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A1C reduction and safety in patients with T1DM and T2DM

A1C reduction with ADMELOG was comparable to Humalog®

ADMELOG demonstrated non-inferiority vs Humalog and a non–US-approved insulin lispro 100 Units/mL in SORELLA 2, a 26-week head-to-head trial in adult patients with type 2 diabetes1

ADMELOG
+
Lantus®

Humalog
+
Lantus

Adjusted mean difference of -0.06% (non-inferiority margin of 0.3%; N=505; 95% CI: -0.209 to 0.091)

STUDY RESULT: Patients treated with ADMELOG demonstrated non-inferiority in A1C change from baseline compared with patients treated with Humalog (-0.86% and -0.80%, respectively), at a prespecified non-inferiority margin of 0.3% (adjusted mean difference of -0.06%; 95% CI: -0.209 to 0.091).1

SORELLA 2 STUDY DESIGN: A 26-week, open-label, active-controlled study evaluated the glucose lowering effect of ADMELOG plus insulin glargine, 100 Units/mL, compared to that of Comparator (another insulin lispro product, 100 Units/mL, or a non–US-approved insulin lispro, 100 Units/mL), plus insulin glargine, 100 Units/mL. A total of 505 patients with T2DM treated with insulin glargine 100 Units/mL and rapid-acting mealtime insulin analogs participated in the study. Patients were randomized to ADMELOG (n=253) or Comparator (n=252). ADMELOG or Comparator was administered by subcutaneous injection immediately prior to meals. The primary endpoint was a change in AlC from baseline to week 26 (non-inferiority margin of 0.3%; Cl of -0.209 to 0.091).1,2

See SORELLA 2 abstract at PubMed.gov

Incidence of adverse events for ADMELOG and Humalog

Incidence of any or severe hypoglycemia for ADMELOG, Humalog, and a non–US-approved insulin lispro 100 Units/mL in SORELLA 2, a 26-week head-to-head trial in adult patients with type 2 diabetes1,2

In this trial, hypoglycemia was the only adverse reaction occurring in 5% of patients treated with ADMELOG.1

This trial was not designed to evaluate the relative safety between ADMELOG and Humalog, and Comparator adverse event rates are not an adequate basis for comparison of rates between the products. Rates of hypoglycemia depend on numerous factors; therefore, comparing ADMELOG with other products is not appropriate. The rates of hypoglycemia may not be representative of rates that will occur in clinical practice.1

In the ADMELOG trials, severe hypoglycemia was defined as an event requiring assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. Documented symptomatic hypoglycemia was defined as an event with typical symptoms of hypoglycemia accompanied by a self-monitored glucose value equal to or less than 70 mg/dL.1,2

A1C reduction with ADMELOG was comparable to Humalog

ADMELOG demonstrated non-inferiority vs Humalog and a non–US-approved insulin lispro 100 Units/mL in SORELLA 1, a 26-week head-to-head trial in adult patients with type 1 diabetes1

ADMELOG
+
Lantus

 

n=253

 

Humalog
+
Lantus

 

n=254

 

Adjusted mean difference of 0.06% (non-inferiority margin of 0.3%; N=507; 95% CI: -0.086 to 0.201)

STUDY RESULT: Patients treated with ADMELOG demonstrated non-inferiority in A1C change from baseline compared with patients treated with Humalog (-0.40% and -0.46%, respectively), at a prespecified non-inferiority margin of 0.3% (adjusted mean difference of 0.06%; N=507; 95% CI: -0.086 to 0.201).1,4

SORELLA 1 STUDY DESIGN: A 26-week, open-label, active-controlled study evaluated the glucose lowering effect of ADMELOG plus insulin glargine, 100 Units/mL, compared to that of Comparator (another insulin lispro product, 100 Units/mL, or a non–US-approved insulin lispro, 100 Units/mL), plus insulin glargine, 100 Units/mL. A total of 507 patients with T1DM treated with insulin glargine 100 Units/mL and rapid-acting mealtime insulin analogs participated in the study. Patients were randomized to ADMELOG (n=253) or Comparator (n=254). ADMELOG or Comparator was administered by subcutaneous injection immediately prior to meals. The primary endpoint was a change in AlC from baseline to week 26 (non-inferiority margin of 0.3%; Cl of -0.086 to 0.20l).1,3,4

See SORELLA 1 abstract at PubMed.gov

Incidence of adverse events for ADMELOG and Humalog

Incidence of any or severe hypoglycemia for ADMELOG, Humalog, and a non–US-approved insulin lispro 100 Units/mL in SORELLA 1, a 26-week head-to-head trial in adult patients with type 1 diabetes, followed by a 26-week safety extension1,3,4

Common adverse reactions at 52 weeks (other than hypoglycemia) occurring in 5% of adult patients with type 1 diabetes treated with ADMELOG1,3,4

This trial was not designed to evaluate the relative safety between ADMELOG and Humalog, and Comparator adverse event rates are not an adequate basis for comparison of rates between the products. Rates of hypoglycemia depend on numerous factors; therefore, comparing ADMELOG with other products is not appropriate. The rates of hypoglycemia may not be representative of rates that will occur in clinical practice.1

In the ADMELOG trials, severe hypoglycemia was defined as an event requiring assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. Documented symptomatic hypoglycemia was defined as an event with typical symptoms of hypoglycemia accompanied by a self-monitored glucose value equal to or less than 70 mg/dl.1,4

References:
  1. ADMELOG Prescribing Information.
  2. Derwahl K-M, Bailey TS, Wernicke-Panten K, Ping L, Pierre S. Diabetes Technol Ther. 2018;20(1):49-58. Epub 2017 Dec 12.
  3. Data on file (SORELLA 1 study, October 2016).
  4. Garg SK, Wernicke-Panten K, Rojeski M, Pierre S, Kirchhein Y, Jedynasty K. Diabetes Technol Ther. 2017;19(9):516-526. Epub 2017 Aug 30.