Ignite Creation Date:
2025-12-25 @ 4:29 AM
Ignite Modification Date:
2026-03-01 @ 10:02 AM
Study NCT ID:
NCT01686620
Status:
COMPLETED
Last Update Posted:
2015-07-28
First Post:
2012-09-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study Evaluating Safety and Efficacy of BIOD-123 Compared to Insulin Lispro (Humalog®)
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': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 132}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-07', 'dispFirstSubmitDate': '2015-07-22', 'completionDateStruct': {'date': '2013-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-07-22', 'studyFirstSubmitDate': '2012-09-13', 'dispFirstSubmitQcDate': '2015-07-22', 'studyFirstSubmitQcDate': '2012-09-13', 'dispFirstPostDateStruct': {'date': '2015-07-28', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2015-07-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-09-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in HbA1C', 'timeFrame': 'Baseline and 18 week treatment period'}], 'secondaryOutcomes': [{'measure': 'Hypoglycemic event rates', 'timeFrame': 'Baseline and 18 week treatment period'}, {'measure': 'Insulin dose', 'timeFrame': 'Baseline and 18 week treatment period'}, {'measure': 'Daily blood glucose measures', 'timeFrame': 'Baseline and 18 week treatment period'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Mealtime insulin', 'Ultra-rapid acting insulin', 'Prandial insulin'], 'conditions': ['Type 1 Diabetes Mellitus']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the safety and efficacy of BIOD-123 compared to insulin lispro (Humalog®) when used as part of a basal-bolus regimen in patients with type 1 diabetes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Established clinical diagnosis of type 1 diabetes, consistent with ADA classification criteria (Diabetes Care 35: S64-S71, 2012), for more than 1 year.\n* Age: 18 years old, or older.\n* Body Mass Index: between 18 and 35 kg/m2, inclusive.\n* Willing to use insulin glargine as the only basal insulin throughout the duration of the trial.\n* Willingness not to use insulin pump treatment and only use the study glucose meter and CGM devices during the duration of the trial.\n\nExclusion Criteria:\n\n* History of known hypersensitivity to any of the components in the study medication\n* Treatment with pramlintide or GLP-1 analogs within 30 days of screening or anticipated use of these medications during the course of the study.\n* Treatment with oral or intravenous corticosteroids in the last 3 months prior to screening. Standard doses of inhalational corticosteroid used as part of a long term treatment regimen are allowed.\n* Consistent recent hypoglycemic unawareness within the last six months\n* History of more than two severe hypoglycemic events within six months prior to screening'}, 'identificationModule': {'nctId': 'NCT01686620', 'briefTitle': 'A Study Evaluating Safety and Efficacy of BIOD-123 Compared to Insulin Lispro (Humalog®)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Biodel'}, 'officialTitle': 'A Randomized, Parallel Group Trial Evaluating Safety and Efficacy of BIOD-123 Compared to Insulin Lispro (Humalog®) in Subjects With Type 1 Diabetes Using Basal-bolus Insulin Injection Therapy', 'orgStudyIdInfo': {'id': '3-201'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'BIOD-123', 'description': 'BIOD-123 used as prandial insulin', 'interventionNames': ['Drug: BIOD-123']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Lispro (Humalog)', 'description': 'Lispro (Humalog) used as prandial insulin', 'interventionNames': ['Drug: Lispro (Humalog)']}], 'interventions': [{'name': 'BIOD-123', 'type': 'DRUG', 'armGroupLabels': ['BIOD-123']}, {'name': 'Lispro (Humalog)', 'type': 'DRUG', 'armGroupLabels': ['Lispro (Humalog)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92801', 'city': 'Anaheim', 'state': 'California', 'country': 'United States', 'facility': 'Anaheim Clinical Trials, LLC', 'geoPoint': {'lat': 33.83529, 'lon': -117.9145}}, {'zip': '91911', 'city': 'Chula Vista', 'state': 'California', 'country': 'United States', 'facility': 'Profil Research Institute', 'geoPoint': {'lat': 32.64005, 'lon': -117.0842}}, {'zip': '94520', 'city': 'Concord', 'state': 'California', 'country': 'United States', 'facility': 'John Muir Physician Network Clinical Research Center', 'geoPoint': {'lat': 37.97798, 'lon': -122.03107}}, {'zip': '92037', 'city': 'La Jolla', 'state': 'California', 'country': 'United States', 'facility': 'Scripps Whittier Diabetes Institute', 'geoPoint': {'lat': 32.84727, 'lon': -117.2742}}, {'zip': '95032', 'city': 'Los Gatos', 'state': 'California', 'country': 'United States', 'facility': 'Private Practice - Richard Cherlin, MD.', 'geoPoint': {'lat': 37.22661, 'lon': -121.97468}}, {'zip': '91606', 'city': 'North Hollywood', 'state': 'California', 'country': 'United States', 'facility': 