Study identifier:ACA401
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
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
Type 2 Diabetes Mellitus
Phase 4
No
pramlintide acetate (Symlin), rapid acting insulin (Humalog® [insulin lispro], Novolog® [insulin aspart], or Apidra® [insulin glulisine]), basal insulin (Lantus® [insulin glargine], or Levemir® [insulin detemir])
All
112
Interventional
18 Years - 75 Years
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Verified 01 Mar 2015 by AstraZeneca Pharmaceuticals
AstraZeneca Pharmaceuticals
-
No locations available
Arms | Assigned Interventions |
---|---|
Experimental: Group A | Drug: pramlintide acetate (Symlin) subcutaneous injection (60 mcg or 120 mcg), immediately prior to major meals Other Name: Symlin Drug: basal insulin (Lantus® [insulin glargine], or Levemir® [insulin detemir]) subcutaneous injection, dosing based on titration guidelines |
Active Comparator: Group B | Drug: rapid acting insulin (Humalog® [insulin lispro], Novolog® [insulin aspart], or Apidra® [insulin glulisine]) subcutaneous injection, dosing based on titration guidelines Drug: basal insulin (Lantus® [insulin glargine], or Levemir® [insulin detemir]) subcutaneous injection, dosing based on titration guidelines |