Efficacy of Glimepiride/Metformin Fixed-Dose Combination Versus Metformin

Uptration in Type 2 Diabetic Patients Inadequately Controlled on Metformin

Monotherapy, a Randomized, Multicenter, Parallel-Group, Open Study in Korea
Year: 2011
Abstract Number: 2275-PO
Authors: HYE-SOON KIM, DOO MAN KIM, BONG SOO CHA, TAE SUN PARK,
KYOUNG-AH KIM, DONG-LIM KIM, CHOON HEE CHUNG, JEONG HYUN PARK, HAK
CHUL JANG, DONG-SEOP CHOI
Institutions: Daegu, Republic of Korea, Seoul, Republic of Korea, Jeon-ju, Republic of Korea,
Ilsan, Republic of Korea, Wonju, Republic of Korea, Pusan, Republic of Korea, Bundang,
Republic of Korea

Results: The aim of this study was to compare the efficacy and safety of early combination
therapy with glimepiride/metformin to metformin uptitration in reducing HbA1c levels from
baseline over 24 weeks. A randomized, multicenter, parallel-group, open study was performed
with arms of glimepiride/metformin (initial dosage 2/500 mg/day) and metformin uptitration
(initial dosage 1,000 mg/day) in type 2 diabetic patients inadequately controlled by metformin
monotherapy. Dosage was titrated to a maximum (8/2,000 mg and 2,500 mg, respectively) in
order to reach the glycemic control goals (140200 mg/dL of self monitored blood glucose
without hypoglycemia). Serum hemoglobin A1c (HbA1c), fasting and postprandial glucose were
measured for efficacy analysis. In all, 209 patients were randomized (glimepiride/metformin,
n=101; metformin uptitraion, n=108). There was no significant difference in baseline
characteristics between groups. At the end of the study, adjusted mean change in HbA1c level
was significantly higher in the glimipiride/metformin group than metformin uptration group:
-1.2% and -0.93%, respecvively (P<0.0001). A higher proportion of patients from the
glimepiride/metformin group reached the goal of HbA1c<7% (73.3% vs. 46.2%; P=0.0002) and
fasting glucose <140 mg/dL (83.3% vs, 68.1%; P=0.016). More patients experienced
hypoglycemia with glimepiride/metformin (41% vs. 5.6%; P<0.0001) but there was no serious
hypoglycemia in any group. Metformin had a beneficial effect on body weight (mean change
from baseline - 0.72kg; between group difference -1.63 kg; P<0.05). Overall, both treatments
were well tolerated and revealed similar safety profiles. This study demonstrated
glimepiride/metformin fixed-dose combination therapy being more efficacious than metformin
uptitration in type2 diabetic patients inadequately controlled by metformin monotherapy in
Korea.
http://professional.diabetes.org/Abstracts_Display.aspx?CID=88978