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Dapagliflozin Metformin Xr

Xigduo Xr New Fda Drug Approval | Centerwatch

Xigduo Xr New Fda Drug Approval | Centerwatch

Xigduo XR is a combination of dapagliflozin, an inhibitor of sodium-glucose cotransporter 2 (SGLT2), and metformin hydrochloride extended-release, a biguanide. SGLT2 inhibitors remove glucose from the body via the kidneys. Xigduo XR is specifically indicatedas an adjunct therapy to diet and exercise to improve glycemic control in adults with type II diabetes mellitus when treatment with both dapagliflozin and metformin is appropriate. Xigduo XR is supplied as a tablet for oral administration. The starting dose should be individualized based on each patients current treatment regimen. The maximum daily recommended dose is 10 mg for dapagliflozin and 2,000 mg for metformin HCl. Xigduo XR should be taken once daily in the morning with food with gradual dose escalation to reduce the risk of gastrointestinal side effects due to metformin. The FDA approval of Xigduo XR was based on four Phase III clinical trials, which provided clinical evidence for the efficacy and safety of dapagliflozin and metformin IR or XR tablets in treatment-nave patients, in patients inadequately controlled on metformin, as well as compared to a sulfonylurea (glipizide) plus metformin. There have been no clinical studies conducted with Xigduo XR combination tablets. Bioequivalence was demonstrated in healthy adults between Xigduo XR and dapagliflozin plus metformin XR as separate tablets. Adverse reactions associated with the use of Xigduo XR may include, but are not limited to, the following: Xigduo XR combines two anti-hyperglycemic agents with complementary mechanisms of action, dapagliflozin, an inhibitor of sodium-glucose cotransporter 2 (SGLT2), and metformin hydrochloride (HCl) extended-release, a biguanide, in a once-daily oral tablet. SGLT2 inhibitors are a class of medicines that remove gl Continue reading >>

Dapagliflozin And Metformin Extended-release Tablets

Dapagliflozin And Metformin Extended-release Tablets

Dapagliflozin and Metformin Extended-Release Tablets Generic Name: Dapagliflozin and Metformin Extended-Release Tablets (dap a gli FLOE zin & met FOR min) Rarely, metformin may cause an acid health problem in the blood (lactic acidosis). The risk of lactic acidosis is higher in people with kidney problems and in people who take certain other drugs like topiramate . The risk is also higher in people with liver problems or heart failure, in older people (65 or older), or with alcohol use. If lactic acidosis happens, it can lead to other health problems and can be deadly. Lab tests to check the kidneys may be done while taking this medicine (dapagliflozin and metformin extended-release tablets). Talk with the doctor. Call your doctor right away if you have signs of too much lactic acid in the blood (lactic acidosis) like fast breathing, fast or slow heartbeat, a heartbeat that does not feel normal, very bad upset stomach or throwing up, feeling very sleepy, shortness of breath, feeling very tired or weak, very bad dizziness , feeling cold, or muscle pain or cramps. Do not take this medicine (dapagliflozin and metformin extended-release tablets) if you have a very bad infection, low oxygen, or a lot of fluid loss ( dehydration ). If you have liver disease , talk with your doctor. Talk with your doctor before you drink alcohol. If you are having an exam or test with contrast or have had one within the past 48 hours, talk with your doctor. Tell all of your health care providers that you take this medicine (dapagliflozin and metformin extended-release tablets). This includes your doctors, nurses, pharmacists, and dentists. Uses of Dapagliflozin and Metformin Extended-Release Tablets: It is used to lower blood sugar in patients with high blood sugar (diabetes). Ladies A Moment Continue reading >>

Dapagliflozin-metformin Tablet, Immediate Release And Extended Release, Biphasic 24hr (tablet,immed & Ext Release,biphasic 24hr)

Dapagliflozin-metformin Tablet, Immediate Release And Extended Release, Biphasic 24hr (tablet,immed & Ext Release,biphasic 24hr)

