CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 1,297 enrolled
Drug / intervention
pramlintide acetatedrug
Likely dose
Pramlintide acetate subcutaneous injection prior to each major mealAI-extracted
Key inclusion· 4
  • ✓Type 1 or type 2 diabetes on insulin therapy
  • ✓Failed to achieve desired glycemic control despite appropriate, individualized insulin regimens
  • ✓A1C ≤9.0% within 3 months of study enrollment
  • ✓Receiving ongoing diabetes care under guidance of a Health Care Provider trained in SYMLIN use
Key exclusion· 7
  • ✕Poor compliance with current insulin regimen as defined by HCP
  • ✕Poor compliance with prescribed blood glucose self-monitoring as defined by HCP
  • ✕Recurrent patient-ascertained severe hypoglycemia requiring assistance during the past 6 months
  • ✕Hypoglycemia unawareness

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00229658
NCT00229658N/ACompleted
CompareCT.gov

A Prospective, Open-Label, Observational Study Evaluating SYMLIN® (Pramlintide Acetate) Injection Use in Insulin Using Patients With Type 2 and Type 1 Diabetes Following SYMLIN Introduction Into the Marketplace

AstraZeneca·observational·Posted Sep 30, 2005·Updated Mar 25, 2015

In Brief

An observational study evaluating pramlintide acetate for Type 1 Diabetes Mellitus and Type 2 Diabetes Mellitus. Completed, enrolled 1,297 participants across 107 sites.

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsType 1 Diabetes Mellitus, Type 2 Diabetes Mellitus
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 30, 2005
Enrollment StartSep 1, 2005
Primary CompletionMay 1, 2008
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 20.8 years ago

Interventions

pramlintide acetatedrug

Subcutaneous injection prior to each major meal