Ignite Creation Date:
2025-12-25 @ 2:03 AM
Ignite Modification Date:
2026-03-01 @ 6:02 AM
Study NCT ID:
NCT01885260
Status:
COMPLETED
Last Update Posted:
2016-07-04
First Post:
2013-06-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety, Tolerability and Efficacy of ISIS-GCGRRx in Type 2 Diabetes
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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 77}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-06', 'dispFirstSubmitDate': '2016-06-14', 'completionDateStruct': {'date': '2014-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-06-30', 'studyFirstSubmitDate': '2013-06-13', 'dispFirstSubmitQcDate': '2016-06-14', 'studyFirstSubmitQcDate': '2013-06-19', 'dispFirstPostDateStruct': {'date': '2016-06-16', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2016-07-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-06-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The effect of ISIS-GCGRRx on serum fructosamine', 'timeFrame': '14 Weeks', 'description': 'Change from Baseline to Week 14'}], 'secondaryOutcomes': [{'measure': 'The safety of ISIS-GCGRRx', 'timeFrame': '25 Weeks', 'description': 'By determining the incidence, severity, dose-relationship adverse effects, and changes in laboratory evaluations'}, {'measure': 'The tolerability of ISIS-GCGRRx', 'timeFrame': '25 Weeks', 'description': 'By determining the incidence, severity, dose-relationship adverse effects, and changes in laboratory evaluations'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Type 2 Diabetes Mellitus', 'T2DM'], 'conditions': ['Type 2 Diabetes Mellitus']}, 'referencesModule': {'references': [{'pmid': '30765435', 'type': 'DERIVED', 'citation': 'Morgan ES, Tai LJ, Pham NC, Overman JK, Watts LM, Smith A, Jung SW, Gajdosik M, Krssak M, Krebs M, Geary RS, Baker BF, Bhanot S. Antisense Inhibition of Glucagon Receptor by IONIS-GCGRRx Improves Type 2 Diabetes Without Increase in Hepatic Glycogen Content in Patients With Type 2 Diabetes on Stable Metformin Therapy. Diabetes Care. 2019 Apr;42(4):585-593. doi: 10.2337/dc18-1343. Epub 2019 Feb 14.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the efficacy, safety and tolerability of ISIS-GCGRRx in combination with metformin versus placebo + metformin'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female, age 18 to 75\n* BMI greater than or equal to 25\n* HbA1c greater than or equal to 7.5% and less than or equal to 10.5%\n* Type 2 Diabetes Mellitus and on stable dose of oral metformin\n* Agree to conduct home-based (fasted) blood glucose testing as directed\n\nExclusion Criteria:\n\n* Clinically significant abnormalities in medical history or physical exam\n* Show evidence of uncorrected hypothyroidism or hyperthyroidism hormone results\n* History of renal transplantation or renal dialysis\n* History of liver disease\n* History of greater than 3 episodes of severe hypoglycemia within 6 months of screening\n* Use of oral anti-diabetic medication other than metformin within 3 months of screening\n* History of diabetic ketoacidosis\n* Any other significant illness or condition that may interfere with the patient participating or completing the study\n* Inability or unwillingness to comply with protocol or study procedures'}, 'identificationModule': {'nctId': 'NCT01885260', 'briefTitle': 'Safety, Tolerability and Efficacy of ISIS-GCGRRx in Type 2 Diabetes', 'organization': {'class': 'INDUSTRY', 'fullName': 'Ionis Pharmaceuticals, Inc.'}, 'officialTitle': 'A Double Blind, Placebo-Controlled, Phase 2 Study to Assess the Safety, Tolerability and Efficacy of ISIS 449884 Administered Once Weekly to Patients With Type 2 Diabetes Mellitus Being Treated With Metformin', 'orgStudyIdInfo': {'id': 'ISIS 449884-CS2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ISIS-GCGRRx Dose Level 1', 'description': 'ISIS-GCGRRx Dose Level 1', 'interventionNames': ['Drug: ISIS-GCGRRx - Dose Level 1']}, {'type': 'EXPERIMENTAL', 'label': 'ISIS-GCGRRx Dose Level 2', 'description': 'ISIS-GCGRRx Dose Level 2', 'interventionNames': ['Drug: ISIS-GCGRRx - Dose Level 2']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'ISIS-GCGRRx - Dose Level 1', 'type': 'DRUG', 'otherNames': ['Isis 449884'], 'description': '3 doses on alternate days during the first week and then once weekly for 12 weeks', 'armGroupLabels': ['ISIS-GCGRRx Dose Level 1']}, {'name': 'ISIS-GCGRRx - Dose Level 2', 'type': 