Xigduo Xr

Hypesthesia, Hypesthesia, Hypesthesia + 13 more
Treatment
6 FDA approvals
20 Active Studies for Xigduo Xr

What is Xigduo Xr

DapagliflozinThe Generic name of this drug
Treatment SummaryMetformin 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.
Farxigais 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 PatientsInsulin 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 bodyMetformin 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 RiskThe 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 University of California, Los Angeles in Los Angeles, United States.

Tailored DPP for Prediabetes

17 - 25
All Sexes
Los Angeles, CA
The goal of this study is to enhance reach and uptake of diabetes prevention among young adults, with a focus on recruiting underserved and high-need students who face additional challenges, including food and financial insecurity. The specific aims are: Aim 1 - Evaluate the efficacy of an AYA-tailored version of the UC DPP for mitigating type 2 diabetes risk (i.e., weight change) in a pre/post pilot trial. The investigators hypothesize that the AYA-tailored intervention will be effective at producing 5% weight loss from baseline to program completion (at 9-months). Aim 2 - Assess the feasibility and acceptability of an AYA-tailored version of the UC DPP program. The investigators hypothesize that it will be feasible to recruit the desired number of participants given proposed innovative outreach strategies, and that the AYA-tailored intervention will be deemed acceptable to participants both qualitatively and in regards to their retention in the program at rates similar to the larger UC DPP. The investigators will recruit 80 UCLA undergraduate students. Participants will be asked to complete a brief screening online form to assess eligibility and to collect contact information. The PI and/or Research Assistants (RAs) will reach out to eligible participants to obtain informed consent and enroll them in the pilot trial. The investigators will randomize participants to the tailored DPP cohort vs control cohort. Control participants will be offered the opportunity to participate in the tailored DPP in the following academic year. The tailored DPP intervention will be online and asynchronously. Participants will be asked to complete the intervention lessons on their own time. Each lesson typically takes on average 15 minutes to complete. Control group will receive each intervention materials via e-mail for participants to review on their own time and will receive acceptability surveys. The interventions for the control group will be remote. A research assistant will meet with control participants via Zoom to explain the intervention materials. Control group will receive access to a study habits intervention, alcohol use intervention, and financial literacy intervention. At the end of each quarter (Fall, Winter, and Spring), both control and intervention participants will receive an email with a unique link to a brief REDCap survey to ascertain acceptability of sessions/lessons. Furthermore, participants will complete baseline and 9-month follow-up assessments. Participants will complete a 30 minute questionnaire and height/weight measurements will be collected by a RA. Participants will be asked to self-report weight and physical activity at the end of the fall and winter quarter; data will be collected via brief REDCap survey.
Recruiting
Has No Placebo
University of California, Los AngelesLauren E Wisk, PhD
Image of New York University Langone Health in New York, United States.

GGTA1 KO Thymokidney for Kidney Failure

40 - 70
All Sexes
New York, NY
The purpose of this study is to evaluate the safety and efficacy of the GGTA1 KO Thymokidney in patients with end-stage renal disease (ESRD) who are either not eligible for conventional allogeneic kidney transplantation (Group 1) or are on an Organ Procurement and Transplantation Network (OPTN) kidney transplant waitlist, but are more likely to die or go untransplanted within 5 years than receive a kidney transplant (Group 2). The study consists of xenotransplantation followed by a 24-week Post-transplant Follow-up Period (Part A) to evaluate the efficacy and safety objectives followed by a Long-term Follow-up Period (Part B) to evaluate participant survival, GGTA1 KO Thymokidney survival, and screening for zoonotic infections. Part B will continue for the lifetime of the participant or for 52 weeks following nephrectomy, if required.
Phase 1 & 2
Recruiting
New York University Langone HealthUnited Therapeutics
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Image of The Worship Center Cristian Church in Birmingham, United States.

