Ignite Creation Date:
2025-12-25 @ 12:40 AM
Ignite Modification Date:
2025-12-27 @ 11:05 AM
Study NCT ID:
NCT00442767
Status:
COMPLETED
Last Update Posted:
2018-07-10
First Post:
2007-03-01
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Post-meal Insulin Dosing With Adjuvant Pre-meal Pramlintide in Children With Type 1 Diabetes Mellitus
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003922', 'term': 'Diabetes Mellitus, Type 1'}, {'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'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007328', 'term': 'Insulin'}, {'id': 'D061267', 'term': 'Insulin Aspart'}, {'id': 'D061268', 'term': 'Insulin Lispro'}, {'id': 'C105254', 'term': 'pramlintide'}], 'ancestors': [{'id': 'D011384', 'term': 'Proinsulin'}, {'id': 'D061385', 'term': 'Insulins'}, {'id': 'D010187', 'term': 'Pancreatic Hormones'}, {'id': 'D036361', 'term': 'Peptide Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D061266', 'term': 'Insulin, Short-Acting'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'rheptull@montefiore.org', 'phone': '718-920-4664', 'title': 'Dr. Rubina Heptulla', 'organization': 'Montefiore Medical Center'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '1 year', 'eventGroups': [{'id': 'EG000', 'title': 'Insulin Therapy', 'description': 'Rapid acting Insulin therapy - before meal: Insulin therapy was continued as per prescribed home regimen without pramlintide. Subjects self-administered a rapid-acting insulin analog (aspart or lispro) bolus based on their individual insulin: carbohydrate ratio, before meal.', 'otherNumAtRisk': 8, 'deathsNumAtRisk': 8, 'otherNumAffected': 0, 'seriousNumAtRisk': 8, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Pramlintide + Insulin Therapy', 'description': 'Pre-meal Pramlintide and Post-meal Insulin therapy: 30mcg of pramlintide was administered subcutaneously immediately prior to the meal and insulin was given 15 minutes after the meal. The dose of insulin was reduced by 20%.', 'otherNumAtRisk': 8, 'deathsNumAtRisk': 8, 'otherNumAffected': 0, 'seriousNumAtRisk': 8, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Assess the Mean Area Under the Curve (AUC) for Blood Glucose Concentration in Subjects Treated With Pramlintide + Insulin, Compared to Insulin Alone', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rapid Acting Insulin Therapy - Before Meal', 'description': 'Rapid acting Insulin therapy - before meal: Insulin therapy was continued as per prescribed home regimen without pramlintide. Subjects self-administered a rapid-acting insulin analog (aspart or lispro) bolus based on their individual insulin: carbohydrate ratio, before meal.'}, {'id': 'OG001', 'title': 'Pre-meal Pramlintide and Post-meal Insulin Therapy', 'description': 'Pre-meal Pramlintide and Post-meal Insulin therapy: 30mcg of pramlintide was administered subcutaneously immediately prior to the meal and insulin was given 15 minutes after the meal. The dose of insulin was reduced by 20%.'}], 'classes': [{'categories': [{'measurements': [{'value': '205', 'spread': '116', 'groupId': 'OG000'}, {'value': '993', 'spread': '141', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '0 to 240 minutes post-dose', 'description': 'Blood glucose concentration in terms of mean AUC (0 to 240 minutes) was determined in subjects treated with Pramlintide + Insulin vs. Insulin alone', 'unitOfMeasure': 'mmol*L/min', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Measure of Glucagon Concentration in Subjects Treated With Pramlintide + Insulin, Compared to Insulin Alone.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rapid Acting Insulin Therapy - Before Meal', 'description': 'Rapid acting Insulin therapy - before meal: Insulin therapy was continued as per prescribed home regimen without pramlintide. Subjects self-administered a rapid-acting insulin analog (aspart or lispro) bolus based on their individual insulin: carbohydrate ratio, before meal.'}, {'id': 'OG001', 'title': 'Pre-meal Pramlintide and Post-meal Insulin Therapy', 'description': 'Pre-meal Pramlintide and Post-meal Insulin therapy: 30mcg of pramlintide was administered subcutaneously immediately prior to the meal and insulin was given 15 minutes after the meal. The dose of insulin was reduced by 20%.'}], 'classes': [{'categories': [{'measurements': [{'value': '6060', 'spread': '459', 'groupId': 'OG000'}, {'value': '7575', 'spread': '479', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '0 to 120 minutes post-dose', 'description': 'Glucagon concentration in terms of mean AUC (0 to 120 minutes) was determined in subjects treated with Pramlintide + Insulin vs. Insulin alone', 'unitOfMeasure': 'ng*L/min', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Insulin Therapy / Pramlintide + Insulin Therapy', 'description': 'Rapid acting Insulin therapy - before meal: Insulin therapy was continued as per prescribed home regimen without pramlintide. Subjects self-administered a rapid-acting insulin analog (aspart or lispro) bolus based on their individual insulin: carbohydrate ratio, before meal.