Jardiance (empagliflozin) is a medicine for type 2 diabetes approved by the FDA in 2014. It is approved to help lower blood sugar levels in adults and children with type 2 diabetes and to lower the risk of major events like heart attacks and strokes in adults with type 2 diabetes and heart disease. It is not approved for use in type 1 diabetes. Jardiance is also approved for use in people without diabetes who have heart failure or kidney disease.
How Does It Work for Type 2 Diabetes?
Jardiance lowers blood sugar. Normally, the kidneys filter sugar in a way that keeps it in the bloodstream rather than allowing it to leave the body through the urine. The kidney protein responsible for this process is sodium-glucose cotransporter-2 (SGLT2). Jardiance works by temporarily stopping the SGLT2 proteins from working, allowing more sugar (glucose) to leave the body through the urine. Through this process, it can also cause weight loss and a decrease in blood pressure.
How Was It Studied for Type 2 Diabetes?
Clinical studies were conducted to test if Jardiance was safe and effective for lowering HbA1c (a blood test that shows your 3-month average blood sugar control) and blood sugars in people with type 2 diabetes. Most studies defined a high HbA1c as 7% or higher. The studies focused on adults and children (ages 10-17) with type 2 diabetes. In one study, the effects of Jardiance on type 2 diabetes were studied among people with kidney disease. In another study, the effects of Jardiance on major events like death from heart disease, heart attack, or stroke were studied among people with type 2 diabetes and heart disease. Some studies also looked at the effect of Jardiance on body weight and blood pressure. Jardiance was compared with a placebo containing no medicine and against other diabetes medicines including insulin, linagliptin, metformin, pioglitazone , and sulfonylureas (such as glimepiride).
The studies included people who were White, Black, or Asian, including those who identified as Hispanic or Latino. Most studies did not include people with very high blood sugars (for example, people with fasting readings above 240 mg/dL), people who recently had a heart attack or stroke, people on weight loss medicines or another weight loss plan, or people with liver issues. Only one study included people with kidney issues.
What Were the Benefits?
Results from the clinical studies are provided below. Your results may be different from what was seen in clinical studies. Ethnicity, race, geographic location, sex, body weight, and length of time having diabetes did not affect how well Jardiance worked.
Jardiance in adults with type 2 diabetes
The effects of Jardiance were studied in adults who had type 2 diabetes who had a high HbA1c. Some participants were taking no other diabetes medicines and others were taking a combination of medicines such as insulin, metformin, pioglitazone, or sulfonylureas. The studies lasted 18 to 78 weeks. Compared to placebo, the average decrease in HbA1c was greater with both of the studied doses of Jardiance. A greater decrease in blood pressure and weight loss was also seen in both doses of Jardiance compared to placebo.
About how much did fasting blood sugar levels go down | About how much did HbA1c go down? | |
Jardiance 10 mg alone | 19 mg/dL | 0.7% |
Jardiance 25 mg alone | 25 mg/dL | 0.8% |
Jardiance 10 mg with other diabetes medicines | 10 to 20 mg/dL | 0.2% to 2.1% |
Jardiance 25 mg with other diabetes medicines | 15 to 22 to 60 mg/dL | 0.6% to 2.1% |
Placebo | 6 to 12 mg/dL | 0.1% to 0.2% |
Jardiance in adults with type 2 diabetes with kidney disease
The effects of Jardiance were studied in adults who had type 2 diabetes, mild to severe kidney disease, and had a high HbA1c. Compared to the existing diabetes medicines that they were taking, the average decrease in HbA1c from the beginning of the study to week 24 was greater when adding on Jardiance. However, the people in the study had no change in fasting blood sugars.
About how much did HbA1c go down? | |
Jardiance 25 mg daily | 0.5% |
Jardiance in children with type 2 diabetes
The effects of Jardiance were studied in children aged 10 to 17 who had type 2 diabetes and had a high HbA1c. Compared to placebo, the average decrease in HbA1c and fasting blood sugars from the beginning of the study to week 26 were greater with Jardiance.
About how much did fasting blood sugar levels go down | About how much did HbA1c go down? | |
Jardiance 10 mg or 25 mg daily | 19 mg/dL | 0.2% |
Placebo | None (17 mg/dL increase) | None (0.7% increase) |
Jardiance in adults with type 2 diabetes and heart disease
The effects of Jardiance were studied in adults who had type 2 diabetes, heart disease, and had a high HbA1c. Patients were followed in this study for an average of 3.1 years. Compared to placebo, Jardiance decreased heart-related death, heart attacks, and strokes.
