Abstract
Objective To conduct a subanalysis of the randomized MARCH (Metformin and AcaRbose in Chinese as the initial Hypoglycemic treatment) trial to investigate whether specific characteristics are associated with the efficacy of either acarbose or metformin as initial therapy.
Research design and methods A total of 657 type 2 diabetes patients who were randomly assigned to 48 weeks of therapy with either acarbose or metformin in the MARCH trial were divided into two groups based upon their hemoglobin A1c (HbA1c) levels at the end of follow-up: HbA1c <7% (<53 mmol/mol) and ≥7% (≥53 mmol/mol). Univariate, multivariate, and stepwise linear regression analyses were applied to identify the factors associated with treatment efficacy.
Main outcome measures Because this was a subanalysis, no measurement was performed.
Results Univariate analysis showed that the efficacy of acarbose and metformin was influenced by HbA1c, fasting blood glucose (FBG), and 2 hour postprandial venous blood glucose (2hPPG) levels, as well as by changes in body mass index (BMI) (p ≤ 0.006). Multivariate analysis and stepwise linear regression analyses indicated that lower baseline 2hPPG values and greater changes in BMI were factors that positively influenced efficacy in both treatment groups (p ≤ 0.05). Stepwise regression model analysis also revealed that a lower baseline homeostasis model assessment-estimated insulin resistance (HOMA-IR) and higher serum insulin area under the curve (AUC) were factors positively influencing HbA1c normalization in all patients (p ≤ 0.032).
Conclusions Newly diagnosed type 2 diabetes patients with lower baseline 2hPPG and HOMA-IR values are more likely to achieve glucose control with acarbose or metformin treatment. Furthermore, the change in BMI after acarbose or metformin treatment is also a factor influencing HbA1c normalization. A prospective study with a larger sample size is necessary to confirm our results as well as measure β cell function and examine the influence of the patients’ dietary habits.
Declaration of funding
This study was not funded.
Author contributions: W.Y. and J.Z. contributed to the design of the study and data acquisition. X.X., Z.Y. and X.W. contributed to data acquisition. N.W. developed the manuscript and statistically analyzed the data. All authors critically reviewed the manuscript for important intellectual content, and all read and approved the final version submitted. W.Y. is the guarantor of this work and, as such, had full access to all data in the study and takes responsibility for the integrity of the data and the accuracy of the analysis.
Declaration of financial/other relationships
J.Z., N.W., X.X., Z.Y., X.W., and W.Y. have disclosed that they have no significant relationships with or financial interests in any commercial companies related to this study or article.
Peer reviewers 1 and 2 are CMRO Editorial Board members. CMRO peer reviewer 3 has no relevant financial or other relationships to disclose.
Acknowledgments
Bayer Healthcare (Beijing, China) provided the acarbose tablets, and Double Crane Pharma (Beijing, China) provided the metformin tablets used in the MARCH study. Editorial assistance with the manuscript was freely provided by Content Ed Net, Shanghai Co. Ltd.