Clinical Studies

There are no clinically meaningful differences between MERILOG (insulin aspart-szjj) injection 100 Units/mL and Novolog.

The PK Profiles of MERILOG (insulin aspart-szjj) injection 100 Units/mL & NovoLog Were Superimposable in 30 Subjects With T1D¹

Phase 1 PK/PD Study Design: A single-center, randomized, double-blind, 3-period, 6-sequence, euglycemic clamp crossover study conducted in 30 adult male subjects with T1D. Subjects received 0.3 U/kg of each treatment (MERILOG, NovoLog, or a non–US-approved insulin aspart) under fasted conditions and underwent a 12-h euglycemic clamp technique to assess PK/PD activity for up to 12 h. The primary PK/PD endpoints were the areas under the plasma insulin concentration–time curve from time zero to INS-AUC_last and extrapolated to INS-AUC_inf, INS-C_max, and the areas under the body weight-standardized 
GIR-AUC_0-12h among the 3 treatments.¹

The study population only included males. Restriction of studies to males alone is considered acceptable, as insulin sensitivity in women may vary during the menstrual cycle.²

The PD Profiles of MERILOG & NovoLog Were Similar, Displaying Short Time–Action Profiles¹

Phase 1 PK/PD Study Design: A single-center, randomized, double-blind, 3-period, 6-sequence, euglycemic clamp crossover study conducted in 30 adult male subjects with T1D. Subjects received 0.3 U/kg of each treatment (MERILOG, NovoLog, or a non–US-approved insulin aspart) under fasted conditions and underwent a 12-h euglycemic clamp technique to assess PK/PD activity for up to 12 h. The primary PK/PD endpoints were the areas under the plasma insulin concentration–time curve from time zero to INS-AUC_last and extrapolated to INS-AUC_inf, INS-C_max, and the areas under the body weight-standardized 
GIR-AUC_0-12h among the 3 treatments.¹

The study population only included males. Restriction of studies to males alone is considered acceptable, as insulin sensitivity in women may vary during the menstrual cycle.²

MERILOG Was Noninferior to NovoLog as Demonstrated by Similar Changes in A1C From Baseline to Week 26^3,4

Phase 3 GEMELLI 1 Study Design: An open-label, multicenter, parallel-group, phase 3 clinical trial conducted in 597 adult subjects with T1D or T2D. Subjects were randomized 1:1 to receive 100 U/mL (dose range 1-80 U) of the treatment drug (MERILOG or NovoLog) SC before meals with Gla-100 QD up to Week 52. The primary endpoint was the change in A1C from baseline to Week 26. The secondary endpoints were the percentage of study participants with A1C <7.0% (<53 mmol/mol), changes in FPG from baseline to Week 26 and Week 52, changes in the mean 24-h plasma glucose concentration from baseline to Week 26 and Week 52, and PPG excursions from baseline to Week 26 and Week 52. The 6-month extension aimed to evaluate the efficacy, safety, and immunogenicity of MERILOG during the entire 12-month period.^3-5 

• The open-label design is a potential limitation of this study; blinding was not possible as the devices used to administer the treatments differed.³

See GEMELLI 1 26 week Study Results³

See GEMELLI 1 52-week Study Results⁴

‡Hypoglycemia is defined as a measurable glucose concentration <70 mg/dL (<3.9 mmol/L) but ≥54 mg/dL (≥3.0 mmol/L). Severe hypoglycemia is defined as a severe event characterized by altered mental and/or physical functioning that requires assistance from another person for recovery, irrespective of glucose level.⁶

A1C, Hemoglobin A1c; CI, Confidence Interval; EU, European Union; FPG, Fasting Plasma Glucose; 
GIR-AUC, Glucose Infusion Rate Area Under the Curve; INS-AUC_inf, Insulin Area Under the Curve extrapolated to infinity; INS-AUC_last, Insulin Area Under the Curve to last measurable concentration;  INS-C_max, Maximum Plasma Concentration of Insulin; LS, Least Squares; PD, Pharmacodynamics; PK, Pharmacokinetics; 
QD, Once Daily; SAEs, serious adverse events; SC, Subcutaneous; SE, Standard Error; T1D, Type 1 Diabetes; TEAEs, treatment-emergent adverse events; US, United States.