Conditions: Type 2 Diabetes Mellitus
Keywords: diabetes exenatide Byetta insulin lispro Humalog insulin glargine Lantus Amylin Lilly
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 1036
Healthy volunteers: no

Brief summary:
The study will compare two combination therapies: 1) Combined Basal Insulin Glargine (once a day), Exenatide (twice a day), and Metformin Therapy; or 2) Combined Basal Insulin Glargine (once a day), Bolus Insulin Lispro (three times a day), and Metformin Therapy, in subjects with Type 2 Diabetes Mellitus who have inadequate glycemic control.

Detailed description:

Arms:
arm 1: Basal Insulin/Glargine, Exenatide and Metformin Therapy (BET) arm 2: Basal Insulin/Glargine, Bolus Insulin Lispro and Metformin Therapy (BBT)

Interventions: intervention 1: exenatide intervention 2: insulin lispro intervention 3: Metformin intervention 4: Insulin/ Glargine
Intervention descriptions: intervention 1: subcutaneous injection, 5mcg (4 weeks) followed by 10mcg (26 weeks), twice a day intervention 2: titrated based on pre-meal glucose level; three times a day intervention 3: None intervention 4: None

Protocol document: