIOD-531, a rapidly absorbed concentrated insulin to that associated with Humalog Mix 75/25 and Humulin R U-500.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18-65\n* BMI \\> 25 kg/m2\n* Type 2 Diabetes Mellitus\n* HbA1c \\< 10.0%\n* Subject uses 50-200 units of insulin/day\n\nExclusion Criteria:\n\n* Type 1 Diabetes Mellitus\n* History of bariatric surgery\n* Corticosteroid therapy\n* Significant cardiovascular or other major organ disease\n* Females who are breast feeding or pregnant\n* A sexually active person not using adequate contraceptive methods'}, 'identificationModule': {'nctId': 'NCT02212951', 'briefTitle': 'Comparison of Postprandial Glucose Control Associated With BIOD-531 vs. Humalog Mix 75/25 vs. Humulin R U-500', 'organization': {'class': 'INDUSTRY', 'fullName': 'Biodel'}, 'officialTitle': 'A Single-blind Crossover Study of the Pharmacokinetic and Postprandial Glucose Dynamics of BIOD-531 Compared to Humulin R U-500 and Humalog Mix 75/25 in Subjects With Type 2 Diabetes Mellitus Who Are Treated With 50-200 Units of Insulin Per Day', 'orgStudyIdInfo': {'id': '3-152'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'BIOD-531 pre-meal', 'description': 'Subcutaneous injection of 0.6 U/kg immediately before the start of the standardized breakfast', 'interventionNames': ['Drug: BIOD-531']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Humalog Mix 75/25 pre-meal', 'description': 'Subcutaneous injection of 0.6 U/kg immediately before the start of the standardized breakfast', 'interventionNames': ['Drug: Humalog Mix 75/25']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Humulin R U-500', 'description': 'Subcutaneous injection of 0.6 U/kg immediately before the start of a standardized breakfast', 'interventionNames': ['Drug: Humulin R U-500']}, {'type': 'EXPERIMENTAL', 'label': 'BIOD-531 post-meal', 'description': 'Subcutaneous injection of 0.6 U/kg 20 minutes after the start of the standardized breakfast', 'interventionNames': ['Drug: BIOD-531']}], 'interventions': [{'name': 'BIOD-531', 'type': 'DRUG', 'armGroupLabels': ['BIOD-531 post-meal', 'BIOD-531 pre-meal']}, {'name': 'Humalog Mix 75/25', 'type': 'DRUG', 'armGroupLabels': ['Humalog Mix 75/25 pre-meal']}, {'name': 'Humulin R U-500', 'type': 'DRUG', 'armGroupLabels': ['Humulin R U-500']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Chula Vista', 'state': 'California', 'country': 'United States', 'facility': 'Profil Institute for Clinical Research', 'geoPoint': {'lat': 32.64005, 'lon': -117.0842}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Biodel', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}