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

AstraZeneca1,297 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

1,297

Conditions

Type 1 Diabetes Mellitus Type 2 Diabetes Mellitus

Interventions

pramlintide acetateDRUG

Subcutaneous injection prior to each major meal

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (107)

Outcomes

Primary Outcomes

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

Time frame: 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.

Time frame: 0-3 months

Secondary Outcomes

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.

Time frame: >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.

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

Research Site

Birmingham, Alabama, United States

Research Site

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

...and 97 more locations

Time frame: >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

Time frame: 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.

Time frame: 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.

Time frame: >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.

Time frame: >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.

Time frame: 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.

Time frame: 6 months

Change in Body Weight From Baseline at Month 3

Mean change in body weight from baseline at month 3

Time frame: 3 months

Change in Body Weight From Baseline at Month 6

Mean change in body weight from baseline at month 6

Time frame: 6 months