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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Type 1 | Patients with type 1 diabetes |
| |
| Type 2 | Patients with type 2 diabetes |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| pramlintide acetate | Drug | Subcutaneous injection prior to each major meal |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Patient-Ascertained Severe Hypoglycemia (PASH) During the Adjustment Period | 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 | 0-3 months |
| Annual Event Rate of Patient-Ascertained Severe Hypoglycemia (PASH) During the Adjustment Period | 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. 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. | 0-3 months |
| Measure | Description | Time Frame |
|---|---|---|
| The Incidence of Patient-Ascertained Severe Hypoglycemia (PASH) During the Steady State Period | The steady state period represents the >3-6 months of pramlintide treatment following the adjustment period. 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. |
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Inclusion Criteria:
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:
Exclusion Criteria:
The following exclusion criteria are consistent with the SYMLIN package insert and specifically exclude patients who:
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cross-section of clinical practice settings
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| Name | Affiliation | Role |
|---|---|---|
| Vice President, Medical Development, MD | Amylin Pharmaceuticals, LLC. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Birmingham | Alabama | United States | |||
| Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20518811 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Type 1 Diabetes | Insulin using patients with Type 1 diabetes |
| FG001 | Type 2 Diabetes | Insulin using patients with Type 2 diabetes |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| >3-6 months |
| The Annual Event Rate of Patient-Ascertained Severe Hypoglycemia (PASH) During the Steady State Period | 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. 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. | >3-6 months |
| Incidence of Medically Assisted Severe Hypoglycemia (MASH) During the Adjustment Period | 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 | 0-3 months |
| The Annual Event Rate of Medically Assisted Severe Hypoglycemia (MASH) During the Adjustment Period | 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. 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. | 0-3 months |
| Incidence of Medically Assisted Severe Hypoglycemia (MASH) During the Steady State Period | The steady state period represents the >3-6 months of pramlintide treatment following the adjustment period. 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. | >3-6 months |
| Annual Event Rate of Medically Assisted Severe Hypoglycemia (MASH) During the Steady State Period | 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. 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. | >3-6 months |
| Change in HbA1c From Baseline at Month 3 | Change in HbA1c from baseline at month 3. The HbA1c test measures the percent of glycosylated hemoglobin in the blood. | 3 months |
| Change in HbA1c From Baseline at Month 6 | Change in HbA1c from baseline at month 6. The HbA1c test measures the percent of glycosylated hemoglobin in the blood. | 6 months |
| Change in Body Weight From Baseline at Month 3 | Mean change in body weight from baseline at month 3 | 3 months |
| Change in Body Weight From Baseline at Month 6 | Mean change in body weight from baseline at month 6 | 6 months |
| Montgomery |
| Alabama |
| United States |
| Research Site | Tucson | Arizona | United States |
| Research Site | Anaheim | California | United States |
| Research Site | Encinitas | California | United States |
| Research Site | Escondido | California | United States |
| Research Site | Fresno | California | United States |
| Research Site | Lafayette | California | United States |
| Research Site | Moreno Valley | California | United States |
| Research Site | Sacramento | California | United States |
| Research Site | Salinas | California | United States |
| Research Site | Santa Barbara | California | United States |
| Research Site | Torrance | California | United States |
| Research Site | Vacaville | California | United States |
| Research Site | Arvada | Colorado | United States |
| Research Site | Aurora | Colorado | United States |
| Research Site | Norwalk | Connecticut | United States |
| Research Site | Wilmington | Delaware | United States |
| Research Site | Hialeah | Florida | United States |
| Research Site | Jacksonville | Florida | United States |
| Research Site | Maitland | Florida | United States |
| Research Site | Melbourne | Florida | United States |
| Research Site | Miami | Florida | United States |
| Research Site | Plantation | Florida | United States |
| Research Site | Tallahassee | Florida | United States |
| Research Site | Winter Haven | Florida | United States |
| Research Site | Canton | Georgia | United States |
| Research Site | Columbus | Georgia | United States |
| Research Site | Roswell | Georgia | United States |
| Research Site | Valdosta | Georgia | United States |
| Research Site | ‘Aiea | Hawaii | United States |
| Research Site | Caldwell | Idaho | United States |
| Research Site | Idaho Falls | Idaho | United States |
| Research Site | Pocatello | Idaho | United States |
| Research Site | Evergreen Park | Illinois | United States |
| Research Site | Wheaton | Illinois | United States |
| Research Site | Fort Wayne | Indiana | United States |
| Research Site | Franklin | Indiana | United States |
| Research Site | Indianapolis | Indiana | United States |
| Research Site | Des Moines | Iowa | United States |
| Research Site | Shawnee Mission | Kansas | United States |
| Research Site | Wichita | Kansas | United States |
| Research Site | Louisville | Kentucky | United States |
| Research Site | Baton Rouge | Louisiana | United States |
| Research Site | Lafayette | Louisiana | United States |
| Research Site | Laplace | Louisiana | United States |
| Research Site | Glen Burnie | Maryland | United States |
| Research Site | Towson | Maryland | United States |
| Research Site | Ann Arbor | Michigan | United States |
| Research Site | Bloomfield | Michigan | United States |
| Research Site | Detroit | Michigan | United States |
| Research Site | Grand Rapids | Michigan | United States |
