Soliqua (lixisenatide + glargine)

Medical Disclaimer

This article is for informational purposes only and does not constitute medical advice. Always consult your physician or a qualified healthcare provider regarding any medical condition or treatment.

Key Takeaways

  • Soliqua is a once-daily subcutaneous injection pen combining lixisenatide (a short-acting GLP-1 receptor agonist) with insulin glargine 100 units/mL (a long-acting basal insulin) in a fixed-ratio formulation.
  • Two pen strengths are available — Soliqua 100/33 (15 to 60 units glargine plus 5 to 20 mcg lixisenatide) and Soliqua 100/50 (in some regions) — allowing flexible titration of basal insulin while delivering proportional lixisenatide.
  • Combined A1C reduction is typically 1.5 to 2.5 percent in patients inadequately controlled on basal insulin alone, with reduced weight gain compared with intensifying insulin alone and improved postprandial glucose from the lixisenatide component.
  • Common side effects include nausea, hypoglycemia (mainly from glargine), injection site reactions, and rare risks of pancreatitis, severe gastrointestinal effects, and allergic reactions.
  • Soliqua is administered within one hour before the first meal of the day, providing 24-hour basal coverage from glargine plus postprandial glucose control from lixisenatide's effect on gastric emptying and glucagon suppression.

Soliqua is a once-daily subcutaneous injection that combines lixisenatide (a short-acting GLP-1 receptor agonist) with insulin glargine 100 units/mL (a long-acting basal insulin) in one fixed-ratio pen. It is designed for adults with type 2 diabetes inadequately controlled on basal insulin or a GLP-1 alone, offering combined A1C reduction of 1.5 to 2.5 percent with less weight gain than intensifying insulin alone.

What Soliqua Contains

Soliqua is manufactured by Sanofi. Each pen contains two active ingredients in a fixed ratio:

  • Insulin glargine 100 units/mL — a long-acting basal insulin analog that provides 24-hour glucose lowering through subcutaneous depot release. The same molecule as Lantus and Basaglar. Lowers fasting blood glucose by suppressing hepatic glucose production overnight.
  • Lixisenatide — a short-acting GLP-1 receptor agonist administered once daily before the first meal. Slows gastric emptying, suppresses glucagon, and enhances glucose-dependent insulin release. Particularly effective at controlling postprandial glucose excursions of the first meal of the day.

The combination targets fasting glucose (glargine) and postprandial glucose (lixisenatide) in a single daily injection, addressing two pillars of glucose control simultaneously.

Available Pen Strengths

Pen Insulin glargine per mL Lixisenatide per mL Dose Range
Soliqua 100/33 100 units 33 mcg 15 to 60 units (glargine) + 5 to 20 mcg (lixisenatide) per day

In the United States, the 100/33 pen is the only available strength. Each unit dialed on the pen delivers 1 unit of glargine and 0.33 mcg of lixisenatide. Dosing starts at 15 units once daily and titrates by 2 to 4 units every 1 to 2 weeks based on fasting glucose, up to a maximum of 60 units daily. Beyond 60 units, lixisenatide exceeds its 20 mcg approved maximum and Soliqua is no longer appropriate — switch to basal-bolus insulin or another regimen.

Dosing Instructions

  • Inject once daily, within one hour before the first meal of the day.
  • Use the abdomen, thigh, or upper arm — rotate sites within and between regions.
  • Do not mix Soliqua with any other insulin.
  • If a dose is missed and breakfast has not yet happened or is just starting, take it immediately. If breakfast is over and several hours have passed, skip the dose and resume the next day — do not double up.
  • Use a new pen needle for each injection. Discard used needles in an FDA-cleared sharps container.

Who Soliqua Is For

Soliqua is approved for adults with type 2 diabetes as an adjunct to diet and exercise when:

  • A1C remains above goal on basal insulin alone (up to 60 units daily) or on lixisenatide alone
  • The patient prefers a once-daily injection over basal-bolus insulin (multiple daily injections)
  • Weight gain from intensifying insulin is undesirable
  • Postprandial glucose excursions, particularly at breakfast, are problematic

It is not approved for type 1 diabetes, diabetic ketoacidosis, or pediatric use. It is not appropriate for patients requiring more than 60 units of basal insulin daily.

How Well Soliqua Works

Pivotal trials (LixiLan-L and LixiLan-O) showed:

  • LixiLan-L (Soliqua vs glargine alone, in patients inadequately controlled on basal insulin): A1C reduction of 1.1 percent with Soliqua vs 0.6 percent with glargine alone, plus a 0.7 kg weight loss with Soliqua vs 0.7 kg gain with glargine.
  • LixiLan-O (Soliqua vs glargine vs lixisenatide alone, in metformin-treated patients): A1C reduction of 1.6 percent with Soliqua vs 1.3 percent with glargine alone vs 0.9 percent with lixisenatide alone.
  • Weight effect: Soliqua causes neutral or modest weight loss (0.7 to 1.4 kg), compared with weight gain typically seen with insulin intensification.
  • Hypoglycemia: rates are similar to or slightly lower than insulin glargine alone at matched A1C reductions.
  • Postprandial glucose: reduced 50 to 80 mg/dL after the first meal due to lixisenatide’s effect on gastric emptying.

Side Effects

Side Effect Source Approximate Frequency
Nausea Lixisenatide 10 to 25 percent (usually mild, improves over 4 to 8 weeks)
Hypoglycemia Glargine 20 to 30 percent at least one episode/year (mild)
Severe hypoglycemia Glargine 1 to 3 percent/year
Diarrhea Lixisenatide 5 to 10 percent
Vomiting Lixisenatide 5 to 8 percent
Headache Both 5 to 7 percent
Injection site reactions Both 3 to 7 percent
Upper respiratory tract infections Both 5 percent
Allergic reactions Lixisenatide Rare
Pancreatitis Lixisenatide Rare (less than 0.5 percent)
Acute kidney injury (from dehydration) Lixisenatide Rare
Gallbladder disease Lixisenatide (class effect) Rare
Severe gastrointestinal symptoms Lixisenatide Rare

Contraindications and Warnings

  • Hypersensitivity to insulin glargine, lixisenatide, or other GLP-1 receptor agonists.
  • Active diabetic ketoacidosis or type 1 diabetes.
  • Personal or family history of medullary thyroid carcinoma or MEN2 syndrome (class warning for GLP-1 receptor agonists based on rodent thyroid C-cell findings).
  • Severe gastroparesis or other significant gastrointestinal motility disorders — lixisenatide further slows gastric emptying.
  • History of pancreatitis: use cautiously.
  • Severe renal impairment (eGFR less than 30): use with caution; lixisenatide has limited data.
  • Pregnancy: insulin glargine is preferred during pregnancy, but lixisenatide is not recommended.

Drug Interactions

  • Oral medications with narrow therapeutic windows or requiring rapid absorption: take at least 1 hour before Soliqua, since lixisenatide slows gastric emptying and can delay or reduce oral drug absorption.
  • Beta blockers and clonidine can mask hypoglycemia symptoms.
  • ACE inhibitors, ARBs, fibrates, and certain antidepressants can potentiate insulin’s hypoglycemic effect.
  • Corticosteroids, thiazide diuretics, and atypical antipsychotics can raise blood glucose and may require dose increases.
  • Alcohol: increases hypoglycemia risk; consume in moderation with food.

Cost and Insurance

Without insurance, Soliqua retails for approximately $700 to $900 per month for a 30-day supply of pens. Sanofi’s manufacturer savings card can reduce out-of-pocket costs for commercially insured patients to as little as $0 to $99 per month, with annual savings limits. Medicare and Medicaid patients are not eligible for the savings card but may qualify for Sanofi’s patient assistance program based on income. Insulin price reforms enacted in 2023 capped insulin out-of-pocket costs for Medicare beneficiaries at $35 per month for each insulin product, including Soliqua under most Part D plans.

Storage and Handling

  • Unopened pens: refrigerate at 36 to 46 degrees F (2 to 8 degrees C) until expiration date.
  • In-use pens: store at room temperature, 59 to 86 degrees F (15 to 30 degrees C), for up to 28 days. Discard after 28 days even if pen contains drug.
  • Do not freeze. Do not use if frozen.
  • Protect from heat and direct sunlight.
  • Always use a new pen needle for each injection.
  • Dispose of needles and pens in an FDA-cleared sharps container.

Soliqua vs Xultophy and Basal-Bolus Insulin

Approach Daily Injections A1C Reduction Weight Effect Hypoglycemia Risk
Soliqua (glargine + lixisenatide) 1 per day 1.5 to 2.5% Neutral or modest loss Moderate
Xultophy (degludec + liraglutide) 1 per day 1.5 to 2.5% Neutral or loss (2 to 3 kg) Lower (degludec)
Basal-bolus insulin 4 to 5 per day 1.5 to 2.5% Weight gain 2 to 4 kg Higher
Basal insulin + separate GLP-1 2 per day (1 daily basal + 1 weekly GLP-1) 1.8 to 3.0% Weight loss possible Moderate

Soliqua’s main advantage over basal-bolus insulin is reduced injection burden (1 vs 4 to 5 daily injections) and reduced weight gain. Its main disadvantage versus separate basal insulin plus a weekly GLP-1 (like semaglutide) is that lixisenatide is short-acting and has more modest A1C and weight effects than weekly GLP-1 agonists.

