Improved glycemic control and reduced bodyweight with exenatide: A double-blind, randomized, phase 3 study in Japanese patients with suboptimally controlled type 2 diabetes over 24 weeks.

ABSTRACT:

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Aims/Introduction:  To evaluate the efficacy and safety of the glucagon-like peptide-1 receptor agonist, exenatide, in Japanese patients with type 2 diabetes mellitus suboptimally controlled despite therapeutic doses of a sulfonylurea alone or combined with a biguanide or thiazolidinedione.

Materials and methods

  Patients were randomized to a placebo or exenatide, either 5 or 10 μg, given subcutaneously b.i.d. in addition to oral therapy. Patients randomized to 10 μg exenatide received 5 μg b.i.d. for the first 4 weeks, followed by 10 μg b.i.d. for the last 20 weeks.

Results

  A total of 179 patients received the study drug and composed the full analysis set (n = 35, placebo; n = 72, exenatide 5 μg; n = 72, exenatide 10 μg; 68% male; 58 ± 10 years; body ma

SUBMITTER: Kadowaki T 

PROVIDER: S-EPMC4014921 | biostudies-literature | 2011 Jun

REPOSITORIES: biostudies-literature