Ignite Creation Date:
2025-12-25 @ 12:16 AM
Ignite Modification Date:
2025-12-25 @ 10:18 PM
Study NCT ID:
NCT00229658
Status:
COMPLETED
Last Update Posted:
2015-03-25
First Post:
2005-09-28
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
An Observational Study Evaluating SYMLIN® (Pramlintide Acetate) Injection Use in Insulin Using Patients With Type 2 and Type 1 Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003922', 'term': 'Diabetes Mellitus, Type 1'}, {'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'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': 'C105254', 'term': 'pramlintide'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Clinical.Trials@bms.com', 'title': 'Bristol-Myers Squibb Study Director', 'organization': 'Bristol-Myers Squibb'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Type 1 Diabetes', 'description': 'Insulin using patients with Type 1 diabetes', 'otherNumAtRisk': 766, 'otherNumAffected': 0, 'seriousNumAffected': 14}, {'id': 'EG001', 'title': 'Type 2 Diabetes', 'description': 'Insulin using patients with Type 2 diabetes', 'otherNumAtRisk': 531, 'otherNumAffected': 0, 'seriousNumAffected': 13}], 'seriousEvents': [{'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 766, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 531, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Angina unstable', 'stats': [{'groupId': 'EG000', 'numAtRisk': 766, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 531, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Atrioventricular block complete', 'stats': [{'groupId': 'EG000', 'numAtRisk': 766, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 531, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Cardiac failure congestive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 766, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 531, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Coronary artery disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 766, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 531, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 766, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 531, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Pancreatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 766, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 531, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 766, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 531, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Hernia obstructive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 766, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 531, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Cholecystitis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 766, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 531, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 766, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 531, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 766, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 531, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Diverticulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 766, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 531, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Osteomyelitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 766, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 531, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 766, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 531, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 766, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 531, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Urosepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 766, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 531, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Diabetic ketoacidosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 766, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 531, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Rheumatoid arthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 766, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 531, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Chronic lymphocytic leukaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 766, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 531, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Ovarian granulosa-theca cell tumour', 'stats': [{'groupId': 'EG000', 'numAtRisk': 766, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 531, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Presyncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 766, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 531, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 766, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 531, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Ureteric stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 766, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 531, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Ovarian cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 766, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 531, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 766, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 531, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 766, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 531, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Skin ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 766, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 531, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 766, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 531, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Incidence of Patient-Ascertained Severe Hypoglycemia (PASH) During the Adjustment Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '766', 'groupId': 'OG000'}, {'value': '531', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Type 1 Diabetes', 'description': 'Insulin using patients with Type 1 diabetes'}, {'id': 'OG001', 'title': 'Type 2 Diabetes', 'description': 'Insulin using patients with Type 2 diabetes'}], 'classes': [{'categories': [{'measurements': [{'value': '4.8', 'groupId': 'OG000'}, {'value': '2.8', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '0-3 months', 'description': 'PASH is defined as episodes of hypoglycemia requiring the assistance of another individual (including aid in ingestion of oral carbohydrate); and/or requiring the administration of glucagon injection, intravenous glucose, or other medical intervention. The adjustment period represents the initial 0-3 months of pramlintide treatment', 'unitOfMeasure': 'Incidence (%)', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat'}, {'type': 'PRIMARY', 'title': 'Annual Event Rate of Patient-Ascertained Severe Hypoglycemia (PASH) During the Adjustment Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '766', 'groupId': 'OG000'}, {'value': '531', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Type 1 Diabetes', 'description': 'Insulin using patients with Type 1 diabetes'}, {'id': 'OG001', 'title': 'Type 2 Diabetes', 'description': 'Insulin using patients with Type 2 diabetes'}], 'classes': [{'categories': [{'measurements': [{'value': '0.3255', 'groupId': 'OG000'}, {'value': '0.1941', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '0-3 months', 'description': 'The annual event rate was calculated as the total number of events during the time period divided by the total years of exposure to pramlintide for all patients during the time period. The adjustment period represents the initial 0-3 months of pramlintide treatment.\n\nPASH is defined as episodes of hypoglycemia requiring the assistance of another individual (including aid in ingestion of oral carbohydrate); and/or requiring the administration of glucagon injection, intravenous glucose, or other medical intervention.', 'unitOfMeasure': 'Events per patient year', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat'}, {'type': 'SECONDARY', 'title': 'The Incidence of Patient-Ascertained Severe Hypoglycemia (PASH) During the Steady State Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '512', 'groupId': 'OG000'}, {'value': '387', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Type 1 Diabetes', 'description': 'Insulin using patients with Type 1 diabetes'}, {'id': 'OG001', 'title': 'Type 2 Diabetes', 'description': 'Insulin using patients with Type 2 diabetes'}], 'classes': [{'categories': [{'measurements': [{'value': '1.8', 'groupId': 'OG000'}, {'value': '0.3', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '>3-6 months', 'description': 'The steady state period represents the \\>3-6 months of pramlintide treatment following the adjustment period.\n\nPASH is defined as episodes of hypoglycemia requiring the assistance of another individual (including aid in ingestion of oral carbohydrate); and/or requiring the administration of glucagon injection, intravenous glucose, or other medical intervention.', 'unitOfMeasure': 'Incidence (%)', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat, number analyzed includes patients still enrolled in the study during the steady-state period (3-6 months)'}, {'type': 'SECONDARY', 'title': 'The Annual Event Rate of Patient-Ascertained Severe Hypoglycemia (PASH) During the Steady State Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '512', 'groupId': 'OG000'}, {'value': '387', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Type 1 Diabetes', 'description': 'Insulin using patients with Type 1 diabetes'}, {'id': 'OG001', 'title': 'Type 2 Diabetes', 'description': 'Insulin using patients with Type 2 diabetes'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0844', 'groupId': 'OG000'}, {'value': '0.0248', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '>3-6 months', 'description': 'The annual event rate was calculated as the total number of events during the time period divided by the total years of exposure to pramlintide for all patients during the time period. The steady state period represents the \\>3-6 months of pramlintide treatment following the adjustment period.