Conditions: Type 2 Diabetes Mellitus
Keywords: Symlin Amylin insulin Humalog Novolog Apidra
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 112
Healthy volunteers: no

Brief 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.

Detailed description:

Arms:
arm 1: None arm 2: None

Interventions: intervention 1: pramlintide acetate (Symlin) intervention 2: rapid acting insulin (Humalog® [insulin lispro], Novolog® [insulin aspart], or Apidra® [insulin glulisine]) intervention 3: basal insulin (Lantus® [insulin glargine], or Levemir® [insulin detemir])
Intervention descriptions: intervention 1: subcutaneous injection (60 mcg or 120 mcg), immediately prior to major meals intervention 2: subcutaneous injection, dosing based on titration guidelines intervention 3: subcutaneous injection, dosing based on titration guidelines

Protocol document: