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Powerful A1C reduction

A1C REDUCTION FROM BASELINE OF 8.1% to 6.9%

  • At Week 30, the 1.1% mean reduction in A1C from baseline with SOLIQUA 100/33 was ~2x greater than the 0.6% reduction with insulin glargine (100 Units/mL)1
  • The mean final dose of SOLIQUA 100/33 and insulin glargine 100 Units/mL at Week 30 was equivalent: 46.7 Units (for SOLIQUA 100/33: 46.7 Units insulin glargine/15.6 mcg lixisenatide)
  • The difference in effect observed in the trial may not necessarily reflect the effect that will be observed in the care setting where alternative insulin glargine dosage can be used

For further details, please refer to the study design in the link below.

DESIGNED TO EVALUATE THE EFFICACY AND SAFETY OF SOLIQUA 100/33 VS LANTUS®

A total of 736 patients with T2DM participated in a randomized, 30-week, open-label, multicenter study to evaluate the efficacy and safety of SOLIQUA 100/33 compared to Lantus®.1

Lantus® Titration
  • Adult patients with T2DM, mean age 60 years, uncontrolled on a stable daily basal insulin dose ± 1 or 2 oral antidiabetic drugs (OADs) for ≥6 months (A1C of 7.5%-10%; fasting plasma glucose [FPG] ≤180 mg/dL) were screened
  • Eligible patients (n=1018) were enrolled in a 6-week run-in period where they remained on or were switched to Lantus® if on another basal insulin and had their dose titrated/stabilized while continuing on metformin (if previously taken). Any other OADs were discontinued
Randomization
  • Patients inadequately controlled at the end of the run-in period (n=736; A1C between 7% and 10%; FPG ≤140 mg/dL) and on an insulin glargine dose of 20-50 Units (mean dose of 35 Units) were randomized to SOLIQUA 100/33 (n=367) or Lantus® (n=369)
Treatment Period
  • The primary endpoint was: change from baseline A1C at Week 303
  • The maximum allowable insulin glargine dose was 60 Units for both treatment groups1
  • The trial was designed to show the contribution of the GLP-1 RA component to glycemic lowering, and the insulin glargine dose and the dosing algorithm were selected to isolate the effect of the GLP-1 RA component

Post hoc Analysis: Patients treated with Soliqua 100/33 achieved a mean A1C < 7% regardless of A1C level prior to screening phase

MEAN A1C CHANGE GROUPED BY A1C LEVEL AT SCREENING4,5

  • Analysis description: LixiLan-L Clinical Trial post hoc analysis of patients who completed the 6-week screening phase (treatment with Lantus® only) and completed the 30-week treatment phase (patients randomized to remain on Lantus® or switch to SOLIQUA 100/33)4
  • Analysis limitations: Patients who used rescue therapy or discontinued treatment early (including 40 SOLIQUA 100/33 patients and 34 Lantus® patrients) were not included4
  • The difference in effect observed in the trial may not necessarily be reflected in the care setting where alternative insulin glargine dosage can be used

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