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Pharmacokinetics of empagliflozin, a sodium glucose cotransporter-2 (SGLT2) inhibitor, and metformin following co-administration in healthy volunteers.
Int J Clin Pharmacol Ther. 2013 Feb; 51(2):132-40.IJ

Abstract

OBJECTIVE

This open-label study investigated potential drug-drug interactions between empagliflozin and metformin.

METHODS

16 healthy men received treatment A (empagliflozin 50 mg q.d. for 5 days), treatment B (empagliflozin 50 mg q.d. for 4 days with metformin 1,000 mg b.i.d. for 3 days and 1,000 mg q.d. on Day 4) and treatment C (metformin 1,000 mg b.i.d. for 3 days and 1,000 mg q.d .on Day 4) in the sequence AB then C, or C then AB.

RESULTS

Metformin had no clinically relevant effect on the area under the steady state plasma concentration-time curve (AUC(τ,ss) geometric mean ratio (GMR): 96.9; 90% CI: 92.3 - 101.7) or the maximum plasma concentration at steady state (C(max,ss) GMR: 100.5; 90% CI: 88.8 - 113.7) of empagliflozin. Similarly, empagliflozin had no clinically relevant effect on AUC(τ,ss) (GMR: 100.7; 90% CI: 95.9 - 105.6) or C(max,ss) (GMR: 103.6; 90% CI: 96.5 - 111.2) of metformin. The renal clearance of empagliflozin and metformin were unaffected by co-administration. Both drugs were well tolerated alone and in combination and did not cause hypoglycemia.

CONCLUSIONS

These data support co-administration of empagliflozin and metformin without dose adjustment.

Authors+Show Affiliations

Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT, USA. sreeraj.macha@boehringer-ingelheim.comNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial
Journal Article
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

23253948

Citation

Macha, Sreeraj, et al. "Pharmacokinetics of Empagliflozin, a Sodium Glucose Cotransporter-2 (SGLT2) Inhibitor, and Metformin Following Co-administration in Healthy Volunteers." International Journal of Clinical Pharmacology and Therapeutics, vol. 51, no. 2, 2013, pp. 132-40.
Macha S, Dieterich S, Mattheus M, et al. Pharmacokinetics of empagliflozin, a sodium glucose cotransporter-2 (SGLT2) inhibitor, and metformin following co-administration in healthy volunteers. Int J Clin Pharmacol Ther. 2013;51(2):132-40.
Macha, S., Dieterich, S., Mattheus, M., Seman, L. J., Broedl, U. C., & Woerle, H. J. (2013). Pharmacokinetics of empagliflozin, a sodium glucose cotransporter-2 (SGLT2) inhibitor, and metformin following co-administration in healthy volunteers. International Journal of Clinical Pharmacology and Therapeutics, 51(2), 132-40. https://doi.org/10.5414/CP201794
Macha S, et al. Pharmacokinetics of Empagliflozin, a Sodium Glucose Cotransporter-2 (SGLT2) Inhibitor, and Metformin Following Co-administration in Healthy Volunteers. Int J Clin Pharmacol Ther. 2013;51(2):132-40. PubMed PMID: 23253948.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Pharmacokinetics of empagliflozin, a sodium glucose cotransporter-2 (SGLT2) inhibitor, and metformin following co-administration in healthy volunteers. AU - Macha,Sreeraj, AU - Dieterich,Sabine, AU - Mattheus,Michaela, AU - Seman,Leo J, AU - Broedl,Uli C, AU - Woerle,Hans J, PY - 2013/01/24/accepted PY - 2012/12/21/entrez PY - 2012/12/21/pubmed PY - 2013/4/5/medline SP - 132 EP - 40 JF - International journal of clinical pharmacology and therapeutics JO - Int J Clin Pharmacol Ther VL - 51 IS - 2 N2 - OBJECTIVE: This open-label study investigated potential drug-drug interactions between empagliflozin and metformin. METHODS: 16 healthy men received treatment A (empagliflozin 50 mg q.d. for 5 days), treatment B (empagliflozin 50 mg q.d. for 4 days with metformin 1,000 mg b.i.d. for 3 days and 1,000 mg q.d. on Day 4) and treatment C (metformin 1,000 mg b.i.d. for 3 days and 1,000 mg q.d .on Day 4) in the sequence AB then C, or C then AB. RESULTS: Metformin had no clinically relevant effect on the area under the steady state plasma concentration-time curve (AUC(τ,ss) geometric mean ratio (GMR): 96.9; 90% CI: 92.3 - 101.7) or the maximum plasma concentration at steady state (C(max,ss) GMR: 100.5; 90% CI: 88.8 - 113.7) of empagliflozin. Similarly, empagliflozin had no clinically relevant effect on AUC(τ,ss) (GMR: 100.7; 90% CI: 95.9 - 105.6) or C(max,ss) (GMR: 103.6; 90% CI: 96.5 - 111.2) of metformin. The renal clearance of empagliflozin and metformin were unaffected by co-administration. Both drugs were well tolerated alone and in combination and did not cause hypoglycemia. CONCLUSIONS: These data support co-administration of empagliflozin and metformin without dose adjustment. SN - 0946-1965 UR - https://www.unboundmedicine.com/medline/citation/23253948/Pharmacokinetics_of_empagliflozin_a_sodium_glucose_cotransporter_2__SGLT2__inhibitor_and_metformin_following_co_administration_in_healthy_volunteers_ L2 - http://www.dustri.com/nc/journals-in-english.html?artId=10284 DB - PRIME DP - Unbound Medicine ER -