Efficacy of insulin glargine and glimepiride in controlling blood glucose of ethnic Japanese patients with type 2 diabetes mellitus.
BACKGROUND
To evaluate the efficacy and safety of glimepiride plus insulin glargine in ethnic Japanese patients with type 2 diabetes mellitus (T2DM).


METHODS
This 24-week, open-label, single-arm study was conducted in eight centers in Brazil. One hundred ethnic Japanese T2DM patients with inadequate glycemic control [HbA(1c): 8.0-11.0% and fasting plasma glucose (FPG)>or=140 mg/dL] on oral antidiabetic drugs (OADs) were enrolled. Patients were treated once daily with glimepiride 3mg (morning) and glargine (bedtime) with dose titration to achieve FPG 72-100mg/dL.


RESULTS
At Week 24, the mean dose of glargine was 37.6 IU/day. There were significant decreases (p<0.0001) compared with baseline, for mean HbA(1c) (1.5%), mean FPG (88.3mg/dL) (p<0.0001), mean PPG (112.0mg/dL), and mean fasting C-peptide (1.14 ng/mL). Peptide index (peak-basal/basal) in carbohydrate challenge test increased by 2.24 units. No severe adverse events, including severe hypoglycemia were reported.


CONCLUSIONS
Our study suggests that combined therapy of insulin glargine and glimepiride should be considered for T2DM patients who have unsatisfactory response to previous OAD treatment.
Kawamori
Ryuzo
R
Division of Metabolism and Endocrinology, Department of Internal Medicine, Juntendo University, 2-1-1 Hongo, Bunkyo-ku, Tokyo, Japan. kawamori@med.juntendo.ac.jp
Eliaschewitz
Freddy G
FG
Takayama
Hideichi
H
Hayashida
Cesar Y
CY
D001786:Blood Glucose / Q000187:drug effects / Q000378:metabolism*; D002096:C-Peptide / Q000097:blood; D003924:Diabetes Mellitus, Type 2 / Q000097:blood / Q000188:drug therapy*; D004305:Dose-Response Relationship, Drug; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D007328:Insulin / Q000031:analogs & derivatives* / Q000627:therapeutic use; D000069036:Insulin Glargine; D049528:Insulin, Long-Acting; D007564:Japan; D008297:Male; D008875:Middle Aged; D013453:Sulfonylurea Compounds / Q000627:therapeutic use*
D001786:Blood Glucose; D002096:C-Peptide; D007328:Insulin; D049528:Insulin, Long-Acting; D013453:Sulfonylurea Compounds; D000069036:Insulin Glargine; C057619:glimepiride