Abstract
BackgroundThis study aimed to explore parameters which will predict good control of HbA1c after adding a second anti-diabetic drug in patients with type 2 diabetes mellitus (T2DM) inadequately controlled with metformin monotherapy.MethodsFifty-one patients (M/F: 25/26, mean age: 53.7 ± 8.2 years, mean glycated hemoglobin [HbA1c] 8.4 ± 1.2%) with T2DM inadequately controlled with metformin were randomized to add-on glibenclamide or acarbose for 16 weeks. Before and after combination therapy, the subjects underwent a 2-hour liquid mixed meal tolerance test to determine insulin secretion (HOMA-β, insulinogenic index, and disposition index [DI]) and insulin sensitivity (HOMA-IR and Matsuda insulin sensitivity index).ResultsAt baseline, there was a significant inverse relationship between DI120 and HbA1c (p = 0.001) in all subjects. The addition of glibenclamide and acarbose improved HbA1c significantly from 8.6 ± 1.6% to 7.4 ± 1.2% (p < 0.001), and from 8.2 ± 0.8% to 7.5 ± 0.8% (p < 0.001), respectively. In the glibenclamide group, DI120 significantly increased from 51.2 ± 24.2 to 74.9 ± 41.9 (p < 0.05), and in the acarbose group, from 62.5 ± 31.4 to 91.7 ± 36.2 (p < 0.05), respectively. Multiple regression analyses showed that both baseline HbA1c and DI120 independently predicted reduction of HbA1c as well as final HbA1c after combination therapy.ConclusionsIn patients with T2DM inadequately controlled with metformin, add-on oral anti-diabetic agent with glibenclamide or acarbose resulted in the significant HbA1c reduction and improvement of β-cell function. Subjects with greater baseline β-cell function reserve displayed better glycemic response in the combination therapy of metformin with glibenclamide or acarbose.Trial registrationThis study was registered in the ClinicalTrials.gov with registration number of NCT00417729.
Highlights
This study aimed to explore parameters which will predict good control of Glycated hemoglobin (HbA1c) after adding a second anti-diabetic drug in patients with type 2 diabetes mellitus (T2DM) inadequately controlled with metformin monotherapy
It has been reported that addition of sulfonylurea or acarbose can improve glycemic control in diabetic patients who fail to reach their HbA1c target with metformin alone, but limited data are available guiding the add-on class of oral anti-diabetic drug (OAD) in patients with T2DM inadequately controlled with metformin [7]
This study aimed to compare the clinical efficacy of addition of glibenclamide and acarbose and evaluate whether β-cell function could predict glycemic control in patients with T2DM poorly controlled with metformin
Summary
This study aimed to explore parameters which will predict good control of HbA1c after adding a second anti-diabetic drug in patients with type 2 diabetes mellitus (T2DM) inadequately controlled with metformin monotherapy. It has been reported that addition of sulfonylurea or acarbose can improve glycemic control in diabetic patients who fail to reach their HbA1c target with metformin alone, but limited data are available guiding the add-on class of oral anti-diabetic drug (OAD) in patients with T2DM inadequately controlled with metformin [7]. This study aimed to compare the clinical efficacy of addition of glibenclamide and acarbose and evaluate whether β-cell function could predict glycemic control (indicated as HbA1c) in patients with T2DM poorly controlled with metformin
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