Xigduo XR

Drug

Drug Profile

Xigduo XR is a fixed-dose oral combination of dapagliflozin and extended-release metformin hydrochloride used as an adjunct to diet and exercise to improve glycemic control in type 2 diabetes mellitus in adults and pediatric patients aged 10 years and older. It combines an SGLT2 inhibitor with a biguanide. U.S. initial approval was in 2014.

Drug Class
SGLT2 inhibitor and biguanide combination
Approval Status
FDA approved (Initial U.S. Approval: 2014)
Mechanism of Action
Combination mechanism through SGLT2 inhibition (dapagliflozin) and biguanide glucose-lowering effects (metformin).
Brand Names
  • \XIGDUO XR\
Indications
  • \Adjunct to diet and exercise to improve glycemic control in adults and pediatric patients aged 10 years and older with type 2 diabetes mellitus\

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Related Clinical Trials

NCT ID Title Status Phase
NCT02722239

An Open-label, Randomized, Crossover Study of Comparative Pharmacokinetics and Bioequivalence of Dapagliflozin + Metformin, 10 mg + 1000 mg Versus the Combined Use of Forxiga™, 10 mg and Two Glucophage® Long, ER Tablets, 500 mg Co-administered to Healthy Volunteers Under Standard Fed Conditions

COMPLETED PHASE1