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

Completed

Conditions: Type 2 Diabetes Mellitus
Type 1 Diabetes Mellitus

Interventions: Drug: pramlintide acetate

Registration Number: NCT00229658

Lead Sponsor: AstraZeneca

Brief Summary: 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 1297

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

Study & Design

Study Type: OBSERVATIONAL

Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Type 1	pramlintide acetate	Patients with type 1 diabetes
Type 2	pramlintide acetate	Patients with type 2 diabetes

Primary Outcome Measures

Name	Time	Method
Annual Event Rate of Patient-Ascertained Severe Hypoglycemia (PASH) During the Adjustment Period	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.
Incidence of Patient-Ascertained Severe Hypoglycemia (PASH) During the Adjustment Period	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

Secondary Outcome Measures

Name	Time	Method
The Incidence of Patient-Ascertained Severe Hypoglycemia (PASH) During the Steady State Period	>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.
Incidence of Medically Assisted Severe Hypoglycemia (MASH) During the Adjustment Period	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
Incidence of Medically Assisted Severe Hypoglycemia (MASH) During the Steady State Period	>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.
The Annual Event Rate of Patient-Ascertained Severe Hypoglycemia (PASH) During the Steady State Period	>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.
The Annual Event Rate of Medically Assisted Severe Hypoglycemia (MASH) During the Adjustment Period	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.
Change in HbA1c From Baseline at Month 3	3 months	Change in HbA1c from baseline at month 3. The HbA1c test measures the percent of glycosylated hemoglobin in the blood.
Change in Body Weight From Baseline at Month 3	3 months	Mean change in body weight from baseline at month 3
Change in HbA1c From Baseline at Month 6	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 6	6 months	Mean change in body weight from baseline at month 6
Annual Event Rate of Medically Assisted Severe Hypoglycemia (MASH) During the Steady State Period	>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.