P-390 Saxagliptin Improves Glycaemic Control Either As Add-On Therapy To Metformin Or As Initial Combination Therapy With Metformin In Patients With Type 2 Diabetes

Pfützner A. (Mainz), Gurieva I. (Moscow), Antsiferov M. (Moscow), Allen E. (Princeton, NJ), Ravichandran S. (Princeton, NJ), Chen R. (Princeton, NJ)
Aims: Saxagliptin (SAXA) is a potent, selective dipeptidyl peptidase-4 (DPP-4) inhibitor, specifically designed for extended inhibition of the DPP-4 enzyme. The efficacy and safety of SAXA was assessed in two Phase III trials (CV181014/Study 1 and CV181039/Study 2), either as add-on therapy in patients with type 2 diabetes mellitus (T2DM) inadequately controlled by metformin (MET) alone (HbA1c 7.0–10.0%) or as initial combination therapy with MET in drug-naïve T2DM patients (HbA1c 8.0–12.0%), respectively.
Methods: Following a placebo (PBO) run-in, patients (n = 743) on MET in Study 1 were randomised to receive once-daily SAXA 2.5, 5 or 10 mg, or PBO, plus their stable MET dose, and drug-naïve patients (n = 1306) in Study 2 were randomised to receive SAXA/MET 5/500 mg (S5/MET), 10/500 mg (S10/MET), SAXA 10 mg or MET 500 mg once-daily. In the MET treatment arms of Study 2, MET was up-titrated incrementally (Weeks 1–5) to a maximum of 2000 mg/day. Both studies’ primary endpoint was HbA1c change from baseline at 24 weeks.
Results: Treatment groups were well balanced at baseline for HbA1c (Study 1, 8.0–8.1%; Study 2, 9.4–9.6%). At Week 24, significant (p Conclusions: SAXA add-on or initial combination therapy with MET provided significant and clinically meaningful reductions in key parameters of glycaemic control and was well tolerated in patients with T2DM.
Saxagliptin improves glycaemic control either as add-on therapy to metformin or as initial combination therapy with metformin in patients with type 2 diabetes