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Oral hypoglycemic drug.
Mechanism of action
Dapagliflozin is a potent (inhibition constant (Ki) 0.55 nM), a selective, reversible inhibitor of sodium-glucose cotransporter type 2 (SGLT2). SGLT2 is selectively expressed in the kidneys and is not found in more than 70 other tissues of the body (including in the liver, skeletal muscles, adipose tissue, mammary glands, bladder and brain). SGLT2 is the main carrier involved in the process of glucose reabsorption in the renal tubules. Glucose reabsorption in the renal tubules in patients with type 2 diabetes mellitus (type 2 diabetes) continues despite hyperglycemia. By inhibiting the renal transfer of glucose, dapagliflozin reduces its reabsorption in the renal tubules, which leads to the elimination of glucose by the kidneys. The result of dapagliflozin is a decrease in fasting and postprandial glucose concentrations, as well as a decrease in the concentration of glycosylated hemoglobin in patients with type 2 diabetes.
Glucose excretion (glucosuric effect) is observed already after taking the first dose of the drug, it persists for the next 24 hours and lasts for the duration of therapy. The amount of glucose excreted by the kidneys due to this mechanism depends on the concentration of glucose in the blood and on the glomerular filtration rate (GFR). Dapagliflozin does not interfere with normal endogenous glucose production in response to hypoglycemia. The effect of dapagliflozin does not depend on insulin secretion and insulin sensitivity. In clinical studies of Farxiga ™, an improvement in β-cell function was noted (HOMA test, homeostasis model assessment).
Excretion of glucose by the kidneys, caused by dapagliflozin, is accompanied by loss of calories and weight loss. Inhibition of sodium glucose cotransport by dapagliflozin is accompanied by weak diuretic and transient natriuretic effects.
Dapagliflozin does not affect other glucose transporters that transport glucose to peripheral tissues and shows more than 1,400 times greater selectivity for SGLT2 than for SGLT1, the main intestinal transporter responsible for glucose absorption.
After dapagliflozin was taken by healthy volunteers and patients with type 2 diabetes, an increase in the amount of glucose excreted by the kidneys was observed. When receiving dapagliflozin at a dose of 10 mg / day for 12 weeks, patients with type 2 diabetes took about 70 g of glucose / day by the kidneys (which corresponds to 280 kcal / day). In patients with type 2 diabetes who took dapagliflozin at a dose of 10 mg / day for a long time (up to 2 years), glucose excretion was maintained throughout the entire course of therapy.
The excretion of glucose by the kidneys with dapagliflozin also leads to osmotic diuresis and an increase in urine volume. The increase in urine volume in patients with diabetes mellitus 2 who took dapagliflozin at a dose of 10 mg / day was maintained for 12 weeks and was approximately 375 ml / day. The increase in urine volume was accompanied by a small and transient increase in sodium excretion by the kidneys, which did not change the serum sodium concentration.
A planned analysis of the results of 13 placebo-controlled studies demonstrated a decrease in systolic blood pressure (SBP) by 3.7 mm Hg. and diastolic blood pressure (DBP) at 1.8 mm Hg. at week 24 of dapagliflozin therapy at a dose of 10 mg / day compared with a decrease in SBP and DBP by 0.5 mm Hg. in the placebo group. A similar decrease in blood pressure was observed during 104 weeks of treatment.
When using dapagliflozin in a dose of 10 mg / day in patients with type 2 diabetes with inadequate glycemic control and arterial hypertension, receiving angiotensin II receptor blockers, ACE inhibitors, incl. in combination with another antihypertensive drug, a decrease in the glycosylated hemoglobin index by 3.1% and a decrease in the MAP by 4.3 mm Hg were noted. after 12 weeks of therapy compared with placebo.
Type 2 diabetes in addition to diet and exercise to improve glycemic control as:
- additions to therapy with metformin, sulfonylurea derivatives (including in combination with metformin), thiazolidinedione, dipeptidyl peptidase 4 (DPP-4) inhibitors (including in combination with metformin), insulin preparations (including in combination with one or two hypoglycemic drugs for oral administration) in the absence of adequate glycemic control on this therapy;
- starting combination therapy with metformin, with appropriateness of this therapy.
