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

Chongqing Medical University18 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Healthy

Interventions

Needle-free jet injection with insulin lisproDEVICE

Subjects injected by jet injectors which deliver insulin lispro

Conventional pen injection with insulin lisproDEVICE

Subjects injected by conventional insulin pens which deliver insulin lispro

Eligibility

Sex: ALLMin age: 18 YearsMax age: 40 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

The First Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, China

Outcomes

Primary Outcomes

Early insulin exposure

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

Secondary Outcomes

Pharmacodynamics

Time frame: AUC of GIR for 0-30 min, 30-60 min, 60-90 min, 90-120 min, 0-420 min,respectively

Pharmacodynamics

Time frame: 50% glucose clearance time (GIR- TAUC50%)

Pharmacodynamics

Time frame: Time to maximum GIR (GIR-Tmax)

Pharmacodynamics

Time frame: Maximum GIR (GIRmax)

Pharmacokinetics

Time frame: AUC of insulin concentration for 30-60 min, 60-90 min, 90-120 min, 0-420 min,respectively

Pharmacokinetics

Time frame: The time to peak plasma insulin concentrations (Ins-Tmax)

Pharmacokinetics

Time frame: The maximal insulin levels (Ins-Cmax)

Pharmacokinetics

Time frame: 50% insulin absorption time (Ins-TAUC50%)

Data from ClinicalTrials.gov

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