Glossary

TERM DEFINITION

DEFINITION

A1c

The test that measures your average blood glucose level over the past 2 to 3 months. Sometimes also called the hemoglobin A1c, or HbA1c.


BASAL INSULIN

Also referred to as “long-acting insulin.” Provides blood sugar—lowering activity for approximately 24 hours. Along with the rest of your treatment plan, it can help control your blood sugar between meals and while you are sleeping.


BLOOD SUGAR

A common name for glucose, one of the simplest forms of sugar, blood glucose, or blood sugar, is the amount of glucose in the blood and is the body’s main source of energy.


CLINICAL STUDY 

A research study involving human participants that is intended to determine safety and efficacy of medications and/or medical devices.


COMMERCIAL INSURANCE

Insurance from a public or private company rather than the government.


DIABETIC KETOACIDOSIS

Also known as DKA, this is an emergency condition in which extremely high blood glucose levels and extremely low levels of insulin cause the body to break down fat for energy. Blood acids, called ketones, begin to collect in the blood and urine. Signs of DKA are nausea and vomiting, stomach pain, fruity breath odor, and rapid breathing. Untreated DKA can lead to coma and death.


GASTROPARESIS

Also known as delayed gastric emptying, it is a condition in which the muscles in your stomach don’t function properly. It results in slowing down or stopping food from moving from the stomach to the small intestine, making blood sugar control difficult.


GLP-1 RA (GLUCAGON-LIKE PEPTIDE-1 RECEPTOR AGONIST)

A medicine that mimics naturally occurring GLP-1. GLP-1 RAs activate GLP-1 receptors to slow the movement of food through your stomach. They also increase insulin release and reduce glucagon secretion after meals.


GLUCAGON

A hormone produced by the alpha cells in the pancreas. It raises blood glucose.


GLUCOSE

One of the simplest forms of sugar that is used for energy in the body.


HYPOGLYCEMIA

Low blood sugar.


INSULIN

A hormone that the pancreas makes to help your body use blood glucose for energy or store it for later use.


INSULIN GLARGINE

Long-acting man-made version of human insulin.


LIXISENATIDE

 Injectable that stimulates the pancreas to secrete insulin.


MAXIMUM TOLERATED DOSE

The highest dose of a medicine or treatment that will produce the desired effect without resulting in unacceptable side effects.


MEDICARE PART D

Medicare drug coverage for medications.


OPEN LABEL

A trial where both patient and experimenter are aware which treatment is being provided.


POST-HOC ANALYSIS

A process that involves looking at data after a study has been concluded and trying to find patterns that were not primary objectives of the study. 


RANDOMIZED STUDY

A clinical study in which the participants are allocated randomly to receive an experimental clinical intervention (such as a new antibiotic) or a control intervention. The control intervention may be a placebo or the usually used treatment for a condition (standard of care).


RECEPTOR ANTAGONIST (RA)

Binds and blocks receptor rather than activating it.


STATISTICAL SIGNIFICANCE

The level of statistical significance depends on the number of participants studied and the observations made, as well as the magnitude of differences observed.


STUDY DESIGN

The investigative methods and strategies used in the clinical study. A description of the way the clinical trial will be conducted.


SUBCUTANEOUS

Under the skin.


THIAZOLIDINEDIONES (TZDS)

Help insulin work in muscles and fat cells.


TYPE 1 DIABETES

A condition where your pancreas can no longer produce insulin. People with type 1 diabetes must take insulin.


TYPE 2 DIABETES

A condition where your pancreas does not produce enough insulin and/or does not correctly use the insulin it produces.


SOLIQUA 100/33 is an injectable prescription medicine that contains 2 diabetes medicines, insulin glargine and lixisenatide, which may improve blood sugar (glucose) control in adults with type 2 diabetes when used with diet and exercise.

