title: Efficacy of glimepiride/metformin fixed-dose combination vs metformin uptitration in type 2 diabetic patients inadequately controlled on low-dose metformin monotherapy: A randomized, open label, parallel group, multicenter study in Korea.
abstract: OBJECTIVE
  To compare the efficacy and safety of early combination therapy with glimepiride/metformin to metformin uptitration in reducing glycated hemoglobin (HbA1c) levels in Korean type 2 diabetic patients inadequately controlled on low-dose metformin monotherapy.
  
  
  METHODS
  In a randomized, open label, parallel group, multicenter study, 209 Korean type 2 diabetic patients (HbA1c 7.0-10.0%, on metformin 500-1,000 mg/day) received glimepiride/metformin fixed-dose combination (G/M FDC) or metformin uptitration treatment (Met UP). The primary end-point was the change in HbA1c from baseline to week 24.
  
  
  RESULTS
  G/M FDC therapy provided significantly greater adjusted mean decreases vs Met UP therapy in HbA1c (-1.2 vs -0.8%, P < 0.0001), and fasting plasma glucose (-35.7 vs -18.6 mg/dL, P < 0.0001). A significantly greater proportion of patients with G/M FDC therapy achieved HbA1c < 7% (74.7 vs 46.6%, P < 0.0001) at the end of the study. More patients experienced hypoglycemia with G/M FDC therapy compared with Met UP therapy (41 vs 5.6%, P < 0.0001), but there was no serious hypoglycemia in any group. A modest increase in mean bodyweight occurred in the patients who were treated with G/M FDC therapy (1.0 kg), whereas a slight decrease was observed in the patients who were treated with Met UP therapy (-0.7 kg).
  
  
  CONCLUSIONS
  The present study showed that glimepiride/metformin fixed-dose combination therapy was more effective in glycemic control than metformin uptitration, and was well tolerated in type 2 diabetic patients inadequately controlled by low-dose metformin monotherapy in Korea. This trial was registered with ClinicalTrial.gov (no. NCT00612144).
authors.affiliation: Department of Internal Medicine, Keimyung University School of Medicine Daegu, Korea.
authors.forename: Hye-Soon
authors.initials: HS
authors.lastname: Kim
authors.affiliation: Department of Internal Medicine, Hallym University College of Medicine Seoul, Korea.
authors.forename: Doo-Man
authors.initials: DM
authors.lastname: Kim
authors.affiliation: Department of Internal Medicine, Yonsei University College of Medicine Seoul, Korea.
authors.forename: Bong-Soo
authors.initials: BS
authors.lastname: Cha
authors.affiliation: Department of Endocrinology and Metabolism, Chonbuk National University Hospital Jeonju, Korea.
authors.forename: Tae Sun
authors.initials: TS
authors.lastname: Park
authors.affiliation: Department of Internal Medicine, Dongguk University College of Medicine Goyang, Korea.
authors.forename: Kyoung-Ah
authors.initials: KA
authors.lastname: Kim
authors.affiliation: Department of Internal Medicine, Konkuk University School of Medicine Seoul, Korea.
authors.forename: Dong-Lim
authors.initials: DL
authors.lastname: Kim
authors.affiliation: Department of Internal Medicine, Yonsei University Wonju College of Medicine Wonju, Korea.
authors.forename: Choon Hee
authors.initials: CH
authors.lastname: Chung
authors.affiliation: Paik Institute for Clinical Research, Department of Internal Medicine, College of Medicine, Inje University Busan, Korea.
authors.forename: Jeong-Hyun
authors.initials: JH
authors.lastname: Park
authors.affiliation: Department of Internal Medicine, Seoul National University Bundang Hospital Seongnam, Korea.
authors.forename: Hak Chul
authors.initials: HC
authors.lastname: Jang
authors.affiliation: Division of Endocrinology and Metabolism, Department of Internal Medicine, Korea University College of Medicine Seoul, Korea.
authors.forename: Dong-Seop
authors.initials: DS
authors.lastname: Choi
keywords: Glimepiride/metformin combination; Korea; Type 2 diabetes mellitus