Vildagliptin dose-dependently improves glycemic control in Japanese patients with type 2 diabetes mellitus.
OBJECTIVE
To assess the efficacy and tolerability of vildagliptin (10, 25 or 50mg bid) in Japanese patients with type 2 diabetes mellitus (T2DM).


METHODS
This 12-week, multicenter, randomized, double-blind, placebo-controlled, parallel-group study was performed in 291 patients. The primary assessment was change from baseline to endpoint in HbA1c.


RESULTS
Baseline HbA1c averaged 7.4%, and the between-treatment difference (vildagliptin-placebo) in the HbA1c adjusted mean change was -0.8%, -1.0% and -1.2% with vildagliptin 10, 25 and 50mg bid, respectively (p<0.001). Relative to baseline, body weight did not change significantly in vildagliptin groups. There was no increase in incidence of adverse events in the vildagliptin groups (62.0%, 62.5% and 61.8%, 10, 25 and 50mg bid, respectively) compared to placebo (73.6%). No deaths or drug-related serious adverse events were reported. Seven hypoglycemic events were observed (four events (n=3), two events (n=2), and one event (n=1) in the vildagliptin 10 and 50mg bid, and placebo, respectively) and none of them were severe or dose related.


CONCLUSIONS
Vildagliptin 50mg bid was considered to be the most effective and well-tolerated dose, and therefore can be considered the recommended clinical dose for Japanese patients with T2DM.
Kikuchi
Masatoshi
M
Internal Medicine, The Institute for Adult Diseases, Asahi Life Foundation, Tokyo, Japan. m-kikuchi@asahi-life.or.jp
Abe
Nobuyuki
N
Kato
Mitsutoshi
M
Terao
Shinji
S
Mimori
Nobuyuki
N
Tachibana
Hideo
H
D000218:Adamantane / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D000328:Adult; D000368:Aged; D001786:Blood Glucose / Q000187:drug effects* / Q000378:metabolism; D003924:Diabetes Mellitus, Type 2 / Q000097:blood / Q000188:drug therapy* / Q000378:metabolism; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005260:Female; D006442:Glycated Hemoglobin / Q000032:analysis / Q000187:drug effects; D006801:Humans; D007004:Hypoglycemic Agents / Q000008:administration & dosage / Q000009:adverse effects; D007564:Japan; D008297:Male; D008875:Middle Aged; D009570:Nitriles / Q000008:administration & dosage* / Q000009:adverse effects; D010919:Placebos; D011759:Pyrrolidines / Q000008:administration & dosage* / Q000009:adverse effects; D016896:Treatment Outcome; D000077597:Vildagliptin; D055815:Young Adult
D000218:Adamantane; D001786:Blood Glucose; D006442:Glycated Hemoglobin; D007004:Hypoglycemic Agents; D009570:Nitriles; D010919:Placebos; D011759:Pyrrolidines; D000077597:Vildagliptin; C517652:hemoglobin A1c protein, human