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

AstraZeneca

Status: Completed

Conditions: Type 1 Diabetes Mellitus; Type 2 Diabetes Mellitus

Treatments: Drug: pramlintide acetate

Study type: Observational

Funder types: Industry

Identifiers

NCT00229658

137-161

Details and patient eligibility

About

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.

Enrollment: 1,297 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

1,297 participants in 2 patient groups

Type 1

Description:

Patients with type 1 diabetes

Treatment:

Drug: pramlintide acetate

Type 2

Description:

Patients with type 2 diabetes

Treatment:

Drug: pramlintide acetate