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Summary

Aim/hypothesis:  To assess the safety and efficacy of initial combination therapy with sitagliptin and pioglitazone compared with pioglitazone monotherapy in drug-naïve patients with type 2 diabetes.

Methods:  A total of 520 patients were randomised to initial combination therapy with sitagliptin 100 mg q.d. and pioglitazone 30 mg q.d. or pioglitazone 30 mg q.d. monotherapy for 24 weeks.

Results:  Initial combination therapy with sitagliptin and pioglitazone led to a mean reduction from baseline in A1C of −2.4% compared with −1.5% for pioglitazone monotherapy (p < 0.001). Mean reductions from baseline were greater in patients with a baseline A1C ≥ 10% (−3.0% with combination therapy vs. −2.1% with pioglitazone monotherapy) compared with patients with a baseline A1C < 10% (−2.0% with combination therapy vs. −1.1% with pioglitazone monotherapy). Sixty percent of patients in the combination therapy group vs. 28% in the pioglitazone monotherapy group had an A1C of < 7% at week 24 (p < 0.001). Fasting plasma glucose decreased by −63.0 mg/dl (−3.5 mmol/l) in the combination therapy group compared with −40.2 mg/dl (−2.2 mmol/l) for pioglitazone monotherapy (p < 0.001), and 2-h post meal glucose decreased by −113.6 mg/dl (−6.3 mmol/l) with combination therapy compared with −68.9 mg/dl (−3.8 mmol/l) for pioglitazone monotherapy (p < 0.001). Measures related to β-cell function also improved significantly with combination therapy compared with pioglitazone monotherapy. Combination therapy was generally well-tolerated compared with pioglitazone monotherapy, with similar incidences of hypoglycemia (1.1% and 0.8%, respectively), gastrointestinal adverse events (5.7% and 6.9%, respectively), and oedema (2.7% and 3.5%, respectively).

Conclusion/interpretation:  Initial combination therapy with sitagliptin and pioglitazone substantially improved glycemic control and was generally well-tolerated compared with pioglitazone monotherapy.