Headache , diarrhea , nausea , vomiting , runny nose , or sore throat may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly. If stomach symptoms return later (after taking the same dose for several days or weeks), tell your doctor right away. Stomach symptoms that occur after the first days of your treatment may be signs of lactic acidosis . An empty tablet shell may appear in your stool. This effect is harmless because your body has already absorbed the medication . Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects. Tell your doctor right away if you have any serious side effects, including: signs of a urinary tract infection (such as burning/painful/frequent/urgent urination, pink/bloody urine), signs of kidney problems (such as change in the amount of urine, swelling legs/feet). Use of this medication may result in a new yeast infection in the vagina or penis . You are more likely to get a yeast infection if you have had yeast infections in the genital area before. Uncircumcised men are also at an increased risk for infections. Tell your doctor right away if you have signs of yeast infection in the vagina (such as unusual vaginal discharge /burning/ itching /odor) or in the penis (such as redness/ itching /swelling of the penis, unusual discharge from the penis). Your doctor may direct you to use nonprescription antifungal products to treat these infections. Tell your doctor if your condition persists or worsens after treatment. This medication does not usually cause low blood sugar ( hypoglycemia ). Low blood sugar may occur if this drug is prescribed with oth Continue reading >>

Study Of Dapagliflozin In Combination With Metformin Xr To Initiate The Treatment Of Type 2 Diabetes

Study Of Dapagliflozin In Combination With Metformin Xr To Initiate The Treatment Of Type 2 Diabetes

You have reached the maximum number of saved studies (100). Please remove one or more studies before adding more. Study of Dapagliflozin in Combination With Metformin XR to Initiate the Treatment of Type 2 Diabetes The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. ClinicalTrials.gov Identifier: NCT00859898 Information provided by (Responsible Party): Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information The primary purpose of this study is to compare the change from baseline in hemoglobin A1C achieved with dapagliflozin 10 mg in combination with metformin XR as compared with metformin XR monotherapy and compared with Dapagliflozin monotherapy, after 24 weeks of oral administration of double-blind treatment. The safety of treatment with dapagliflozin will also be assessed in this study Drug: Dapagliflozin Drug: Metformin XR Drug: dapagliflozin matching Placebo Drug: metformin HCl Modified Release matching Placebo Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) A Multicenter, Randomized, Double-Blind, Active Controlled, Parallel Group, Phase 3 Trial to Evaluate the Safety and Efficacy of Dapagliflozin 10 mg in Combination With Metformin as Initial Therapy as Compared With Dapagliflozin 10 mg Monotherapy and Metformin Monotherapy in Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control Dapagliflozin: Tablets, Oral, 10 mg, once daily, 24 weeks Metformin XR: Tablets, Oral, up to 2000 mg, once daily, 24 weeks Tablets, Oral, 10 mg, once daily, 24 weeks Tablets, Oral, up to 2000 mg, once d Continue reading >>

Significant Reduction In A1c Levels When Patients Need More

Significant Reduction In A1c Levels When Patients Need More

Postmarketing cases of metformin-associated lactic acidosis have resulted in death, hypothermia, hypotension, and resistant bradyarrhythmias. Symptoms included malaise, myalgias, respiratory distress, somnolence, and abdominal pain. Laboratory abnormalities included elevated blood lactate levels, anion gap acidosis, increased lactate/pyruvate ratio, and metformin plasma levels generally >5 mcg/mL. Risk factors include renal impairment, concomitant use of certain drugs, age >65 years old, radiological studies with contrast, surgery and other procedures, hypoxic states, excessive alcohol intake, and hepatic impairment. Steps to reduce the risk of and manage metformin-associated lactic acidosis in these high risk groups are provided in the Full Prescribing Information. If lactic acidosis is suspected, discontinue XIGDUO XR and institute general supportive measures in a hospital setting. Prompt hemodialysis is recommended. Contraindications Warnings and Precautions Hypotension: Dapagliflozin causes intravascular volume contraction, and symptomatic hypotension can occur. Assess and correct volume status before initiating XIGDUO XR in patients with impaired renal function, elderly patients, or patients on loop diuretics. Monitor for hypotension. Ketoacidosis has been reported in patients with type 1 and type 2 diabetes receiving dapagliflozin. Some cases were fatal. Assess patients who present with signs and symptoms of metabolic acidosis for ketoacidosis, regardless of blood glucose level. If suspected, discontinue XIGDUO XR, evaluate and treat promptly. Before initiating XIGDUO XR, consider risk factors for ketoacidosis. Patients on XIGDUO XR may require monitoring and temporary discontinuation in situations known to predispose to ketoacidosis. Acute Kidney Injury and Impai Continue reading >>

Xigduo Xr (dapagliflozin/metformin) Dosing, Indications, Interactions, Adverse Effects, And More

Xigduo Xr (dapagliflozin/metformin) Dosing, Indications, Interactions, Adverse Effects, And More