Black Impact for Heart Health

18+
Male
Birmingham, AL
The goal of this clinical trial is to evaluate the implementation and effectiveness of the Black Impact program-a church-based cardiovascular health (CVH) intervention-in Black men aged 35-70 who are at risk for heart disease, diabetes, obesity, and related conditions. The main questions this study aims to answer are: * Does participation in the Black Impact program improve cardiovascular health metrics (e.g., blood pressure, cholesterol, blood sugar) and health behaviors among Black men at The Worship Center Christian Church (TWC)? * What factors influence the adoption, delivery, and sustainability of the Black Impact program in a faith-based setting? Researchers will compare an immediate-start intervention group and a delayed-start (waitlist control) group to assess both short-term health outcomes and program implementation factors. Participants will: * Attend a 90-minute weekly session for 24 weeks, including 45 minutes of physical activity led by a certified trainer and 45 minutes of health education delivered by trained coaches. * Receive one-on-one support from a community health worker to reduce barriers to care and engage with primary care. * Complete biometric health screenings and surveys at baseline, 12 weeks, and 24 weeks to assess clinical and behavioral outcomes. * Use a smartwatch, blood pressure cuff, and other tools to track progress in real time. * Participate in exit focus groups or interviews to share feedback about the intervention. * A subset of TWC leaders and interventionists (N=15) will also be interviewed to assess implementation, resource needs, and sustainability. This study uses the RE-AIM framework to assess Reach, Effectiveness, Adoption, Implementation, and Maintenance, and aims to inform scalable strategies for improving CVH among Black men in trusted community settings.
Waitlist Available
Has No Placebo
The Worship Center Cristian Church
Have you considered Xigduo Xr clinical trials? We made a collection of clinical trials featuring Xigduo Xr, we think they might fit your search criteria.Go to Trials
Image of University of British Columbia - Okanagan in Kelowna, Canada.

Estrogen and Testosterone for Gender Differences in Physiology

18 - 40
All Sexes
Kelowna, Canada
Due to historical exclusion of females from research, there are gaps in the understanding of female physiology, how it differs from males, and how sex-specific hormones contribute. As a result, many diagnoses and treatments are based on male physiology and may not be appropriate or effective for females. Females consistently experience greater risk and report worse neurological outcomes in many diseases, including stroke, cardiac arrest, and dementia. As research in females progresses, differences between sexes and changes throughout the lifespan (e.g., puberty, menopause) highlight the importance of understanding the effects of sex and sex-specific hormones on the body. The brain is arguably the most important organ in the body, consuming 20% of the body's total energy. Previous research supports higher blood flow to the brain in females, and research in animals suggests hormones such as estrogen, progesterone, and testosterone are responsible. However, it is extremely difficult to isolate these hormones in humans, due to natural fluctuations (i.e., menstrual cycle). Therefore, the investigators plan to explore the direct role of these sex-specific hormones in regulating blood flow to the brain by blocking hormone production in healthy males and females and giving back testosterone and estrogen, respectively. The investigators will then conduct a range of tests to look at blood flow to the brain at rest and during various stressors. This research will provide crucial insight into how males and females differ in regulation of brain blood flow and inform new treatments and therapies to a wide range of brain injuries and diseases, improving outcomes and reducing the sex disparity in clinical pathways.
Waitlist Available
Has No Placebo
University of British Columbia - OkanaganPhilip Ainslie, PhD
Image of Los Angeles General Medical Center in Los Angeles, United States.

Supportive Management for Heart Failure and Methamphetamine Addiction

18+
All Sexes
Los Angeles, CA
Heart failure (HF) affects over 6 million people in the US and is a major cause of both hospital admissions and death. HF has many causes and contributing factors. One of the most aggressive forms of HF is associated with methamphetamine abuse, which has become its own epidemic in the US over the past twenty years. People who use methamphetamine tend to develop HF at a much younger age, with more severe disease and more serious consequences. A recent analysis using nationwide data, methamphetamine use doubled the risk of death or hospitalizations compared to non-users in patients with HF. Thus, methamphetamine users with HF represent a very high-risk group of patients from a healthcare perspective. HF may be reversible in some patients who use methamphetamine if patients can achieve 1) abstain from further methamphetamine use and 2) consistently take all the medications that can improve HF. These two goals are very difficult to achieve in practice, as the care of both methamphetamine addiction and HF requires specialized medical expertise and intensive regular follow up of patients. In general, achievement of one goal is not possible without the other. Patients who use methamphetamine have poor adherence to medical follow-up and therapies, and abstinence from methamphetamine is difficult to maintain. This is further complicated because the current model of HF care does not incorporate treatment for methamphetamine use. The current study proposes to launch a multidisciplinary clinic that treats both HF and methamphetamine use disorder at the same time. The HF care will be led by a cardiologist while the methamphetamine use treatment will be led by a psychiatric clinical pharmacist trained in addiction medicine. State-of-the-art HF care will include optimization of four pillar HF medications. Methamphetamine use treatment will include counseling and incentivized abstinence known as contingency management (CM). The investigators will manage the patients in the clinic for 6 months total. The investigators are interested in demonstrating that this integrated clinic model will result in improved delivery of care for these patients by reporting the rates of successful abstinence from methamphetamine, improved optimization of the four HF medications, and enhanced patient reported quality of life over the 6 months of follow up. The investigators will also collect data on the costs associated with providing this level of care and estimate a range of potential cost-savings.
Waitlist Available
Has No Placebo
Los Angeles General Medical Center (+1 Sites)Tien Ng, PharmD
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