  • It has not been studied in people with a history of pancreatitis. 
  • It is not recommended for people who also take lixisenatide or other medicines called GLP-1 receptor agonists. 
  • It is not for use in people with type 1 diabetes, or people with diabetic ketoacidosis. 
  • It has not been studied in people who have a stomach problem that causes slow emptying (gastroparesis) and is not for people with slow emptying of the stomach. 
  • It has not been studied in people who also take a short-acting (prandial) insulin. 
  • It is not known if SOLIQUA 100/33 is safe and effective in children under 18 years of age. 

Important Safety Information

Important Safety Information

Important Safety Information for SOLIQUA 100/33 (insulin glargine and lixisenatide) injection 100 Units/mL and 33 mcg/mL

What is the most important information I should know about SOLIQUA 100/33?
Do not share your SOLIQUA 100/33 pen with other people, even if the needle has been changed. You may give other people a serious infection, or get a serious infection from them.

SOLIQUA 100/33 can cause serious side effects, including inflammation of the pancreas, which may be severe and lead to death.

Before using SOLIQUA 100/33, tell your doctor if you have had pancreatitis, stones in your gallbladder (cholelithiasis), or a history of alcoholism. These medical problems may make you more likely to get pancreatitis.

Stop taking SOLIQUA 100/33 and call your healthcare provider right away if you have pain in your stomach area (abdomen) that is severe, and will not go away. The pain may be felt in the back area. The pain may happen with or without vomiting.

Who should not use SOLIQUA 100/33?
Do not use SOLIQUA 100/33 if you:

  • are having an episode of low blood sugar (hypoglycemia).
  • are allergic to insulin glargine, lixisenatide, or any of the ingredients in SOLIQUA 100/33. Symptoms of a severe allergic reaction with SOLIQUA 100/33 may include swelling of the face, lips, tongue, or throat, fainting or feeling dizzy, problems breathing or swallowing, very rapid heartbeat, severe rash or itching, or low blood pressure.

Before using SOLIQUA 100/33, tell your healthcare provider about all your medical conditions, including if you:

  • have or have had problems with your pancreas, your kidneys, or your liver, stones in your gallbladder, or a history of alcoholism.
  • have heart failure or other heart problems. If you have heart failure, it may get worse while you take thiazolidinediones (TZDs).
  • have severe problems with your stomach, such as slowed emptying of your stomach or problems digesting food.
  • are taking certain medicines called glucagon-like peptide 1 receptor agonists (GLP-1 receptor agonists).
  • have had an allergic reaction to a GLP-1 receptor agonist.
  • are pregnant or breastfeeding or plan to become pregnant or to breastfeed. It is not known if SOLIQUA 100/33 will harm your unborn baby or pass into your breast milk.

Tell your healthcare provider about all the medicines you take, including all prescription and over-the-counter medicines, vitamins, and herbal supplements. SOLIQUA 100/33 may affect the way some medicines work. Before using SOLIQUA 100/33, talk to your healthcare provider about low blood sugar and how to manage it.

How should I use SOLIQUA 100/33?

  • Do not change your dose without first talking to your healthcare provider.
  • Check the pen label each time you inject to make sure you are using the correct medicine.
  • Do not take more than 60 units of SOLIQUA 100/33 each day. Do not take SOLIQUA 100/33 with other GLP-1 receptor agonists.
  • Only use SOLIQUA 100/33 that is clear and colorless to almost colorless. If you see small particles, return it to your pharmacy for replacement.
  • Change (rotate) your injection sites within the area you chose with each dose to reduce your risk of getting pitted or thickened skin (lipodystrophy) and skin with lumps (localized cutaneous amyloidosis) at the injection sites. Do not use the same spot for each injection or inject where the skin is pitted, thickened, lumpy, tender, bruised, scaly, hard, scarred or damaged.
  • Do not remove SOLIQUA 100/33 from the pen with a syringe.
  • Do not re-use or share needles with other people. You may give other people a serious infection, or get a serious infection from them.
  • Check your blood sugar levels. Ask your healthcare provider what your blood sugar should be and when you should check.

