Ignite Creation Date:
2025-12-26 @ 10:45 PM
Ignite Modification Date:
2025-12-26 @ 10:45 PM
Study NCT ID:
NCT01299012
Status:
COMPLETED
Last Update Posted:
2017-02-09
First Post:
2011-02-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Liraglutide as Additional Treatment in Patients With Type 1 Diabetes Mellitus
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003922', 'term': 'Diabetes Mellitus, Type 1'}], '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': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069450', 'term': 'Liraglutide'}], 'ancestors': [{'id': 'D052216', 'term': 'Glucagon-Like Peptide 1'}, {'id': 'D004763', 'term': 'Glucagon-Like Peptides'}, {'id': 'D052336', 'term': 'Proglucagon'}, {'id': 'D005768', 'term': 'Gastrointestinal Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-02', 'completionDateStruct': {'date': '2013-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-02-08', 'studyFirstSubmitDate': '2011-02-01', 'studyFirstSubmitQcDate': '2011-02-17', 'lastUpdatePostDateStruct': {'date': '2017-02-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-02-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Improved Blood Glucose comtrol in Type 1 Diabetes Patients with Liraglutide', 'timeFrame': '20 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Type 1 Diabetes Mellitus']}, 'descriptionModule': {'briefSummary': 'Evaluating the use of Liraglutide in patients with Type 1 Diabetes.', 'detailedDescription': 'This investigation will be a retrospective chart review of in type 1 diabetics who have been treated with liraglutide. The study will be conducted at Diabetes-Endocrinology Center of WNY at Millard Fillmore Hospital, affiliated to the State University of New York at Buffalo.\n\nStudy Population: 40 patients with type 1 diabetes on treatment with either continuous subcutaneous insulin infusion (CSII; also known as insulin pump) or multiple (four or more) injections of insulin per day on continuous glucose monitoring system (CGMS) will be included in the study. These patients with type 1 diabetes have been treated with liraglutide in addition to insulin. The investigators would retrospectively review their charts to evaluate decreases in fasting, postprandial and the overall mean glucose concentrations.\n\nThe investigators will compare the mean fasting, the mean weekly glucose and the standard deviation of weekly blood glucose concentrations as recorded by continuous glucose monitoring prior to and following one week and 12 weeks of treatment with liraglutide daily. In addition, the investigators will compare the time spent at glucose concentrations \\>150 and 200mg/dl and \\<70 and \\<40 mg/dl. HbA1c levels before and after 12 weeks of treatment with liraglutide daily will be compared.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Type 1 Diabetes Mellitus', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Type 1 Diabetes Mellitus\n\nExclusion Criteria:\n\n* Type 2 Diabetes Mellitus'}, 'identificationModule': {'nctId': 'NCT01299012', 'briefTitle': 'Liraglutide as Additional Treatment in Patients With Type 1 Diabetes Mellitus', 'organization': {'class': 'OTHER', 'fullName': 'University at Buffalo'}, 'officialTitle': 'Liraglutide as Additional Treatment in Patients With Type 1 Diabetes Mellitus, a Retrospective Chart Review', 'orgStudyIdInfo': {'id': '1954'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Liraglutide', 'type': 'DRUG', 'otherNames': ['Victoza'], 'description': 'Liraglutide s/c 0.6mg once daily.'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Paresh Dandona', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University at Buffalo'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University at Buffalo', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Paresh Dandona', 'investigatorAffiliation': 'Kaleida Health'}}}}