Ignite Creation Date:
2025-12-24 @ 6:47 PM
Ignite Modification Date:
2026-01-02 @ 1:15 PM
Study NCT ID:
NCT00694057
Status:
COMPLETED
Last Update Posted:
2011-06-14
First Post:
2008-06-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety, Tolerance and Activity of HE3286 in Patients With Type 2 Diabetes Mellitus
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C524733', 'term': '17-ethynyl-5-androstene-3, 7, 17-triol'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 164}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-06', 'completionDateStruct': {'date': '2010-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-06-11', 'studyFirstSubmitDate': '2008-06-06', 'studyFirstSubmitQcDate': '2008-06-06', 'lastUpdatePostDateStruct': {'date': '2011-06-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-06-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To evaluate the change in HbA1c from baseline to week 12 in the HE3286 treated group when compared to the placebo group.', 'timeFrame': '12-weeks'}, {'measure': 'To evaluate the safety and tolerance of HE3286 10 mg per day (5 mg BID) compared to placebo from baseline to week 12.', 'timeFrame': '12-weeks'}], 'secondaryOutcomes': [{'measure': 'To evaluate the effect of HE3286 on fasting blood glucose over time.', 'timeFrame': '12-weeks'}, {'measure': 'To evaluate the effect of HE3286 on insulin sensitivity over time.', 'timeFrame': '12-weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Type 2 Diabetes Mellitus', 'Metformin', 'HbA1c'], 'conditions': ['Type 2 Diabetes Mellitus']}, 'descriptionModule': {'briefSummary': 'This is a phase II, double-blind, randomized, placebo-controlled study of the safety, tolerance and activity of HE3286 in patients with type 2 diabetes mellitus. Patients receiving stable metformin or who are drug-naive will receive study treatment (HE3286 or placebo) for a treatment period of 12-weeks.', 'detailedDescription': 'Hollis-Eden Pharmaceuticals, Inc. is developing a new class of therapeutics for the treatment of Type 2 diabetes. The investigational drug, HE3286, holds the potential to be the first in a new class of insulin sensitizers with a potentially novel mechanism of action that may improve the current therapeutic options available to a T2DM patient.\n\nThis is a phase II, double-blind, randomized, placebo-controlled study of the safety, tolerance and activity of HE3286 in patients with type 2 diabetes mellitus. Patients receiving stable metformin or who are drug-naive will receive study treatment (HE3286 or placebo) for a treatment period of 12-weeks. Changes in hemoglobin A1c (HbA1c) will be assessed over a treatment period of 12-weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Main Inclusion Criteria:\n\n* Patient with a diagnosis of Type 2 Diabetes Mellitus (T2DM)\n* Patient must be a) on a stable dose of metformin as monotherapy for at least 10 weeks prior to screening; or b) drug-naive, defined as never having received drug treatment for T2DM or not having received antidiabetic drug therapy during the 3 months prior to screening.\n* Patient with a fasting blood glucose level of ≤ 225 mg/dL at screening (≤ 255 mg/dl for drug-naive patients);\n* Patient with HbA1c levels \\>7.5% (7.0 - 10.5% for drug-naive patients) at screening;\n* Patient with BMI 28-37 kg/m2 for females 28-39 kg/m2 for males\n\nMain Exclusion Criteria:\n\n* Patient who has a history of clinically significant cardiovascular disease (including coronary artery disease), clinically significant hepatic, respiratory or renal abnormalities within 6 months prior to screening;\n* Patient with unstable diabetic complications requiring treatment or ongoing active intervention;\n* Patient with a history of long term insulin therapy within the past year;\n* Patient who has had therapy with rosiglitazone, pioglitazone, exendin-4 or sitagliptin, alone or in combination within 6 months prior to screening;\n* Patient who has any clinically significant abnormalities in laboratory results at screening;'}, 'identificationModule': {'nctId': 'NCT00694057', 'briefTitle': 'Safety, Tolerance and Activity of HE3286 in Patients With Type 2 Diabetes Mellitus', 'organization': {'class': 'INDUSTRY', 'fullName': 'Harbor Therapeutics'}, 'officialTitle': 'A Phase II, Double Blind, Randomized, Placebo-Controlled Study of the Safety, Tolerance and Activity of HE3286 When Administered Orally for 12 Weeks to Adult Patients With Type 2 Diabetes Mellitus', 'orgStudyIdInfo': {'id': 'HE3286-0401'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo capsules BID', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Active', 'description': 'HE3286 10 mg (5 mg BID)', 'interventionNames': ['Drug: HE3286']}], 'interventions': [{'name': 'HE3286', 'type': 'DRUG', 'description': 'HE3286 10 mg per day (5 mg BID)', 'armGroupLabels': ['Active']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo capsules BID', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92801', 'city': 'Anaheim', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 33.83529, 'lon': -117.9145}}, {'zip': '92805', 'city': 'Anaheim', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 33.83529, 'lon': -117.9145}}, {'zip': '90211', 'city': 'Beverly Hills', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 34.07362, 'lon': -118.40036}}, {'zip': '90620', 'city': 'Buena Park', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 33.86751, 'lon': -117.99812}}, {'zip': '91505', 'city': 'Burbank', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 34.18084, 'lon': -118.30897}}, {'zip': '95608', 'city': 'Carmichael', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 38.61713, 'lon': -121.32828}}, {'zip': '92025', 'city': 'Escondido', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 33.11921, 'lon': -117.08642}}, {'zip': '93726', 'city': 'Fresno', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 36.74773, 'lon': -119.77237}}, {'zip': '90255', 'city': 'Huntington Park', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 33.98168, 'lon': -118.22507}}, {'zip': '90806', 'city': 'Long Beach', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 33.76696, 'lon': -118.18923}}, {'zip': '90057', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '91950', 'city': 'National City', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 32.67811, 'lon': -117.0992}}, {'zip': '95661', 'city': 'Roseville', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 38.75212, 'lon': -121.28801}}, {'zip': '60616', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '70808', 'city': 'Baton Rouge', 'state': 'Louisiana', 'country': 'United States', 'geoPoint': {'lat': 30.44332, 'lon': -91.18747}}, {'zip': '63141', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '89106', 'city': 'Las Vegas', 'state': 'Nevada', 'country': 'United States', 'geoPoint': {'lat': 36.17497, 'lon': -115.13722}}, {'zip': '89148', 'city': 'Las Vegas', 'state': 'Nevada', 'country': 'United States', 'geoPoint': {'lat': 36.17497, 'lon': -115.13722}}, {'zip': '79905', 'city': 'El Paso', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 31.75872, 'lon': -106.48693}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '84107', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}, {'zip': '53142', 'city': 'Kenosha', 'state': 'Wisconsin', 'country': 'United States', 'geoPoint': {'lat': 42.58474, 'lon': -87.82119}}], 'overallOfficials': [{'name': 'Dwight R. Stickney, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Harbor Therapeutics'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Harbor Therapeutics', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Dwight Stickney, MD - Chief Medical Officer', 'oldOrganization': 'Hollis-Eden Pharmaceuticals'}}}}