Ignite Creation Date:
2025-12-24 @ 11:55 PM
Ignite Modification Date:
2025-12-25 @ 9:51 PM
Study NCT ID:
NCT01334151
Status:
COMPLETED
Last Update Posted:
2013-07-26
First Post:
2011-04-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Pharmacokinetic and Pharmacodynamic Properties of BIOD-105 and BIOD-107 Compared to Humalog® in Subjects With Type 1 Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003922', 'term': 'Diabetes Mellitus, Type 1'}], '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'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D061268', 'term': 'Insulin Lispro'}], 'ancestors': [{'id': 'D061266', 'term': 'Insulin, Short-Acting'}, {'id': 'D061385', 'term': 'Insulins'}, {'id': 'D010187', 'term': 'Pancreatic Hormones'}, {'id': 'D036361', 'term': 'Peptide Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 13}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-07', 'completionDateStruct': {'date': '2011-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-07-24', 'studyFirstSubmitDate': '2011-04-11', 'studyFirstSubmitQcDate': '2011-04-12', 'lastUpdatePostDateStruct': {'date': '2013-07-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-04-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Speed of absorption', 'timeFrame': '480 minutes', 'description': 'The speed of absorption will be assessed by the time to reach 50% of maximum insulin concentration (TINS-50%-early, time before CINS max) and the onset of action will be assessed by the time to reach 50% of the maximum glucose infusion rate (TGIR-50%- early).'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Diabetes Mellitus Type 1']}, 'descriptionModule': {'briefSummary': 'The primary objective of this study is to assess the speed of absorption and onset of action of BIOD-105 and BIOD-107 and compare them to Humalog®.', 'detailedDescription': 'The secondary objectives of this study are to assess other pharmacokinetic characteristics of BIOD-105 and BIOD-107 and compare those to Humalog®, to assess other pharmacodynamic characteristics of BIOD-105 and BIOD-107 and compare those to Humalog®, and to evaluate the safety and tolerability of BIOD-105 and BIOD-107 compared to Humalog®.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nSubjects must present with the following:\n\n1. Body Mass Index: ≥ 18 - ≤ 28 kg/m2\n2. Diagnosed with type 1 diabetes mellitus for at least 1 year\n3. Insulin antibody less than or equal to 10 μU/mL at screening\n\nExclusion Criteria:\n\nSubjects presenting with any of the following will not be included in the study:\n\n1. Type 2 diabetes mellitus\n2. Serum C-peptide \\> 1.0 ng/mL\n3. HbA1c \\> 10.0%\n4. History of hypersensitivity to any of the components in the study medication\n5. Treatment with any other investigational drug in the last 30 days before screening visit\n6. Regular smoking as assessed clinically by the Investigator.'}, 'identificationModule': {'nctId': 'NCT01334151', 'briefTitle': 'Pharmacokinetic and Pharmacodynamic Properties of BIOD-105 and BIOD-107 Compared to Humalog® in Subjects With Type 1 Diabetes', 'organization': {'class': 'INDUSTRY', 'fullName': 'Biodel'}, 'officialTitle': 'A Double-blind Study of the Pharmacokinetic and Pharmacodynamic Properties of BIOD-105 and BIOD-107 Compared to Humalog® in Subjects With Type 1 Diabetes Including Assessments of Safety and Injection Site Toleration', 'orgStudyIdInfo': {'id': 'VIAject 039J'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Humalog®', 'description': 'Humalog®, administered subcutaneously on 1 occasion', 'interventionNames': ['Drug: Insulin LISPRO']}, {'type': 'EXPERIMENTAL', 'label': 'BIOD- 105', 'description': 'BIOD- 105 administered subcutaneously on 1 occasion', 'interventionNames': ['Drug: recombinant human insulin']}, {'type': 'EXPERIMENTAL', 'label': 'BIOD-107', 'description': 'BIOD-107 administered subcutaneously on 1 occasion', 'interventionNames': ['Drug: recombinant human insulin']}], 'interventions': [{'name': 'Insulin LISPRO', 'type': 'DRUG', 'description': 'Single doses of: 0.15 U/kg', 'armGroupLabels': ['Humalog®']}, {'name': 'recombinant human insulin', 'type': 'DRUG', 'description': 'Single doses of: 0.15 U/kg', 'armGroupLabels': ['BIOD- 105', 'BIOD-107']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91911', 'city': 'Chula Vista', 'state': 'California', 'country': 'United States', 'facility': 'Profil Institute for Clinical Research, Inc. (PICR)', 'geoPoint': {'lat': 32.64005, 'lon': -117.0842}}], 'overallOfficials': [{'name': 'Linda Morrow, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Profil Institute for Clinical Research, Inc. (PICR)'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Biodel', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}