1 tab. dapagliflozin propandiol monohydrate 12.3 mg, which corresponds to the content of dapagliflozin 10 mg
Excipients: microcrystalline cellulose - 171.45 mg, anhydrous lactose - 50 mg, crospovidone - 10 mg, silicon dioxide - 3.75 mg, magnesium stearate - 2.5 mg.
The composition of the shell: Opadray® II yellow - 10 mg (polyvinyl alcohol partially hydrolyzed - 4 mg, titanium dioxide - 2.35 mg, macrogol 3350 - 2.02 mg, talc - 1.48 mg, iron dye yellow oxide - 0.15 mg).
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Dosage and Administration
The drug is taken orally, regardless of the meal.
Monotherapy: the recommended dose of Farxiga ™ is 10 mg 1 time / day.
Combination therapy: the recommended dose of Farxiga ™ is 10 mg 1 time / day in combination with metformin, sulfonylurea derivatives (including in combination with metformin), thiazolidinedione, DPP-4 inhibitors (including in combination with metformin ), insulin preparations (including in combination with one or two hypoglycemic preparations for oral administration).
In order to reduce the risk of hypoglycemia with co-administration of the Farxiga®z® drug with insulin preparations or drugs that increase insulin secretion (for example, with a sulfonylurea derivative), it may be necessary to reduce the dose of insulin preparations or drugs that increase insulin secretion.
Starting combination therapy with metformin: the recommended dose of the drug Farxiga ™ is 10 mg 1 time / day, the dose of metformin is 500 mg 1 time / day. In case of inadequate glycemic control, the dose of metformin should be increased.
When violations of the liver of mild or moderate severity there is no need to adjust the dose. For patients with severely impaired liver function, an initial dose of 5 mg is recommended. With good tolerance, the dose can be increased to 10 mg.
The effectiveness of dapagliflozin depends on the function of the kidneys. In patients with impaired renal function of moderate severity, the effectiveness of treatment is reduced, and in patients with severe impairment, most likely, is absent. Farxiga ™ is contraindicated in patients with moderate to severe renal failure (CC <60 ml="" min="" or="" gfr="" 60="" 1="" 73="" m2="" with="" end-stage="" renal="" disease="" when="" violations="" of="" the="" kidney="" mild="" dose="" adjustment="" is="" not="" required="" p="">
The safety and efficacy of dapagliflozin in children and adolescents under the age of 18 years has not been studied.
Elderly patients dose adjustment is not required. However, when choosing a dose, it should be borne in mind that this category of patients is more likely to have impaired renal function and the risk of diminishing BCC. Since the clinical experience of the drug in patients aged 75 years and older is limited, it is contraindicated to begin therapy with dapagliflozin in this age group.
The pre-planned analysis of pooled data included the results of 12 placebo-controlled studies in which 1,193 patients took dapagliflozin at a dose of 10 mg and 1,393 patients received placebo.
The overall incidence of adverse events (short-term therapy) in patients taking dapagliflozin at a dose of 10 mg was similar to that in the placebo group. The number of adverse events leading to discontinuation of therapy was small and balanced between treatment groups. The most frequent adverse events that led to the discontinuation of dapagliflozin therapy at a dose of 10 mg were an increase in the concentration of creatinine in the blood (0.4%), urinary tract infection (0.3%), nausea (0.2%), dizziness (0.2%) and rash (0.2% ). In one patient who took dapagliflozin, the development of an adverse event on the part of the liver was diagnosed with drug-induced hepatitis and / or autoimmune hepatitis.
The most frequent adverse reaction was hypoglycemia, the development of which depended on the type of basic therapy used in each study. The incidence of mild hypoglycemia was similar in treatment groups, including placebo.
Description of individual unwanted reactions
The incidence of hypoglycemia depended on the type of basic therapy used in each study.
