What’s a beast of an A1c? Well, if you’re an adult with type 2 diabetes doing what you can—dieting, exercising, taking diabetes medication—and your A1c is still hard to handle, it’s not just high…it’s a beast. So before you blame yourself, ask if your treatment plan could be helping to keep your A1c levels under control.

When paired with diet and exercise, SOLIQUA 100/33 may go beyond what other individual diabetes medications (eg, insulin alone) can do on their own

By combining 2 medicines in 1 pen, SOLIQUA 100/33 works all day and all night to help control blood sugar and lower A1c. The 2 medications in the SOLIQUA 100/33 pen are:  

  • Lantus® (insulin glargine injection) 100 Units/mL: The most prescribed long-acting insulin used to control high blood sugar in adults with type 2 diabetes and adults and pediatric patients (children 6 years and older) with type 1 diabetes mellitus
  • Adlyxin® (lixisenatide injection): A non-insulin glucagon-like peptide-1 receptor agonist (GLP-1 RA) that helps the body produce more insulin

There are many treatments your doctor may recommend to help you manage your A1c

Here’s what SOLIQUA 100/33 can do compared to other kinds of type 2 diabetes treatments:

  • For patients with uncontrolled A1c taking up to 2 oral diabetes medications,

    SOLIQUA 100/33 along with diet and exercise was proven to lower A1c to below 7%* In nearly 3 out of 4 people

    *Individual results may vary.

      In a clinical study of adults uncontrolled on diabetes pills with type 2 diabetes (LixiLan-O), 74% of patients using SOLIQUA 100/33 lowered their A1c below 7%, while 59% of patients on Lantus® (insulin glargine injection) 100 Units/mL and 33% of patients on lixisenatide reached an A1c below 7%. The A1c average was reduced from a starting point of 8.1% to 6.5% in patients taking SOLIQUA 100/33, from 8.1% to 6.8% in patients taking Lantus, and from 8.1% to 7.3% in patients taking lixisenatide at the end of 30 weeks.

      Your doctor may prescribe a dose of insulin that is different from the doses used in the study. The results seen in the trial may not reflect your results.

      The clinical study (LixiLan-O) showed that in patients treated with metformin, SOLIQUA 100/33 improved blood sugar control compared to its individual components, a long-acting insulin (Lantus), and a non-insulin, diabetes medicine (lixisenatide). The study included 1,479 patients with type 2 diabetes who were on metformin alone or a second oral diabetes medication which was subsequently discontinued and whose A1c was not at goal. After 4 weeks of taking metformin alone, during which time the metformin dose was optimized, 1,170 patients who had still not achieved their A1c goal with A1c 7-10%, had a fasting blood sugar 250 mg/dL, and were on 1500 mg/dL metformin continued in the study. For the next 30 weeks patients continued taking metformin and were also treated with either SOLIQUA 100/33 (469 patients), Lantus (467 patients), or lixisenatide (234 patients). In the patients receiving insulin glargine 100 units/mL in the form of Lantus or SOLIQUA 100/33, the insulin glargine dose was adjusted in accordance with fasting self-monitored blood glucose measures aiming for a target of (80-100 mg/dL) with a dose cap of 60 units in both the Lantus and SOLIQUA 100/33 groups. The study showed that combining lixisenatide with Lantus in SOLIQUA 100/33 can help lower blood sugar even further than its individual components in patients taking metformin. SOLIQUA 100/33 was also able to improve glycemic control with no increases in either hypoglycemia or weight as compared to Lantus.


      Common Study Design terms found in the Glossary

  • For patients with uncontrolled A1c on long-acting insulin,

    SOLIQUA 100/33 along with diet and exercise was proven to lower A1c by almost 2x as much as long-acting insulin

    In the clinical study detailed below, more people taking SOLIQUA 100/33 reached their A1c goal of 7%* or lower than those who were taking long-acting insulin. 

    *Individual results may vary.

