An Observational Study Evaluating SYMLIN® (Pramlintide Acetate) Injection Use in Insulin Using Patients With Type 2 and Type 1 Diabetes

Study Overview
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Brief Summary
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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.

Official Title
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A Prospective, Open-Label, Observational Study Evaluating SYMLIN® (Pramlintide Acetate) Injection Use in Insulin Using Patients With Type 2 and Type 1 Diabetes Following SYMLIN Introduction Into the Marketplace

Conditions
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Type 1 Diabetes Mellitus, Type 2 Diabetes Mellitus

Intervention / Treatment
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* Drug: pramlintide acetate


Participation Criteria
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Eligibility Criteria
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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: Have failed to achieve the desired or optimal level of glycemic control despite utilizing appropriate, individualized insulin regimens Have A1C <=9.0% within 3 months of study enrollment Are receiving ongoing diabetes care under the guidance of a Health Care Provider (HCP) trained in the use of SYMLIN Exclusion Criteria: The following exclusion criteria are consistent with the SYMLIN package insert and specifically exclude patients who: Are poorly compliant with their current insulin regimen, as defined by their HCP Are poorly compliant with prescribed blood glucose self monitoring, as defined by their HCP Have experienced recurrent patient-ascertained severe hypoglycemia requiring assistance during the past 6 months Have hypoglycemia unawareness Have a confirmed diagnosis of gastroparesis Require the use of drugs that stimulate gastrointestinal motility 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 Have been treated with SYMLIN within 3 months prior to study start

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Type 1<br>Patients with type 1 diabetes | Drug: pramlintide acetate<br>* Subcutaneous injection prior to each major meal<br>* Other names: Symlin;|
| Type 2<br>Patients with type 2 diabetes | Drug: pramlintide acetate<br>* Subcutaneous injection prior to each major meal<br>* Other names: Symlin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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. | >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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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diabetes, pramlintide, Symlin, Amylin, phase 4