In studies of dapagliflozin as monotherapy, combination therapy with metformin for up to 102 weeks, the incidence of episodes of mild hypoglycemia was similar (<5%) in treatment groups, including placebo. In all studies, episodes of severe hypoglycemia were rarely observed, and their frequency was comparable between the dapagliflozin group and placebo.
Adverse reactions associated with a decrease in BCC (including reports of dehydration, hypovolemia, or arterial hypotension) were noted in 0.8% and 0.4% of patients taking dapagliflozin 10 mg and placebo, respectively; severe reactions were observed in <0.2% of patients, and they were comparable in the dapagliflozin 10 mg and placebo groups.
Vulvovaginitis, balanitis and similar genital infections
Vulvovaginitis, balanitis, and similar genital infections are noted in 4.8% and 0.9% of patients taking dapagliflozin 10 mg and placebo, respectively. Most infections were mild or moderate; the initial course of standard therapy was effective, and therefore patients rarely stopped taking dapagliflozin. These infections more often developed in women (6.9% and 1.5% with dapagliflozin and placebo, respectively), and in patients with such infections in history, they more often recurred.
Urinary tract infections
Urinary tract infections are more common with dapagliflozin 10 mg than with placebo (4.3% compared with 3.7%, respectively). Most infections were mild or moderate; the initial course of standard therapy was effective, and therefore patients rarely stopped using dapagliflozin. These infections more often developed in women, and in patients with such infections in history, they more often recurred.
Parathyroid hormone (PTH)
A slight increase in serum PTH concentration was noted, and to a greater extent in patients with higher baseline PTH concentrations. Studies of bone mineral density in patients with normal renal function or mild renal impairment did not reveal bone loss during one year of therapy.
In clinical studies, the overall proportion of patients with malignant or unspecified tumors was similar in the dapagliflozin group (1.47%) and the placebo / comparator group (1.35%). According to animal studies, the drug did not show carcinogenic or mutagenic properties. When considering the development of tumors of various organ systems, the relative risk associated with dapagliflozin was above 1 for some tumors (bladder, prostate, breast) and below 1 for others (for example, blood and lymphatic system, ovaries, urinary system) , generally without increasing the risk of developing tumors associated with dapagliflozin. The increased / decreased risk was not statistically significant for any organ system. Given the lack of information on the development of tumors in preclinical studies, as well as the short latent period between the first exposure of the drug and the diagnosis of the tumor, the causal relationship is assessed as unlikely. Since the numerical imbalance of breast, bladder and prostate tumors requires special attention, the study of this issue will be continued in the framework of post-registration studies.
Elderly patients (≥65 years)
Adverse reactions associated with impaired renal function or renal failure were reported in 2.5% of patients who received dapagliflozin and 1.1% of patients who received placebo in a group of patients aged ≥65 years. The most common adverse reaction associated with impaired renal function was an increase in serum creatinine concentration. Most of these reactions were transient and reversible. Among patients aged ≥65 years, a decrease in BCC, most often recorded as arterial hypotension, was observed in 1.5% and 0.4% of patients taking dapagliflozin and placebo, respectively.
- diabetes mellitus type 1;
- diabetic ketoacidosis;
- moderate to severe renal failure (GFR <60 ml="" min="" 1="" 73="" m2="" or="" end-stage="" renal="" disease="" p="">
- hereditary lactose intolerance, lactase deficiency and glucose-galactose intolerance;
- breastfeeding period;
- children's and teenage age up to 18 years (safety and efficiency are not studied);
- patients taking "loop" diuretics, or with a reduced BCC, for example, due to acute diseases (such as gastrointestinal diseases);
- Elderly patients aged 75 years and older (to start therapy);
- increased individual sensitivity to any component of the drug.
With caution: severe liver failure, urinary tract infection, risk of diminished BCC, elderly patients, chronic heart failure, increased hematocrit.
Dapagliflozin may increase the diuretic effect of thiazide and "loop" diuretics and increase the risk of dehydration and hypotension.
Against the background of the use of insulin and drugs that increase insulin secretion, hypoglycemia may occur. Therefore, in order to reduce the risk of hypoglycemia with a joint appointment of the drug Farxiga ™ with an insulin preparation or a drug that increases insulin secretion, it may be necessary to lower the dose of the insulin preparation or the drug that increases insulin secretion.