| Research Site | Duluth | Minnesota | United States |
| Research Site | Eagan | Minnesota | United States |
| Research Site | Butte | Montana | United States |
| Research Site | Las Vegas | Nevada | United States |
| Research Site | Reno | Nevada | United States |
| Research Site | Hamilton | New Jersey | United States |
| Research Site | Jersey City | New Jersey | United States |
| Research Site | Livingston | New Jersey | United States |
| Research Site | Moorestown | New Jersey | United States |
| Research Site | Neptune City | New Jersey | United States |
| Research Site | North Plainfield | New Jersey | United States |
| Research Site | Albany | New York | United States |
| Research Site | Binghamton | New York | United States |
| Research Site | Forest Hills | New York | United States |
| Research Site | Lawrence | New York | United States |
| Research Site | New York | New York | United States |
| Research Site | Riverhead | New York | United States |
| Research Site | Rochester | New York | United States |
| Research Site | Staten Island | New York | United States |
| Research Site | Utica | New York | United States |
| Research Site | Greensboro | North Carolina | United States |
| Research Site | Morehead City | North Carolina | United States |
| Research Site | Raleigh | North Carolina | United States |
| Research Site | Cincinnati | Ohio | United States |
| Research Site | Columbus | Ohio | United States |
| Research Site | Mentor | Ohio | United States |
| Research Site | Toledo | Ohio | United States |
| Research Site | Portland | Oregon | United States |
| Research Site | Salem | Oregon | United States |
| Research Site | Bridgeville | Pennsylvania | United States |
| Research Site | Carlisle | Pennsylvania | United States |
| Research Site | Erie | Pennsylvania | United States |
| Research Site | Sewickley | Pennsylvania | United States |
| Research Site | Columbia | South Carolina | United States |
| Research Site | Orangeburg | South Carolina | United States |
| Research Site | Sumter | South Carolina | United States |
| Research Site | Chattanooga | Tennessee | United States |
| Research Site | Hendersonville | Tennessee | United States |
| Research Site | Hixon | Tennessee | United States |
| Research Site | Memphis | Tennessee | United States |
| Research Site | Nashville | Tennessee | United States |
| Research Site | Austin | Texas | United States |
| Research Site | Beaumont | Texas | United States |
| Research Site | Houston | Texas | United States |
| Research Site | San Antonio | Texas | United States |
| Research Site | Provo | Utah | United States |
| Research Site | Salt Lake City | Utah | United States |
| Research Site | McLean | Virginia | United States |
| Research Site | Norton | Virginia | United States |
| Research Site | Puyallup | Washington | United States |
| Research Site | Seattle | Washington | United States |
| Research Site | Spokane | Washington | United States |
| Research Site | Tacoma | Washington | United States |
| Research Site | Walla Walla | Washington | United States |
| Research Site | Milwaukee | Wisconsin | United States |
| COMPLETED |
|
| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Type 1 Diabetes | Insulin using patients with Type 1 diabetes |
| BG001 | Type 2 Diabetes | Insulin using patients with Type 2 diabetes |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Body Weight | Mean | Standard Deviation | kg |
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| Duration of Diabetes | Mean | Standard Deviation | years |
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| HbA1c | Mean | Standard Deviation | % |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Incidence of Patient-Ascertained Severe Hypoglycemia (PASH) During the Adjustment Period | 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 | Intent-to-Treat | Posted | Number | Incidence (%) | 0-3 months |
|
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| |||||||||||||||||||||||||||||
| Primary | Annual Event Rate of Patient-Ascertained Severe Hypoglycemia (PASH) During the Adjustment Period | 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. 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. | Intent-to-Treat | Posted | Number | Events per patient year | 0-3 months |
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| Secondary | The Incidence of Patient-Ascertained Severe Hypoglycemia (PASH) During the Steady State Period | The steady state period represents the >3-6 months of pramlintide treatment following the adjustment period. 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. | Intent-to-Treat, number analyzed includes patients still enrolled in the study during the steady-state period (3-6 months) | Posted | Number | Incidence (%) | >3-6 months |
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| Secondary | The Annual Event Rate of Patient-Ascertained Severe Hypoglycemia (PASH) During the Steady State Period | 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. 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. | Intent-to-Treat, number analyzed includes patients still enrolled in the study during the steady-state period (3-6 months) | Posted | Number | Events per patient year | >3-6 months |
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| Secondary | Incidence of Medically Assisted Severe Hypoglycemia (MASH) During the Adjustment Period | 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 | Intent-to-Treat. | Posted | Number | Incidence (%) | 0-3 months |
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| Secondary | The Annual Event Rate of Medically Assisted Severe Hypoglycemia (MASH) During the Adjustment Period | 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. 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. | Intent-to-Treat | Posted | Number | Events per patient year | 0-3 months |
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| Secondary | Incidence of Medically Assisted Severe Hypoglycemia (MASH) During the Steady State Period | The steady state period represents the >3-6 months of pramlintide treatment following the adjustment period. 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. | Intent-to-Treat, number analyzed includes patients still enrolled in the study during the steady-state period (3-6 months) | Posted | Number | Incidence (%) | >3-6 months |
