[Efficacy and tolerability of sitagliptin in type 2 diabetic patients inadequately controlled with metformin. A prospective observational study in austrian primary care].

OBJECTIVES

This non-interventional study aimed to assess the characteristics of diabetic patients treated with metformin monotherapy in Austria. In patients who received an add-on therapy with sitagliptin, efficacy and tolerability of this combination was assessed in a real-life setting.

PATIENTS, METHODS: Blood glucose control, metabolic status, concurrent disorders and diabetic comorbidities were documented in 2313 type 2 diabetic patients treated with metformin alone by office-based general practitioners and internists. In 679 patients (with HbA1c > 7% and body mass index > 26 kg/m(2)), sitagliptin as an add-on therapy to metformin was initiated. These patients were followed for 6 months (mean time).

RESULTS

82.8% of the patients included in the initial assessment (= entire cohort, n = 2313) had not achieved the blood glucose targets recommended by the Austrian Diabetes Association (HbA(1c) ≤ 6.5%). In patients with baseline HbA(1c) > 7% (mean: 8.3%) and body mass index > 26 kg/m(2), additional administration of sitagliptin 100 mg/day resulted in an HbA(1c) reduction of 1.13 ± 0.04 % (mean ± standard error of the mean, p < 0.0001) within 6 months. The proportion of patients achieving an HbA(1c) < 7 or ≤ 6.5% was 44.9% and 19.1%, respectively. Fasting and postprandial blood glucose levels were reduced by 36.3 ± 1.6 mg/dl and 60.0 ± 3.2 mg/dl, respectively (both p < 0.0001). Body weight declined by 2.8 ± 0.2 kg (p < 0.0001). The majority of patients evaluated therapy with sitagliptin as "well tolerated".

CONCLUSIONS

Patients with type 2 diabetes frequently do not receive add-on therapy required for achieving the target values of glycaemic control. Sitagliptin is an effective, well-tolerated option for insufficiently controlled type 2 diabetic patients on metformin monotherapy in line with current guidelines.