The metabolism of dapagliflozin is mainly carried out by glucuronide conjugation under the action of UGT1A9.
During in vitro studies, dapagliflozin did not inhibit cytochrome P450 isoenzymes of CYP1A2, CYP2A6, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, CYP3A4, and did not induce CYP1A2, CYP22 isoenzymes, CYP2A6, CYP3A4, CYP2A6, CYP2A6. In this regard, the effect of dapagliflozin on the metabolic clearance of concomitant drugs that are metabolized by these isoenzymes is not expected.
Effects of Other Drugs on Dapagliflozin
Interaction studies involving healthy volunteers, mainly taking a single dose of the drug, have shown that metformin, pioglitazone, sitagliptin, glimepiride, voglibose, hydrochlorothiazide, bumetanide, valsartan or simvastatin do not affect the pharmacokinetics of dapagliflozine.
After joint use of dapagliflozin and rifampicin, an inducer of various active transporters and drug metabolizing enzymes, a decrease in systemic exposure (AUC) of dapagliflozin by 22% was observed, with no clinically significant effect on the daily glucose excretion by the kidneys. It is not recommended to adjust the dose of the drug. No clinically significant effect is expected when used with other inducers (for example, carbamazepine, phenytoin, phenobarbital).
After the joint use of dapagliflozin and mefenamic acid (UGT1A9 inhibitor), a 55% increase in systemic exposure to dapagliflozin was noted, but without a clinically significant effect on the daily excretion of glucose by the kidneys. It is not recommended to adjust the dose of the drug.
The effect of dapagliflozin on other drugs
In studies of interactions involving healthy volunteers, mainly taking a single dose of the drug, dapagliflozin did not interfere with aphromine pharmacokinetics of metformin, pioglitazone, sitagliptin, glimepiride, hydrochlorothiazide, bumetanide, valsartan, digoxin (P-gp substrate), or orp, bumetanide, valsartan, digoxin (substrate P-gl or, or -tromide, bumetanide, valsartan, digoxin (substrate P-gl or, or), or pimlitrid, hydrochlorothiazide, bumetanide, valsartan, digoxin (substrate P-gl or, or). CYP2C9 isoenzyme), or on the anticoagulant effect, as assessed by MHO. The use of dapagliflozin in a single dose of 20 mg and simvastatin (CYP3A4 isoenzyme substrate) resulted in an increase of 19% in the AUC of simvastatin and in a 31% AUC of simvastatinic acid. Increasing the exposure of simvastatin and simvastatinic acid is not considered clinically significant.
Other types of interaction
The effects of smoking, diet, taking herbal remedies and drinking alcohol on the parameters of dapagliflozin pharmacokinetics have not been studied.
Pregnancy and Lactation
Due to the fact that the use of dapagliflozin during pregnancy has not been studied, the drug is contraindicated in this category of patients. If pregnancy is diagnosed, dapagliflozin therapy should be discontinued.
It is not known whether dapagliflozin and / or its inactive metabolites into breast milk. Risk to infants / babies cannot be excluded. Dapagliflozin contraindicated during breastfeeding.
Use in patients with impaired renal function
The effectiveness of dapagliflozin depends on the kidney function, and this efficiency is reduced in patients with moderate renal insufficiency and is probably absent in patients with severe renal impairment. Among patients with moderate renal insufficiency (CC <60 ml="" min="" or="" estimated="" gfr="" 60="" 1="" 73="" m2="" a="" greater="" proportion="" of="" patients="" receiving="" dapagliflozin="" showed="" an="" increase="" in="" the="" concentration="" creatinine="" phosphorus="" pth="" and="" arterial="" hypotension="" placebo="" farxiga="" is="" contraindicated="" with="" moderate="" to="" severe="" renal="" failure="" cc="" was="" not="" studied="" 30="" end-stage="" disease="" p="">
It is recommended to monitor kidney function as follows:
- before the start of therapy with dapagliflozin and at least once a year thereafter;
- before the start of concomitant medication, which can reduce kidney function, and periodically afterwards;
- in violation of renal function, close to moderate severity, at least 2-4 times a year. If the renal function decreases below QC <60 ml="" min="" or="" estimated="" gfr="" 60="" 1="" 73="" m2="" dapagliflozin="" should="" be="" stopped="" p="">
Use in patients with impaired liver function
In clinical studies, limited data on the use of the drug in patients with impaired liver function were obtained. Dapagliflozin exposure is increased in patients with severely impaired liver function.
