New combination diabetes treatment launched

Suliqua is a titratable, fixed-ratio combination of insulin glargine and lixisenatide, indicated for use in combination with metformin for the treatment of adults with type II diabetes.

The dose of Suliqua is titrated based on the patient's need for insulin. | SANOFI
The dose of Suliqua is titrated based on the patient's need for insulin. | SANOFI

Insulin glargine is a long-acting basal insulin that primarily targets fasting plasma glucose. Lixisenatide is a GLP-1 receptor agonist that predominantly lowers postprandial glucose. Suliqua combines the two complementary mechanisms of action to improve glycaemic control in patients with type II diabetes.

Suliqua is available in two disposable SoloStar pens, delivering 10–40 units of insulin glargine in combination with 5–20 microgram lixisenatide, or 30–60 units of insulin glargine in combination with 10–20 microgram lixisenatide.

Clinical studies

The safety and efficacy of insulin glargine/lixisenatide were investigated in two 30-week, open-label, randomised, active-controlled trials in patients with type II diabetes. The first study (LixiLan-O) compared the combination with its individual components in patients inadequately controlled on metformin (with or without a second oral hypoglycaemic) and the second study (LixiLan-L) compared the combination with insulin glargine alone in patients inadequately controlled on basal insulin.

LixiLan-O

Patients in the LixiLan-O study entered a 4-week run-in phase during which treatment with metformin was optimised and other treatment was discontinued, then those with an HbA1c range of 53–86mmol/mol (7 to 10%; n=1170) were randomised to receive either the combination, insulin glargine or lixisenatide.

Baseline HbA1c was 65mmol/mol (8.1%) in all three groups and at week 30, investigators found that patients treated with the combination product showed significant improvements in HbA1c compared to those who received insulin glargine or lixisenatide (final HbA1c levels 48mmol/mol, 51mmol/mol and 56mmol/mol [6.5%, 6.8% and 7.3%], respectively; p < 0.0001 for both comparisons).

LixiLan-L

After a 6-week run-in phase when insulin glargine was either introduced or further titrated, and oral hypoglycaemics other than metformin were stopped, patients in LixiLan-L (n=736) were randomised to receive either the combination product or insulin glargine.

At week 30, HbA1c levels were reduced to a greater extent in patients treated with the combination product than in those treated with insulin glargine (-1.1% vs -0.6%, p<0.0001; final HbA1c 52mmol/mol vs 58mmol/mol [6.9% vs 7.5%]).

Safety

In both studies, the safety profile of the combination product reflected the established safety profiles of insulin glargine and lixisenatide. The combination was associated with weight loss of 0.3kg and 0.7kg in the two studies respectively, compared with increases of 1.1kg and 0.7kg for insulin glargine (p < 0.0001 for both comparisons). Rates of symptomatic hypoglycaemia reported for insulin glargine/lixisenatide were similar to those seen with insulin glargine alone.

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