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

Incidence of Patient-Ascertained Severe Hypoglycemia (PASH) During the Adjustment Period

Time frame · 0-3 months

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

Annual Event Rate of Patient-Ascertained Severe Hypoglycemia (PASH) During the Adjustment Period

Time frame · 0-3 months

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.

The Incidence of Patient-Ascertained Severe Hypoglycemia (PASH) During the Steady State Period

Time frame · >3-6 months

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.

The Annual Event Rate of Patient-Ascertained Severe Hypoglycemia (PASH) During the Steady State Period

Time frame · >3-6 months

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.

Incidence of Medically Assisted Severe Hypoglycemia (MASH) During the Adjustment Period

Time frame · 0-3 months

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

The Annual Event Rate of Medically Assisted Severe Hypoglycemia (MASH) During the Adjustment Period

Time frame · 0-3 months

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.

Incidence of Medically Assisted Severe Hypoglycemia (MASH) During the Steady State Period

Time frame · >3-6 months

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.

Annual Event Rate of Medically Assisted Severe Hypoglycemia (MASH) During the Steady State Period

Time frame · >3-6 months

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.

Change in HbA1c From Baseline at Month 3

Time frame · 3 months

Change in HbA1c from baseline at month 3. The HbA1c test measures the percent of glycosylated hemoglobin in the blood.

Change in HbA1c From Baseline at Month 6

Time frame · 6 months

Change in HbA1c from baseline at month 6. The HbA1c test measures the percent of glycosylated hemoglobin in the blood.

Change in Body Weight From Baseline at Month 3

Time frame · 3 months

Mean change in body weight from baseline at month 3

Change in Body Weight From Baseline at Month 6

Time frame · 6 months

Mean change in body weight from baseline at month 6