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- 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.
- Authors
Kim, Hye‐soon; Kim, Doo‐man; Cha, Bong‐soo; Park, Tae Sun; Kim, Kyoung‐ah; Kim, Dong‐lim; Chung, Choon Hee; Park, Jeong‐hyun; Jang, Hak Chul; Choi, Dong‐seop
- Abstract
Aims/Introduction To compare the efficacy and safety of early combination therapy with glimepiride/metformin to metformin uptitration in reducing glycated hemoglobin ( Hb A1c) levels in Korean type 2 diabetic patients inadequately controlled on low-dose metformin monotherapy. Materials and Methods In a randomized, open label, parallel group, multicenter study, 209 Korean type 2 diabetic patients ( Hb A1c 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 Hb A1c from baseline to week 24. Results G/ M FDC therapy provided significantly greater adjusted mean decreases vs Met UP therapy in Hb A1c (−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 Hb A1c < 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). Conclusion 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).
- Subjects
KOREA; METFORMIN; TYPE 2 diabetes; MEDICAL centers; BLOOD sugar
- Publication
Journal of Diabetes Investigation, 2014, Vol 5, Issue 6, p701
- ISSN
2040-1116
- Publication type
Academic Journal
- DOI
10.1111/jdi.12201