ADMELOG + Lantus®
Humalog + Lantus
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 A1C from baseline to week 26 (non-inferiority margin of 0.3%; Cl of −0.209 to 0.091).1,2
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
ADMELOG + Lantus
Humalog + Lantus
STUDY RESULT: Patients treated with ADMELOG demonstrated non-inferioirity 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).1,3,4
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 A1C from baseline to week 26 (non-inferiority margin of 0.3%; Cl of −0.086 to 0.20l).1,3,4
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.
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.
