Ignite Creation Date:
2025-12-24 @ 9:16 PM
Ignite Modification Date:
2026-01-02 @ 4:37 AM
Study NCT ID:
NCT00460304
Status:
COMPLETED
Last Update Posted:
2009-04-03
First Post:
2007-04-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Pramlintide on Meal Time Insulin Bolus
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2011-07-18', 'releaseDate': '2011-06-17'}, {'resetDate': '2013-10-27', 'releaseDate': '2013-08-23'}], 'estimatedResultsFirstSubmitDate': '2011-06-17'}}, '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': 'C105254', 'term': 'pramlintide'}, {'id': 'D000095583', 'term': 'Continuous Glucose Monitoring'}], 'ancestors': [{'id': 'D001774', 'term': 'Blood Chemical Analysis'}, {'id': 'D019963', 'term': 'Clinical Chemistry Tests'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D003940', 'term': 'Diagnostic Techniques, Endocrine'}, {'id': 'D008991', 'term': 'Monitoring, Physiologic'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-04', 'completionDateStruct': {'date': '2008-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-04-02', 'studyFirstSubmitDate': '2007-04-11', 'studyFirstSubmitQcDate': '2007-04-12', 'lastUpdatePostDateStruct': {'date': '2009-04-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-04-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The mean ICR from Vist 3a-e and 4a-e will be compared. Percentage reduction of ICR will be calculated. From these the mean ICR will be calculated.', 'timeFrame': '12-10-07'}], 'secondaryOutcomes': [{'measure': 'The mean post-meal glucose from the four hour period after beginning a meal will be averaged for each bolus wave form. Then the three wave form mean glucose results will be compared.', 'timeFrame': '12-10-07'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Type I diabetes', 'Insulin pump', 'Continuous glucose monitoring', 'Insulin to carbohydrate ratio', 'Correction factor', 'Pramlintide'], 'conditions': ['Type 1 Diabetes']}, 'referencesModule': {'references': [{'pmid': '17003291', 'type': 'BACKGROUND', 'citation': 'Edelman S, Garg S, Frias J, Maggs D, Wang Y, Zhang B, Strobel S, Lutz K, Kolterman O. A double-blind, placebo-controlled trial assessing pramlintide treatment in the setting of intensive insulin therapy in type 1 diabetes. Diabetes Care. 2006 Oct;29(10):2189-95. doi: 10.2337/dc06-0042.'}, {'type': 'BACKGROUND', 'citation': 'Symlin (package insert) San Diego, CA Amylin Pharmacetucials. 2005'}, {'pmid': '18220597', 'type': 'BACKGROUND', 'citation': 'King AB, Armstrong DU. Basal bolus dosing: a clinical experience. Curr Diabetes Rev. 2005 May;1(2):215-20. doi: 10.2174/1573399054022794.'}, {'pmid': '19888377', 'type': 'BACKGROUND', 'citation': 'King AB, Armstrong DU. A prospective evaluation of insulin dosing recommendations in patients with type 1 diabetes at near normal glucose control: Basal dosing. J Diabetes Sci Technol. 2007 Jan;1(1):36-41. doi: 10.1177/193229680700100106.'}, {'pmid': '19888378', 'type': 'BACKGROUND', 'citation': 'King AB, Armstrong DU. A prospective evaluation of insulin dosing recommendations in patients with type 1 diabetes at near normal glucose control: bolus dosing. J Diabetes Sci Technol. 2007 Jan;1(1):42-6. doi: 10.1177/193229680700100107.'}, {'pmid': '7672483', 'type': 'BACKGROUND', 'citation': 'Young AA, Gedulin B, Vine W, Percy A, Rink TJ. Gastric emptying is accelerated in diabetic BB rats and is slowed by subcutaneous injections of amylin. Diabetologia. 1995 Jun;38(6):642-8. doi: 10.1007/BF00401833.'}, {'pmid': '9005972', 'type': 'BACKGROUND', 'citation': 'Gedulin BR, Rink TJ, Young AA. Dose-response for glucagonostatic effect of amylin in rats. Metabolism. 1997 Jan;46(1):67-70. doi: 10.1016/s0026-0495(97)90170-0.'