At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 4, Randomized, Open Label, Parallel Group, Multicenter Study to Characterize Regimens of Basal Insulin Intensified With Either Symlin® or Rapid Acting Insulin in Patients With Type 2 Diabetes
In Brief
A Phase 4 clinical trial evaluating pramlintide acetate (Symlin), rapid acting insulin (Humalog® [insulin lispro], Novolog® [insulin aspart], or Apidra® [insulin glulisine]), and 1 other intervention for Type 2 Diabetes Mellitus. Completed, enrolled 112 participants across 37 sites.
Detailed Summary
This will be a randomized, open label, parallel group, multicenter study. There will be two phases in the study. Phase 1 (Baseline to Week 24) will compare the efficacy and safety of regimens of basal insulin intensified with either Symlin or rapid acting insulin in patients with type 2 diabetes who have either been on a prior regimen of insulin for less than 6 months and were taking less than 50 U total of insulin per day OR are candidates for the initiation of insulin therapy. The purpose of Phase 2 (Week 24 to Week 36) is to explore further intensification of diabetes regimens in patients failing to achieve HbA1c \<=6.5% at Week 24.
Study Details
Timeline
Interventions
subcutaneous injection (60 mcg or 120 mcg), immediately prior to major meals
subcutaneous injection, dosing based on titration guidelines
subcutaneous injection, dosing based on titration guidelines