\n\nPre-meal Pramlintide and Post-meal Insulin therapy: 30mcg of pramlintide was administered subcutaneously immediately prior to the meal and insulin was given 15 minutes after the meal. The dose of insulin was reduced by 20%.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Eight study subjects were screened and all subjects completed both study visits.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Insulin Therpy / Pramlintide + Insulin Therapy', 'description': 'Rapid acting Insulin therapy - before meal: Insulin therapy was continued as per prescribed home regimen without pramlintide. Subjects self-administered a rapid-acting insulin analog (aspart or lispro) bolus based on their individual insulin: carbohydrate ratio, before meal.\n\nPre-meal Pramlintide and Post-meal Insulin therapy: 30mcg of pramlintide was administered subcutaneously immediately prior to the meal and insulin was given 15 minutes after the meal. The dose of insulin was reduced by 20%.'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '8', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '16.2', 'spread': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 8}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-06', 'completionDateStruct': {'date': '2009-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-06-07', 'studyFirstSubmitDate': '2007-03-01', 'resultsFirstSubmitDate': '2018-03-13', 'studyFirstSubmitQcDate': '2007-03-01', 'lastUpdatePostDateStruct': {'date': '2018-07-10', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-06-07', 'studyFirstPostDateStruct': {'date': '2007-03-02', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-07-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2009-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Assess the Mean Area Under the Curve (AUC) for Blood Glucose Concentration in Subjects Treated With Pramlintide + Insulin, Compared to Insulin Alone', 'timeFrame': '0 to 240 minutes post-dose', 'description': 'Blood glucose concentration in terms of mean AUC (0 to 240 minutes) was determined in subjects treated with Pramlintide + Insulin vs. Insulin alone'}], 'secondaryOutcomes': [{'measure': 'Measure of Glucagon Concentration in Subjects Treated With Pramlintide + Insulin, Compared to Insulin Alone.', 'timeFrame': '0 to 120 minutes post-dose', 'description': 'Glucagon concentration in terms of mean AUC (0 to 120 minutes) was determined in subjects treated with Pramlintide + Insulin vs. Insulin alone'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['pediatric', 'juvenile', 'diabetes mellitus', 'Pediatric type 1 diabetes mellitus'], 'conditions': ['Type 1 Diabetes Mellitus']}, 'referencesModule': {'references': [{'pmid': '19140902', 'type': 'BACKGROUND', 'citation': 'Hassan K, Heptulla RA. Reducing postprandial hyperglycemia with adjuvant premeal pramlintide and postmeal insulin in children with type 1 diabetes mellitus. Pediatr Diabetes. 2009 Jun;10(4):264-8. doi: 10.1111/j.1399-5448.2008.00490.x. Epub 2008 Dec 18.'}]}, 'descriptionModule': {'briefSummary': 'The primary objective of this study is to examine the effect of pramlintide given pre-meal and insulin given just after a meal vs. standard therapy of pre-meal insulin on post-prandial glucose excursions.\n\nThe secondary objective is to examine the effect of pramlintide and insulin on glucagon suppression in type 1 diabetes.', 'detailedDescription': 'Following approval by the Institutional Review Board at Baylor College of Medicine 8 adolescents (6 males, 2 females) with type 1 diabetes were recruited to the open-labeled, non-randomized, crossover study. Two male subjects were African American; the remaining subjects were all Caucasian. Six subjects were on insulin pump therapy, and the two on insulin glargine, self-administered at -90minutes. Subjects had their last meal before 12 midnight, and stayed at our research center from 7AM until completion of the study at 2PM. Study A was done before study B.\n\nBasal insulin doses of the subjects were kept constant through studies A and B. No subject was prescribed pramlintide any time in the past prior to participation in this study.