Individualize starting dose based on patients current therapy Take once daily in morning with food, with gradual dose escalation to reduce the adverse GI effects due to metformin Adjust dose based on effectiveness and tolerability; not to exceed daily dose of dapagliflozin 10 mg and metformin 2000 mg (ie, 2 tablets of 5mg/1000mg) Patients taking an evening dose of metformin XR should skip their last dose before starting dapagliflozin/metformin the following morning eGFR 30-45 mL/min/1.73 m: Not recommended to initiate treatment Monitor eGFR at least annually or more often for those at risk for renal impairment (eg, elderly) If eGFR falls below 45mL/min/1.73 m while taking metformin, risks and benefits of continuing therapy should be evaluated If eGFR falls below 30 mL/min/1.73 m: while taking metformin, discontinue the drug Correct volume depletion before initiating in patients not previously treated with dapagliflozin Not for type 1 diabetes mellitus or diabetic ketoacidosis eGFR 30-60 mL/min (8-28.3%; placebo 6.5-16.1%) Age 65 yr and eGFR 30-60 mL/min (7-35.1%; placebo 4.9-19.1%) Female genital mycotic infections (6.9-8.4%) Male genital mycotic infections (2.7-2.8%) Patients on loop diuretics (0-9.7%; 1.8-2.5%) Patients with moderate renal impairment, GFR 30-60 mL/min (0.9-1.9%; placebo 1.5-1.9%) Acute kidney injury and impairment in renal function Cholestatic, hepatocellular, and mixed hepatocellular liver injury Lactic acidosis caused by metformin accumulation (plasma concentration >5 mcg/mL) is a rare but potentially severe consequence; if it occurs, mortality is ~50% Risk increases with certain conditions (eg, renal impairment, sepsis, dehydration, excess alcohol intake, hepatic impairment, and acute CHF) Onset is subtle, accompanied only by nonspecific symptoms Continue reading >>

New Metformin Combination Medicine Approved For Type 2 Diabetes

New Metformin Combination Medicine Approved For Type 2 Diabetes

On October 30, the US Food and Drug Administration (FDA) approved the combination oral diabetes drug Xigduo XR for use, along with a healthful diet and exercise, in adults with Type 2 diabetes. The medicine, a development of AstraZeneca, combines dapagliflozin (brand name Farxiga), an SGLT2 inhibitor, and extended-release metformin (Glucophage XR and others). In the process of filtering the blood, the kidneys typically reabsorb all the filtered glucose and return it to the bloodstream. One of the main proteins responsible for this reabsorption is SGLT2. By inhibiting the action of SGLT2, Farxiga blocks the reabsorption of glucose by the kidneys, promoting a loss of glucose in the urine and lowering blood glucose levels. Metformin works by decreasing the amount of glucose made by the liver and by improving insulin sensitivity in the liver, muscle, and fat cells. Xigduo XR, the first once-daily combination tablet of an SGLT2 inhibitor and extended-release metformin approved in the United States, will be offered in doses of 5 milligrams of dapagliflozin/500 milligrams of metformin, 5 milligrams of dapagliflozin/1,000 milligrams of metformin, 10 milligrams of dapagliflozin/500 milligrams of metformin, and 10 milligrams of dapagliflozin/1,000 milligrams of metformin to be taken once a day in the morning with food. This medicine should not be used in people with Type 1 diabetes, diabetic ketoacidosis (a potentially life-threatening condition marked by a chemical imbalance in the body), or moderate to severe kidney impairment. Because of the inclusion of metformin, Xigduo XR carries the risk of a rare but serious metabolic complication known as lactic acidosis. The most commonly reported side effects of Farxiga plus metformin compared to placebo (inactive treatment) plus metfo Continue reading >>

Xigduo Xr (dapagliflozin/metformin Hydrochloride) Dose, Indications, Adverse Effects, Interactions... From Pdr.net

Xigduo Xr (dapagliflozin/metformin Hydrochloride) Dose, Indications, Adverse Effects, Interactions... From Pdr.net

Xigduo XR Oral Tab ER: 10-1000mg, 10-500mg, 2.5-1000mg, 5-1000mg, 5-500mg For the treatment of type 2 diabetes mellitus in combination with diet and exercise. Individualize the dose based on efficacy and tolerability. Give dose PO once daily in the morning with food. CURRENTLY TAKING DAPGLIFLOZIN: Initiate at the dose that contains metformin 500 mg with a similar total daily dose of dapagliflozin; increase the dose gradually to reduce the GI side effects due to metformin. In older patients, use a conservative initial and maintenance dose of metformin due to the potential for decreased renal function; carefully assess renal function before dose selection. CURRENTLY TAKING METFORMIN: In patients currently treated with metformin, initiate at the dose containing dapagliflozin 5 mg with a similar total daily dose of metformin. For patients requiring a dose of 5 mg dapagliflozin with 2,000 mg metformin, use 2 of the dapagliflozin 2.5 mg/metformin 1,000 mg XR tablets PO once daily. Patients taking an evening dose of metformin XR should skip their last dose before starting dapagliflozin; metformin. Correct volume depletion prior to initiation of dapagliflozin. CURRENTLY TAKING BOTH DRUGS: May switch to combination product using the same total daily doses of each component. For patients requiring a dose of 5 mg dapagliflozin with 2,000 mg metformin, use 2 of the dapagliflozin 2.5 mg/metformin 1,000 mg XR tablets PO once daily. Max: metformin 2,000 mg/day and dapagliflozin 10 mg/day PO. Dapagliflozin 10 mg/day PO and metformin 2000 mg/day PO. Dapagliflozin 10 mg/day PO and metformin 2000 mg/day PO. Safety and efficacy have not been established. Safety and efficacy have not been established. Avoid use in patients with clinical or laboratory evidence of hepatic disease as there is Continue reading >>

Fed And Fasted Single-dose Assessment Of Bioequivalence Of Dapagliflozin And Metformin Extended-release Fixed-dose Combination Tablets Relative To Single-component Dapagliflozin And Metformin Extended-release Tablets In Healthy Subjects

Fed And Fasted Single-dose Assessment Of Bioequivalence Of Dapagliflozin And Metformin Extended-release Fixed-dose Combination Tablets Relative To Single-component Dapagliflozin And Metformin Extended-release Tablets In Healthy Subjects

Volume 38, Issue 1 , 1 January 2016, Pages 99-109 Fed and Fasted Single-dose Assessment of Bioequivalence of Dapagliflozin and Metformin Extended-release Fixed-dose Combination Tablets Relative to Single-component Dapagliflozin and Metformin Extended-release Tablets in Healthy Subjects Author links open overlay panel David W.BoultonPhD1 In patients with type 2 diabetes mellitus, fixed-dose combinations (FDCs) of antihyperglycemic medications may provide complementary efficacy while reducing tablet burden and improving compliance. The aim of this study was to assess the bioequivalence and tolerability of 2 FDCs of dapagliflozin and metformin extended-release (XR) versus their individual component (IC) tablets. An open-label, balanced, randomized, 2-way crossover, 4-arm study was conducted in 129 healthy Brazilian subjects (aged 1855 years). Two oral doses of the FDCs (5mg dapagliflozin and 500mg metformin XR, and 10 mg dapagliflozin and 1000 mg metformin XR) were evaluated in fed and fasted states. Under fed and fasted conditions the 5 mg dapagliflozin and 500 mg metformin XR FDC showed bioequivalence to its ICs. The 10 mg dapagliflozin and 1000 mg metformin XR FDC was bioequivalent to its ICs in fed subjects. Although AUC for the 10 mg dapagliflozin and 1000 mg metformin XR FDC was bioequivalent in fasted subjects, the Cmax for metformin was not bioequivalent to its ICs in fasted subjects (upper 90% CI was 127.5%, and thus outside the 80%125% bioequivalence interval). The small increase in the fasted state is not considered clinically meaningful due to the small magnitude of the difference (9.2%), the lack of metformin Cmax being associated with efficacy or tolerability concerns, and the fasted state not being the recommended state for dosing of metformin XR. The safet Continue reading >>

Dapagliflozin And Metformin

Dapagliflozin And Metformin

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Dapagliflozin/metformin/saxagliptin - Astrazeneca

Dapagliflozin/metformin/saxagliptin - Astrazeneca

Dapagliflozin/metformin/saxagliptin - AstraZeneca Dapagliflozin/metformin/saxagliptin - AstraZeneca Alternative Names: Dapagliflozin/metformin extended release/saxagliptin; Dapagliflozin/saxagliptin/metformin extended release; Metformin extended release/dapagliflozin/saxagliptin; Metformin extended release/saxagliptin/dapagliflozin; Saxagliptin/metformin extended release/dapagliflozin * Final gross price and currency may vary according to local VAT and billing address. * Your purchase entitles you to full access to the information contained in our drug profile at the time of purchase. A link to download a PDF version of the drug profile will be included in your email receipt. Adis is an information provider. We do not sell or distribute the pharmaceutical compounds written about in this database. Class Adamantanes; Antihyperglycaemics; Azabicyclo compounds; Biguanides; Chlorobenzenes; Dipeptides; Glucosides; Nitriles; Organic bridged compounds; Piperidines; Pyrans; Small molecules Mechanism of Action AMP activated protein kinase stimulants; CD26 antigen inhibitors; Gluconeogenesis inhibitors; Sodium-glucose transporter 2 inhibitors Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases. Continue reading >>

Xigduo Xr (dapagliflozin,metformin) Dosage, Indication, Interactions, Side Effects | Empr

Xigduo Xr (dapagliflozin,metformin) Dosage, Indication, Interactions, Side Effects | Empr

Moderate-to-severe renal impairment (eGFR <60mL/min/1.73m2), ESRD, or on dialysis. Metabolic acidosis, diabetic ketoacidosis. Increased risk of metformin-associated lactic acidosis in renal or hepatic impairment, concomitant use of certain drugs (eg, cationic drugs), 65yrs of age, undergoing radiological contrast study, surgery and other procedures, hypoxic states, and excessive alcohol intake; discontinue if lactic acidosis occurs. Discontinue at time of, or prior to intravascular iodinated contrast imaging in patients with a history of hepatic impairment, alcoholism, heart failure, or will be given intra-arterial contrast; reevaluate eGFR 48hrs after procedure and restart therapy if renally stable. Correct volume depletion before initiating. Monitor for symptomatic hypotension in renal impairment (eGFR <60mL/min/1.73m2), elderly, low systolic BP, or on loop diuretics. Assess for ketoacidosis in presence of signs/symptoms of metabolic acidosis, regardless of blood glucose levels; discontinue if suspected, evaluate and treat; consider risk factors before initiation (eg, pancreatic insulin deficiency, caloric restriction, alcohol abuse). Assess renal function prior to starting and periodically thereafter; more frequently in elderly. Risk of acute kidney injury in hypovolemia, chronic renal insufficiency, CHF, and concomitant drugs (eg, diuretics, ACEIs, ARBs, NSAIDs). Consider temporarily discontinuing in reduced oral intake or fluid losses; monitor for acute kidney injury; discontinue and treat if occurs. Elderly, debilitated, uncompensated strenuous exercise, malnourished or deficient caloric intake, adrenal or pituitary insufficiency, or alcohol intoxication: increased risk of hypoglycemia. Monitor for genital mycotic infections, UTIs, hematology (esp. serum Vit. B12 Continue reading >>

Dapagliflozin, Metformin Xr, Or Both: Initial Pharmacotherapy For Type 2 Diabetes, A Randomised Controlled Trial.

Dapagliflozin, Metformin Xr, Or Both: Initial Pharmacotherapy For Type 2 Diabetes, A Randomised Controlled Trial.

Int J Clin Pract. 2012 May;66(5):446-56. doi: 10.1111/j.1742-1241.2012.02911.x. Epub 2012 Mar 13. Dapagliflozin, metformin XR, or both: initial pharmacotherapy for type 2 diabetes, a randomised controlled trial. VA San Diego Healthcare System Research Service and University of California San Diego School of Medicine, San Diego, CA, USA. Combining metformin (XR) with dapagliflozin to initiate pharmacotherapy in patients with type 2 diabetes (T2D) and high baseline HbA1c may be advantageous. We conducted two randomised, double-blind, three-arm 24-week trials in treatment-nave patients to compare dapagliflozin plus metformin, dapagliflozin alone and metformin alone. Eligible patients had baseline HbA1c 7.5-12%. Each trial had three arms: dapagliflozin plus metformin, dapagliflozin monotherapy and metformin monotherapy. Dapagliflozin in combination and as monotherapy was dosed at 5 mg (Study 1) and 10 mg (Study 2). Metformin in combination and as monotherapy was titrated to 2000 mg. The primary endpoint was HbA1c change from baseline; secondary endpoints included change in fasting plasma glucose (FPG) and weight. In both trials, combination therapy led to significantly greater reductions in HbA1c compared with either monotherapy: -2.05 for dapagliflozin + metformin, -1.19 for dapagliflozin, and -1.35 for metformin (p < 0.0001) (Study 1); -1.98 for dapagliflozin + metformin, -1.45 for dapagliflozin and -1.44 for metformin (p < 0.0001) (Study 2). Combination therapy was statistically superior to monotherapy in reduction of FPG (p < 0.0001 for both studies); combination therapy was more effective than metformin for weight reduction (p < 0.0001). Dapagliflozin 10 mg was non-inferior to metformin in reducing HbA1c (Study 2). Events suggestive of genital infection were reported Continue reading >>

Investigational Compound Dapagliflozin With Metformin Extended-release (xr) As Initial Combination Therapy Significantly Improved Blood Sugar Control In Previously-untreated Adult Type 2 Diabetes Patients With High Blood Sugar Levels

Investigational Compound Dapagliflozin With Metformin Extended-release (xr) As Initial Combination Therapy Significantly Improved Blood Sugar Control In Previously-untreated Adult Type 2 Diabetes Patients With High Blood Sugar Levels

Investigational Compound Dapagliflozin with Metformin Extended-Release (XR) as Initial Combination Therapy Significantly Improved Blood Sugar Control in Previously-Untreated Adult Type 2 Diabetes Patients with High Blood Sugar Levels SAN DIEGO--( BUSINESS WIRE )-- Bristol-Myers Squibb Company (NYSE: BMY) and AstraZeneca (NYSE: AZN) today announced results from two 24-week Phase 3 clinical studies examining the investigational compound dapagliflozin at 5 mg or 10 mg (clinical trial dose) plus metformin extended-release (XR). In previously-untreated adults with type 2 diabetes who had high baseline blood sugar levels (glycosylated hemoglobin levels or HbA1c) of up to 12% (mean baseline of 9%), the studies showed that dapagliflozin plus metformin XR significantly reduced blood sugar levels compared to dapagliflozin or metformin XR alone plus placebo. There were no major hypoglycemia-related events in the studies. Minor hypoglycemia was observed more frequently in the combination arm than for either agent alone. The results of the two studies were presented at the 71st American Diabetes Association (ADA) Scientific Sessions in San Diego, CA. The studies showed that dapagliflozin in combination with metformin XR improved morning blood sugar (fasting plasma glucose, or FPG), had a higher proportion of patients achieving a therapeutic glycemic response of HbA1c < 7% and improved weight reduction compared to dapagliflozin or metformin XR alone. In addition, the clinical trial dose of dapagliflozin 10 mg was non-inferior compared to metformin XR in reducing blood sugar levels and was statistically superior to metformin XR in reducing morning blood sugar and weight. Signs, symptoms and other reports suggestive of genital infections were more common in the dapagliflozin treatment Continue reading >>

Xigduo Xr (dapagliflozin And Metformin Hcl Extended-release Tablets): Side Effects, Interactions, Warning, Dosage & Uses

Xigduo Xr (dapagliflozin And Metformin Hcl Extended-release Tablets): Side Effects, Interactions, Warning, Dosage & Uses

(dapagliflozin and metformin HCl) Extended-Release Tablets Postmarketing cases of metformin-associated lactic acidosis have resulted in death, hypothermia, hypotension, and resistant bradyarrhythmias. The onset of metformin-associated lactic acidosis is often subtle, accompanied only by nonspecific symptoms such as malaise, myalgias, respiratory distress, somnolence, and abdominal pain. Metformin-associated lactic acidosis was characterized by elevated blood lactate levels ( > 5 mmol/Liter), anion gap acidosis (without evidence of ketonuria or ketonemia), an increased lactate/pyruvate ratio; and metformin plasma levels generally > 5 mcg/mL [see WARNINGS AND PRECAUTIONS ]. Risk factors for metformin-associated lactic acidosis include renal impairment, concomitant use of certain drugs (e.g., carbonic anhydrase inhibitors such as topiramate), age 65 years old or greater, having a radiological study with contrast, surgery and other procedures, hypoxic states (e.g., acute congestive heart failure), excessive alcohol intake, and hepatic impairment. Steps to reduce the risk of and manage metformin-associated lactic acidosis in these high risk groups are provided in the full prescribing information [see DOSAGE AND ADMINISTRATION , CONTRAINDICATIONS , WARNINGS AND PRECAUTIONS , DRUG INTERACTIONS , and Use in Specific Populations ]. If metformin-associated lactic acidosis is suspected, immediately discontinue XIGDUO XR and institute general supportive measures in a hospital setting. Prompt hemodialysis is recommended [see WARNINGS AND PRECAUTIONS ]. XIGDUO XR (dapagliflozin and metformin HCl)extended-release tablets contain two oral antihyperglycemic medications usedin the management of type 2 diabetes : dapagliflozin and metforminhydrochloride. Dapagliflozin is described chemic Continue reading >>

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