What are the possible side effects of SOLIQUA 100/33?
SOLIQUA 100/33 can cause serious side effects, including:

  • Serious allergic reactions. Stop taking SOLIQUA 100/33 and get help right away if you have any symptoms of a serious allergic reaction, including swelling of your face, lips, tongue, or throat, problems breathing or swallowing, severe rash or itching, fainting or feeling dizzy, and very rapid heartbeat.
  • Low blood sugar (hypoglycemia). Your risk for getting low blood sugar is higher if you take another medicine that can cause low blood sugar. Signs and symptoms of low blood sugar may include headache, dizziness, drowsiness, sweating, weakness, irritability, hunger, blurred vision, fast heartbeat, feeling jittery, confusion, and anxiety.
  • Kidney problems (kidney failure). In people who have kidney problems, diarrhea, nausea, and vomiting may cause a loss of fluids (dehydration), which may worsen kidney problems.
  • Low potassium in your blood (hypokalemia).
  • Heart failure. Taking certain diabetes pills called TZDs (thiazolidinediones) with SOLIQUA 100/33 may cause heart failure in some people. This can happen even if you have never had heart failure or heart problems before. If you already have heart failure, it may get worse while you take TZDs with SOLIQUA 100/33. Tell your healthcare provider if you have any new or worse symptoms of heart failure, including shortness of breath, swelling of your ankles or feet, or sudden weight gain. Treatment with TZDs and SOLIQUA 100/33 may need to be adjusted or stopped if you have new or worse heart failure.

The most common side effects of SOLIQUA 100/33 include low blood sugar (hypoglycemia), nausea, diarrhea, upper respiratory infection, stuffy or runny nose, and headache. Nausea and diarrhea usually happen more often when you first start using SOLIQUA 100/33.

Click here for full Prescribing Information for SOLIQUA 100/33.
Click here for information on Sharps Medical Waste Disposal.
Click here to learn more about Sanofi’s commitment to fighting counterfeit drugs.

If you are a patient experiencing problems with a Sanofi U.S. product, please contact Sanofi U.S. at 1-800-633-1610.

The health information contained herein is provided for general educational purposes only. Your healthcare provider is the single best source of information regarding your health. Please consult your healthcare provider if you have any questions about your health or treatment.

Important Safety Information

Important Safety Information

Important Safety Information for SOLIQUA 100/33 (insulin glargine and lixisenatide) injection 100 Units/mL and 33 mcg/mL

What is the most important information I should know about SOLIQUA 100/33?
Do not share your SOLIQUA 100/33 pen with other people, even if the needle has been changed. You may give other people a serious infection, or get a serious infection from them.

SOLIQUA 100/33 can cause serious side effects, including inflammation of the pancreas, which may be severe and lead to death.

Before using SOLIQUA 100/33, tell your doctor if you have had pancreatitis, stones in your gallbladder (cholelithiasis), or a history of alcoholism. These medical problems may make you more likely to get pancreatitis.

Stop taking SOLIQUA 100/33 and call your healthcare provider right away if you have pain in your stomach area (abdomen) that is severe, and will not go away. The pain may be felt in the back area. The pain may happen with or without vomiting.

Who should not use SOLIQUA 100/33?
Do not use SOLIQUA 100/33 if you:

  • are having an episode of low blood sugar (hypoglycemia).
  • are allergic to insulin glargine, lixisenatide, or any of the ingredients in SOLIQUA 100/33. Symptoms of a severe allergic reaction with SOLIQUA 100/33 may include swelling of the face, lips, tongue, or throat, fainting or feeling dizzy, problems breathing or swallowing, very rapid heartbeat, severe rash or itching, or low blood pressure.

Before using SOLIQUA 100/33, tell your healthcare provider about all your medical conditions, including if you:

  • have or have had problems with your pancreas, your kidneys, or your liver, stones in your gallbladder, or a history of alcoholism.
  • have heart failure or other heart problems. If you have heart failure, it may get worse while you take thiazolidinediones (TZDs).
  • have severe problems with your stomach, such as slowed emptying of your stomach or problems digesting food.
  • are taking certain medicines called glucagon-like peptide 1 receptor agonists (GLP-1 receptor agonists).
  • have had an allergic reaction to a GLP-1 receptor agonist.
  • are pregnant or breastfeeding or plan to become pregnant or to breastfeed. It is not known if SOLIQUA 100/33 will harm your unborn baby or pass into your breast milk.

