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

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, 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

Abstract

Aims/introduction: 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.

Materials and 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).

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).

Keywords: Glimepiride/metformin combination; Korea; Type 2 diabetes mellitus.

Figures

Figure 1
Figure 1
Titration algorithm. G/M, glimepiride/metformin; M, metformin; SMBG, self-monitored blood glucose.
Figure 2
Figure 2
Patients' disposition. †Occlusion and stenosis of carotid artery. ‡Death; the cause of death was car accident. None of the serious adverse events (SAEs) were considered by the investigator to be treatment related.

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Source: PubMed

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