Soliqua 100/33 (insulin glargine and lixisenatide injection)

The following drug information is obtained from various newswires, published medical journal articles, and medical conference presentations.


Approval Status:

Approved November 2016

Specific Treatments:

inadequately controlled type II diabetes

Therapeutic Areas

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General Information

Soliqua 100/33 is a combination of insulin glargine, a basal insulin analog, and lixisenatide, a GLP-1 receptor agonist. 

Soliqua 100/33 is specifically indicated as an adjunct to diet and exercise to improve glycemic control in adults with type II diabetes mellitus inadequately controlled on basal insulin (less than 60 units daily) or lixisenatide.

Soliqua 100/33 is supplied as an injection for subcutaneous administration into the thigh, upper arm, or abdomen. Lixisenatide or basal insulin should be discontinued prior to initiation of Soliqua 100/33. In patients inadequately controlled on less than 30 units of basal insulin or on lixisenatide, the starting dosage is 15 units (15 units insulin glargine/5 mcg lixisenatide) given subcutaneously once daily. In patients inadequately controlled on 30 to 60 units of basal insulin, the starting dosage is 30 units (30 units insulin glargine/10 mcg lixisenatide) given subcutaneously once daily. Soliqua 100/33 should be Injected once a day within the hour prior to the first meal of the day. The maximum daily dosage is 60 units (60 units of insulin glargine and 20 mcg of lixisenatide). Soliqua 100/33 Pen delivers doses from 15 to 60 units with each injection. Use alternative antidiabetic products if patients require a Soliqua 100/33 daily dosage below 15 units or over 60 units. Please see full prescribing information for titration recommendations. 

Clinical Results

FDA Approval

The FDA approval of Soliqua was based on an insulin intensification study. Soliqua 100/33 showed better HbA1c (average blood sugar over time) lowering versus Lantus with a majority of the 736 patients (55% vs. 30%) achieving the American Diabetes Association target of less than 7% at 30 weeks. Subjects treated with Soliqua 100/33 experienced similar rates of documented (<70 mg/dL) hypoglycemia compared to Lantus-treated subjects. 

Side Effects

Adverse effects associated with the use of Soliqua 100/33 may include, but are not limited to, the following:

  • hypoglycemia
  • allergic reactions
  • nausea
  • nasopharyngitis
  • diarrhea
  • upper respiratory tract infection
  • headache

Mechanism of Action

Soliqua 100/33 is a combination of insulin glargine, a basal insulin analog, and lixisenatide, a GLP-1 receptor agonist. The primary activity of insulin, including insulin glargine, is regulation of glucose metabolism. Insulin and its analogs lower blood glucose by stimulating peripheral glucose uptake, especially by skeletal muscle and fat, and by inhibiting hepatic glucose production. Insulin inhibits lipolysis and proteolysis, and enhances protein synthesis. Lixisenatide is a GLP-1 receptor agonist that increases glucose-dependent insulin release, decreases glucagon secretion, and slows gastric emptying. 

Additional Information

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