\n\nPASH is defined as episodes of hypoglycemia requiring the assistance of another individual (including aid in ingestion of oral carbohydrate); and/or requiring the administration of glucagon injection, intravenous glucose, or other medical intervention.', 'unitOfMeasure': 'Events per patient year', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat, number analyzed includes patients still enrolled in the study during the steady-state period (3-6 months)'}, {'type': 'SECONDARY', 'title': 'Incidence of Medically Assisted Severe Hypoglycemia (MASH) During the Adjustment Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '766', 'groupId': 'OG000'}, {'value': '531', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Type 1 Diabetes', 'description': 'Insulin using patients with Type 1 diabetes'}, {'id': 'OG001', 'title': 'Type 2 Diabetes', 'description': 'Insulin using patients with Type 2 diabetes'}], 'classes': [{'categories': [{'measurements': [{'value': '1.8', 'groupId': 'OG000'}, {'value': '0.4', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '0-3 months', 'description': 'MASH is defined as episodes of severe hypoglycemia requiring IM glucagon, IV glucose, hospitalization, paramedic assistance, emergency room visit, and/or is assessed as a serious adverse event (SAE) by the investigator. MASH is a subset of PASH. The adjustment period represents the initial 0-3 months of pramlintide treatment', 'unitOfMeasure': 'Incidence (%)', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat.'}, {'type': 'SECONDARY', 'title': 'The Annual Event Rate of Medically Assisted Severe Hypoglycemia (MASH) During the Adjustment Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '766', 'groupId': 'OG000'}, {'value': '531', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Type 1 Diabetes', 'description': 'Insulin using patients with Type 1 diabetes'}, {'id': 'OG001', 'title': 'Type 2 Diabetes', 'description': 'Insulin using patients with Type 2 diabetes'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0996', 'groupId': 'OG000'}, {'value': '0.0185', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '0-3 months', 'description': 'The annual event rate was calculated as the total number of events during the time period divided by the total years of exposure to pramlintide for all patients during the time period. The adjustment period represents the initial 0-3 months of pramlintide treatment.\n\nMASH is defined as episodes of severe hypoglycemia requiring IM glucagon, IV glucose, hospitalization, paramedic assistance, emergency room visit, and/or is assessed as a serious adverse event (SAE) by the investigator. MASH is a subset of PASH.', 'unitOfMeasure': 'Events per patient year', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat'}, {'type': 'SECONDARY', 'title': 'Incidence of Medically Assisted Severe Hypoglycemia (MASH) During the Steady State Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '512', 'groupId': 'OG000'}, {'value': '387', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Type 1 Diabetes', 'description': 'Insulin using patients with Type 1 diabetes'}, {'id': 'OG001', 'title': 'Type 2 Diabetes', 'description': 'Insulin using patients with Type 2 diabetes'}], 'classes': [{'categories': [{'measurements': [{'value': '0.8', 'groupId': 'OG000'}, {'value': '0.3', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '>3-6 months', 'description': 'The steady state period represents the \\>3-6 months of pramlintide treatment following the adjustment period.\n\nMASH is defined as episodes of severe hypoglycemia requiring IM glucagon, IV glucose, hospitalization, paramedic assistance, emergency room visit, and/or is assessed as a serious adverse event (SAE) by the investigator. MASH is a subset of PASH.', 'unitOfMeasure': 'Incidence (%)', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat, number analyzed includes patients still enrolled in the study during the steady-state period (3-6 months)'}, {'type': 'SECONDARY', 'title': 'Annual Event Rate of Medically Assisted Severe Hypoglycemia (MASH) During the Steady State Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '512', 'groupId': 'OG000'}, {'value': '387', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Type 1 Diabetes', 'description': 'Insulin using patients with Type 1 diabetes'}, {'id': 'OG001', 'title': 'Type 2 Diabetes', 'description': 'Insulin using patients with Type 2 diabetes'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0375', 'groupId': 'OG000'}, {'value': '0.0124', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '>3-6 months', 'description': 'The annual event rate was calculated as the total number of events during the time period divided by the total years of exposure to pramlintide for all patients during the time period. The steady state period represents the \\>3-6 months of pramlintide treatment following the adjustment period.