Efficacy and safety of adding pioglitazone or sitagliptin to patients with type 2 diabetes insufficiently controlled with metformin and a sulfonylurea.

OBJECTIVE

To evaluate the efficacy and safety of add-on pioglitazone versus sitagliptin in patients with type 2 diabetes inadequately controlled on metformin and a sulfonylurea (SU).

METHODS

This 24-week, randomized, open-label study compared pioglitazone (30 mg daily, n = 59) and sitagliptin (100 mg daily, n = 60) in patients with inadequate glycemic control (glycosylated hemoglobin [HbA1c] ≥7.0% to <11.0%) while receiving a stable dose of metformin (≥1,500 mg daily) and an SU (≥half-maximal dose).

RESULTS

The mean changes in HbA1c from baseline was -0.94 ± 0.12% with pioglitazone and -0.71 ± 0.12% with sitagliptin, for a between-groups difference of -0.23 ± 0.16% (P = .16). The mean change in fasting plasma glucose (FPG) were -35.7 ± 4.0 mg/dL with pioglitazone and -22.8 ± 4.0 mg/dL with sitagliptin, for a between-groups difference of -12.9 ± 5.7 mg/dL (P = .02). Pioglitazone was associated with a significant decrease in high-sensitive C-reactive protein (hs-CRP), but sitagliptin did not. The mean weight gain was higher in the pioglitazone group, with a between-group difference of 1.6 kg (P<.01). Overall adverse events (AEs) were similar in both groups. However, the incidence of edema was higher with pioglitazone, and the incidence of gastrointestinal AEs was higher with sitagliptin.

CONCLUSION

Pioglitazone and sitagliptin achieved similar improvements in overall glycemic control in patients with type 2 diabetes inadequately controlled with metformin and an SU. However there were some differences in terms of FPG, hs-CRP, lipids, body-weight change, and AEs.