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
STUDY DESIGN: SORELLA 2 was a 26-week, open-label, active-controlled study to evaluate the efficacy and safety of ADMELOG (n=253) compared with another insulin lispro product (100 Units/mL) (n=252), administered subcutaneously immediately prior to meals in adult patients with type 2 diabetes on insulin glargine (100 Units/mL). At randomization, all patients were treated with Lantus and a short-acting mealtime insulin analog. The primary endpoint was change in A1C from baseline to week 26.1
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. 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.1,2
STUDY DESIGN: SORELLA 2 was a 26-week, open-label, active-controlled study to evaluate the efficacy and safety of ADMELOG (n=253) compared with another insulin lispro product (100 Units/mL) (n=252), administered subcutaneously immediately prior to meals in adult patients with type 2 diabetes on insulin glargine (100 Units/mL). At randomization, all patients were treated with Lantus and a short-acting mealtime insulin analog. The primary endpoint was change in A1C from baseline to week 26.1
ADMELOG
+
Lantus
Humalog
+
Lantus
STUDY RESULT: Patients treated with ADMELOG demonstrated non-inferiority in A1C change from baseline compared with patients treated with Humalog (-0.40% 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
STUDY DESIGN: SORELLA 1 was a 26-week, open-label, active-controlled, intent-to-treat study to evaluate efficacy and safety of ADMELOG (n=253) compared with another insulin lispro product (100 Units/mL) (n=254), when administered subcutaneously immediately prior to meals in adult patients with type 1 diabetes on insulin glargine (100 Units/mL). At randomization, all patients were treated with Lantus and a short-acting mealtime insulin analog. The primary endpoint was a change in A1C from baseline to week 26.1,3
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. 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.1,4
STUDY DESIGN: SORELLA 1 was a 26-week, open-label, active-controlled, intent-to-treat study to evaluate efficacy and safety of ADMELOG (n=253) compared with another insulin lispro product (100 Units/mL) (n=254), when administered subcutaneously immediately prior to meals in adult patients with type 1 diabetes on insulin glargine (100 Units/mL). At randomization, all patients were treated with Lantus and a short-acting mealtime insulin analog. Adverse events were evaluated at 26 weeks and also after a 26-week safety extension (a total of 52 weeks).1,3,4
