Post-meal β-cell function predicts the efficacy of glycemic control in patients with type 2 diabetes inadequately controlled by metformin monotherapy after addition of glibenclamide or acarbose

Po-Hsun Chen, Yi-Ting Tsai, Jun-Sing Wang, Shi-Dou Lin, Wen-Jane Lee, Shih-Li Su, I-Te Lee, Shih-Te Tu, Yao-Hsien Tseng, Wayne H-H Sheu, Shih-Yi Lin, Po-Hsun Chen, Yi-Ting Tsai, Jun-Sing Wang, Shi-Dou Lin, Wen-Jane Lee, Shih-Li Su, I-Te Lee, Shih-Te Tu, Yao-Hsien Tseng, Wayne H-H Sheu, Shih-Yi Lin

Abstract

Background: 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.

Methods: Fifty-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).

Results: At 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.

Conclusions: In 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 registration: This study was registered in the ClinicalTrials.gov with registration number of NCT00417729.

Keywords: Beta-cell function; Disposition index; Glycated hemoglobin; Glycemic control; Metformin.

Figures

Figure 1
Figure 1
CONSORT flow diagram.

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