'DRUG', 'otherNames': ['Isis 449884'], 'description': '3 doses on alternate days during the first week and then once weekly for 12 weeks', 'armGroupLabels': ['ISIS-GCGRRx Dose Level 2']}, {'name': 'Placebo', 'type': 'DRUG', 'description': '3 doses on alternate days during the first week and then once weekly for 12 weeks', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35216', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Isis Investigational Site', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '35662', 'city': 'Muscle Shoals', 'state': 'Alabama', 'country': 'United States', 'facility': 'Isis Investigational Site', 'geoPoint': {'lat': 34.74481, 'lon': -87.66753}}, {'zip': '92801', 'city': 'Anaheim', 'state': 'California', 'country': 'United States', 'facility': 'Isis Investigational Site', 'geoPoint': {'lat': 33.83529, 'lon': -117.9145}}, {'zip': '91710', 'city': 'Chino', 'state': 'California', 'country': 'United States', 'facility': 'Isis Investigational Site', 'geoPoint': {'lat': 34.01223, 'lon': -117.68894}}, {'zip': '90057', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Isis Investigational Site', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '32720', 'city': 'DeLand', 'state': 'Florida', 'country': 'United States', 'facility': 'Isis Investigational Site', 'geoPoint': {'lat': 29.02832, 'lon': -81.30312}}, {'zip': '33306', 'city': 'Fort Lauderdale', 'state': 'Florida', 'country': 'United States', 'facility': 'Isis Investigational Site', 'geoPoint': {'lat': 26.12231, 'lon': -80.14338}}, {'zip': '33143', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Isis Investigational Site', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '30066', 'city': 'Marietta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Isis Investigational Site', 'geoPoint': {'lat': 33.9526, 'lon': -84.54993}}, {'zip': '89101', 'city': 'Las Vegas', 'state': 'Nevada', 'country': 'United States', 'facility': 'Isis Investigational Site', 'geoPoint': {'lat': 36.17497, 'lon': -115.13722}}, {'zip': '45245', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'Isis Investigational Site', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '73103', 'city': 'Oklahoma City', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'Isis Investigational Site', 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}, {'zip': '97404', 'city': 'Eugene', 'state': 'Oregon', 'country': 'United States', 'facility': 'Isis Investigational Site', 'geoPoint': {'lat': 44.05207, 'lon': -123.08675}}, {'zip': '78404', 'city': 'Corpus Christi', 'state': 'Texas', 'country': 'United States', 'facility': 'Isis Investigational Site', 'geoPoint': {'lat': 27.80058, 'lon': -97.39638}}, {'zip': '77450', 'city': 'Katy', 'state': 'Texas', 'country': 'United States', 'facility': 'Isis Investigational Site', 'geoPoint': {'lat': 29.78579, 'lon': -95.8244}}, {'zip': '84107', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'Isis Investigational Site', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}, {'zip': '98057', 'city': 'Renton', 'state': 'Washington', 'country': 'United States', 'facility': 'Isis Investigational Site', 'geoPoint': {'lat': 47.48288, 'lon': -122.21707}}, {'zip': '99202', 'city': 'Spokane', 'state': 'Washington', 'country': 'United States', 'facility': 'Isis Investigational Site', 'geoPoint': {'lat': 47.65966, 'lon': -117.42908}}, {'zip': '1829', 'city': 'Lenasia South', 'state': 'Gauteng', 'country': 'South Africa', 'facility': 'Isis Investigational Site'}, {'zip': '1818', 'city': 'Soweto', 'state': 'Gauteng', 'country': 'South Africa', 'facility': 'Isis Investigational Site', 'geoPoint': {'lat': -26.26781, 'lon': 27.85849}}, {'zip': '4091', 'city': 'Durban', 'state': 'KwaZulu-Natal', 'country': 'South Africa', 'facility': 'Isis Investigational Site', 'geoPoint': {'lat': -29.8579, 'lon': 31.0292}}, {'zip': '7700', 'city': 'Cape Town', 'state': 'Western Cape', 'country': 'South Africa', 'facility': 'Isis Investigational Site', 'geoPoint': {'lat': -33.92584, 'lon': 18.42322}}, {'zip': '7500', 'city': 'Parow, Cape Town', 'state': 'Western Cape', 'country': 'South Africa', 'facility': 'Isis Investigational Site'}, {'zip': '7130', 'city': 'Western Cape', 'state': 'Western Cape', 'country': 'South Africa', 'facility': 'Isis Investigational Site'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ionis Pharmaceuticals, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}