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About Apidra®

Rapid-Acting Apidra

PK/PD Studies: Results show a fast onset of action2,5, lower post-meal BG levels3,5 and fast absorption regardless of weight4,5

Faster Onset and Shorter Duration of Action

vs. RHI and lispro: Insulin activity in obese (BMI: 30-40 kg/m2), non-diabetic subjects in a PK study5,6,7,a

The action profile of Apidra was not affected by skin thickness or BMI2

a There is no evidence to suggest that these PK/PD differences impact overall glycemic control.
For the purposes of this trial, references to lispro refer to Humalog® (insulin lispro).

n=18


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Becker study: The pharmacokinetics and pharmacodynamics of Apidra, RHI, and lispro were examined in a single-dose, randomized, double-blind, 3-way crossover euglycemic clamp study of 18 obese, nondiabetic subjects. An SC injection of 0.3 U/kg of each insulin was administered in the abdominal area in predetermined sequences. The washout periods between the clamp procedures for each insulin were at least 7 days. After administration, infusion of a 20% glucose solution started when BG fell below 10% of mean baseline level. PD parameters were derived from the individual glucose infusion rate profiles.2,5 Point estimate vs Apidra (95% CI): RHI: -36 min (-96; -20 min).

Lower Post-Meal Blood Glucose

vs. aspart§: During the first hour following a meal3

Apidra was associated with lower BG levels during the first hour after a standard meal in insulin naive, obese patients with T2DM3

§For the purposes of this trial, references to aspart refer to Novolog® (insulin aspart injection).

n=30

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Bolli study: A multinational, randomized, double-blind, two-way crossover trial to compare the PK and PD properties of SC Apidra and insulin aspart§ in 30 insulin-naive, obese, T2DM subjects. Patients fasted overnight and received a 0.2 U/kg SC dose of either Apidra or aspart§ 2 minutes before starting a standardized meal. The procedure was repeated with the alternative insulin after a 7-day washout period. The primary objective was to assess the PD effect (as measured by AUC) of each insulin during the first hour after a standard meal.3

Faster absorption vs. Lispro regardless of weight4,a

Absorption in non-diabetic patients4,a

The onset of action overall was faster for Apidra in the first dosing hour (GIR-AUC0-1h with 0.2U/kg was 102.3+/-75.1 vs. 83.1+/-72.8 mg/kg, P<0.05)

a There is no evidence to suggest that these PK/PD differences impact overall glycemic control.
For the purposes of this trial, references to lispro refer to Humalog®.

n=20

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Heise study: A randomized, double-blind, single-center, 4-way crossover euglycemic clamp study examined the PD and PK of Apidra and lispro. Eighty nondiabetic subjects (ages 18-65) were randomized to treatment groups and stratified by BMI into 4 classes as indicated on the graph, with 20 subjects in each group. Subjects fasted overnight prior to the day of receiving study medication. Insulin (0.2 or 0.4 U/kg) was administered by SC injection into the abdominal area. The euglycemic clamp device measured BG continuously and automatically adjusted and recorded the infusion rate of a 20% glucose solution each minute to maintain BG levels at 10% below the individual fasting BG concentration. PD parameters were derived from the individual glucose infusion rate profiles.4

For additional information about Apidra contact Sanofi US Medical Information
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Clinical results

See how Apidra performed in a 24-week OPAL study.

Dosing

Get information about how to initiate and dose Apidra using the AACE Algorithm.

$0* Co-pay and Savings Offers

Apidra offers a way for patients with and without insurance to save. See if your patients are eligible.