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Farxiga (Dapagliflozin Propanediol) - Summary

 
 



FARXIGA SUMMARY

FARXIGA is available as a film-coated tablet for oral administration containing the equivalent of 5 mg dapagliflozin as dapagliflozin propanediol or the equivalent of 10 mg dapagliflozin as dapagliflozin propanediol.

FARXIGA (dapagliflozin) is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus [see Clinical Studies ].

Limitation of Use

FARXIGA is not recommended for patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis.


See all Farxiga indications & dosage >>

NEWS HIGHLIGHTS

Published Studies Related to Farxiga (Dapagliflozin)

Changes in insulin sensitivity and insulin secretion with the sodium glucose cotransporter 2 inhibitor dapagliflozin. [2014]
CONCLUSIONS: In patients with T2DM and inadequate glycemic control, dapagliflozin

[Effect of dapagliflozin in patients with type 2 diabetes who have inadequate glycaemic control with glimepiride]. [Article in German] [2013]
to glimepiride in patients with uncontrolled T2DM... CONCLUSIONS: Dapagliflozin added to glimepiride in patients with T2DM

Effect of dapagliflozin in patients with type 2 diabetes who have inadequate glycaemic control with glimepiride: a randomized, 24-week, double-blind, placebo-controlled trial. [2011]
to glimepiride in patients with uncontrolled T2DM... CONCLUSIONS: Dapagliflozin added to glimepiride in patients with T2DM

Effect of dapagliflozin in patients with type 2 diabetes who have inadequate glycaemic control with metformin: a randomised, double-blind, placebo-controlled trial. [2010]
metformin... INTERPRETATION: Addition of dapagliflozin to metformin provides a new therapeutic

A study of dapagliflozin in patients with type 2 diabetes receiving high doses of insulin plus insulin sensitizers: applicability of a novel insulin-independent treatment. [2009]
CONCLUSIONS: In patients receiving high insulin doses plus insulin sensitizers

more studies >>

Clinical Trials Related to Farxiga (Dapagliflozin)

Dapagliflozin As Additional Treatment To Liraglutide And Insulin In Patients With Type 1 Diabetes [Recruiting]
This is a single center, prospective, randomized, double blinded placebo controlled study conducted I patients with type 1 diabetes. The aim of this study is to examine the additive effects of GLP-1 agonist and SGLT2 inhibitor in patients with type 1 diabetes in terms of possible improved glycemic control, reduced glycemic variability, reduced insulin dosages, additional effects of weight loss and blood pressure reduction.

Drug Interaction Study of Saxagliptin in Combination With Dapagliflozin in Healthy Participants [Completed]
The purpose of this study is to evaluate whether the pharmacokinetics (body concentrations/metabolism of the drug) of Saxagliptin and Dapagliflozin are affected when they are administered together

Bioequivalence/Food Effect - Saxa/Dapa Dual Fixed Dose Combination (FDC) [Completed]
The purpose of this study is to demonstrate the bioequivalence (BE) of Saxagliptin and Dapagliflozin from a 2. 5-mg Saxagliptin/5-mg Dapagliflozin FDC tablet after oral administration relative to 2. 5-mg Saxagliptin and 5-mg Dapagliflozin tablets administered orally together in the fasted state and to demonstrate the BE of Saxagliptin and Dapagliflozin from a 5-mg Saxagliptin/10-mg Dapagliflozin FDC tablet after oral administration relative to 5-mg Saxagliptin and 10-mg Dapagliflozin tablets administered orally together in the fasted state. Demonstrating bioequivalence refers to showing that the FDC tablet and co-administration of the individual components yield similar blood levels/concentrations of the drug and are handled by the body similarly.

Effects of Dapagliflozin 10 mg on Insulin Resistance in Patients With Type 2 Diabetes Mellitus. [Recruiting]
This is an 8-week, single centre, randomized, parallel-group, double-blind, placebo-controlled Phase IV study to evaluate the effect of dapagliflozin on tissue specific insulin sensitivity in patients with Type 2 diabetes mellitus.

Pharmacodynamics, Pharmacokinetics, Safety and Tolerability of Ultra Low Doses of Dapagliflozin in Healthy Subjects [Completed]
The purpose of this study is to evaluate the pharmacodynamics (PD), pharmacokinetics (PK), safety and tolerability following single oral doses of 0. 001 mg to 2. 5 mg dapagliflozin in healthy subjects.

more trials >>


Page last updated: 2015-08-10

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