\n\nStudy A:Insulin therapy was continued as per prescribed home regimen without pramlintide. Subjects self-administered a rapid-acting insulin analog (aspart or lispro) bolus based on their individual insulin: carbohydrate ratio, following which they received 12oz (591ml) of Boost High Protein drink (360 calories, 50gms carbohydrate, 12 gms fat) at 9AM (0 minutes). The Boost was consumed in 5 - 7 minutes. Blood samples were collected for the analysis of blood glucose (BG) levels at -60, -30, -10, and 0 minutes, and every 10 minutes thereafter for the first hour, every 20 minutes for the second hour, and every 30 minutes until the study ended. Blood samples were also collected throughout the study at multiple time points for the analysis of insulin and glucagon levels. Subjects were provided with lunch at 2PM, and discharged.\n\nStudy B:The study protocol was identical to study A except 30mcg of pramlintide was administered subcutaneously immediately prior to drinking the Boost at 9AM, and no insulin was given before the meal but was given 15 minutes after the meal (9:15AM) and the dose was reduced by 20%. Study B was conducted within 3 to 4 weeks of study A.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '21 Years', 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Type 1 diabetes only\n* Diagnosed with T1DM for at least 1 year\n* HbA1C less than or equal to 8.5%\n* Currently treated using insulin glargine with or without Humalog/ Novolog or on the insulin pump\n* Hemoglobin equal to or greater than 12mg/dL\n* Otherwise healthy, EXCEPT for T1DM and treated hypothyroidism\n* Negative pregnancy test, in the case of females\n\nExclusion Criteria:\n\n* Lack of supportive family\n* Evidence or history of chemical abuse\n* BMI (body mass index) greater than the 90th percentile OR less than the 10th percentile for age\n* Patient who is poorly compliant with current insulin management and/or Prescribed self blood glucose monitoring\n* Patient who experiences recurrent severe hypoglycemia episodes (requiring assistance/ hospitalizations) in the past 6 months\n* Have hypoglycemia unawareness\n* Have a confirmed diagnosis of gastroparesis, and/ or require medications that stimulate gastrointestinal motility\n* Pregnant or lactating patients, or patients planning on becoming pregnant'}, 'identificationModule': {'nctId': 'NCT00442767', 'briefTitle': 'Post-meal Insulin Dosing With Adjuvant Pre-meal Pramlintide in Children With Type 1 Diabetes Mellitus', 'organization': {'class': 'OTHER', 'fullName': 'Montefiore Medical Center'}, 'officialTitle': 'Reducing Postprandial Hyperglycemia With Adjuvant Premeal Pramlintide and Postmeal Insulin in Children With Type 1 Diabetes Mellitus.', 'orgStudyIdInfo': {'id': 'H-18629'}, 'secondaryIdInfos': [{'id': 'GCRC protocol #:0954'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Rapid acting Insulin therapy - before meal', 'description': 'Insulin therapy was continued as per prescribed home regimen without pramlintide. Subjects self-administered a rapid-acting insulin analog (aspart or lispro) bolus based on their individual insulin: carbohydrate ratio, before meal', 'interventionNames': ['Drug: Insulin']}, {'type': 'EXPERIMENTAL', 'label': 'Pre-meal Pramlintide and Post-meal Insulin therapy', 'description': '30mcg of pramlintide was administered subcutaneously immediately prior to the meal and insulin was given 15 minutes after the meal. The dose of insulin was reduced by 20%.', 'interventionNames': ['Drug: Pramlintide + Insulin']}], 'interventions': [{'name': 'Insulin', 'type': 'DRUG', 'otherNames': ['aspart or lispro'], 'description': 'Insulin therapy was continued as per prescribed home regimen without pramlintide. Subjects self-administered a rapid-acting insulin analog (aspart or lispro) bolus based on their individual insulin: carbohydrate ratio, before meal.', 'armGroupLabels': ['Rapid acting Insulin therapy - before meal']}, {'name': 'Pramlintide + Insulin', 'type': 'DRUG', 'otherNames': ['Pramlintide Acetate'], 'description': '30mcg of pramlintide was administered subcutaneously immediately prior to the meal and insulin was given 15 minutes after the meal. The dose of insulin was reduced by 20%.', 'armGroupLabels': ['Pre-meal Pramlintide and Post-meal Insulin therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10467', 'city': 'The Bronx', 'state': 'New York', 'country': 'United States', 'facility': 'Montefiore Medical Center', 'geoPoint': {'lat': 40.84985, 'lon': -73.86641}}], 'overallOfficials': [{'name': 'Rubina A Heptulla, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Montefiore Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Montefiore Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Amylin Pharmaceuticals, LLC.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Rubina Heptulla', 'investigatorAffiliation': 'Montefiore Medical Center'}}}}