Synjardy

Congestive Heart Failure, Physical Activity, Monotherapy + 8 more

Treatment

6 FDA approvals

20 Active Studies for Synjardy

What is Synjardy

Empagliflozin

The Generic name of this drug

Treatment Summary

Metformin is a medication used to treat type 2 diabetes. It is the first-line drug of choice for managing type 2 diabetes and is taken by more than 120 million people around the world. Metformin lowers blood sugar levels without causing hypoglycemia, increases insulin sensitivity, and leads to modest weight loss. It was first approved in Canada in 1972 and in the United States in 1995. Metformin is available in regular and extended-release form.

Jardiance

is the brand name

image of different drug pills on a surface

Synjardy Overview & Background

Brand Name

Generic Name

First FDA Approval

How many FDA approvals?

Jardiance

Empagliflozin

2014

24

Approved as Treatment by the FDA

Empagliflozin, also called Jardiance, is approved by the FDA for 6 uses including 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

Type 2 Diabetes

Used to treat Type 2 Diabetes Mellitus in combination with Metformin

Diet

Used to treat Diet in combination with Metformin

Cardiovascular Diseases

Cardiovascular Mortality

Effectiveness

How Synjardy Affects Patients

Insulin is a hormone that helps control the amount of sugar in the blood. People with Type II diabetes have a decreased sensitivity to insulin, which means their pancreas cannot keep up with regulating their sugar levels. Metformin works to reduce the amount of sugar produced by the liver and absorbed by the intestines, as well as increase the body's sensitivity to insulin. In a clinical trial, people taking Metformin had decreased fasting blood sugar levels by an average of 59 mg/dL, while those taking a placebo had increased levels by 6.3 mg/dL. Metformin also decreased HbA1c by 1

How Synjardy works in the body

Metformin works in several ways to reduce blood glucose levels. It decreases the amount of glucose produced in the liver, decreases the amount of glucose absorbed from food in the intestines, and makes cells more sensitive to insulin. Metformin enters liver cells through a transporter called OCT1, and accumulates in the mitochondria. It blocks the production of energy in the mitochondria, turning on an enzyme called AMPK. This helps to decrease fat production and increase fat burning, as well as reduce glucose production in the liver. In the intestines, metformin increases anaerobic glucose metabolism, leading to less net glucose uptake and

When to interrupt dosage

The suggested dose of Synjardy is contingent upon the recognized disorder, including Diet, inadequate response to metformin and Diabetic Ketoacidosis. The quantity differs, in line with the methodology of delivery (e.g. Oral or Tablet - Oral) listed in the table below.

Condition

Dosage

Administration

Cardiovascular Diseases

10.0 mg, 25.0 mg, , 5.0 mg, 12.5 mg

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

Type 2 Diabetes

10.0 mg, 25.0 mg, , 5.0 mg, 12.5 mg

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

Diet

10.0 mg, 25.0 mg, , 5.0 mg, 12.5 mg

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

Cardiovascular Mortality

10.0 mg, 25.0 mg, , 5.0 mg, 12.5 mg

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

Heart Failure

10.0 mg, 25.0 mg, , 5.0 mg, 12.5 mg

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

Therapeutic procedure

10.0 mg, 25.0 mg, , 5.0 mg, 12.5 mg

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

Ejection fraction decreased

10.0 mg, 25.0 mg, , 5.0 mg, 12.5 mg

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

Hospitalizations

10.0 mg, 25.0 mg, , 5.0 mg, 12.5 mg

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

Congestive Heart Failure

10.0 mg, 25.0 mg, , 5.0 mg, 12.5 mg

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

Physical Activity

10.0 mg, 25.0 mg, , 5.0 mg, 12.5 mg

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

Monotherapy

10.0 mg, 25.0 mg, , 5.0 mg, 12.5 mg

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

Warnings

Synjardy Contraindications

Condition

Risk Level

Notes

Kidney Failure

Do Not Combine

Renal Dialysis

Do Not Combine

Severe Hypersensitivity Reactions

Do Not Combine

Empagliflozin may interact with Pulse Frequency

There are 20 known major drug interactions with Synjardy.

Common Synjardy Drug Interactions

Drug Name

Risk Level

Description

Acetazolamide

Minor

Empagliflozin may increase the diuretic activities of Acetazolamide.

Ambrisentan

Minor

Empagliflozin may increase the hypotensive activities of Ambrisentan.

