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~2x greater HbA1c reduction vs Lantus® from baseline of 8.1% to 6.9%

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.

Secondary endpoint:

  • 3 lbs was the mean difference between the treatment arms at Week 30 (+1.5 lbs for insulin glargine vs -1.5 lbs for SOLIQUA 100/33).3 The clinical relevance of this finding is unclear
  • Weight gain can occur with insulin containing products, including SOLIQUA 100/33, and has been attributed to the anabolic effects of insulin

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

Designed to evaluate the efficacy 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®.

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 (HbA1c 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 during which 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; HbA1c 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 in mean HbA1c at Week 30
  • The maximum allowable insulin glargine dose was 60 Units for both treatment groups
  • The trial was designed to show the contribution of the GLP-1 component to glycemic lowering and the insulin glargine dose and the dosing algorithm was selected to isolate the effect of the GLP-1 component