Use in patients with the risk of reducing the BCC development of arterial hypotension and / or electrolyte imbalance
In accordance with the mechanism of action dapagliflozin increases diuresis, accompanied by a slight decrease in blood pressure. The diuretic effect may be more pronounced in patients with very high blood glucose concentrations.
Dapagliflozin is contraindicated in patients taking "loopback" diuretics, or in patients with reduced BCC, for example, due to acute diseases (such as gastrointestinal diseases).
Care must be taken in patients for whom dapagliflozin-induced reduction in blood pressure may pose a risk, for example, in patients with a history of cardiovascular disease, in patients with a history of arterial hypotension who are receiving antihypertensive therapy, or in elderly patients.
When taking dapagliflozin, careful monitoring of the state of the BCC and electrolyte concentrations (for example, physical examination, blood pressure measurement, laboratory tests, including hematocrit) are recommended against the background of concomitant conditions that may lead to a decrease in the BCC. When reducing the BCC, it is recommended to temporarily stop taking dapagliflozin before correcting this condition.
With the post-marketing use of the drug, ketoacidosis has been reported, incl. diabetic ketoacidosis, in patients with type 1 and 2 diabetes mellitus, taking the drug Farxiga ™ and other inhibitors of SGLT2, although a causal link has not been established.Forsig ™ is not indicated for the treatment of patients with type 1 diabetes.
Patients taking Farxiga ™ ™ with signs and symptoms indicating ketoacidosis, including nausea, vomiting, abdominal pain, malaise, and shortness of breath, should be checked for ketoacidosis even if the blood glucose concentration is below 14 mmol / L. If ketoacidosis is suspected, the possibility of withdrawing or discontinuing the use of Forsigum ™ should be considered and the patient should be examined immediately.
Factors predisposing to the development of ketoacidosis include low functional β-cell activity due to dysfunction of the pancreas (for example, diabetes mellitus type 1, pancreatitis or pancreatic surgery in history) insulin due to infection, disease or surgery, and alcohol abuse. The drug Farxiga®® should be used with caution in these patients.
Urinary tract infection
When analyzing the combined data, the use of dapagliflozin up to 24 weeks of urinary tract infection is more often noted with the use of dapagliflozin at a dose of 10 mg compared with placebo. The development of pyelonephritis was noted infrequently, with a similar frequency in the control group. The excretion of glucose by the kidneys may be accompanied by an increased risk of developing urinary tract infections, therefore, when treating pyelonephritis or urosepsis, the possibility of temporary discontinuation of dapagliflozin therapy should be considered.
Urosepsis and pyelonephritis. With post-marketing use of the drug, serious urinary tract infections, including urosepsis and pyelonephritis, have been reported, requiring hospitalization of patients taking Farxiga ™ and other SGLT2 inhibitors. Therapy with SGLT2 inhibitors increases the risk of developing urinary tract infections. Patients should be monitored for signs and symptoms of urinary tract infections and, if indicated, should be treated immediately.
Older patients are more likely to have impaired renal function and / or use of antihypertensive drugs that can affect kidney function, such as ACE inhibitors and angiotensin II type 1 receptor antagonists (ARA). For older patients, the same recommendations apply for renal impairment as for all patient populations.
In the group of patients aged ≥65 years, a greater proportion of patients who received dapagliflozin developed adverse reactions associated with impaired renal function or renal insufficiency compared with placebo. The most common adverse reaction associated with impaired renal function was an increase in serum creatinine, most cases were transient and reversible.
