A comparison study on efficacy, insulin sensitivity and safety of Glimepiride/Metformin fixed dose combination versus glimepiride single therapy on type 2 diabetes mellitus patients with basal insulin therapy

•Combination of oral hypoglycemic agents and insulin has the synergistic effect.•Glimepiride/metformin/insulin was more effective than high dose glimepiride/insulin.•Glimepiride/metformin/insulin and high dose glimepiride/insulin are relatively safe. The aim of this study was to analyze the efficacy...

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Published in:Diabetes research and clinical practice 2019-09, Vol.155, p.107796-107796, Article 107796
Main Authors: Yu, Hea Min, Kim, Sang Jin, Chun, Sung Wan, Park, Keun Young, Lim, Dong Mee, Lee, Jong Min, Hong, Jun Hwa, Park, Kang Seo
Format: Article
Language:English
Subjects:
Metformin
Sulfonylurea compounds
Type 2 diabetes mellitus
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Summary:•Combination of oral hypoglycemic agents and insulin has the synergistic effect.•Glimepiride/metformin/insulin was more effective than high dose glimepiride/insulin.•Glimepiride/metformin/insulin and high dose glimepiride/insulin are relatively safe. The aim of this study was to analyze the efficacy, insulin sensitivity and safety in the event of administering sulfonylurea-based drugs and metformin in combination with basal insulin. A randomized, open-label, parallel, 16-week trial was conducted across four study centers. The 97 type 2 diabetic patients were selected and randomized into two groups, the insulin glargine plus fixed-dose combination glimepiride 1 mg and metformin 500 mg twice daily group (the G/M group) and the insulin glargine plus glimepiride 4 mg once daily group (the G group). The primary endpoint evaluated was change in HbA1c. The secondary endpoints evaluated were changes in fasting blood glucose (FPG), 2-h post prandial glucose (PPG 2 h), insulin, and C-peptide levels. The G/M group was found to have experienced a significantly greater decrease in HbA1c, as well as PPG 2 h compared to the G group. While no significant intergroup difference was found regarding FPG in the ITT, the G/M group in the PP set experienced a significantly greater decrease in FPG. Comparison of combined therapy consisting of either the G/M group or the G group indicated that both forms of therapy are relatively safe but that the former more effectively decreases blood glucose levels.
ISSN:0168-8227
1872-8227
DOI:10.1016/j.diabres.2019.107796