}, {'pmid': '10741687', 'type': 'BACKGROUND', 'citation': 'Rushing PA, Lutz TA, Seeley RJ, Woods SC. Amylin and insulin interact to reduce food intake in rats. Horm Metab Res. 2000 Feb;32(2):62-5. doi: 10.1055/s-2007-978590.'}, {'pmid': '11469628', 'type': 'BACKGROUND', 'citation': 'Gross TM, Mastrototaro JJ. Efficacy and reliability of the continuous glucose monitoring system. Diabetes Technol Ther. 2000;2 Suppl 1:S19-26. doi: 10.1089/15209150050214087. No abstract available.'}]}, 'descriptionModule': {'briefSummary': 'The primary objective is to establish the mean percentage of change in the insulin-to-carbohydrate ratio due to pramlintide treatment once a maximum tolerated dose or 6 mcg before each meal is reached. The secondary objective is to establish which insulin bolus wave form is associated with the lowest post-bolus without hypoglycemia in subjects treated with maximum pramlintide dosage.', 'detailedDescription': 'Pramlintide. an amylinomimetic, is effective in reducing post-meal glucose by non-insulin means. As such, when patients requiring insulin treatment are treated with pramlintide, the bolus insulin does must be reduced. Current recommendations suggest a 50% reduction but in our experience and that of a recent study this appears excessive. By using continuous glucose monitoring(CGM) to guide pre-meal insulin treatment, we will determine the percentage reduction in meal time insulin bolus comparing pre-pramlintide to maximum pramlintide treatment. We anticipate that the reduction in bolus dosage will be about 25%. In addition, the secondary aim of this study is to determine which bolus pattern, standard, square or dual wave, provides the best post-meal glucose control with pramlintide therapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age: \\>17\n* Type I diabetes\n* Onset of diabetes \\>3 months\n* Use of insulin pump \\>3 months\n* Hb A1C \\<8.9%\n* Demonstrated compliance to clinic visits\n* Demonstrated knowledge and use of bolus dosing calculations, carbohydrate counting, use of insulin pump and blood glucose meter\n* Monitor blood glucose \\>4/day\n\nExclusion Criteria:\n\n* Pregnancy or nursing\n* Recent (within last 3 months) factor that may cause change in insulin sensitivity, e.g. severe emotional or physical stress, recent significant infection or surgery. etc.\n* Renal failure (creatinine \\>1.5 mg/dl\n* Symptomatic gastroparesis\n* Using a medication that would interfere with insulin sensitivity\n* Treatment with extenatide or DPP IV inhibitor within the last 4 weeks\n* HbA1C change \\>0.9 % within the last 3 months\n* Significant change in eating or activity pattern\n* Weight change of \\>1.9 kg within the last 3 months\n* ALT \\>3 times upper limits of normal'}, 'identificationModule': {'nctId': 'NCT00460304', 'briefTitle': 'The Effect of Pramlintide on Meal Time Insulin Bolus', 'organization': {'class': 'INDUSTRY', 'fullName': 'Diabetes Care Center'}, 'officialTitle': 'The Effect of Pramlintide on Meal Time Insulin Bolus', 'orgStudyIdInfo': {'id': '07-01'}}, 'armsInterventionsModule': {'interventions': [{'name': 'pramlintide', 'type': 'DRUG'}, {'name': 'continuous glucose monitoring', 'type': 'PROCEDURE'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Allen B King, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Diabetes Care Center'}, {'name': 'Gary S Wolfe, RN, CCM', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Diabetes Care Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Diabetes Care Center', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Amylin Pharmaceuticals, LLC.', 'class': 'INDUSTRY'}]}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2011-06-17', 'type': 'RELEASE'}, {'date': '2011-07-18', 'type': 'RESET'}, {'date': '2013-08-23', 'type': 'RELEASE'}, {'date': '2013-10-27', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Allen B. King, MD, Medical Director, Diabetes Care Center'}}}}