Lixisenatide Combination Therapy Outperforms Single Treatment Option for T2D

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Patients in the combination arm also reached the target HbA1c level faster than those using just the single treatment therapy.

Juan Frias, Sanofi, Lixisenatide, EASD, Diabetes

The combination insulin glargine and lixisenatide injection (100 units/mL and 33 mcg/mL) provided earlier blood sugar control to more adults with type 2 diabetes (T2D) compared to insulin glargine 100 units/mL alone.

The Sanofi-produced injection, commercially known as Soliqua, allowed more patients to reach target hemoglobin A1C (HbA1c) levels at 8 and 12 weeks compared to the single solution injection, according to a posthoc analysis that was presented at the European Association for the Study of Diabetes (EASD) 53rd annual meeting in Lisbon, Portugal.

"Reaching an HbA1c target quickly can have a benefit for adults with type 2 diabetes," Juan Frias (pictured), MD, the president and principal investigator of the National Research Institute in Los Angeles, California, said in a statement. "Early, effective glycemic control can lead to better outcomes, both clinically and in terms of the overall cost of care."

The analysis examined 2 phase III trials, LixiLan-O and LixiLan-L, both of which compared the combination therapy with insulin glargine 100 units/mL on top of (if previously administered) metformin in almost 2000 adults with T2D (LixiLan-O n= 1170; LixiLan-L n=736). The trials examined blood glucose levels at 8 and 12 weeks and utilized the Kaplan-Meier method to estimate time to control.

In the LixiLan-O trial, 186 (39.7%) of the 469 patients in the combination arm reached target HbA1c levels, compared to 128 (27.5%) of the 467 in the single therapy arm. At 12 weeks, the combination therapy outperformed insulin glargine alone with 279 (59.6%) patients reaching target, compared to 209 (44.8%) (HR 1.5 [1.3, 1.7], CI 95%; p<0.0001)

In LixiLan-L, 116 (31.7%) of 365 patients reached control at 8 weeks in the combination arm, compared to 73 (20%) in the single therapy arm. When compared at 12 weeks, 168 (45.9%) in the combination arm reached target compared to 87 (23.8%) (HR 2.0 [1.7,2.5], CI 95%; p<0.0001).

The median time for 50% of patients to achieve HbA1c levels less than 7% in LixiLan-O was 85 days in the combination arm, compared to 166 days in the single therapy arm. In the LixiLan-L trial, 50% of the combination therapy arm achieved Hb1Ac less than 7% at 153 days, while the single-therapy arm never achieved the endpoint.

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