Safety and Efficacy of Exenatide in Patients With Type 2 Diabetes Using Thiazolidinediones or Thiazolidinediones and Metformin

What this study is testing ClinicalTrials.gov NCT00099320 ↗

Description as written by the study sponsor.

This study is designed to compare the effects of twice-daily exenatide plus oral antidiabetic (OAD) agents and twice-daily placebo plus OAD with respect to glycemic control, as measured by hemoglobin A1c (HbA1c), in patients with type 2 diabetes who experience inadequate glycemic control with OAD alone.

Treatments tested

• exenatide also known as Byetta, AC2993, synthetic exendin-4 Drug

  After a 2-week placebo lead-in period (twice daily, given subcutaneously) in addition to their current therapy regimen, subjects will administer 20 mcg of exenatide (2 units \[5 μg\] ), twice daily by subcutaneous injection, for the first 4 weeks of therapy, and then 40 μL of study drug (4 units \[10 μg\] of exenatide) twice daily by subcutaneous injection, for the remaining 12 weeks of therapy.

• Placebo Drug

  After a 2-week placebo lead-in period (twice daily, given subcutaneously) in addition to their current therapy regimen, subjects will administer placebo (in equivalent amounts to exenatide) for 16 weeks of therapy.