Soliqua and Xultophy launch the insulin plus GLP-1 combinations

On November 21, 2016, Sanofi's Soliqua 100/33 became available in US pharmacies, according to FDA drug listing records showing that date as the marketing start date for the product's packaging.^[1] Soliqua combines insulin glargine, a long-acting insulin, with lixisenatide, a GLP-1 receptor agonist, in one pen.^[1][2] The drug's FDA label lists its initial US approval as 2016 and describes it as an add-on to diet and exercise to improve blood sugar control in adults with type 2 diabetes.^[2]

The same news cycle noted a second combination product, Novo Nordisk's Xultophy 100/3.6, pairing insulin degludec with the GLP-1 drug liraglutide, also reaching the market on the same day. The sources reviewed for this article do not include FDA data specifically documenting Xultophy's launch date or label details, so those specifics are not confirmed here.

For Soliqua, the label spells out important limits. It is not recommended together with any other GLP-1 receptor agonist product, is not meant for treating diabetic ketoacidosis, and has not been studied alongside mealtime insulin.^[2] Patients starting Soliqua must first stop any prior basal insulin or GLP-1 drug.^[2] Dosing starts at 15 units a day for people new to basal insulin or a GLP-1 agonist, or already on less than 30 units of basal insulin; those on 30 to 60 units of basal insulin start at a higher dose.^[2] The pen delivers between 15 and 60 units per injection, with a daily maximum of 60 units of insulin glargine and 20 micrograms of lixisenatide.^[2]

The label also lists common side effects reported in 5% or more of patients in trials: low blood sugar, nausea, nasopharyngitis (common cold-type symptoms), diarrhea, upper respiratory infection, and headache.^[2] Warnings cover more serious risks, including severe allergic reactions, acute pancreatitis, kidney injury from fluid loss, and severe gastrointestinal reactions; the label notes the drug is not recommended for patients with severe gastroparesis or end-stage kidney disease.^[2] A 2025 label update added stronger language on severe gastrointestinal adverse reactions, and a 2024 update added a warning about pulmonary aspiration risk during general anesthesia or deep sedation.^[2]

Why it matters for patients

Before combination pens like Soliqua existed, someone using both a basal insulin and a GLP-1 drug for type 2 diabetes typically needed two separate injections. A fixed-ratio pen reduces that to one shot a day, which may simplify a daily routine for some patients. But the tradeoff is less flexibility: the two drugs are locked together in a set ratio, so a patient's insulin dose can't be adjusted without also changing the lixisenatide dose, and vice versa.^[2]

The label's discontinuation rule is also practical to understand: someone switching to Soliqua from another basal insulin or a different GLP-1 medicine must stop that prior treatment before starting, rather than layering the new pen on top of it.^[2] The label explicitly advises against combining Soliqua with any other GLP-1 receptor agonist product, which matters for anyone whose regimen might otherwise include a separate GLP-1 drug alongside their insulin.^[2]

Because Soliqua's approval and current label apply only to type 2 diabetes, not to weight management or type 1 diabetes, patients considering it for other reasons would not find that use supported in the prescribing information reviewed here.^[2]

What happens next

The FDA label for Soliqua has continued to be revised well beyond its 2016 launch, with the most recent changes noted in the sources dated November 2024 and May 2025, adding new warnings about anesthesia-related aspiration risk and severe gastrointestinal reactions.^[2] Whether similar updates have been made to Xultophy's label is not addressed in the sources available for this article.