Place in Modern Type 2 Diabetes Care

ADA Standards of Care 2024 recommend fixed-ratio basal insulin plus GLP-1 combinations (Soliqua or Xultophy) for patients with type 2 diabetes inadequately controlled on basal insulin alone, before escalating to basal-bolus regimens. The combination reduces injection burden, weight gain, and hypoglycemia risk while achieving similar A1C reductions. For broader treatment context, see our type 2 diabetes treatment options page.

Comparison to Separate Components

Patients can achieve similar effects by taking insulin glargine (Lantus or Basaglar) plus separate lixisenatide (Adlyxin) injections. Soliqua simplifies to one injection daily, which improves adherence. Cost depends on insurance — the manufacturer prices Soliqua similarly to a single brand drug, often making it competitive with separate components.

Practical Considerations

  • Inject within one hour before the first meal of the day, consistently.
  • If you miss breakfast, do not take Soliqua and wait until breakfast the next day.
  • Monitor blood glucose regularly, including fasting and post-breakfast values, to guide dose titration.
  • Watch for symptoms of pancreatitis (severe upper abdominal pain radiating to the back, persistent vomiting) — stop and seek medical care immediately.
  • Stay hydrated — GLP-1 receptor agonists like lixisenatide can cause dehydration through nausea or reduced intake, which can affect kidney function.
  • Carry fast-acting glucose (glucose tablets, juice, candy) to treat hypoglycemia.
  • Inform any new clinician about Soliqua before surgery or contrast imaging.
  • Discuss the timing of other oral medications — take them at least 1 hour before Soliqua to avoid absorption interference.

Soliqua and Weight

Unlike basal insulin alone, which typically causes 2 to 4 kg of weight gain over a year, Soliqua tends to be weight-neutral or produce modest weight loss (0.7 to 1.4 kg). This is largely due to the appetite-suppressing and gastric-emptying effects of lixisenatide offsetting insulin’s anabolic effect. For more substantial weight loss, weekly GLP-1 receptor agonists like semaglutide or tirzepatide are more effective — see our pieces on Wegovy vs Ozempic and Mounjaro vs Ozempic.

The Bottom Line

Soliqua is a once-daily subcutaneous injection combining insulin glargine 100 units/mL with the short-acting GLP-1 receptor agonist lixisenatide in a fixed-ratio pen. It is FDA-approved for adults with type 2 diabetes inadequately controlled on basal insulin (up to 60 units daily) or lixisenatide alone. Combined A1C reduction of 1.5 to 2.5 percent comes with reduced injection burden compared with basal-bolus insulin and less weight gain than intensifying insulin alone. Common side effects include nausea (which improves over weeks), hypoglycemia from glargine, and injection site reactions. It is administered within one hour before the first meal of the day and is contraindicated in medullary thyroid carcinoma history, severe gastroparesis, and active diabetic ketoacidosis. Talk to your clinician about whether Soliqua fits your basal insulin needs, weight goals, and treatment intensification preferences.

Frequently Asked Questions

What is Soliqua?

Soliqua is a once-daily subcutaneous injection that combines lixisenatide (a short-acting GLP-1 receptor agonist) with insulin glargine 100 units/mL (a long-acting basal insulin) in one fixed-ratio pen. It is FDA-approved for adults with type 2 diabetes inadequately controlled on basal insulin alone (up to 60 units daily) or lixisenatide alone.

How is Soliqua different from Xultophy?

Both are fixed-ratio basal insulin plus GLP-1 combinations. Soliqua uses insulin glargine plus lixisenatide (a short-acting GLP-1). Xultophy uses insulin degludec plus liraglutide (a longer-acting GLP-1). Soliqua's lixisenatide has stronger postprandial effects on the first meal of the day, while Xultophy's liraglutide provides 24-hour GLP-1 coverage with stronger overall weight loss. Choice often depends on insurance coverage and prescriber preference.

What are the most common side effects of Soliqua?

The most common are nausea (10 to 25 percent, usually mild and improves over weeks), hypoglycemia (from glargine), injection site reactions, diarrhea, vomiting, and headache. Less common but serious risks include pancreatitis, severe hypoglycemia, severe gastrointestinal symptoms, allergic reactions, acute kidney injury from dehydration, and rare gallbladder disease.

How much does Soliqua cost?

Without insurance, Soliqua typically retails for $700 to $900 per month for a 30-day supply of pens. Sanofi's manufacturer savings card can reduce out-of-pocket costs for commercially insured patients to as little as $0 to $99 per month, with annual savings limits. Medicare and Medicaid patients are not eligible for the savings card but may qualify for Sanofi's patient assistance program based on income.

Sources

  1. U.S. Food and Drug Administration. Soliqua 100/33 (insulin glargine and lixisenatide injection) Prescribing Information. https://www.accessdata.fda.gov/drugsatfda_docs/label/
  2. American Diabetes Association. Standards of Care in Diabetes 2024. Diabetes Care 47(Suppl 1).