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| Secondary | Annual Event Rate of Medically Assisted Severe Hypoglycemia (MASH) During the Steady State Period | 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. 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. | Intent-to-Treat, number analyzed includes patients still enrolled in the study during the steady-state period (3-6 months) | Posted | Number | Events per patient year | >3-6 months |
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| Secondary | Change in HbA1c From Baseline at Month 3 | Change in HbA1c from baseline at month 3. The HbA1c test measures the percent of glycosylated hemoglobin in the blood. | Intent-to-Treat, patients who discontinue SYMLIN 7 or more days prior to a site visit are not included in the analyses | Posted | Mean | Standard Error | percent | 3 months |
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| Secondary | Change in HbA1c From Baseline at Month 6 | Change in HbA1c from baseline at month 6. The HbA1c test measures the percent of glycosylated hemoglobin in the blood. | Intent-to-Treat, patients who discontinue SYMLIN 7 or more days prior to a site visit are not included in the analyses | Posted | Mean | Standard Error | percent | 6 months |
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| Secondary | Change in Body Weight From Baseline at Month 3 | Mean change in body weight from baseline at month 3 | Intent-to-Treat, patients who discontinue SYMLIN 7 or more days prior to a site visit are not included in the analyses | Posted | Mean | Standard Error | kg | 3 months |
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| Secondary | Change in Body Weight From Baseline at Month 6 | Mean change in body weight from baseline at month 6 | Intent-to-Treat, patients who discontinue SYMLIN 7 or more days prior to a site visit are not included in the analyses | Posted | Mean | Standard Error | kg | 6 months |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Type 1 Diabetes | Insulin using patients with Type 1 diabetes | 14 | 0 | 766 | |||
| EG001 | Type 2 Diabetes | Insulin using patients with Type 2 diabetes | 13 | 0 | 531 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Angina pectoris | Cardiac disorders | MedDRA 10.1 | Non-systematic Assessment |
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| Angina unstable | Cardiac disorders | MedDRA 10.1 | Non-systematic Assessment |
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| Atrioventricular block complete | Cardiac disorders | MedDRA 10.1 | Non-systematic Assessment |
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| Cardiac failure congestive | Cardiac disorders | MedDRA 10.1 | Non-systematic Assessment |
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| Coronary artery disease | Cardiac disorders | MedDRA 10.1 | Non-systematic Assessment |
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| Myocardial infarction | Cardiac disorders | MedDRA 10.1 | Non-systematic Assessment |
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| Pancreatitis | Gastrointestinal disorders | MedDRA 10.1 | Non-systematic Assessment |
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| Chest pain | General disorders | MedDRA 10.1 | Non-systematic Assessment |
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| Hernia obstructive | General disorders | MedDRA 10.1 | Non-systematic Assessment |
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| Cholecystitis acute | Hepatobiliary disorders | MedDRA 10.1 | Non-systematic Assessment |
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| Appendicitis | Infections and infestations | MedDRA 10.1 | Non-systematic Assessment |
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| Cellulitis | Infections and infestations | MedDRA 10.1 | Non-systematic Assessment |
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| Diverticulitis | Infections and infestations | MedDRA 10.1 | Non-systematic Assessment |
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| Osteomyelitis | Infections and infestations | MedDRA 10.1 | Non-systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA 10.1 | Non-systematic Assessment |
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| Sepsis | Infections and infestations | MedDRA 10.1 | Non-systematic Assessment |
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| Urosepsis | Infections and infestations | MedDRA 10.1 | Non-systematic Assessment |
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| Diabetic ketoacidosis | Metabolism and nutrition disorders | MedDRA 10.1 | Non-systematic Assessment |
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| Rheumatoid arthritis | Musculoskeletal and connective tissue disorders | MedDRA 10.1 | Non-systematic Assessment |
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| Chronic lymphocytic leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.1 | Non-systematic Assessment |
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| Ovarian granulosa-theca cell tumour | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.1 | Non-systematic Assessment |
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| Presyncope | Nervous system disorders | MedDRA 10.1 | Non-systematic Assessment |
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| Syncope | Nervous system disorders | MedDRA 10.1 | Non-systematic Assessment |
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| Ureteric stenosis | Renal and urinary disorders | MedDRA 10.1 | Non-systematic Assessment |
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| Ovarian cyst | Reproductive system and breast disorders | MedDRA 10.1 | Non-systematic Assessment |
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| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 10.1 | Non-systematic Assessment |
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| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 10.1 | Non-systematic Assessment |
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| Skin ulcer | Skin and subcutaneous tissue disorders | MedDRA 10.1 | Non-systematic Assessment |
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| Deep vein thrombosis | Vascular disorders | MedDRA 10.1 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Bristol-Myers Squibb Study Director | Bristol-Myers Squibb | Clinical.Trials@bms.com |
| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| D003924 | Diabetes Mellitus, Type 2 |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C105254 | pramlintide |
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| >=65 years |
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| Male |
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