Details

Autor(en) / Beteiligte

• Patel, C. G.
• Kornhauser, D.
• Vachharajani, N.
• Komoroski, B.
• Brenner, E.
• Handschuh del Corral, M.
• Li, L.
• Boulton, D. W.

Titel

Saxagliptin, a potent, selective inhibitor of DPP-4, does not alter the pharmacokinetics of three oral antidiabetic drugs (metformin, glyburide or pioglitazone) in healthy subjects

Ist Teil von

• Diabetes, obesity & metabolism, 2011-07, Vol.13 (7), p.604-614

Ort / Verlag

Oxford, UK: Blackwell Publishing Ltd

Erscheinungsjahr

2011

Quelle

Access via Wiley Online Library

Beschreibungen/Notizen

• Aim: To evaluate the pharmacokinetic interactions of the potent, selective, dipeptidyl peptidase‐4 inhibitor, saxagliptin, in combination with metformin, glyburide or pioglitazone. Methods: To assess the effect of co‐administration of saxagliptin with oral antidiabetic drugs (OADs) on the pharmacokinetics and tolerability of saxagliptin, 5‐hydroxy saxagliptin, metformin, glyburide, pioglitazone and hydroxy‐pioglitazone, analyses of variance were performed on maximum (peak) plasma drug concentration (Cmax), area under the plasma concentration–time curve from time zero to infinity (AUC∞) [saxagliptin + metformin (study 1) and saxagliptin + glyburide (study 2)] and area under the concentration–time curve from time 0 to time t (AUC) [saxagliptin + pioglitazone (study 3)] for each analyte in the respective studies. Studies 1 and 2 were open‐label, randomized, three‐period, three‐treatment, crossover studies, and study 3 was an open‐label, non‐randomized, sequential study in healthy subjects. Results: Co‐administration of saxagliptin with metformin, glyburide or pioglitazone did not result in clinically meaningful alterations in the pharmacokinetics of saxagliptin or its metabolite, 5‐hydroxy saxagliptin. Following co‐administration of saxagliptin, there were no clinically meaningful alterations in the pharmacokinetics of metformin, glyburide, pioglitazone or hydroxy‐pioglitazone. Saxagliptin was generally safe and well tolerated when administered alone or in combination with metformin, glyburide or pioglitazone. Conclusions: Saxagliptin can be co‐administered with metformin, glyburide or pioglitazone without a need for dose adjustment of either saxagliptin or these OADs.