Ignite Creation Date:
2025-12-24 @ 7:11 PM
Ignite Modification Date:
2026-02-03 @ 12:45 PM
Study NCT ID:
NCT02824003
Status:
COMPLETED
Last Update Posted:
2018-05-08
First Post:
2016-06-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study to Evaluate the Effect of ISIS GCGRRx on Hepatic Lipid and Glycogen Content 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': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 15}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-05', 'completionDateStruct': {'date': '2017-05-22', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-05-04', 'studyFirstSubmitDate': '2016-06-15', 'studyFirstSubmitQcDate': '2016-07-05', 'lastUpdatePostDateStruct': {'date': '2018-05-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-07-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-12-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in fasting hepatic glycogen content', 'timeFrame': 'Week 14', 'description': 'Change from Baseline'}, {'measure': 'Change in fasting hepatic lipid content', 'timeFrame': 'Week 14', 'description': 'Change from Baseline'}], 'secondaryOutcomes': [{'measure': 'Safety and Tolerability will be assessed by determining the incidence, severity, dose relationship of adverse effects, and changes in laboratory evaluations', 'timeFrame': '38 weeks', 'description': 'Safety results in patients dosed with ISIS 449884 will be compared with those from patients dosed with placebo'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Type 2 Diabetes']}, '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 effect of ISIS 449884 (ISIS-GCGRRX) on Hepatic Lipid and Glycogen Content in patients with Type 2 Diabetes being treated with 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 ≥ 25.0 kg/m2 \\< 36.0 kg/m2\n* HbA1c ≥ 7.5% and ≤ 10.5%\n* Type 2 Diabetes Mellitus and on stable dose of Metformin. Patients must have been on a stable dose of oral metformin (at least 1000 mg/day) for a minimum of 3 months prior to screening evaluation and will be required to continue their stable dose of metformin throughout the study. Patients on a stable dose of metformin plus a sulfonylurea (SU) or metformin plus a dipeptidyl peptidase-IV (DPPIV) inhibitor for a minimum of 3 months prior to Screening evaluation may be allowed\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\n* History of liver 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* Treatment with any other antidiabetic drug(s) other than metformin, SU or DPPIV 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': 'NCT02824003', 'briefTitle': 'Study to Evaluate the Effect of ISIS GCGRRx on Hepatic Lipid and Glycogen Content in Type 2 Diabetes', 'organization': {'class': 'INDUSTRY', 'fullName': 'Ionis Pharmaceuticals, Inc.'}, 'officialTitle': 'Double Blind, Randomized, Placebo-Controlled, Phase 2A Mechanistic Study to Evaluate the Effect of ISIS 449884 (ISIS-GCGRRx) on Hepatic Lipid and Glycogen Content in Patients With Type 2 Diabetes Being Treated With Metformin', 'orgStudyIdInfo': {'id': 'ISIS 449884-CS3'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ISIS-GCGRRx', 'description': 'ISIS-GCGRRx once weekly dosing for 13 weeks', 'interventionNames': ['Drug: ISIS-GCGRRx']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'once weekly dosing for 13 weeks', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'ISIS-GCGRRx', 'type': 'DRUG', 'otherNames': ['ISIS 449884'], 'description': 'once weekly dosing for 13 weeks', 'armGroupLabels': ['ISIS-GCGRRx']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'once weekly dosing for 13 weeks', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'A-1130', 'city': 'Vienna', 'country': 'Austria', 'facility': 'Ionis Investigator Site', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}], 'overallOfficials': [{'name': 'Sanjay Bhanot', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Ionis Pharmaceuticals'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ionis Pharmaceuticals, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}