Ignite Creation Date:
2025-12-24 @ 7:02 PM
Ignite Modification Date:
2025-12-29 @ 12:03 PM
Study NCT ID:
NCT00675857
Status:
COMPLETED
Last Update Posted:
2010-08-24
First Post:
2008-05-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Phase IIa Proof-of-concept Study of NC-503 in Patients With Type II Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D024821', 'term': 'Metabolic Syndrome'}], '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': 'D007333', 'term': 'Insulin Resistance'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-08', 'completionDateStruct': {'date': '2010-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-08-23', 'studyFirstSubmitDate': '2008-05-08', 'studyFirstSubmitQcDate': '2008-05-08', 'lastUpdatePostDateStruct': {'date': '2010-08-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-05-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline to Week 26 in HbA1c levels', 'timeFrame': '26 weeks'}], 'secondaryOutcomes': [{'measure': 'Change in HbA1c levels', 'timeFrame': '26 weeks'}, {'measure': 'The rate of achieving glycemic control', 'timeFrame': '26 weeks'}, {'measure': 'Change in fasting serum glucose levels', 'timeFrame': '26 weeks'}]}, 'conditionsModule': {'keywords': ['Type II diabetes', 'Metabolic syndrome'], 'conditions': ['Diabetes Mellitus, Type 2', 'Metabolic Syndrome X']}, 'descriptionModule': {'briefSummary': 'The main objectives of the current study are to establish the safety and clinical proof-of-concept of NC-503 in inadequately controlled patients with Type 2 diabetes and features of metabolic syndrome treated with either metformin, a sulfonylurea agent, or metformin in combination with a sulfonylurea agent.', 'detailedDescription': 'Phase IIa Multi-center, randomized, double-blind, placebo-controlled and parallel-designed study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '95 Years', 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age and gender eligibility: 30 years and older\n* Diagnosis of Type 2 diabetes mellitus\n* Patients treated with a stable therapeutic dose of either metformin, a sulfonylurea agent, or metformin in combination with a sulfonylurea agent for a minimum period of 3 months prior to the Screening visit\n* Patients must have HbA1C level between 7.0-10.0 %, inclusively at screening\n* The participant must have central obesity (Waist circumference) defined per country/ethnic group: Europids: men ≥ 94 cm, women ≥ 80 cm; South Asian, Chinese \\& Japanese: men ≥ 90 cm, women ≥ 80 cm; and any one of the following metabolic syndrome characteristics at screening:\n* Reduced HDL cholesterol ≤ 1.0 mmol/L\n* Hypertriglyceridemia ≥ 1.7 mmol/L or treatment for dyslipidemia\n* Hypertension: ≥ 130/85 mm Hg blood pressure or treatment with antihypertensive medication.\n* Patients must have a Glomerular Filtration Rate (GFR) of ≥ 60 mL/min, and no history of dialysis.\n\nExclusion Criteria:\n\n* Patients having received insulin, thiazolidinediones (TZDs) or non-thiazolidinedione hypoglycemic agents other than metformin or sulfonylurea agents within three months prior to screening\n* Has had, within the last 6 months, evidence of significant heart disease or stroke, including myocardial infarction, unstable angina, coronary bypass and/or percutaneous transluminal coronary angioplasty (PTCA), congestive heart failure (New York Heart Association Class III-IV), or severe ischemic disease\n* Patients who have an increased red blood cell (RBC) turn-over or Thalassemia or anemia\n* Known HIV or history of viral hepatitis type B or C.