\n\nMASH is defined as episodes of severe hypoglycemia requiring IM glucagon, IV glucose, hospitalization, paramedic assistance, emergency room visit, and/or is assessed as a serious adverse event (SAE) by the investigator. MASH is a subset of PASH.', 'unitOfMeasure': 'Events per patient year', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat, number analyzed includes patients still enrolled in the study during the steady-state period (3-6 months)'}, {'type': 'SECONDARY', 'title': 'Change in HbA1c From Baseline at Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '414', 'groupId': 'OG000'}, {'value': '371', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Type 1 Diabetes', 'description': 'Insulin using patients with Type 1 diabetes'}, {'id': 'OG001', 'title': 'Type 2 Diabetes', 'description': 'Insulin using patients with Type 2 diabetes'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.12', 'spread': '0.037', 'groupId': 'OG000'}, {'value': '-0.33', 'spread': '0.056', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3 months', 'description': 'Change in HbA1c from baseline at month 3. The HbA1c test measures the percent of glycosylated hemoglobin in the blood.', 'unitOfMeasure': 'percent', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat, patients who discontinue SYMLIN 7 or more days prior to a site visit are not included in the analyses'}, {'type': 'SECONDARY', 'title': 'Change in HbA1c From Baseline at Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '347', 'groupId': 'OG000'}, {'value': '290', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Type 1 Diabetes', 'description': 'Insulin using patients with Type 1 diabetes'}, {'id': 'OG001', 'title': 'Type 2 Diabetes', 'description': 'Insulin using patients with Type 2 diabetes'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.26', 'spread': '0.046', 'groupId': 'OG000'}, {'value': '-0.44', 'spread': '0.071', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 months', 'description': 'Change in HbA1c from baseline at month 6. The HbA1c test measures the percent of glycosylated hemoglobin in the blood.', 'unitOfMeasure': 'percent', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat, patients who discontinue SYMLIN 7 or more days prior to a site visit are not included in the analyses'}, {'type': 'SECONDARY', 'title': 'Change in Body Weight From Baseline at Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '443', 'groupId': 'OG000'}, {'value': '370', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Type 1 Diabetes', 'description': 'Insulin using patients with Type 1 diabetes'}, {'id': 'OG001', 'title': 'Type 2 Diabetes', 'description': 'Insulin using patients with Type 2 diabetes'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.95', 'spread': '0.154', 'groupId': 'OG000'}, {'value': '-1.94', 'spread': '0.237', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3 months', 'description': 'Mean change in body weight from baseline at month 3', 'unitOfMeasure': 'kg', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat, patients who discontinue SYMLIN 7 or more days prior to a site visit are not included in the analyses'}, {'type': 'SECONDARY', 'title': 'Change in Body Weight From Baseline at Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '364', 'groupId': 'OG000'}, {'value': '294', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Type 1 Diabetes', 'description': 'Insulin using patients with Type 1 diabetes'}, {'id': 'OG001', 'title': 'Type 2 Diabetes', 'description': 'Insulin using patients with Type 2 diabetes'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.77', 'spread': '0.246', 'groupId': 'OG000'}, {'value': '-1.98', 'spread': '0.322', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 months', 'description': 'Mean change in body weight from baseline at month 6', 'unitOfMeasure': 'kg', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat, patients who discontinue SYMLIN 7 or more days prior to a site visit are not included in the analyses'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Type 1 Diabetes', 'description': 'Insulin using patients with Type 1 diabetes'}, {'id': 'FG001', 'title': 'Type 2 Diabetes', 'description': 'Insulin using patients with Type 2 diabetes'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '766'}, {'groupId': 'FG001', 'numSubjects': '531'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '541'}, {'groupId': 'FG001', 'numSubjects': '364'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '225'}, {'groupId': 'FG001', 'numSubjects': '167'}]}], 'dropWithdraws': [{'type': 'Administrative', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Investigator decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '80'}, {'groupId': 'FG001', 'numSubjects': '60'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '82'}, {'groupId': 'FG001', 'numSubjects': '55'}]}, {'type': 'Serious Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Withdrawal of consent', 'reasons': [{'groupId': 'FG000', 'numSubjects': '46'}, {'groupId': 'FG001', 'numSubjects': '39'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '766', 'groupId': 'BG000'}, {'value': '531', 'groupId': 'BG001'}, {'value': '1297', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Type 1 Diabetes', 'description': 'Insulin using patients with Type 1 diabetes'}, {'id': 'BG001', 'title': 'Type 2 Diabetes', 'description': 'Insulin using patients with Type 2 diabetes'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '721', 'groupId': 'BG000'}, {'value': '406', 'groupId': 'BG001'}, {'value': '1127', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '37', 