BACKGROUND: At present, China has listed the compound tablet containing a fixed 
dose of rosiglitazone and metformin, Avandamet, which may improve patient 
compliance. The aim of this study was to evaluate the efficacy and safety of 
Avandamet or uptitrated metformin treatment in patients with type 2 diabetes 
inadequately controlled with metformin alone.
METHODS: This study was a 48-week, multicenter, randomized, open-labeled, 
active-controlled trial. Patients with inadequate glycaemic control (glycated 
hemoglobin [HbA1c] 7.5-9.5%) receiving a stable dose of metformin (≥1500 mg) 
were recruited from 21 centers in China (from 19 November, 2009 to 15 March, 
2011). The primary objective was to compare the proportion of patients who 
reached the target of HbA1c ≤7% between Avandamet and metformin treatment.
RESULTS: At week 48, 83.33% of patients reached the target of HbA1c ≤7% in 
Avandamet treatment and 70.00% in uptitrated metformin treatment, with 
significantly difference between groups. The target of HbA1c ≤6.5% was reached 
in 66.03% of patients in Avandamet treatment and 46.88% in uptitrated metformin 
treatment. The target of fasting plasma glucose (FPG) ≤6.1 mmol/L was reached in 
26.97% of patients in Avandamet treatment and 19.33% in uptitrated metformin 
treatment. The target of FPG ≤7.0 mmol/L was reached in 63.16% of patients in 
Avandamet treatment and 43.33% in uptitrated metformin treatment. Fasting 
insulin decreased 3.24 ± 0.98 μU/ml from baseline in Avandamet treatment and 
0.72 ± 1.10 μU/ml in uptitrated metformin treatment. Overall adverse event (AE) 
rates and serious AE rates were similar between groups. Hypoglycaemia occurred 
rarely in both groups.
CONCLUSIONS: Compared with uptitrated metformin, Avandamet treatment provided 
significant improvements in key parameters of glycemic control and was generally 
well tolerated.
REGISTRATION NUMBER: ChiCTR-TRC-13003776.