\n* Any type of diabetes other than Type 2 diabetes\n* Significant hepatic enzyme elevation\n* Body mass index (BMI) of \\> 40kg/m2\n* Current or previous use of oral or injectable corticosteroids, or conditions that require the use of corticosteroids, during the three months prior to screening'}, 'identificationModule': {'nctId': 'NCT00675857', 'briefTitle': 'A Phase IIa Proof-of-concept Study of NC-503 in Patients With Type II Diabetes', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bellus Health Inc. - a GSK company'}, 'officialTitle': 'A Phase IIa Study of the Safety and Clinical Proof-of-concept of NC-503 (Eprodisate Disodium) in Patients With Type II Diabetes and Features of Metabolic Syndrome', 'orgStudyIdInfo': {'id': 'CL-503011'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'A', 'interventionNames': ['Other: placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'B', 'interventionNames': ['Drug: NC-503 (eprodisate disodium)']}], 'interventions': [{'name': 'NC-503 (eprodisate disodium)', 'type': 'DRUG', 'description': 'capsules of 400 mg Dosage: 4 capsules (1600 mg) BID for 26 weeks', 'armGroupLabels': ['B']}, {'name': 'placebo', 'type': 'OTHER', 'description': 'Dosage: 4 capsules BID for 26 weeks', 'armGroupLabels': ['A']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'T3B 0M3', 'city': 'Calgary', 'state': 'Alberta', 'country': 'Canada', 'geoPoint': {'lat': 51.05011, 'lon': -114.08529}}, {'zip': 'R3E 3P4', 'city': 'Winnipeg', 'state': 'Manitoba', 'country': 'Canada', 'geoPoint': {'lat': 49.8844, 'lon': -97.14704}}, {'zip': 'M9R 4E1', 'city': 'Etobicoke', 'state': 'Ontario', 'country': 'Canada', 'geoPoint': {'lat': 43.64415, 'lon': -79.56985}}, {'zip': 'N6A 4V2', 'city': 'London', 'state': 'Ontario', 'country': 'Canada', 'geoPoint': {'lat': 42.98339, 'lon': -81.23304}}, {'zip': 'L6H 3P1', 'city': 'Oakville', 'state': 'Ontario', 'country': 'Canada', 'geoPoint': {'lat': 43.45011, 'lon': -79.68292}}, {'zip': 'K1H 1A2', 'city': 'Ottawa', 'state': 'Ontario', 'country': 'Canada', 'geoPoint': {'lat': 45.41117, 'lon': -75.69812}}, {'zip': 'K1K 4L2', 'city': 'Ottawa', 'state': 'Ontario', 'country': 'Canada', 'geoPoint': {'lat': 45.41117, 'lon': -75.69812}}, {'zip': 'L4J 8L7', 'city': 'Thornhill', 'state': 'Ontario', 'country': 'Canada', 'geoPoint': {'lat': 43.80011, 'lon': -79.4163}}, {'zip': 'M4R 2G4', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'M5C 2T2', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'G7H 5H6', 'city': 'Chicoutimi', 'state': 'Quebec', 'country': 'Canada', 'geoPoint': {'lat': 48.41963, 'lon': -71.06369}}, {'zip': 'J4V 2H1', 'city': 'Greenfield Park', 'state': 'Quebec', 'country': 'Canada', 'geoPoint': {'lat': 45.48649, 'lon': -73.46223}}, {'zip': 'H7T 2P5', 'city': 'Laval', 'state': 'Quebec', 'country': 'Canada', 'geoPoint': {'lat': 45.56995, 'lon': -73.692}}, {'zip': 'H1T 2M4', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': 'H2W 1T7', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': 'H3A 1A1', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': 'H3H 2L9', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': 'H3N 1S4', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': 'G1V 4G5', 'city': 'Québec', 'state': 'Quebec', 'country': 'Canada', 'geoPoint': {'lat': 46.81228, 'lon': -71.21454}}, {'zip': 'J1G 1B8', 'city': 'Sherbrooke', 'state': 'Quebec', 'country': 'Canada', 'geoPoint': {'lat': 45.40008, 'lon': -71.89908}}, {'zip': 'J1H 5N4', 'city': 'Sherbrooke', 'state': 'Quebec', 'country': 'Canada', 'geoPoint': {'lat': 45.40008, 'lon': -71.89908}}], 'overallOfficials': [{'name': 'Jean-Louis Chiasson, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Hotel-Dieu du Centre Hospitalier de l'Université de Montréal"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bellus Health Inc. - a GSK company', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Francis Gauthier, Project Manager', 'oldOrganization': 'Bellus Health Inc.'}}}}