Elderly patients may have a higher risk of reducing BCC, and diuretics are more likely to be taken. A greater proportion of patients aged ≥65 years who received dapagliflozin had adverse reactions associated with a decrease in BCC.
Experience with the drug in patients aged 75 years and older is limited. It is contraindicated to begin therapy with dapagliflozin in this population.
Chronic heart failure
The experience of using the drug in patients with chronic heart failure I-II FC according to the NYHA classification is limited, and in clinical studies, dapagliflozin was not used in patients with chronic heart failure III-IV FC according to NYHA.
When using dapagliflozin, an increase in hematocrit was observed, and therefore caution should be exercised in patients with an increased hematocrit.
Evaluation results of urine analysis
Due to the mechanism of action of the drug, the results of urine glucose testing in patients taking Farxiga ™ will be positive.
Effect on the determination of 1,5-anhydroglucitol
Evaluation of glycemic control using the determination of 1,5-anhydroglucitol is not recommended, because measuring 1,5-anhydroglucitol is not a reliable method for patients taking SGLT2 inhibitors. Alternative methods should be used to evaluate glycemic control.
Influence on ability to drive motor transport and control mechanisms
Studies on the effect of dapagliflozin on the ability to drive vehicles and mechanisms have been conducted.
Dapagliflozin is safe and well tolerated by healthy volunteers when taken once in doses of up to 500 mg (50 times higher than the recommended dose). Glucose was determined in the urine after taking the drug (at least 5 days after taking a dose of 500 mg), while no cases of dehydration, arterial hypotension, electrolyte imbalance, or clinically significant effect on the QTc interval were detected. The incidence of hypoglycemia was similar to the frequency with placebo. In clinical studies in healthy volunteers and patients with T2DM who took the drug once in doses up to 100 mg (10 times higher than the maximum recommended dose) for 2 weeks, the incidence of hypoglycemia was slightly higher than when taking placebo, and did not depend on the dose . The incidence of adverse events, including dehydration or hypotension, was similar to the incidence in the placebo group, with no clinically significant, dose-dependent changes in laboratory parameters, including serum electrolyte concentrations and biomarkers of renal function.
Treatment: in case of overdose, it is necessary to carry out maintenance therapy, taking into account the patient's condition. Removal of dapagliflozin using hemodialysis has not been studied.
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- Evaluation of the effect of dapagliflozin on cardiac repolarization: a thorough QT/QTc study
- Dapagliflozin treatment in patients with different stages of type 2 diabetes mellitus: effects on glycaemic control and body weight
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- Effect of a high-fat meal on the pharmacokinetics of dapagliflozin, a selective SGLT2 inhibitor, in healthy subjects
- 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
- Dapagliflozin, a Novel, Selective SGLT2 Inhibitor, Improved Glycemic Control Over 2 Weeks in Patients With Type 2 Diabetes Mellitus
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- Influence of Hepatic Impairment on the Pharmacokinetics and Safety Profile of Dapagliflozin: An Open-Label, Parallel-Group, Single-Dose Study
- Synthesis and biological evaluation of SGLT2 inhibitors: gem-difluoromethylenated Dapagliflozin analogs
- Dapagliflozin, metformin XR, or both: initial pharmacotherapy for type 2 diabetes, a randomised controlled trial
- Dapagliflozin has no effect on markers of bone formation and resorption or bone mineral density in patients with inadequately controlled type 2 diabetes mellitus on metformin
- Dapagliflozin monotherapy in drug-naïve patients with diabetes: a randomized-controlled trial of low-dose range
- Discovery of Dapagliflozin: A Potent, Selective Renal Sodium-Dependent Glucose Cotransporter 2 (SGLT2) Inhibitor for the Treatment of Type 2 Diabetes
- Dapagliflozin for the Treatment of Type 2 Diabetes
- Effect of dapagliflozin in patients with type 2 diabetes who have inadequate glycaemic control with metformin: a randomised, double-blind, placebo-controlled trial
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- Dapagliflozin: A Once-Daily Oral Therapy Sodium-Glucose Cotransporter-2 Inhibitor for the Treatment of Adult Patients with Type 2 Diabetes