Ignite Creation Date:
2025-12-24 @ 11:54 PM
Ignite Modification Date:
2025-12-25 @ 9:49 PM
Study NCT ID:
NCT00909051
Status:
COMPLETED
Last Update Posted:
2023-06-06
First Post:
2009-05-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
GlucoVIP - Diabetes Treatment by Glucobay® With a Special Therapeutic View to Chosen Patient Groups
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Croatia']}, 'conditionBrowseModule': {'meshes': [{'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': 'D020909', 'term': 'Acarbose'}], 'ancestors': [{'id': 'D014312', 'term': 'Trisaccharides'}, {'id': 'D009844', 'term': 'Oligosaccharides'}, {'id': 'D011134', 'term': 'Polysaccharides'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 15729}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-03-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-06', 'completionDateStruct': {'date': '2010-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-06-05', 'studyFirstSubmitDate': '2009-05-26', 'studyFirstSubmitQcDate': '2009-05-26', 'lastUpdatePostDateStruct': {'date': '2023-06-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2009-05-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Data collection on patients weight and waist circumference, fasting blood glucose, postprandial blood glucose (2h), HbA1C; exploratory analysis according to patient groups (concomitant cardiovascular disease groups, BMI)', 'timeFrame': 'During observation period of three months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Diabetes Mellitus'], 'conditions': ['Diabetes Mellitus']}, 'referencesModule': {'references': [{'pmid': '23435929', 'type': 'RESULT', 'citation': 'Zhang W, Kim D, Philip E, Miyan Z, Barykina I, Schmidt B, Stein H; Gluco VIP study. A multinational, observational study to investigate the efficacy, safety and tolerability of acarbose as add-on or monotherapy in a range of patients: the Gluco VIP study. Clin Drug Investig. 2013 Apr;33(4):263-74. doi: 10.1007/s40261-013-0063-3.'}]}, 'descriptionModule': {'briefSummary': 'Evaluation of safety and effectiveness of Glucobay® under daily-life treatment conditions in a large sample of patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '* Patients with untreated or pretreated diabetes mellitus type 2\n* No Glucobay® intake within the last 3 months before documentation of initial visit\n* Exclusion Criteria: contraindication stated in the local Glucobay® product information; warnings and precautions must be considered.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with untreated or pretreated diabetes mellitus or patients for which acarbose is indicated and without acarbose treatment within the last three months before study inclusion. The decision for treatment type and duration is taken by the investigator and is made before inclusion into the study.\n\nExclusion Criteria:\n\n* Exclusion criteria must be read in conjunction with the local product information.'}, 'identificationModule': {'nctId': 'NCT00909051', 'briefTitle': 'GlucoVIP - Diabetes Treatment by Glucobay® With a Special Therapeutic View to Chosen Patient Groups', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bayer'}, 'officialTitle': 'Diabetes Treatment by Glucobay® With a Special Therapeutic View to Chosen Patient Groups', 'orgStudyIdInfo': {'id': '14284'}, 'secondaryIdInfos': [{'id': 'GB0701', 'type': 'OTHER', 'domain': 'Company internal'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group 1', 'interventionNames': ['Drug: Acarbose (Glucobay, BAYG5421)']}], 'interventions': [{'name': 'Acarbose (Glucobay, BAYG5421)', 'type': 'DRUG', 'description': 'Patients with diabetes type 2 newly treated with Glucobay', 'armGroupLabels': ['Group 1']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Multiple Locations', 'country': 'Algeria'}, {'city': 'Multiple Locations', 'country': 'Bosnia and Herzegovina'}, {'city': 'Multiple Locations', 'country': 'Cambodia'}, {'city': 'Multiple Locations', 'country': 'China'}, {'city': 'Multiple Locations', 'country': 'Hong Kong'}, {'city': 'Multiple Locations', 'country': 'India'}, {'city': 'Multiple Locations', 'country': 'Indonesia'}, {'city': 'Multiple Locations', 'country': 'Malaysia'}, {'city': 'Multiple Locations', 'country': 'Moldova'}, {'city': 'Multiple Locations', 'country': 'Pakistan'}, {'city': 'Multiple Locations', 'country': 'Philippines'}, {'city': 'Multiple Locations', 'country': 'Russia'}, {'city': 'Multiple Locations', 'country': 'Singapore'}, {'city': 'Multiple Locations', 'country': 'South Korea'}, {'city': 'Multiple Locations', 'country': 'Thailand'}, {'city': 'Multiple Locations', 'country': 'Vietnam'}], 'overallOfficials': [{'name': 'Bayer Study Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bayer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bayer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}