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PIVOTAL TRIAL DATA

For adult patients uncontrolled on oral antidiabetic agents (OADs)SOLIQUA 100/33 SIGNIFICANTLY REDUCED A1C OVER 30 WEEKS1

  • 74% OF PATIENTS GOT TO ADA GOAL (<7%) WITH SOLIQUA 100/33 33% of GLP-1 RA (lixisenatide) patients and 59% of Lantus® patients got to goal
  • Reduction in A1C from baseline to Week 30

  • Eligible patients (N=1479) were enrolled in a 4-week run-in period during which they stopped taking any second OAD and titrated metformin to ≥2000 mg/d or maximum tolerated dose (≥1500 mg/d)
  • Patients inadequately controlled at the end of the run-in period (N=1170) were randomized to either SOLIQUA 100/33 (n=469), Lantus (n=467), or lixisenatide (n=234), with metformin
  • Criteria for randomization: A1C between 7% and 10% FPG ≤250 mg/dL
  • The maximum allowable insulin glargine dose was 60 Units for both the SOLIQUA 100/33 and Lantus treatment groups

FPG. fasting plasma glucose.

POST HOC SUBGROUP ANALYSIS

For patients with A1C ≥9%SOLIQUA 100/33 REDUCED A1C BY 2.9%2

Reduction in A1C from baseline to Week 30

  • In this post hoc subgroup analysis of the Lixilan-0 clinical trial, patients with A1C ≥9%-10.4% at baseline were evaluated. Doses were similar between SOLIOUA 100/33 (45 Units) and Lantus (44 Units)2,3
  • Analysis limitations: This study was not designed or powered to detect differences between treatments within this subgroup. Analysis included limited sample size, N=134. P values are for descriptive purposes only without multiplicity adjustments
  • The difference in effect observed in this subgroup analysis may not necessarily reflect the effect that will be observed in the care setting where alternative insulin glargine dosage can be used

For patients with A1C ≥9%MORE PATIENTS GOT TO ADA GOAL (<7%) WITH SOLIQUA 100/332

SOLIQUA 100/33 demonstrated a result consistent with the result in the pivotal trial

  • In this post hoc subgroup analysis of the Lixilan-0 clinical trial, patients with A1C ≥9%-10.4% at baseline were evaluated. Doses were similar between SOLIOUA 100/33 (45 Units) and Lantus (44 Units)2,3
  • Analysis limitations: This study was not designed or powered to detect differences between treatments within this subgroup. Analysis included limited sample size, N=134. P values are for descriptive purposes only without multiplicity adjustments
  • The difference in effect observed in this subgroup analysis may not necessarily reflect the effect that will be observed in the care setting where alternative insulin glargine dosage can be used

SAFETY DATA

SOLIQUA 100/33 DEMONSTRATED SAFETY AND TOLERABILITY IN PATIENTS UNCONTROLLED ON OADs1

Severe symptomatic hypoglycemia (0 out of 469 patients)

Hypoglycemia (38 out of 469 patients)

Hypoglycemia is the most common adverse event with insulin-containing therapy.

Severe symptomatic hypoglycemia defined as an event requiring assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions.

Hypoglycemia defined as self-monitored plasma glucose <54 mg/dL

Treatment-emergent adverse events with frequency ≥5%3

§Gastrointestinal adverse reactions occur more frequently at the beginning of therapy.1

TOLERABILITY

PATIENTS WERE 5X LESS LIKELY TO DISCONTINUE SOLIQUA 100/33 VS THE GLP-1 RA (LIXISENATIDE)3

  • 0.9% of patients discontinued SOLIQUA 100/33 due to GI side effects vs 5.2% for the GLP-1 RA (lixisenatide)
  • Incidence of GI side effects in patients uncontrolled on OADs

DOSING

ONE STARTING DOSE OF SOLIQUA 100/33 FOR PATIENTS UNCONTROLLED ON OADs─15 UNITS1

SOLIQUA 100/33 should be taken within the hour prior to the first meal of the day This starting dose provides 15 Units of Lantus® and 5 mcg of lixisenatide, a GLP-1 RA. The maximum dose of SOLIQUA 100/33 is 60 Units. One Unit of SOLIQUA 100/33 contains 1 Unit of Lantus and 0.33 mcg of lixisenatide.

TITRATE BY 2-4 UNITS WEEKLY UNTIL TARGET FPG IS REACHED

SOLOSTAR® TECHNOLOGY YOU AND YOUR OFFICE WILL FIND FAMILIAR