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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02443714

Enrollment

Registered

2015-05-14

Start date

2015-04-30

Completion date

2015-09-30

Last updated

2015-09-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

Needle-Free Jet Injection, Insulin Lispro, pharmacokinetics, pharmacodynamics

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.

Interventions

DEVICEConventional pen injection with insulin lispro

Subjects injected by conventional insulin pens which deliver insulin lispro

DEVICENeedle-free jet injection with insulin lispro

Subjects injected by jet injectors which deliver insulin lispro

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 40 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

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

Secondary

Measure	Time frame
Pharmacodynamics	AUC of GIR for 0-30 min, 30-60 min, 60-90 min, 90-120 min, 0-420 min,respectively
Pharmacokinetics	AUC of insulin concentration for 30-60 min, 60-90 min, 90-120 min, 0-420 min,respectively

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026