Ignite Creation Date:
2025-12-25 @ 1:38 AM
Ignite Modification Date:
2026-03-03 @ 2:41 PM
Study NCT ID:
NCT01908894
Status:
COMPLETED
Last Update Posted:
2013-07-26
First Post:
2013-07-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pharmacokinetic and Pharmacodynamic Properties of BIOD-123 and BIOD-125 Compared to Humalog® in Subjects With Type 1 Diabetes Including Assessments of Injection Site Toleration
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}], 'ancestors': [{'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine 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': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-07', 'completionDateStruct': {'date': '2012-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-07-24', 'studyFirstSubmitDate': '2013-07-24', 'studyFirstSubmitQcDate': '2013-07-24', 'lastUpdatePostDateStruct': {'date': '2013-07-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-07-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Speed of absorption (TINS-50%-early) of BIOD-123 and BIOD-125 versus Humalog.', 'timeFrame': '0-30, 0-60, 0-90, 0-480, and 120-480 minutes', 'description': 'Subjects were to receive study drug at 3 separate dosing visits separated by 3-28 days. The estimated duration of study participation for 1 subject was approximately 12 weeks. The estimated duration of the study was approximately 6 months.'}]}, 'conditionsModule': {'conditions': ['Diabetes Mellitus']}, 'descriptionModule': {'briefSummary': 'The primary objective is to assess the speed of absorption of BIOD-123 and BIOD-125 and compare them to Humalog.', 'detailedDescription': 'The primary objective is to assess the speed of absorption of BIOD-123 and BIOD-125 and compare them to Humalog.\n\nThe secondary objectives are to assess other pharmacokinetic characteristics of BIOD-123 and BIOD-125 and compare those to Humalog®, to assess pharmacodynamic characteristics of BIOD-123 and BIOD-125 and compare those to Humalog®, and to evaluate the safety and tolerability of BIOD-123 and BIOD-125 compared to Humalog®'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age: ≥18 - ≤70 years\n2. BMI: ≥18 - ≤30 kg/m2\n3. Diagnosed with type 1 diabetes mellitus for at least 1 year\n4. Insulin antibody ≤10 μU/mL at screening\n\nExclusion Criteria:\n\n1. Type 2 diabetes mellitus\n2. History of \\>2 severe hypoglycemic events within the 3 months prior to screening\n3. Serum C-peptide \\>1.0 ng/mL\n4. Hemoglobin A1c (HbA1c) \\>10.0%\n5. Females who were breast feeding, pregnant, or intending to become pregnant during the study\n6. A sexually active person who was not using adequate contraceptive methods\n7. Positive serology for human immunodeficiency virus (HIV), Hepatitis B, or Hepatitis C\n8. Abnormal ECG, safety lab, or physical examination results that were deemed clinically significant by the investigator'}, 'identificationModule': {'nctId': 'NCT01908894', 'briefTitle': 'Pharmacokinetic and Pharmacodynamic Properties of BIOD-123 and BIOD-125 Compared to Humalog® in Subjects With Type 1 Diabetes Including Assessments of Injection Site Toleration', 'organization': {'class': 'INDUSTRY', 'fullName': 'Biodel'}, 'officialTitle': 'A Double-blind Study of the Pharmacokinetic and Pharmacodynamic Properties of BIOD-123 and BIOD-125 Compared to Humalog® in Subjects With Type 1 Diabetes Including Assessments of Safety and Injection Site Toleration', 'orgStudyIdInfo': {'id': '3-101'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'BIOD-123', 'description': 'SC administration of 0.20 U/kg', 'interventionNames': ['Drug: BIOD-123']}, {'type': 'EXPERIMENTAL', 'label': 'BIOD-125', 'description': 'SC administration of 0.20 U/kg', 'interventionNames': ['Drug: BIOD-125']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Humalog', 'description': 'SC administration of 0.20 U/kg', 'interventionNames': ['Drug: Humalog']}], 'interventions': [{'name': 'BIOD-123', 'type': 'DRUG', 'armGroupLabels': ['BIOD-123']}, {'name': 'BIOD-125', 'type': 'DRUG', 'armGroupLabels': ['BIOD-125']}, {'name': 'Humalog', 'type': 'DRUG', 'armGroupLabels': ['Humalog']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Biodel', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}