Safety of exenatide once weekly for 52 weeks in Japanese patients with type 2 diabetes mellitus.
OBJECTIVE
An initial 26-week, randomized, open-label study compared the efficacy and safety of exenatide 10 mcg twice daily with exenatide 2 mg once weekly in Asian patients with type 2 diabetes who experienced inadequate glycemic control with oral antidiabetes medications. The aim of this study was to evaluate the safety of exenatide once weekly in Japanese patients, a subset of the initial patient population, who continued into this extension study for an additional 26 weeks of therapy on exenatide once weekly, followed by 10 weeks without exenatide once weekly.


METHODS
Japanese patients initially assigned to exenatide twice daily (n = 62) switched to exenatide once weekly for the extended 26 weeks, and patients initially assigned to exenatide once weekly (n = 74) continued on this regimen for the remainder of the study (total treatment of 52 weeks).


RESULTS
A total of 68% of patients reported one or more treatment-emergent adverse events during the extension period; the most common of these were nasopharyngitis (14%) and vomiting (6%). No major hypoglycemic episodes were reported. Improvements in glycated hemoglobin, fasting plasma glucose and postprandial glucose were maintained over 52 weeks of treatment. At week 52, bodyweight remained reduced from baseline.


CONCLUSIONS
Exenatide once weekly added to oral antidiabetes medication was well tolerated in Japanese patients with type 2 diabetes, and was associated with glycemic control and weight loss through to 52 weeks, supporting the use of exenatide once weekly as an adjunctive treatment for type 2 diabetes in this patient population. The initial 26-week portion of this trial was registered with ClinicalTrials.gov (no. NCT00917267).
The Institute for Adult Diseases Asahi Life Foundation Tokyo Japan.
Yukiko
Y
Onishi
Center for Diabetes and Endocrinology Medical Research Institute Kitano Hospital Osaka Japan.
Hiroyuki
H
Koshiyama
Diabetes Products Eli Lilly Japan Kobe.
Takeshi
T
Imaoka
PharmaNet/i3, an inVentiv Health Company Ann Arbor MI USA.
Harry
H
Haber
PharmaNet/i3, an inVentiv Health Company Indianapolis IN USA.
Jamie
J
Scism-Bacon
Lilly Diabetes Eli Lilly and Company Indianapolis IN USA.
Marilyn K
MK
Boardman
Blood glucose; Exenatide; Japanese