Ignite Creation Date:
2025-12-24 @ 7:56 PM
Ignite Modification Date:
2026-05-01 @ 4:43 AM
Study NCT ID:
NCT01982604
Status:
COMPLETED
Last Update Posted:
2014-10-02
First Post:
2013-11-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of 30 Units of TI (Technosphere® Insulin) Prepared With Insulin From Two Different Suppliers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 38}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-10', 'completionDateStruct': {'date': '2014-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-10-01', 'studyFirstSubmitDate': '2013-11-06', 'studyFirstSubmitQcDate': '2013-11-12', 'lastUpdatePostDateStruct': {'date': '2014-10-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-11-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'AUC (area-under-the-serum-insulin concentration time curve) 0 - 240 minutes', 'timeFrame': '5, 10, 15, 20, 25, 30, 45, 60, 75, 90, 120, 150, 210, 240'}, {'measure': 'Cmax (maximum serum insulin concentration)', 'timeFrame': '5, 10, 15, 20, 25, 30, 45, 60, 75, 90, 120, 150, 210, 240'}], 'secondaryOutcomes': [{'measure': 'GIR (area-under-the-serum Glucose Infusion Rate)', 'timeFrame': '0 to 360'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Healthy Volunteers']}, 'descriptionModule': {'briefSummary': 'A Phase 1, open-label randomized crossover trial in Healthy Volunteers to evaluate the PK/PD of TI (Technosphere® Insulin) prepared with insulin from two different suppliers.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Men and women aged 18 to 55 years, considered healthy based on screening physical examination, medical history, clinical chemistry, and urinalysis\n\n * HNVs with a screening blood pressure less than 140/90 mm Hg\n * Subjects who have hypertension controlled with up to 1 medication and who have a blood pressure less than 140/90 mm Hg\n * Note: For subjects with blood pressure at or above 140/90 mm Hg; two additional readings 5 minutes apart are allowed but the last blood pressure reading must be in range\n * Subjects who have hypercholesterolemia controlled with up to 1 medication and who have a low-density lipoprotein value less than 160 mg/dL\n* Good venous access for blood draws\n* No smoking in the past 6 months (including cigarettes, cigars, and pipes) and urine cotinine testing \\< 100 ng/mL\n* Body mass index (BMI) \\< 32 kg/m2\n* Completion of informed consent form\n\nExclusion Criteria:\n\n* Blood donation (500 mL) within the last 8 weeks\n* Fasting blood sugar \\>100 mg/dL\n* History of coronary artery disease, peripheral vascular disease, or congestive heart failure\n* Allergy to study drug, components of Boost and Boost Plus, or other study material\n* Clinically significant active or chronic illness\n* History of asthma, COPD, or any other clinically relevant chronic lung disease\n* Respiratory tract infection within 4 weeks before screening\n* History of drug or alcohol abuse within the past 5 years\n* Positive urine drug screen\n* Clinically significant screening ECG, physical examination, laboratory test, or vital sign abnormality\n* Exposure to any other investigational drug or device within 30 days before treatment or within 90 days before treatment for drugs known to modify glucose metabolism\n* History of malignancy within the 5 years before screening (other than basal cell carcinoma)\n* History of human immunodeficiency virus (HIV) infection or hepatitis B or C\n* Women who are pregnant, lactating, or planning to become pregnant during the clinical study period\n* Women of childbearing potential (premenopausal who have not undergone hysterectomy or bilateral tubal ligation, or postmenopausal for fewer than 2 years) not practicing adequate birth control. Adequate birth control is defined as using oral, percutaneous, or transdermal contraceptives; condoms and diaphragms (double barrier) with a spermicide; or intrauterine devices. Postmenopausal for the purposes of this clinical study includes experiencing amenorrhea for 2 or more years or being surgically sterile.\n* Any subject who, in the opinion of the PI or a designee, appears not to be qualified for this study'}, 'identificationModule': {'nctId': 'NCT01982604', 'briefTitle': 'Comparison of 30 Units of TI (Technosphere® Insulin) Prepared With Insulin From Two Different Suppliers', 'organization': {'class': 'INDUSTRY', 'fullName': 'Mannkind Corporation'}, 'officialTitle': 'A Phase 1, Open-label, Randomized, Crossover Clinical Trial to Evaluate PK/PD of 30 U TI Inhalation Powders Prepared With Insulin From Two Different Suppliers', 'orgStudyIdInfo': {'id': 'MKC-TI-179'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Sequence (Group) 1', 'description': 'Subjects randomized to Sequence 1 will receive TI in the following sequence:\n\nTI-Inhalation Powder A TI-Inhalation Powder B\n\n\\*30 units (10 units + 20 units)', 'interventionNames': ['Drug: TI-Inhalation Powder A', 'Drug: TI-Inhalation Powder B']}, {'type': 'EXPERIMENTAL', 'label': 'Sequence (Group) 2', 'description': 'Subjects randomized to Sequence 2 will receive TI in the following sequence:\n\nTI-Inhalation Powder B TI-Inhalation Powder A\n\n\\*30 units (10 units + 20 units)', 'interventionNames': ['Drug: TI-Inhalation Powder A', 'Drug: TI-Inhalation Powder B']}], 'interventions': [{'name': 'TI-Inhalation Powder A', 'type': 'DRUG', 'description': 'Inhaled Insulin', 'armGroupLabels': ['Sequence (Group) 1', 'Sequence (Group) 2']}, {'name': 'TI-Inhalation Powder B', 'type': 'DRUG', 'description': 'Inhaled Insulin', 'armGroupLabels': ['Sequence (Group) 1', 'Sequence (Group) 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91911', 'city': 'Chula Vista', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 32.64005, 'lon': -117.0842}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mannkind Corporation', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}