Tell your healthcare provider about all the medicines you take, including all prescription and over-the-counter medicines, vitamins, and herbal supplements. SOLIQUA 100/33 may affect the way some medicines work. Before using SOLIQUA 100/33, talk to your healthcare provider about low blood sugar and how to manage it.

How should I use SOLIQUA 100/33?

  • Do not change your dose without first talking to your healthcare provider.
  • Check the pen label each time you inject to make sure you are using the correct medicine.
  • Do not take more than 60 units of SOLIQUA 100/33 each day. Do not take SOLIQUA 100/33 with other GLP-1 receptor agonists.
  • Only use SOLIQUA 100/33 that is clear and colorless to almost colorless. If you see small particles, return it to your pharmacy for replacement.
  • Change (rotate) your injection sites within the area you chose with each dose to reduce your risk of getting pitted or thickened skin (lipodystrophy) and skin with lumps (localized cutaneous amyloidosis) at the injection sites. Do not use the same spot for each injection or inject where the skin is pitted, thickened, lumpy, tender, bruised, scaly, hard, scarred or damaged.
  • Do not remove SOLIQUA 100/33 from the pen with a syringe.
  • Do not re-use or share needles with other people. You may give other people a serious infection, or get a serious infection from them.
  • Check your blood sugar levels. Ask your healthcare provider what your blood sugar should be and when you should check.

What are the possible side effects of SOLIQUA 100/33?
SOLIQUA 100/33 can cause serious side effects, including:

  • Serious allergic reactions. Stop taking SOLIQUA 100/33 and get help right away if you have any symptoms of a serious allergic reaction, including swelling of your face, lips, tongue, or throat, problems breathing or swallowing, severe rash or itching, fainting or feeling dizzy, and very rapid heartbeat.
  • Low blood sugar (hypoglycemia). Your risk for getting low blood sugar is higher if you take another medicine that can cause low blood sugar. Signs and symptoms of low blood sugar may include headache, dizziness, drowsiness, sweating, weakness, irritability, hunger, blurred vision, fast heartbeat, feeling jittery, confusion, and anxiety.
  • Kidney problems (kidney failure). In people who have kidney problems, diarrhea, nausea, and vomiting may cause a loss of fluids (dehydration), which may worsen kidney problems.
  • Low potassium in your blood (hypokalemia).
  • Heart failure. Taking certain diabetes pills called TZDs (thiazolidinediones) with SOLIQUA 100/33 may cause heart failure in some people. This can happen even if you have never had heart failure or heart problems before. If you already have heart failure, it may get worse while you take TZDs with SOLIQUA 100/33. Tell your healthcare provider if you have any new or worse symptoms of heart failure, including shortness of breath, swelling of your ankles or feet, or sudden weight gain. Treatment with TZDs and SOLIQUA 100/33 may need to be adjusted or stopped if you have new or worse heart failure.

The most common side effects of SOLIQUA 100/33 include low blood sugar (hypoglycemia), nausea, diarrhea, upper respiratory infection, stuffy or runny nose, and headache. Nausea and diarrhea usually happen more often when you first start using SOLIQUA 100/33.

Click here for full Prescribing Information for SOLIQUA 100/33.
Click here for information on Sharps Medical Waste Disposal.
Click here to learn more about Sanofi’s commitment to fighting counterfeit drugs.

If you are a patient experiencing problems with a Sanofi U.S. product, please contact Sanofi U.S. at 1-800-633-1610.

The health information contained herein is provided for general educational purposes only. Your healthcare provider is the single best source of information regarding your health. Please consult your healthcare provider if you have any questions about your health or treatment.