      In a different clinical study of people with type 2 diabetes and uncontrolled on basal insulin (LixiLan-L), more than half (55%) of patients using SOLIQUA 100/33 lowered their A1c below 7%, versus 30% of patients using Lantus. On average, A1c was reduced from a starting point of 8.1% to 6.9% in patients taking SOLIQUA 100/33 and from 8.1% to 7.5% in Lantus patients after 30 weeks of treatment. Patients using SOLIQUA 100/33 achieved almost twice (-1.1% vs -0.6%) the A1c reduction as patients who were using Lantus.

      Your doctor may prescribe a dose of insulin that is different from the doses used in the study. The differences between Lantus and SOLIQUA 100/33 seen in the trial may not reflect your results.

      The clinical study (LixiLan-L) showed how adding a non-insulin diabetes medicine (lixisenatide) to Lantus, a long-acting insulin, in a single injection improves blood sugar control, in patients uncontrolled on basal insulin with or without oral therapies. The study involved 1,018 patients with type 2 diabetes who had been taking a long-acting insulin for 6 months or more and up to 2 oral therapies, but had still not reached their A1c goal (<7%). After 6 weeks of starting and/or optimizing Lantus up to a dose of 50 units or less daily, discontinuing any oral therapy but metformin, and achieving an A1c of 7-10%, with a fasting plasma glucose 140 mg/dL, 736 patients entered the study. For the next 30 weeks, half of the patients continued on Lantus and half were transitioned to SOLIQUA 100/33 (Lantus + non-insulin medicine). The study showed that combining lixisenatide with Lantus in the form of SOLIQUA 100/33 may help to lower blood sugar even further. SOLIQUA 100/33 was also able to improve glycemic control with no increases in either hypoglycemia or weight compared to Lantus.


      Common Study Design terms found in the Glossary

  • For patients with uncontrolled A1c on GLP-1 RAs,

    SOLIQUA 100/33 along with diet and exercise helped to significantly lower A1c

    In a clinical study, more than 6 out of 10 people taking SOLIQUA 100/33 reached their A1c goal of 7% or lower.

      In a different clinical study of people uncontrolled with a max-tolerated dose of a daily or weekly GLP-1 RA with type 2 diabetes (LixiLan-G), more than half (62%) of patients using SOLIQUA 100/33 lowered their A1c below 7%, versus 26% of patients using a GLP-1 RA. On average, A1c was reduced from a starting point of 7.8% to 6.7% in patients taking SOLIQUA 100/33 and 7.8% to 7.4% in patients taking a GLP-1 RA. Patients using SOLIQUA 100/33 achieved almost twice (-1.0% vs -0.4%) the A1c reduction than patients who were using a GLP-1 RA. 

      Your doctor may prescribe a dose of GLP-1 RA that is different from the doses used in the study. The differences between a GLP-1 RA and SOLIQUA 100/33 seen in the trial may not reflect your results.

      The study showed how SOLIQUA 100/33 helped improve blood sugar control for patients uncontrolled on a GLP-1 RA plus oral diabetes medicines.
      The study involved a total of 514 patients with type 2 diabetes who had been on a maximum tolerated dose of a GLP-1 RA and diabetes pills, with A1c between 7-9%. No one in the trial had taken an insulin product within 12 months of the trial.

      After a screening period less than or equal to 2 weeks, patients either continued with their current daily or weekly GLP-1 RA treatment or switched to SOLIQUA 100/33 for 26 weeks. Patients in both groups continued taking their diabetes pills without changing the dosage or frequency. Patients who completed the 26-week treatment period on Soliqua 100/33 were eligible to enter the 26-week extension period if they did not receive rescue therapy. It is important to note that the glycemic control achieved with SOLIQUA 100/33 at week 26 was maintained at week 52 in 197 patients.


      Common Study Design terms found in the Glossary

Hear from real people who have taken soliqua 100/33

Learn about side effects and safety

Resources to help you start treatment

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

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:

  • See "What is the most important information I should know about SOLIQUA 100/33?"
  • Severe allergic reactions. Severe allergic reactions can happen with SOLIQUA 100/33. Stop taking SOLIQUA 100/33 and get medical help right away if you have any symptoms of a severe allergic reaction. See "Who should not use SOLIQUA 100/33?"
  • 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 include: 
    • headache
    • dizzines
    • drowsiness
    • sweating
    • weakness
    • irritability
    • hunger
    • blurred vision
    • fast heartbeat
    • feeling jittery
    • confusion
    • anxiety
    • headache
    • drowsiness
    • weakness
    • hunger
    • fast heartbeat
    • confusion
    • dizziness
    • sweating
    • irritability
    • blurred vision
    • feeling jittery
    • anxiety
  • Kidney problems (kidney failure). In people who have kidney problems, the occurrence of diarrhea, nausea, and vomiting may cause a loss of fluids (dehydration) which may cause kidney problems to get worse.
  • Low potassium in your blood (hypokalemia).
  • Heart failure. Taking certain diabetes pills called TZDs 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. Your healthcare provider should monitor you closely while you are taking 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 by your healthcare provider if you have new or worse heart failure.
  • Gallbladder problems. Gallbladder problems have happened in some people who take SOLIQUA 100/33. Tell your healthcare provider right away if you get symptoms of gallbladder problems which may include:
    • pain in your upper stomach (abdomen)
    • yellowing of skin or eyes (jaundice)
    • fever
    • clay-colored stools
    • pain in your upper stomach (abdomen)
    • fever
    • yellowing of skin or eyes (jaundice)
    • clay-colored stools

The most common side effects of SOLIQUA 100/33 include:

    • low blood sugar (hypoglycemia)
    • diarrhea
    • nausea
    • upper respiratory tract infection
    • stuffy or runny nose and sore throat
    • headache
    • low blood sugar (hypoglycemia)
    • nausea
    • stuffy or runny nose and sore throat
    • diarrhea
    • upper respiratory tract infection
    • headache
 

Nausea and diarrhea usually happen more often when you first start using SOLIQUA 100/33.

These are not all the possible side effects of SOLIQUA 100/33. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 1-800-FDA-1088.

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.

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

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:

  • See "What is the most important information I should know about SOLIQUA 100/33?"
  • Severe allergic reactions. Severe allergic reactions can happen with SOLIQUA 100/33. Stop taking SOLIQUA 100/33 and get medical help right away if you have any symptoms of a severe allergic reaction. See "Who should not use SOLIQUA 100/33?"
  • 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 include: 
    • headache
    • dizzines
    • drowsiness
    • sweating
    • weakness
    • irritability
    • hunger
    • blurred vision
    • fast heartbeat
    • feeling jittery
    • confusion
    • anxiety
    • headache
    • drowsiness
    • weakness
    • hunger
    • fast heartbeat
    • confusion
    • dizziness
    • sweating
    • irritability
    • blurred vision
    • feeling jittery
    • anxiety
  • Kidney problems (kidney failure). In people who have kidney problems, the occurrence of diarrhea, nausea, and vomiting may cause a loss of fluids (dehydration) which may cause kidney problems to get worse.
  • Low potassium in your blood (hypokalemia).
  • Heart failure. Taking certain diabetes pills called TZDs 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. Your healthcare provider should monitor you closely while you are taking 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 by your healthcare provider if you have new or worse heart failure.
  • Gallbladder problems. Gallbladder problems have happened in some people who take SOLIQUA 100/33. Tell your healthcare provider right away if you get symptoms of gallbladder problems which may include:
    • pain in your upper stomach (abdomen)
    • yellowing of skin or eyes (jaundice)
    • fever
    • clay-colored stools
    • pain in your upper stomach (abdomen)
    • fever
    • yellowing of skin or eyes (jaundice)
    • clay-colored stools

The most common side effects of SOLIQUA 100/33 include:

    • low blood sugar (hypoglycemia)
    • diarrhea
    • nausea
    • upper respiratory tract infection
    • stuffy or runny nose and sore throat
    • headache
    • low blood sugar (hypoglycemia)
    • nausea
    • stuffy or runny nose and sore throat
    • diarrhea
    • upper respiratory tract infection
    • headache
 

Nausea and diarrhea usually happen more often when you first start using SOLIQUA 100/33.

These are not all the possible side effects of SOLIQUA 100/33. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 1-800-FDA-1088.

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.