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

Conference: 
Author(s): 
Pfützner A. (Mainz), Gurieva I. (Moscow), Antsiferov M. (Moscow), Allen E. (Princeton, NJ), Ravichandran S. (Princeton, NJ), Chen R. (Princeton, NJ)
Text: 
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.
Literature: 
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