Conditions: Type 2 Diabetes
Keywords: diabetes insulin byetta glucose blood sugar metformin A1c
Allocation: RANDOMIZED | Intervention model: SINGLE_GROUP
Enrollment: 41
Healthy volunteers: yes

Brief summary:
This study is designed to look at how using glargine insulin with oral diabetes medications and exenatide may improve control of blood sugar levels and weight gain in type 2 diabetics.

The main study will last 32 weeks. However, all participants completing 32 weeks will be invited to continue for another 24 weeks taking the insulin and oral medication and exenatide treatment. This extension comparing insulin and oral medication with insulin and oral medication and exenatide will look at the long term weight loss/gain and blood sugar level control effects of this new drug regimen.

There is also a sub-study in the Clinical Research Center (CRC), which requires two 38-hour inpatient stays during the main study. This study offers the opportunity to study 24-hour blood sugar and metabolic patterns quantitatively.

Detailed description:

Arms:
arm 1: Participants will receive exenatide as part of their diabetes treatment arm 2: Participants will receive placebo rather than exenatide as part of their diabetes treatment

Interventions: intervention 1: exenatide intervention 2: placebo
Intervention descriptions: intervention 1: 5mcg twice a day, increasing to 10mcg twice a day for 24 weeks intervention 2: 5mcg twice a day, increased to 10mcg twice a day for 24 weeks

Protocol document: