Xigduo Xr

Hypesthesia, Hypesthesia, Hypesthesia + 13 more

Treatment

6 FDA approvals

20 Active Studies for Xigduo Xr

What is Xigduo Xr

Dapagliflozin

The Generic name of this drug

Treatment Summary

Metformin is a medication used to treat type 2 diabetes. It helps lower blood sugar levels without causing low blood sugar, and can also lead to modest weight loss. It has been prescribed to over 120 million people worldwide, and is the preferred treatment for obese type 2 diabetes patients. Metformin was first approved in Canada in 1972 and in the United States in 1995. It comes in both regular and extended-release forms.

Farxiga

is the brand name

Xigduo Xr Overview & Background

Brand Name

Generic Name

First FDA Approval

How many FDA approvals?

Farxiga

Dapagliflozin

2008

19

Approved as Treatment by the FDA

Dapagliflozin, also known as Farxiga, is approved by the FDA for 6 uses such as Type 2 Diabetes Mellitus and Physical Activity .

Type 2 Diabetes Mellitus

Used to treat Type 2 Diabetes Mellitus in combination with Metformin

Physical Activity

Used to treat Exercise in combination with Metformin

Diet

Used to treat Diet in combination with Metformin

Type 2 Diabetes

Used to treat Type 2 Diabetes Mellitus in combination with Metformin

Pharmaceutical Preparations

Used to treat previously treated with drugs in combination with Saxagliptin

inadequate response to monotherapy

Used to treat inadequate response to monotherapy in combination with Saxagliptin

Effectiveness

How Xigduo Xr Affects Patients

Insulin is an important hormone that helps to regulate the amount of glucose (sugar) in your blood. People with Type 2 diabetes either have trouble responding to insulin or do not produce enough of it. Metformin works by reducing the amount of glucose made in the liver, preventing its absorption in the intestines, and making it easier for cells to use insulin. Unlike other diabetes drugs, it does not increase the levels of insulin in the body. In a 29-week clinical trial, metformin lowered fasting plasma glucose levels by 59 mg/dL and HbA1c (measurement of glucose control)

How Xigduo Xr works in the body

Metformin works to lower blood glucose levels by decreasing the production of glucose in the liver, blocking its absorption in the intestines, and making cells more sensitive to insulin. It enters cells and mitochondria, where it affects the production of ATP and activates an enzyme called AMPK. This enzyme prevents fat production and storage, while also blocking the production of chemical signals that increase glucose production. In the intestines, metformin increases anaerobic glucose metabolism, leading to less glucose being absorbed. It also promotes the metabolism of glucose by increasing another enzyme called GLP-1. How exactly metformin works is still being studied.

When to interrupt dosage

The proposed dosage of Xigduo Xr relies upon the diagnosed ailment, including Diet, inadequate response to metformin and Diabetic Ketoacidosis. The measure of dosage fluctuates with regards to the method of delivery (e.g. Oral or Tablet - Oral) featured in the table underneath.

Condition

Dosage

Administration

Physical Activity

, 5.0 mg, 10.0 mg, 2.5 mg

, Oral, Tablet, film coated, Tablet, film coated - Oral, Tablet, film coated, extended release, Tablet, film coated, extended release - Oral, Tablet, Tablet - Oral

Congestive Heart Failure

, 5.0 mg, 10.0 mg, 2.5 mg

, Oral, Tablet, film coated, Tablet, film coated - Oral, Tablet, film coated, extended release, Tablet, film coated, extended release - Oral, Tablet, Tablet - Oral

Chronic Kidney Disease

, 5.0 mg, 10.0 mg, 2.5 mg

, Oral, Tablet, film coated, Tablet, film coated - Oral, Tablet, film coated, extended release, Tablet, film coated, extended release - Oral, Tablet, Tablet - Oral

Kidney Failure

, 5.0 mg, 10.0 mg, 2.5 mg

, Oral, Tablet, film coated, Tablet, film coated - Oral, Tablet, film coated, extended release, Tablet, film coated, extended release - Oral, Tablet, Tablet - Oral

Hypesthesia

, 5.0 mg, 10.0 mg, 2.5 mg

, Oral, Tablet, film coated, Tablet, film coated - Oral, Tablet, film coated, extended release, Tablet, film coated, extended release - Oral, Tablet, Tablet - Oral

Hypesthesia

, 5.0 mg, 10.0 mg, 2.5 mg

, Oral, Tablet, film coated, Tablet, film coated - Oral, Tablet, film coated, extended release, Tablet, film coated, extended release - Oral, Tablet, Tablet - Oral

Hypesthesia

, 5.0 mg, 10.0 mg, 2.5 mg

, Oral, Tablet, film coated, Tablet, film coated - Oral, Tablet, film coated, extended release, Tablet, film coated, extended release - Oral, Tablet, Tablet - Oral

Diet

, 5.0 mg, 10.0 mg, 2.5 mg

, Oral, Tablet, film coated, Tablet, film coated - Oral, Tablet, film coated, extended release, Tablet, film coated, extended release - Oral, Tablet, Tablet - Oral

Cardiovascular Mortality

, 5.0 mg, 10.0 mg, 2.5 mg

, Oral, Tablet, film coated, Tablet, film coated - Oral, Tablet, film coated, extended release, Tablet, film coated, extended release - Oral, Tablet, Tablet - Oral

Heart Failure

, 5.0 mg, 10.0 mg, 2.5 mg

, Oral, Tablet, film coated, Tablet, film coated - Oral, Tablet, film coated, extended release, Tablet, film coated, extended release - Oral, Tablet, Tablet - Oral

decrease in the glomerular filtration rate

, 5.0 mg, 10.0 mg, 2.5 mg

, Oral, Tablet, film coated, Tablet, film coated - Oral, Tablet, film coated, extended release, Tablet, film coated, extended release - Oral, Tablet, Tablet - Oral

Hospitalizations

, 5.0 mg, 10.0 mg, 2.5 mg

, Oral, Tablet, film coated, Tablet, film coated - Oral, Tablet, film coated, extended release, Tablet, film coated, extended release - Oral, Tablet, Tablet - Oral

Pharmaceutical Preparations

, 5.0 mg, 10.0 mg, 2.5 mg

, Oral, Tablet, film coated, Tablet, film coated - Oral, Tablet, film coated, extended release, Tablet, film coated, extended release - Oral, Tablet, Tablet - Oral

inadequate response to monotherapy

, 5.0 mg, 10.0 mg, 2.5 mg

, Oral, Tablet, film coated, Tablet, film coated - Oral, Tablet, film coated, extended release, Tablet, film coated, extended release - Oral, Tablet, Tablet - Oral

Cardiovascular Diseases

, 5.0 mg, 10.0 mg, 2.5 mg

, Oral, Tablet, film coated, Tablet, film coated - Oral, Tablet, film coated, extended release, Tablet, film coated, extended release - Oral, Tablet, Tablet - Oral

Type 2 Diabetes

, 5.0 mg, 10.0 mg, 2.5 mg

, Oral, Tablet, film coated, Tablet, film coated - Oral, Tablet, film coated, extended release, Tablet, film coated, extended release - Oral, Tablet, Tablet - Oral

Warnings

Xigduo Xr Contraindications

Condition

Risk Level

Notes

Kidney Failure

Do Not Combine

Renal Insufficiency

Do Not Combine

Acidosis

Do Not Combine

Diabetic Ketoacidosis

Do Not Combine

Kidney Failure

Do Not Combine

Dialysis therapy

Do Not Combine

Severe Hypersensitivity Reactions

Do Not Combine

Dapagliflozin may interact with Pulse Frequency

There are 20 known major drug interactions with Xigduo Xr.

Common Xigduo Xr Drug Interactions

Drug Name

Risk Level

Description

Acenocoumarol

Major

The metabolism of Acenocoumarol can be decreased when combined with Dapagliflozin.

Aminophylline

Major

The metabolism of Aminophylline can be decreased when combined with Dapagliflozin.

Amitriptyline

Major

The metabolism of Amitriptyline can be decreased when combined with Dapagliflozin.

Amoxapine

Major

The metabolism of Amoxapine can be decreased when combined with Dapagliflozin.

Anagrelide

Major

The metabolism of Anagrelide can be decreased when combined with Dapagliflozin.

Xigduo Xr Toxicity & Overdose Risk

The toxic dose of metformin in rats has been found to be 1g/kg when taken orally, 500mg/kg when given intraperitoneally, and 300mg/kg when given subcutaneously. In mice, the toxic dose is 1450mg/kg orally, 420mg/kg intraperitoneally, and 225mg/kg subcutaneously. Taking too much metformin can cause an increased risk of lactic acidosis, which is characterized by elevated blood lactate levels, acidosis, and an increased lactate:pyruvate ratio. Risk factors for lactic acidosis include kidney impairment

Xigduo Xr Novel Uses: Which Conditions Have a Clinical Trial Featuring Xigduo Xr?

346 active clinical trials are exploring the potential of Xigduo XR to alleviate Type 2 Diabetes, Type 1 Diabetes and inadequate responses to Metformin treatment.

Condition

Clinical Trials

Trial Phases

Chronic Kidney Disease

102 Actively Recruiting

Not Applicable, Phase 1, Phase 2, Phase 4, Phase 3, Early Phase 1

Congestive Heart Failure

184 Actively Recruiting

Not Applicable, Phase 1, Phase 2, Phase 4, Phase 3, Early Phase 1

decrease in the glomerular filtration rate

0 Actively Recruiting

Cardiovascular Mortality

0 Actively Recruiting

Cardiovascular Diseases

0 Actively Recruiting

Type 2 Diabetes

167 Actively Recruiting

Not Applicable, Phase 1, Phase 2, Phase 3, Phase 4, Early Phase 1

Pharmaceutical Preparations

0 Actively Recruiting

Diet

5 Actively Recruiting

Not Applicable, Phase 1

Hospitalizations

1 Actively Recruiting

Not Applicable

Kidney Failure

40 Actively Recruiting

Phase 4, Phase 2, Phase 3, Not Applicable, Phase 1, Early Phase 1

Heart Failure

0 Actively Recruiting

Hypesthesia

4 Actively Recruiting

Not Applicable, Phase 1

Hypesthesia

8 Actively Recruiting

Not Applicable, Phase 1

Hypesthesia

2 Actively Recruiting

Not Applicable

Physical Activity

24 Actively Recruiting

Not Applicable, Phase 1, Phase 2

inadequate response to monotherapy

0 Actively Recruiting

Patient Q&A Section about xigduo xr

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the best time to take Xigduo?

"You should take XIGDUO XR with or immediately after food in the evening, and approximately at the same time each day for the best effect."

Answered by AI

Does Xigduo make you pee more?

"It is not unusual to experience constipation, increased urination, discomfort with urination, and pain in extremities when you are pregnant."

Answered by AI

What is the difference between metformin and Xigduo?

"Dapagliflozin, a sodium-glucose cotransporter 2 (SGLT2) inhibitor, helps your kidneys get rid of extra sugar in your blood by flushing it out through your urine.

Xigduo XR is a combination of dapagliflozin and metformin extended-release. Dapagliflozin, a sodium-glucose cotransporter 2 (SGLT2) inhibitor, helps your kidneys get rid of extra sugar in your blood by flushing it out through your urine. Metformin extended-release, a biguanide, works by lowering the amount of sugar your liver releases into your blood and helps your body respond better to insulin."

Answered by AI

What is Xigduo XR used for?

"This medication is a combination of two drugs, dapagliflozin and metformin, used to control high blood sugar in people with type 2 diabetes. Controlling high blood sugar helps prevent kidney damage, blindness, nerve problems, loss of limbs, and sexual function problems."

Answered by AI

Clinical Trials for Xigduo Xr

Image of Faculty of Health Sciences in Winnipeg, Canada.

Saskatoon Berries for Type 2 Diabetes

18 - 74
All Sexes
Winnipeg, Canada

Diabetes becomes epidemic in worldwide countries. Diabetes Canada indicated that 30% of adults in Manitoba are diabetes or prediabetes. Nine out of ten diabetic patients are type 2 diabetes (T2D). T2D is characterized by insulin resistance and obesity. Uncontrolled diabetes leads to serious consequences including heart attack, stroke, chronic renal failure, liver failure, blindness and low limb amputation. Most of hypoglycemic medications have certain side effects. Natural foods or nutraceuticals with hypoglycemic potential are expected to provide a safer management for diabetic patients. Saskatoon berry is a popular fruit in Canadian Prairie and Northern states in USA. Our previous studies demonstrated Saskatoon berry (SB) powder attenuated hyperglycemia, hyperlipidemia, insulin resistance, inflammation, liver steatosis and gut dysbiosis in diet-induced insulin resistant mice, a model for T2D. The findings of the glucose and lipid lowering or liver protective effects of SB powder have been supported by another group in Australia in high fat fed rats. Our preliminary studies in 20 healthy subjects demonstrated that dried whole SB (40 g/day for 10 weeks) significantly reduced fasting plasma glucose, total and LDL-cholesterol, systolic blood pressure, and increased plasma glucagon-like peptide compared to baseline, which was associated with increased intake of total fiber and decreased intake of saturated fat. The changes in metabolic and vascular variables significantly correlated with the alterations in gut microbiota The combination of findings suggest that SB is good candidate of prebiotic functional food as a supplemental remedy for reducing the risk for metabolic syndrome and preventing or managing T2D. The effect of Saskatoon berry and its products on metabolic disorders have not been studied in diabetic subjects. We propose to examine the effects of oral administration of freeze-dried whole SB on glucose metabolism, insulin resistance and gut microbiota in untreated prediabetes and new type 2 diabetic patients compared to a control dried fruit in a randomized controlled trial.

Waitlist Available
Dietary Supplement

Faculty of Health Sciences

Image of Columbia University in New York, United States.

MediBeacon Transdermal GFR System for Heart Failure

18+
All Sexes
New York, NY

The goal of this clinical trial is to evaluate the accuracy and feasibility of transdermal glomerular filtration rate (tGFR) assessment using relmapirazin (Lumitrace) and the MediBeacon tGFR system compared to plasma clearance measurement of GFR in adults with heart failure. The main question it aims to answer is the comparison of the transdermal-derived GFR for each participant using the MediBeacon tGFR to their nGFRBSA measurement. Participants will participate in a Screening visit that will take place within 15 days of the scheduled administration of Lumitrace and iohexol. On dosing day, participants will have the tGFR reusable sensor with disposable adhesive ring placed on their chest, and the MediBeacon Transdermal GFR System initiated to collect background fluorescence. Following an injection of Lumitrace and iohexol and the initiation of GFR assessments, participants will be followed at the study center for 10-24 hours. All participants will participate in a follow-up phone call approximately 7 days after the last exposure to Lumitrace and iohexol. Researchers will analyze the results to compare the tGFR values to the nGFRBSA measurements for each participant.

Waitlist Available
Has No Placebo

Columbia University

Richard B Dorshow, PhD

MediBeacon

Image of Central Research Associates - Flourish - PPDS in Birmingham, United States.

CX11 for Type 2 Diabetes

18 - 75
All Sexes
Birmingham, AL

This study is testing whether a new medication called CX11 works and is safe for participants with type 2 diabetes who have not reached good blood sugar control while taking a steady dose of metformin, with or without a steady dose of an SGLT2 inhibitor, for at least 90 days. The study is being done at multiple medical centers. Participants are assigned by chance (randomized) to different groups, and neither the participants nor the study staff know which group they're in (double-blind). The groups are compared side by side (parallel), and some participants will receive inactive pills (placebo) to help measure the true effect of the study drug. After screening, participants will be randomly placed into one of six groups, with equal chances of being in any group. Each group will receive a different dose of CX11 or a placebo. Treatment will last 24 weeks. After that, all participants will have a 2-week follow-up period to check on safety.

Phase 2
Waitlist Available

Central Research Associates - Flourish - PPDS (+29 Sites)

Corxel Pharmaceuticals

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Image of International Diabetes Center in Minneapolis, United States.

Sotagliflozin for Type 1 Diabetes

18 - 75
All Sexes
Minneapolis, MN

The goal of this clinical trial is to develop and evaluate a novel diabetes ketoacidosis risk mitigation strategy to support the safe use of sodium-glucose cotransporter-2 inhibitors (SGLT2i) therapy in participants with type 1 diabetes (T1D) and mild to moderate chronic kidney disease (CKD). The main objectives of this study are to: 1. Evaluate how ketone metrics differ between participants with mild to moderate chronic kidney disease and those with normal renal function in three time periods. 2. Identify potentially modifiable ketosis risk factors. 3. Use continuous glucose monitoring (CGM) and continuous ketone monitoring (CKM) data prior to and following treatment to determine ketosis risk factors and gain knowledge to further refine reporting of risk factors. 4. Gather information on how participants and clinicians like and use the CGM/CKM reports. Participants will be asked to: * Meet with study investigators to determine if they are eligible * Sign written informed consent * Take a pregnancy test, if applicable * Have blood taken to assess kidney function and hemoglobin A1c * Take the study medication, following the study team instructions * Wear the study provided sensor throughout participation. * Complete 5 in person visits, and 11 phone check ins over a nine-month period * Provide feedback on the usefulness of CGM/CKM reports

Phase 2
Waitlist Available

International Diabetes Center

Richard Bergenstal, MD

Image of Seaway Valley Community Health Centre (Cardiac Rehab Program) in Cornwall, Canada.

