Metformin ( Glucophage ) is the only first-line oral hypoglycaemic drug for type 2 diabetes recommended by international guidelines with proven efficacy, safety, and cost-effectiveness. However, little information exists about its use in Asian populations.
The aim of the study was to ascertain the effectiveness of the alpha-glucosidase inhibitor Acarbose ( Glucobay ), extensively adopted in China, compared with Metformin as the alternative initial therapy for newly diagnosed type 2 diabetes.
In this 48-week, randomised, open-label, non-inferiority trial, patients who were newly diagnosed with type 2 diabetes, with a mean glycated haemoglobin ( HbA1c ) of 7.5%, were enrolled from 11 sites in China.
After a 4-week lifestyle modification run-in, patients were assigned to 24 weeks of monotherapy with Metformin or Acarbose as the initial treatment, followed by a 24-week therapy phase during which add-on therapy was used if prespecified glucose targets were not achieved.
Primary endpoints were to establish whether Acarbose was non-inferior to Metformin in HbA1c reduction at week 24 and week 48 timepoints.
The non-inferiority margin was 0.3%, with an expected null difference in the change from baseline to week 48 in glycated hemoglobin.
Analysis was done on a modified intention-to-treat population.
Of the 788 patients randomly assigned to treatment groups, 784 patients started the intended study drug.
Glycated hemoglobin reduction at week 24 was -1.17% in the Acarbose group and -1.19% in the Metformin group. At week 48, the HbA1c reduction was -1.11% ( Acarbose ) and -1.12% ( Metformin ) with difference 0.01% ( p=0.8999 ).
Six ( 2% ) patients in the Acarbose group and seven ( 2% ) patients in the Metformin group had serious adverse events, and two ( 1% ) and four ( 1% ) had hypoglycaemic episodes.
This study has provided evidence that Acarbose is similar to Metformin in efficacy, and is therefore a viable choice for initial therapy in Chinese patients newly diagnosed with type 2 diabetes. ( Xagena )
Yang W et al, The Lancet Diabetes & Endocrinology 2014; 2: 46-55