Ignite Creation Date:
2025-12-25 @ 12:00 AM
Ignite Modification Date:
2025-12-25 @ 9:57 PM
Study NCT ID:
NCT00147758
Status:
COMPLETED
Last Update Posted:
2012-01-18
First Post:
2005-09-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
WelChol® and Sulfonylurea in Treating Patients With Type 2 Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}], 'ancestors': [{'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': 'D000069472', 'term': 'Colesevelam Hydrochloride'}], 'ancestors': [{'id': 'D000499', 'term': 'Allylamine'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000498', 'term': 'Allyl Compounds'}, {'id': 'D000475', 'term': 'Alkenes'}, {'id': 'D006839', 'term': 'Hydrocarbons, Acyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 400}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-01', 'completionDateStruct': {'date': '2006-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-01-16', 'studyFirstSubmitDate': '2005-09-02', 'studyFirstSubmitQcDate': '2005-09-02', 'lastUpdatePostDateStruct': {'date': '2012-01-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To assess the additional lowering of HbA1c achieved by addition of colesevelam hydrochloride to current antidiabetic therapy'}], 'secondaryOutcomes': [{'measure': 'To assess the fasting plasma glucose and fructosamine lowering efficacy;'}, {'measure': 'To assess glycemic control response rate;'}, {'measure': 'To assess the improvement in insulin sensitivity;'}, {'measure': 'To assess the effect on C reactive protein;'}, {'measure': 'To assess lipids and lipoproteins;'}, {'measure': 'To assess the safety and tolerability of colesevelam hydrochloride as add-on therapy'}]}, 'conditionsModule': {'keywords': ['Diabetes Mellitus'], 'conditions': ['Type 2 Diabetes']}, 'referencesModule': {'references': [{'pmid': '18458145', 'type': 'DERIVED', 'citation': 'Fonseca VA, Rosenstock J, Wang AC, Truitt KE, Jones MR. Colesevelam HCl improves glycemic control and reduces LDL cholesterol in patients with inadequately controlled type 2 diabetes on sulfonylurea-based therapy. Diabetes Care. 2008 Aug;31(8):1479-84. doi: 10.2337/dc08-0283. Epub 2008 May 5.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to see how safe and effective and tolerable the use of colesevelam hydrochloride is for type 2 diabetes when added to sulfonylurea alone or in combination with other anti-diabetic drugs.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18-75 years, inclusive\n* Diagnosed with type 2 diabetes\n* Stable dose of sulfonylurea alone or in combination with other anti-diabetic medications for 90 days\n* Hemoglobin A1c value 7.5% to 9.5%, inclusive\n* C peptide \\> 0.5 ng/mL\n* Prescribed ADA diet\n\nExclusion Criteria:\n\n* History of type 1 diabetes or ketoacidosis\n* History of pancreatitis\n* Uncontrolled hypertension\n* Allergy or toxic response to colesevelam or any of its components\n* Serum LDL-C \\< 60 mg/dL\n* Serum TG \\> 500 mg/dL\n* Body mass index (BMI) \\> 45 kg/m2'}, 'identificationModule': {'nctId': 'NCT00147758', 'briefTitle': 'WelChol® and Sulfonylurea in Treating Patients With Type 2 Diabetes', 'organization': {'class': 'INDUSTRY', 'fullName': 'Daiichi Sankyo'}, 'officialTitle': 'A Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of the Efficacy and Safety of WelChol® in Type 2 Diabetics With Inadequate Glycemic Control on Sulfonylurea Monotherapy or Sulfonylurea Therapy in Combination With Other Oral Anti-Diabetic Agents', 'orgStudyIdInfo': {'id': 'WEL-303'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Colesevelam hydrochloride', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'city': 'Tuscumbia', 'state': 'Alabama', 'country': 'United States', 'geoPoint': {'lat': 34.7312, 'lon': -87.70253}}, {'city': 'Little Rock', 'state': 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'Washington', 'country': 'United States', 'geoPoint': {'lat': 47.17176, 'lon': -122.51846}}, {'city': 'Renton', 'state': 'Washington', 'country': 'United States', 'geoPoint': {'lat': 47.48288, 'lon': -122.21707}}, {'city': 'Mexico City', 'country': 'Mexico', 'geoPoint': {'lat': 19.42847, 'lon': -99.12766}}, {'city': 'Lima', 'country': 'Peru', 'geoPoint': {'lat': -12.04318, 'lon': -77.02824}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Daiichi Sankyo', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}