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Efficacy & Safety

A1C reduction with ADMELOG was comparable to Humalog®

ADMELOG demonstrated non-inferiority vs Humalog 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

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

See SORELLA 2 abstract at PubMed.gov

Incidence of hypoglycemia for ADMELOG and Humalog

Incidence of any or severe hypoglycemia for ADMELOG and Humalog in SORELLA 2, a 26-week head-to-head trial in adult patients with type 2 diabetes1,2

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

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

A1C reduction with ADMELOG was comparable to Humalog

ADMELOG demonstrated non-inferiority vs Humalog 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

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

See SORELLA 1 abstract at PubMed.gov

Incidence of hypoglycemia for ADMELOG and Humalog

Incidence of any or severe hypoglycemia for ADMELOG and Humalog 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

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

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

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.