'groupId': 'BG000'}, {'value': '125', 'groupId': 'BG001'}, {'value': '162', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '43.2', 'spread': '13.22', 'groupId': 'BG000'}, {'value': '56.9', 'spread': '11.10', 'groupId': 'BG001'}, {'value': '48.8', 'spread': '14.10', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '500', 'groupId': 'BG000'}, {'value': '296', 'groupId': 'BG001'}, {'value': '796', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '266', 'groupId': 'BG000'}, {'value': '235', 'groupId': 'BG001'}, {'value': '501', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '766', 'groupId': 'BG000'}, {'value': '531', 'groupId': 'BG001'}, {'value': '1297', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Body Weight', 'classes': [{'categories': [{'measurements': [{'value': '87.21', 'spread': '19.843', 'groupId': 'BG000'}, {'value': '112.53', 'spread': '24.790', 'groupId': 'BG001'}, {'value': '97.57', 'spread': '25.273', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Duration of Diabetes', 'classes': [{'categories': [{'measurements': [{'value': '20.66', 'spread': '11.709', 'groupId': 'BG000'}, {'value': '14.76', 'spread': '8.355', 'groupId': 'BG001'}, {'value': '18.24', 'spread': '10.857', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'HbA1c', 'classes': [{'categories': [{'measurements': [{'value': '7.86', 'spread': '1.082', 'groupId': 'BG000'}, {'value': '8.23', 'spread': '1.538', 'groupId': 'BG001'}, {'value': '8.01', 'spread': '1.301', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': '%', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1297}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-02', 'completionDateStruct': {'date': '2008-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-03-05', 'studyFirstSubmitDate': '2005-09-28', 'resultsFirstSubmitDate': '2009-05-05', 'studyFirstSubmitQcDate': '2005-09-28', 'lastUpdatePostDateStruct': {'date': '2015-03-25', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2009-05-05', 'studyFirstPostDateStruct': {'date': '2005-09-30', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2009-06-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of Patient-Ascertained Severe Hypoglycemia (PASH) During the Adjustment Period', 'timeFrame': '0-3 months', 'description': 'PASH is defined as episodes of hypoglycemia requiring the assistance of another individual (including aid in ingestion of oral carbohydrate); and/or requiring the administration of glucagon injection, intravenous glucose, or other medical intervention. The adjustment period represents the initial 0-3 months of pramlintide treatment'}, {'measure': 'Annual Event Rate of Patient-Ascertained Severe Hypoglycemia (PASH) During the Adjustment Period', 'timeFrame': '0-3 months', 'description': 'The annual event rate was calculated as the total number of events during the time period divided by the total years of exposure to pramlintide for all patients during the time period. The adjustment period represents the initial 0-3 months of pramlintide treatment.\n\nPASH is defined as episodes of hypoglycemia requiring the assistance of another individual (including aid in ingestion of oral carbohydrate); and/or requiring the administration of glucagon injection, intravenous glucose, or other medical intervention.'}], 'secondaryOutcomes': [{'measure': 'The Incidence of Patient-Ascertained Severe Hypoglycemia (PASH) During the Steady State Period', 'timeFrame': '>3-6 months', 'description': 'The steady state period represents the \\>3-6 months of pramlintide treatment following the adjustment period.\n\nPASH is defined as episodes of hypoglycemia requiring the assistance of another individual (including aid in ingestion of oral carbohydrate); and/or requiring the administration of glucagon injection, intravenous glucose, or other medical intervention.'}, {'measure': 'The Annual Event Rate of Patient-Ascertained Severe Hypoglycemia (PASH) During the Steady State Period', 'timeFrame': '>3-6 months', 'description': 'The annual event rate was calculated as the total number of events during the time period divided by the total years of exposure to pramlintide for all patients during the time period. The steady state period represents the \\>3-6 months of pramlintide treatment following the adjustment period.\n\nPASH is defined as episodes of hypoglycemia requiring the assistance of another individual (including aid in ingestion of oral carbohydrate); and/or requiring the administration of glucagon injection, intravenous glucose, or other medical intervention.'}, {'measure': 'Incidence of Medically Assisted Severe Hypoglycemia (MASH) During the Adjustment Period', 'timeFrame': '0-3 months', 'description': 'MASH is defined as episodes of severe hypoglycemia requiring IM glucagon, IV glucose, hospitalization, paramedic assistance, emergency room visit, and/or is assessed as a serious adverse event (SAE) by the investigator. MASH is a subset of PASH. The adjustment period represents the initial 0-3 months of pramlintide treatment'}, {'measure': 'The Annual Event Rate of Medically Assisted Severe Hypoglycemia (MASH) During the Adjustment Period', 'timeFrame': '0-3 months', 'description': 'The annual event rate was calculated as the total number of events during the time period divided by the total years of exposure to pramlintide for all patients during the time period. The adjustment period represents the initial 0-3 months of pramlintide treatment.