Abstract

Subjects (N = 22,808) with inadequately controlled type 2 diabetes mellitus (T2DM) were included in a large 6-month observational study in Germany. Rosiglitazone (RSG) was added to existing therapy in line with daily practice, with 19,962 subjects evaluated for efficacy by treatment group: RSG monotherapy (n = 1017), RSG plus metformin (MET) (n = 7160), RSG plus sulphonylurea (n = 5033), triple oral therapy (n = 4247), and the remaining subject population (n = 2505). Overall, RSG significantly reduced median HbA(1c) and fasting blood glucose by 1.3% and 50 mg/dl over 6 months (p < 0.001 for both). The proportion of subjects achieving glycaemic goals of <or= 6.5% and <or= 7.0% increased from 5.7% to 33.8%, and from 13.9% to 55.5%, respectively (p < 0.001 for both). Mean systolic and diastolic blood pressures were reduced in the total subject population by 6 mmHg and 2 mmHg, respectively (p < 0.001 for both). RSG had a neutral or reductive effect on mean weight of most (69%) subjects. Consistent with clinical trial data, RSG mono- or combination therapy improved glycaemic control when used in daily clinical practice and is generally well-tolerated.

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