Ignite Creation Date:
2025-12-25 @ 1:22 AM
Ignite Modification Date:
2025-12-25 @ 11:31 PM
Study NCT ID:
NCT00276393
Status:
COMPLETED
Last Update Posted:
2011-05-23
First Post:
2006-01-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Treatment Trial Evaluating Long Acting Insulin in Type 1 Diabetes
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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'count': 22}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-05', 'completionDateStruct': {'date': '2003-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-05-20', 'studyFirstSubmitDate': '2006-01-11', 'studyFirstSubmitQcDate': '2006-01-11', 'lastUpdatePostDateStruct': {'date': '2011-05-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-01-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2003-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'HbA1c'}, {'measure': 'Hypoglycemic events'}, {'measure': 'Nocturnal hypoglycemia'}, {'measure': 'Mean glucose'}, {'measure': 'Mean fasting glucose'}], 'secondaryOutcomes': [{'measure': 'Days of titration of basal insulin'}, {'measure': 'Fear of hypoglycemia'}, {'measure': 'Continuos glucose monitoring'}]}, 'conditionsModule': {'conditions': ['Type 1 Diabetes']}, 'referencesModule': {'references': [{'pmid': '15616226', 'type': 'RESULT', 'citation': 'Kudva YC, Basu A, Jenkins GD, Pons GM, Quandt LL, Gebel JA, Vogelsang DA, Smith SA, Rizza RA, Isley WL. Randomized controlled clinical trial of glargine versus ultralente insulin in the treatment of type 1 diabetes. Diabetes Care. 2005 Jan;28(1):10-4. doi: 10.2337/diacare.28.1.10.'}]}, 'descriptionModule': {'briefSummary': 'Patients with type 1 diabetes trained in multiple daily insulin injection were treated with two diffferent kinds of long acting insulin preparations. The two insulin preparations were glargine and ultralente insulin. Patients were randomized to receive one of the two insulin preparations for the first 4 months followed by the second preparation for a further four months. Short acting insulin used was the same during both periods. We found that glargine insulin was better than ultralente insulin in our study.', 'detailedDescription': 'Multiple daily insulin injection (MDI) programs are commonly accompanied by considerable glycemic variation and hypoglycemia. In order to determine whether use of insulin glargine as a basal insulin would result in comparable HbA1c with less glycemic variation and hypoglycemia than ultralente insulin, 22 individuals with type 1 diabetes, experienced with MDI, and a HbA1c of \\<7.8 % were randomized, to receive either glargine or ultralente as the basal insulin for 4-months. Aspart insulin was used as the prandial. Physicians providing insulin dose adjustment advice were masked to the type of basal insulin. Treatment with glargine resulted in lower mean HbA1c, less nocturnal variability , and less hypoglycemia primarily due to less daytime hypoglycemia (p=0.002). On the other hand, serious hypoglycemia and average glucose concentration measured with continuous glucose monitoring system (CGMS) did not differ. We conclude that, while use of either ultralente or glargine as a basal insulin can result in excellent glycemic control, treatment with glargine is associated with slightly but significantly lower HbA1C, with less nocturnal glycemic variability and less hypoglycemia.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Type 1 diabetes, HbA1c \\< 7.8%, who have had prior instruction in a complex insulin program, and presently using a MDI insulin program with basal insulin preparations of Glargine or Ultralente and Humalog as the short acting insulin, should be free of hepatorenal abnormalities and hypoglycemia unawareness; non-pregnant, and should be able to perform frequent self monitoring of blood glucose (SMBG) and accept the use of continuous glucose monitoring system (CGMS). They should also possess the skill and understanding of insulin dose adjustments and supplementation.'}, 'identificationModule': {'nctId': 'NCT00276393', 'briefTitle': 'Treatment Trial Evaluating Long Acting Insulin in Type 1 Diabetes', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': 'Randomized Trial Comparing Insulin Glargine to Ultra-Lente Insulin in Type I Diabetes', 'orgStudyIdInfo': {'id': '70-02'}, 'secondaryIdInfos': [{'id': '1A4372'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Basal insulin', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}], 'overallOfficials': [{'name': 'Yogish C. Kudva, M.B.B.S', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayo Clinic', 'class': 'OTHER'}}}}