Pharmacokinetic and Pharmacodynamic Profile of Insulin Lispro Using Needle-Free Jet Injection Technology

Study Overview
=================
Brief Summary
-----------------
Needle-free jet injector provides an alternative for patients with diabetes treated by insulin. This study aimed at evaluating pharmacokinetics and pharmacodynamics (PK-PD) profiles of lispro administered by jet injector and conventional pen.

Detailed Description
-----------------
This is a randomized, double-blind, double-dummy, crossover study. Eighteen healthy volunteers will be recruited. Lispro (0.2 units/kg) will be administered by jet injector or by conventional pen and a seven-hour euglycemic clamp test will be performed. PK-PD profiles of lispro will be calculated.

Official Title
-----------------
Pharmacokinetic and Pharmacodynamic Profile of Insulin Lispro Using Needle-Free Jet Injection Technology

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Device: Needle-free jet injection with insulin lispro
* Device: Conventional pen injection with insulin lispro


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The range of height should be 170±10cm. The range of weight should be ±10%kg. Liver and renal function should be normal. Health subjects with no chronic diseases or medications. Exclusion Criteria: Drug allergy, history of allergic disorders or allergies. A history of liver or kidney disease. Smoker, drinkers. Subjects who participated in other drug trials within a month. Subjects who used medication which is known to organ damage.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Needle-free jet injection<br>Jet injectors deliver insulin at a high velocity (typically.100 m/s) across the skin in the subcutaneous tissue and may dispense the insulin over a larger area than insulin injected with a syringe. | Device: Needle-free jet injection with insulin lispro<br>* Subjects injected by jet injectors which deliver insulin lispro<br>|
| Experimental: Conventional pen<br>Conventional insulin administration with insulin pens. | Device: Conventional pen injection with insulin lispro<br>* Subjects injected by conventional insulin pens which deliver insulin lispro<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Early insulin exposure |  | The area under the curve (AUC) of insulin from 0 to 30min (AUCins, 0-30min) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacodynamics |  | AUC of GIR for 0-30 min, 30-60 min, 60-90 min, 90-120 min, 0-420 min,respectively | 
| Pharmacodynamics |  | 50% glucose clearance time (GIR- TAUC50%) | 
| Pharmacodynamics |  | Time to maximum GIR (GIR-Tmax) | 
| Pharmacodynamics |  | Maximum GIR (GIRmax) | 
| Pharmacokinetics |  | AUC of insulin concentration for 30-60 min, 60-90 min, 90-120 min, 0-420 min,respectively | 
| Pharmacokinetics |  | The time to peak plasma insulin concentrations (Ins-Tmax) | 
| Pharmacokinetics |  | The maximal insulin levels (Ins-Cmax) | 
| Pharmacokinetics |  | 50% insulin absorption time (Ins-TAUC50%) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Needle-Free Jet Injection, Insulin Lispro, pharmacokinetics, pharmacodynamics