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Initial treatment with fixed-dose combination rosiglitazone/glimepiride in patients with previously untreated type 2
H S Chou1, J P Palmer, A R Jones
1Cardiovascular and Metabolic Medicine Development Center, GlaxoSmithKline, King of Prussia, PA, USA.
Aim:
This study assessed the efficacy and safety of two different dosing regimens of fixed-dose combination (FDC) rosiglitazone (RSG) plus glimepiride (GLIM) compared with RSG or GLIM monotherapy in drug-naive subjects with type 2 diabetes mellitus (T2DM).
Methods:
Drug-naive subjects (n = 901) were enrolled into this 28-week, double-blind, parallel-group study if their glycosylated haemoglobin A(1c) (HbA(1c)) was >7.5% but
Results:
At week 28, both RSG/GLIM FDC regimens significantly reduced HbA(1c) (mean +/- s.d.: -2.4 +/- 1.4% FDC regimen A; -2.5 +/- 1.4% FDC regimen B) to a greater extent than RSG (-1.8 +/- 1.5%) or GLIM (-1.7 +/- 1.4%) monotherapy (model-adjusted mean treatment difference, p < 0.0001 vs. both RSG and GLIM). Significantly more subjects achieved HbA(1c) target levels of
Conclusions:
Compared with RSG or GLIM monotherapy, the RSG/GLIM FDC improved glycaemic control with no significant increased risk of hypoglycaemia. RSG/GLIM FDC provides an effective and well-tolerated treatment option for drug-naive individuals with T2DM.
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