Amiloride

Minor

Empagliflozin may increase the diuretic activities of Amiloride.

Angiotensin 1-7

Minor

Empagliflozin may increase the hypotensive activities of Angiotensin 1-7.

Azosemide

Minor

Empagliflozin may increase the diuretic activities of Azosemide.

Synjardy Toxicity & Overdose Risk

The toxic dose of metformin in rats is 1000mg/kg when taken orally, 500mg/kg when given through the abdomen, and 300mg/kg when injected under the skin. The toxic dose in mice is 1450mg/kg orally, 420mg/kg through the abdomen, and 225mg/kg when injected under the skin. Taking too much metformin can lead to lactic acidosis, a serious condition where too much acid builds up in the blood. Risk factors for lactic acidosis include kidney problems, being over 65 years old, taking certain medications, drinking too much alcohol, or having liver disease

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Synjardy Novel Uses: Which Conditions Have a Clinical Trial Featuring Synjardy?

346 active trials are assessing the potential of Synjardy in treating Type 2 Diabetes, Type 1 Diabetes and inadequate response to Metformin therapy.

Condition

Clinical Trials

Trial Phases

Type 2 Diabetes

157 Actively Recruiting

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

Cardiovascular Diseases

0 Actively Recruiting

Congestive Heart Failure

174 Actively Recruiting

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

Hospitalizations

1 Actively Recruiting

Not Applicable

Monotherapy

1 Actively Recruiting

Phase 1, Phase 2

Heart Failure

0 Actively Recruiting

Diet

4 Actively Recruiting

Not Applicable, Phase 1

Therapeutic procedure

0 Actively Recruiting

Ejection fraction decreased

0 Actively Recruiting

Physical Activity

24 Actively Recruiting

Not Applicable, Phase 1, Phase 2

Cardiovascular Mortality

0 Actively Recruiting

Synjardy Reviews: What are patients saying about Synjardy?

5

Patient Review

10/17/2018

Synjardy for Type 2 Diabetes Mellitus

Synjardy has been great for me. I brought my A1C down from 10.6 to 6.0 in a year, and experienced zero negative side effects.

4

Patient Review

4/17/2016

Synjardy for Type 2 Diabetes Mellitus

4

Patient Review

11/9/2017

Synjardy for Type 2 Diabetes Mellitus

2.3

Patient Review

1/30/2019

Synjardy for Type 2 Diabetes Mellitus

My A1C rose from 6.5 to 8.7 after my doctor switched me from Farxiga to Synjardy. I found the latter drug much less effective than the former.

2

Patient Review

9/4/2018

Synjardy for Type 2 Diabetes Mellitus

I unfortunately got a yeast infection from this medication.

1.7

Patient Review

5/12/2019

Synjardy for Type 2 Diabetes Mellitus

Thirst, yeast infection, and constant trips to the bathroom are all unfortunately common side effects of this medication. I've been taking it for five months now and have had to deal with a lot of discomfort as a result.

1

Patient Review

9/9/2018

Synjardy for Type 2 Diabetes Mellitus

I was worried from the start with this prescription. My blood sugar shot up, and even when I increased the dose as directed, it didn't seem to be effective.

1

Patient Review

9/8/2021

Synjardy for Type 2 Diabetes Mellitus

I was in a lot of pain after injuring my knee and was prescribed Synjardy. However, this medication caused me more pain and fatigue than the original injury. I stopped taking it and felt better the next day.
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Patient Q&A Section about synjardy

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

What is Synjardy used for?

"This medication is a combination of 2 drugs: empagliflozin and metformin. It is used with a proper diet and exercise program to lower blood sugar in people with type 2 diabetes. Controlling blood sugar helps prevent kidney damage, blindness, nerve problems, loss of limbs, and sexual function problems."

Answered by AI

What is the side effects of Synjardy?

"Some possible causes of these symptoms include low blood sugar, a urinary tract infection, a stuffy or runny nose and sore throat, yeast infections in females, diarrhea, nausea or vomiting, gas, stomach discomfort, indigestion, weakness, or a headache."

Answered by AI

What is the difference between Synjardy and metformin?

"Synjardy contains both metformin and the drug empagliflozin. Metformin lowers blood sugar levels through several mechanisms, and the addition of empagliflozin provides additional blood sugar lowering effects."

Answered by AI

Are Jardiance and Synjardy the same thing?