'Providence Clinical Research Pharmaseek', 'geoPoint': {'lat': 34.17223, 'lon': -118.37897}}, {'zip': '94110', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'Monteagle Medical Center', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '94401', 'city': 'San Mateo', 'state': 'California', 'country': 'United States', 'facility': 'Mills-Peninsula Health Services', 'geoPoint': {'lat': 37.56299, 'lon': -122.32553}}, {'zip': '33021', 'city': 'Hollywood', 'state': 'Florida', 'country': 'United States', 'facility': 'The Center for Diabetes and Endocrine Care', 'geoPoint': {'lat': 26.0112, 'lon': -80.14949}}, {'zip': '33136', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Miami Diabetes Research Institute', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '32127', 'city': 'Port Orange', 'state': 'Florida', 'country': 'United States', 'facility': 'Progressive Medical Research Pharmaseek', 'geoPoint': {'lat': 29.13832, 'lon': -80.99561}}, {'zip': '30309-1764', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Atlanta Diabetes Associates', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '30076', 'city': 'Roswell', 'state': 'Georgia', 'country': 'United States', 'facility': 'Endocrine Research Solutions', 'geoPoint': {'lat': 34.02316, 'lon': -84.36159}}, {'zip': '83404', 'city': 'Idaho Falls', 'state': 'Idaho', 'country': 'United States', 'facility': 'Rocky Mountain Diabetes and Osteoporosis Center PA', 'geoPoint': {'lat': 43.46658, 'lon': -112.03414}}, {'zip': '67226', 'city': 'Wichita', 'state': 'Kansas', 'country': 'United States', 'facility': 'MidAmerica Diabetes Associates, PA', 'geoPoint': {'lat': 37.69224, 'lon': -97.33754}}, {'zip': '40503', 'city': 'Lexington', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Kentucky Diabetes', 'geoPoint': {'lat': 37.98869, 'lon': -84.47772}}, {'zip': '20852', 'city': 'Rockville', 'state': 'Maryland', 'country': 'United States', 'facility': 'Diabetes & Glandular Disease Research', 'geoPoint': {'lat': 39.084, 'lon': -77.15276}}, {'zip': '48235', 'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': 'Henry Ford Health System', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '59701', 'city': 'Butte', 'state': 'Montana', 'country': 'United States', 'facility': 'Mercury Street Medical', 'geoPoint': {'lat': 46.00382, 'lon': -112.53474}}, {'zip': '89052', 'city': 'Henderson', 'state': 'Nevada', 'country': 'United States', 'facility': 'Desert Endocrinolgy', 'geoPoint': {'lat': 36.0397, 'lon': -114.98194}}, {'zip': '13210', 'city': 'Syracuse', 'state': 'New York', 'country': 'United States', 'facility': 'Research Foundation of SUNY Upstate Medical University', 'geoPoint': {'lat': 43.04812, 'lon': -76.14742}}, {'zip': '28557', 'city': 'Morehead City', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Diabetes & Endocrinology Consultants, PC', 'geoPoint': {'lat': 34.72294, 'lon': -76.72604}}, {'zip': '45236', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'Sentral Clinical Research Services, LLC', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '97239', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Oregon Health Sciences University', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '78731', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'Texas Diabetes and Endocrinology', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'zip': '28803', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Mountain Diabetes & Endrocrine Center', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '75006', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Dallas Diabetes and Endocrine Research Center', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '75231', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Research Institute of Dallas', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '75246', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Baylor Endocrine Center', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '78681', 'city': 'Round Rock', 'state': 'Texas', 'country': 'United States', 'facility': 'Texas Diabetes and Endocrinology', 'geoPoint': {'lat': 30.50826, 'lon': -97.6789}}, {'zip': '78258', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Sonterra Clinical Research', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '98502', 'city': 'Olympia', 'state': 'Washington', 'country': 'United States', 'facility': 'Capital Clinical Research Center', 'geoPoint': {'lat': 47.04491, 'lon': -122.90169}}, {'zip': '98507', 'city': 'Renton', 'state': 'Washington', 'country': 'United States', 'facility': 'Ranier Clinical Research, Inc', 'geoPoint': {'lat': 47.48288, 'lon': -122.21707}}, {'zip': '99202', 'city': 'Spokane', 'state': 'Washington', 'country': 'United States', 'facility': 'Rockwood Clinic', 'geoPoint': {'lat': 47.65966, 'lon': -117.42908}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Biodel', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}