\n\nMASH is defined as episodes of severe hypoglycemia requiring IM glucagon, IV glucose, hospitalization, paramedic assistance, emergency room visit, and/or is assessed as a serious adverse event (SAE) by the investigator. MASH is a subset of PASH.'}, {'measure': 'Incidence of Medically Assisted Severe Hypoglycemia (MASH) During the Steady State Period', 'timeFrame': '>3-6 months', 'description': 'The steady state period represents the \\>3-6 months of pramlintide treatment following the adjustment period.\n\nMASH is defined as episodes of severe hypoglycemia requiring IM glucagon, IV glucose, hospitalization, paramedic assistance, emergency room visit, and/or is assessed as a serious adverse event (SAE) by the investigator. MASH is a subset of PASH.'}, {'measure': 'Annual Event Rate of Medically Assisted Severe Hypoglycemia (MASH) During the Steady State Period', 'timeFrame': '>3-6 months', 'description': 'The annual event rate was calculated as the total number of events during the time period divided by the total years of exposure to pramlintide for all patients during the time period. The steady state period represents the \\>3-6 months of pramlintide treatment following the adjustment period.\n\nMASH is defined as episodes of severe hypoglycemia requiring IM glucagon, IV glucose, hospitalization, paramedic assistance, emergency room visit, and/or is assessed as a serious adverse event (SAE) by the investigator. MASH is a subset of PASH.'}, {'measure': 'Change in HbA1c From Baseline at Month 3', 'timeFrame': '3 months', 'description': 'Change in HbA1c from baseline at month 3. The HbA1c test measures the percent of glycosylated hemoglobin in the blood.'}, {'measure': 'Change in HbA1c From Baseline at Month 6', 'timeFrame': '6 months', 'description': 'Change in HbA1c from baseline at month 6. The HbA1c test measures the percent of glycosylated hemoglobin in the blood.'}, {'measure': 'Change in Body Weight From Baseline at Month 3', 'timeFrame': '3 months', 'description': 'Mean change in body weight from baseline at month 3'}, {'measure': 'Change in Body Weight From Baseline at Month 6', 'timeFrame': '6 months', 'description': 'Mean change in body weight from baseline at month 6'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['diabetes', 'pramlintide', 'Symlin', 'Amylin', 'phase 4'], 'conditions': ['Type 1 Diabetes Mellitus', 'Type 2 Diabetes Mellitus']}, 'referencesModule': {'references': [{'pmid': '20518811', 'type': 'DERIVED', 'citation': 'Pencek R, Roddy T, Peters Y, De Young MB, Herrmann K, Meller L, Nguyen H, Chen S, Lutz K. Safety of pramlintide added to mealtime insulin in patients with type 1 or type 2 diabetes: a large observational study. Diabetes Obes Metab. 2010 Jun;12(6):548-51. doi: 10.1111/j.1463-1326.2010.01201.x.'}]}, 'descriptionModule': {'briefSummary': 'This is an open label, observational study designed to collect data that characterize the use of SYMLIN following the introduction of the medication into the marketplace. Health care providers and subjects selected for study participation are intended to be representative of those providers prescribing, and subjects receiving, SYMLIN therapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'cross-section of clinical practice settings', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The following inclusion criteria are consistent with information in the SYMLIN package insert and apply to insulin using patients with type 2 or type 1 diabetes who:\n\n * Have failed to achieve the desired or optimal level of glycemic control despite utilizing appropriate, individualized insulin regimens\n * Have A1C \\<=9.0% within 3 months of study enrollment\n * Are receiving ongoing diabetes care under the guidance of a Health Care Provider (HCP) trained in the use of SYMLIN\n\nExclusion Criteria:\n\n* The following exclusion criteria are consistent with the SYMLIN package insert and specifically exclude patients who:\n\n * Are poorly compliant with their current insulin regimen, as defined by their HCP\n * Are poorly compliant with prescribed blood glucose self monitoring, as defined by their HCP\n * Have experienced recurrent patient-ascertained severe hypoglycemia requiring assistance during the past 6 months\n * Have hypoglycemia unawareness\n * Have a confirmed diagnosis of gastroparesis\n * Require the use of drugs that stimulate gastrointestinal motility\n * Are female and pregnant or lactating and for whom the HCP determines the potential benefit does not justify the potential risk to the fetus or infant\n * Have been treated with SYMLIN within 3 months prior to study start'}, 'identificationModule': {'nctId': 'NCT00229658', 'briefTitle': 'An Observational Study Evaluating SYMLIN® (Pramlintide Acetate) Injection Use in Insulin Using Patients With Type 2 and Type 1 Diabetes', 'organization': 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