Status:
COMPLETED
An Observational Study Evaluating SYMLIN® (Pramlintide Acetate) Injection Use in Insulin Using Patients With Type 2 and Type 1 Diabetes
Lead Sponsor:
AstraZeneca
Conditions:
Type 1 Diabetes Mellitus
Type 2 Diabetes Mellitus
Eligibility:
All Genders
18+ years
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 sub...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2005
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 1 2008
Estimated Enrollment :
1297 Patients enrolled
Trial Details
Trial ID
NCT00229658
Start Date
September 1 2005
End Date
May 1 2008
Last Update
March 25 2015
Active Locations (107)
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1
Research Site
Birmingham, Alabama, United States
2
Research Site
Montgomery, Alabama, United States
3
Research Site
Tucson, Arizona, United States
4
Research Site
Anaheim, California, United States