FRAME for Heart Failure

18+
All Sexes
Cornwall, Canada

Heart failure is a high-risk, chronic condition that impacts patients' mental health. Approximately 50% of heart failure patients experience comorbid mental health conditions, such as stress, depression and anxiety, which affect their day-to-day lives. Despite this interconnection, the integration of mental health awareness and support into cardiac care remains limited. To address this gap, the FRAME (Foundation, Recognition, Awareness, Management, Engagement) intervention was co-designed by researchers, healthcare providers, health system decisionmakers, and patient partners. This pilot study evaluates the feasibility of implementing the FRAME intervention in pilot clinical sites within two health regions in Ontario, Canada, including team-based family medicine clinics, cardiac rehabilitation/specialist clinics, and emergency departments. Utilizing a pretest-posttest hybrid 1 model intervention design, this study evaluates process indicators and patient-focused outcomes through surveys and semi-structured qualitative interviews. Findings from this study will inform a future large scale cohort study and scalable integration of the FRAME tool into existing cardiac care pathways to enhance mental health awareness and support among heart failure patients.

Recruiting
Has No Placebo

Seaway Valley Community Health Centre (Cardiac Rehab Program) (+8 Sites)

Image of Kaiser Permanente Northern California (KPNC) in Pleasanton, United States.

Deprescribing Beta-Blockers for Diastolic Heart Failure

18+
All Sexes
Pleasanton, CA

The goal of this study is to learn whether stopping beta-blockers can help older adults with heart failure with preserved ejection fraction (HFpEF) feel better and function better. This study will test whether "deprescribing" or stopping these medications in a careful, guided way can improve symptoms and quality of life. Participants will be randomly assigned to one of two groups: Deprescribing group: Beta-blockers are gradually reduced using capsules that contain decreasing doses. Usual care group: Beta-blockers are continued at the usual dose in look-alike capsules. All participants will: * Take study medicine for about 4 months * Have their blood pressure and heart rate monitored * Complete regular phone calls and questionnaires about how they are feeling This study does not involve any experimental medication. Participants active involvement in the study will last approximately 4 months. During these 4 months they will have 8 scheduled telephone visits.

Phase 4
Waitlist Available

Kaiser Permanente Northern California (KPNC)

Parag Goyal, MD, MSc

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Image of NYU Langone Health in New York, United States.

Adaptive Dietary Intervention for Type 2 Diabetes

18+
All Sexes
New York, NY

The investigators will examine the feasibility, acceptability, and effect of an adaptive dietary intervention over 24 weeks (12-week intervention, 12-week follow-up) among Asian Americans with Type 2 diabetes. Participants (N=120; 60 Chinese Americans and 60 Vietnamese Americans) will be 2:1 randomized to one of two arms: adaptive dietary intervention or standard of care (SC). The intervention will begin with continued glucose monitoring (CGM) use only during weeks 0-4. At week 4, participants who achieve the glycemic control goal (at least an 8% increase in time in range \[TIR\] from baseline) will continue with the CGM alone during weeks 4-12 ("CGM Alone"); otherwise, culturally and linguistically adapted glucose excursion minimization (GEM) will be augmented with CGM ("CGM-GEM").

Waitlist Available
Has No Placebo

NYU Langone Health

Yaguang Zheng, PhD, RN

Image of Yale New Haven Hospital-St. Raphael Campus in New Haven, United States.

Dapagliflozin for Heart Failure

18 - 85
All Sexes
New Haven, CT

The overall objective of this study is to determine whether the addition of SGLT2 inhibitors to usual care in hospitalized patients with heart failure associated acute kidney injury is safe and efficacious. Investigators will assess if SGLT2 inhibition improves a composite cardio-renal outcome (mortality, dialysis, AKI progression, decongestion metrics, heart failure symptoms). Secondary objectives of this study are to compare individual components of the composite outcome as well as changes in biomarkers of kidney injury, inflammation, repair and oxidative stress between those exposed to the SGLT2 inhibitor vs placebo.

Phase 2
Waitlist Available

Yale New Haven Hospital-St. Raphael Campus (+1 Sites)

Abinet Aklilu, MD

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