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

Phase 4

Completed

• Conditions: Healthy
• Interventions: Device: Conventional pen injection with insulin lispro; Device: Needle-free jet injection with insulin lispro

• Registration Number: NCT02443714
• Lead Sponsor: Chongqing Medical University

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.

Study Timeline

• Study Start: 2015-04
• Study First Submitted: 2015-05-01
• Study First Submitted QC: 2015-05-13
• Study First Posted: 2015-05-14
• Status Verified: 2015-09
• Primary Completion: 2015-09
• Study Completion: 2015-09
• Last Update Submitted: 2015-09-24
• Last Update Posted: 2015-09-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

Inclusion Criteria

1. The range of height should be 170±10cm.
2. The range of weight should be ±10%kg.
3. Liver and renal function should be normal.
4. Health subjects with no chronic diseases or medications.

Exclusion Criteria

1. Drug allergy, history of allergic disorders or allergies.
2. A history of liver or kidney disease.
3. Smoker, drinkers.
4. Subjects who participated in other drug trials within a month.
5. Subjects who used medication which is known to organ damage.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Conventional pen	Conventional pen injection with insulin lispro	Conventional insulin administration with insulin pens.
Needle-free jet injection	Needle-free jet injection with insulin lispro	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.

Primary Outcome Measures

Name	Time	Method
Early insulin exposure	The area under the curve (AUC) of insulin from 0 to 30min (AUCins, 0-30min)

Secondary Outcome Measures

Name	Time	Method
Pharmacodynamics	Maximum GIR (GIRmax)
Pharmacokinetics	50% insulin absorption time (Ins-TAUC50%)

Trial Locations

Locations (1)

The First Affiliated Hospital of Chongqing Medical University; 🇨🇳 Chongqing, Chongqing, China