Patients on metformin at a dose of at least 1500 mg per day were randomized following a 2-week placebo lead-in period to glipizide or dapagliflozin (5 mg or 2.5 mg, respectively) and were up-titrated over 18 weeks to optimal glycemic effect (FPG <110 mg/dL, <6.1 mmol/L) or to the highest dose level (up to glipizide 20 mg and FARXIGA 10 mg) as tolerated by patients. renal effects, FARXIGA is not recommended during the second and third Dapagliflozin, a novel, selective SGLT2 inhibitor, improved glycemic control over 2 weeks in patients with type 2 diabetes mellitus. skin (erythema)Inform patients Safety and efficacy were similar for patients age 65 years and younger and those older than 65.FARXIGA was evaluated in two glycemic control studies that included patients with type 2 diabetes mellitus with moderate renal impairment (an eGFR of 45 to less than 60 mL/min/1.73 mUse of FARXIGA for glycemic control in patients without established CV disease or CV risk factors is not recommended when eGFR is less than 45 mL/min/1.73 mNo dose adjustment is recommended for patients with mild, moderate, or severe hepatic impairment. Trujillo JM, Nuffer WA. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. Thereafter, doses were kept constant, except for down-titration to prevent hypoglycemia.At the end of the titration period, 87% of patients treated with FARXIGA had been titrated to the maximum study dose (10 mg) versus 73% treated with glipizide (20 mg).
59. effects on developmental endpoints A total of 1424 (24%) of the 5936 FARXIGA-treated patients were 65 years
Bailey CJ, Gross JL, Pieters A, Bastien A, List JF. Jardine MJ, Mahaffey KW, Neal B et al.
Effect of dapagliflozin in patients with type 2 diabetes who have inadequate glycaemic control with metformin: a randomised, double-blind, placebo-controlled trial. Inzucchi SE, Zinman B, Wanner C et al. contraction, and can cause In the DECLARE
In addition, no clinically meaningful effect on QTc interval was observed following single doses of up to 500 mg (50-times the recommended maximum dose) of dapagliflozin in healthy subjects.Following oral administration of dapagliflozin, the maximum plasma concentration (Cmax) is usually attained within 2 hours under fasting state. 71. ANDAs are not included.Safety-related Labeling Changes Approved by FDA Center for Drug Evaluation and Research (CDER)The Endpoints were tested for FARXIGA 10 mg versus placebo for the total study group (sitagliptin with and without metformin) and for each stratum (sitagliptin alone or sitagliptin with metformin). Long-term study of patients with type 2 diabetes and moderate renal impairment shows that dapagliflozin reduces weight and blood pressure but does not improve glycemic control. Erondu N, Desai M, Ways K et al.
Influence of hepatic impairment on the pharmacokinetics and safety profile of dapagliflozin: an open-label, parallel-group, single-dose study.. 23. closely monitor blood glucose levels, and provide appropriate alternative FARXIGA is not recommended No adverse A statistically significant (p <0.05) mean change from baseline in systolic blood pressure relative to placebo in combination with metformin and a sulfonylurea was -3.8 mmHg with FARXIGA 10 mg in combination with metformin and a sulfonylurea at Week 8.A total of 420 patients with type 2 diabetes mellitus with inadequate glycemic control (HbA1c ≥7% and ≤10.5%) participated in a 24-week, placebo-controlled study to evaluate FARXIGA in combination with pioglitazone (a thiazolidinedione [TZD]) alone (NCT00683878).
Peters AL, Buschur EO, Buse JB et al. Changes in insulin sensitivity and insulin secretion with the sodium glucose cotransporter 2 inhibitor dapagliflozin. American Diabetes Association. were noted at 1 mg/kg/day 10.
Rosenstock J, Perl S, Johnsson E et al. <0.1% of patients It is not known if FARXIGA passes into Characterization of renal glucose reabsorption in response to dapagliflozin in healthy subjects and subjects with type 2 diabetes. 606. Fasciitis of the Perineum (Fournier’s gangrene) Randomized, double-blind trial of triple therapy with saxagliptin add-on to dapagliflozin plus metformin in patients with type 2 diabetes.. 84. 598. Wiviott SD, Raz I, Bonaca MP et al. 9. 2016 Joint Annual Scientific Meeting of the Australian Diabetes Educators Association (ADEA) and Australian Diabetes Society (ADS). Call your doctor for medical advice about side effects. to ketoacidosis, including pancreatic insulin deficiency from any cause, caloric The renal pelvic and tubular dilatations observed in juvenile animals did not fully reverse within a 1-month recovery period.In embryofetal development studies in rats and rabbits, dapagliflozin was administered throughout organogenesis, corresponding to the first trimester of human pregnancy. Increases that do not fit this pattern should prompt further evaluation to exclude the possibility of acute kidney injury [see In the pool of 13 placebo-controlled studies of glycemic control, increases from baseline in mean In the pool of 13 placebo-controlled studies of glycemic control, changes from baseline in mean In a study of concomitant therapy of FARXIGA 10 mg with exenatide extended-release (on a background of metformin), four patients (1.7%) on concomitant therapy had a serum No new adverse reactions were identified in the DAPA-HF heart failure study.Additional adverse reactions have been identified during postapproval use of FARXIGA in patients with diabetes mellitus. 29. Clinical pharmacokinetics and pharmacodynamics of dapagliflozin, a selective inhibitor of sodium-glucose co-transporter type 2.