"Jardiance is a medication used to treat type 2 diabetes. It is available as a standalone tablet or as a combination tablet with metformin. The medication works by helping the body to better use insulin. Side effects may include nausea, diarrhea, and headaches. Jardiance is a brand-name medication and costs can vary depending on insurance coverage."

Answered by AI

Clinical Trials for Synjardy

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Maple Syrup for Endurance Cycling Performance

18 - 45
Male
Montreal, Canada

The goal of this clinical trial is to learn whether maple syrup can be used as a natural carbohydrate source to help trained male cyclists perform better during long-duration cycling. The study also aims to learn how different amounts of maple syrup affect energy use in the body, stomach comfort, and feelings of effort and fatigue. The main questions the study aims to answer are: * Does consuming more carbohydrate from maple syrup help participants finish a 20-kilometer cycling time trial faster? * How do different amounts of maple syrup change how the body uses carbohydrates and fats during long exercise? * Are higher amounts of maple syrup easy for participants to tolerate without stomach problems? Researchers will compare four drinks: 1. A placebo drink (a look-alike drink with no calories), 2. A drink that provides 60 grams of carbohydrate per hour, 3. A drink that provides 90 grams per hour, and 4. A drink that provides 120 grams per hour. They will compare these drinks to see whether higher carbohydrate amounts lead to better cycling performance and how each dose affects comfort and metabolism. Participants will: * Attend a screening visit that includes a health check and a glucose tolerance test. * Complete a fitness test to measure their aerobic capacity and practice the cycling tests used in the study. * Take part in four separate exercise sessions in random order. Each session includes: * Drinking one of the four study beverages during 2 hours of steady cycling, * Completing two short, all-out 6-second sprints during the ride, * Completing a 20-kilometer cycling time trial as fast as possible, * Reporting stomach symptoms and perceptions of effort, * Providing breath, blood, urine, and sweat samples so researchers can measure how their body uses fuel. All drinks will look, taste, and smell similar so participants cannot tell which one they are receiving. Meals before each session will be provided to keep conditions the same across visits. This study may help athletes and active people choose natural carbohydrate sources that support both performance and comfort during long endurance exercise. The findings may also guide future research on the use of maple syrup as a sports nutrition option.

Waitlist Available
Paid Trial

Centre EPIC

Jonathan Tremblay, PhD

Mitacs

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PILI Pasifika Program for Cardiometabolic Conditions

18+
All Sexes
Fayetteville, AR

In this study, the investigators are testing the effectiveness and implementation of the Community Health Workers (CHW)-delivered PILI Pasifika Program (PPP) Standard Facilitation or Enhanced Facilitation across 3 regions, the U.S. Affiliated Pacific Islands (USAPI), the continental U.S., and Hawai'i, among 600 Native Hawaiian and Pacific Islander (NHPI) participants in two settings, (clinical and non-clinical) over a 3-year period. The PPP is a 3-month lifestyle intervention that includes a Social Determinants of Health (SDOH) component and was NHPI-adapted from the Diabetes Prevention Program's Lifestyle Program, renamed to the PILI Lifestyle Program (PLP), which demonstrated effectiveness in improving weight, blood pressure, physical activity, and diet among NHPIs. The PPP consists of 8 lifestyle lessons and 4 SDOH activities delivered over a 3-month period. The investigators will conduct an effectiveness-implementation hybrid type 2 trial using a 3 (Region) x 2 (Setting) x 2 (Delivery Mode) factorial design. The long-term objective of this study is threefold: 1. To conduct an effectiveness-implementation hybrid 2 trial to test the effects of the PPP implementation strategies across different settings and modes of delivery among 600 NHPIs at risk for cardiometabolic-related conditions using an NHPI-approved and adapted evaluation framework. The investigators will also assess and compare the cost-effectiveness of the CHW-delivered PPP-Standard Facilitation and PPP-Enhanced Facilitation to support long-term sustainability. 2. To conduct a longitudinal Social Determinants of Health (SDOH) survey embedded within the trial to examine the reliability and validity of indices from 5 adapted SDOH instruments and to assess the associations between SDOH variables and chronic disease risk among NHPIs. 3. To implement and evaluate the contextually-based CHW training program on PPP delivery.

Waitlist Available
Has No Placebo

National Association of Pasifika Organizations (+1 Sites)

Joseph K Kaholokula, PhD

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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. Previous studies in the investigator's group 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. Preliminary studies by the investigators 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. The investigators 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

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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

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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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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)

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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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