Jardiance 10 mg or 25 mg | Placebo | |
Percentage of people who had a heart-related death, nonfatal heart attack, or nonfatal stroke | 10.5% | 12.1% |
What Types of Medicine Interactions Can Happen?
Taking Jardiance with other diabetes medicines such as insulin and sulfonylureas can cause low blood sugars. Your health care provider may decrease the doses of your other diabetes medicines when starting Jardiance to prevent low blood sugars.
Jardiance lowers blood sugar by increasing sugar removal through urination. If you are already taking a medicine that causes an increase in urination such as a diuretic like chlorthalidone and hydrochlorothiazide, adding Jardiance may cause dehydration. Make sure to stay well hydrated.
Jardiance can interact with and lower the blood levels of a mental health medicine called lithium. If you are taking lithium and start taking Jardiance, your health care provider may ask you to complete blood work to monitor your lithium levels more often.
How Do I Take It?
Jardiance is an oral tablet taken once daily. Your health care provider will either prescribe a daily dosage of a full tablet or a half tablet. Read the instructions for use, which you can get from your pharmacist. Your health care provider may recommend taking it in the morning so that the increase in urination will mostly happen during the day and less likely to interrupt your sleep. Jardiance continues to work 3 to 14 days after stopping the medicine.
How Can I Tell If It Is Working?
You can tell if Jardiance is working because your blood sugars and HbA1c will fall. In the studies, blood sugar and HbA1c lowering were noted as soon as the first 4 weeks after starting treatment, but further reduction may occur in the later months. Keep in mind that the HbA1c is a measurement of your 3-month blood sugar average, so it takes time for it to change. If you take a urine glucose test while on Jardiance, it is normal to see higher levels of glucose in the urine.
How Can I Prevent Side Effects or Tell If a Side Effect Is Happening?
Jardiance can cause low blood sugar (hypoglycemia), which can be serious and may lead to death. You may need to check your blood sugar more often if you have changes in your diet, exercise regimen, or medicines for diabetes. It can also cause water loss, which can lead to dehydration. Make sure to stay well-hydrated if you are taking Jardiance. Your health care provider may want to have you complete kidney labs to make sure that your kidneys are not impacted by dehydration.
A dangerous condition called diabetic ketoacidosis can happen. When your body cannot use the sugar that you are taking in because you are not making or taking enough insulin, your body uses a process called ketosis to get energy. Ketosis results in a production of chemicals called ketones, which change the pH of your blood and can be dangerous and even deadly. This condition is more likely to occur if you are not eating like you normally do or miss insulin doses. Symptoms of ketoacidosis include nausea, vomiting, abdominal pain, tiredness, or shortness of breath. Your health care provider may ask you to monitor your ketone levels at home (through a home urine test). Stop Jardiance and get medical help right away if you have symptoms of ketoacidosis.
The risk of infections may be increased, some of which may be serious. Because Jardiance pushes more sugar into the urine, and bacteria and yeast thrive in a high-sugar environment, Jardiance can cause kidney, bladder, and genital yeast infections, possibly leading to more serious infections. Make sure to stay well-hydrated and perform normal hygiene (such as normal daily showers) when taking Jardiance. A serious infection of the genital or perineal area called necrotizing fasciitis of the perineum (Fournier’s gangrene) can happen and can lead to hospitalization, surgeries, and death. Let your health care provider know right away if you have fever or tiredness along with pain, redness, or swelling of the genital or perineal area.
An increase in toe, foot, and leg amputations was seen in people taking Jardiance, particularly in people who have a history of a vein condition called peripheral artery disease or have had previous diabetic foot problems or amputations. Look over your feet daily and let your health care provider know right away if you have any sores, wounds, or suspect any infections.
Allergic reactions can happen, which can be serious. Stop using Jardiance and get medical attention right away if you develop swelling of the lips, face, tongue, or throat (angioedema) or hives. Jardiance may not be safe in pregnancy and is not safe to use while breastfeeding. Let your health care provider know right away if you become pregnant or if you are breastfeeding.
Reports of side effects by persons are very important and are used to add information to the prescribing information. You don’t need to be certain that something you experienced was caused by Jardiance. If you experience anything that you think may be caused by Jardiance, you can report it by calling the FDA at 800-FDA-1088 or Boehringer Ingelheim Pharmaceuticals Inc. at 800-542-6257.
Is There a Coupon Card Available?
A savings card from the manufacturer may allow you to pay as little as $10 for your prescription. Whether you are eligible depends on the type of insurance plan you have and if your insurance covers Jardiance. You can find out more at patient.boehringer-ingelheim.com/us/products/jardiance/type-2-diabetes/pricing.
