AIM: The purpose of this study was to evaluate if superior glycaemic control 
could be achieved with Avandamet® (rosiglitazone/metformin/AVM) compared with 
metformin (MET) monotherapy, and if glycaemic effects attained with AVM are 
durable over 18 months of treatment. Bone mineral density (BMD) and bone 
biomarkers were evaluated in a subgroup of patients.
METHODS: This was a phase IV, randomized, double-blind, multi-centre study in 
688, drug naÏve, male and female patients who had an established clinical 
diagnosis of type 2 diabetes mellitus (T2DM). Patients were randomized in a 1 : 
1 ratio either to AVM or MET.
RESULTS: As initial therapy in patients with T2DM, AVM was superior to MET in 
achieving statistically significant reductions in glycated haemoglobin (HbA1c) 
(p < 0.0001) and fasting plasma glucose (FPG) (p < 0.001), with more patients 
reaching recommended HbA1c and FPG targets for intensive glycaemic control. The 
glycaemic effects attained with AVM compared to MET monotherapy were durable 
over 18 months of treatment. In the bone substudy, AVM was associated with a 
significantly lower BMD in comparison with MET at week 80 in the lumbar spine 
and total hip (p < 0.0012 and p = 0.0005, respectively). Between-treatment 
differences were not statistically significant for distal one-third of radius 
BMD, femoral neck BMD or total BMD.
CONCLUSION: Superior glycaemic control was achieved with AVM compared with MET 
monotherapy. The superior glycaemic effects were shown to be durable over 18 
months of treatment. AVM was associated with a significantly reduced BMD in 
comparison with MET at week 80 in the lumbar spine and total hip.