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

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Device: Needle-free jet injection with insulin lispro; Device: Conventional pen injection with insulin lispro

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 Type: Interventional
• Enrollment (Actual): 18
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Chongqing
    • Chongqing, Chongqing, China, 400016
      • The First Affiliated Hospital of Chongqing Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Needle-free jet injection; 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; Subjects injected by jet injectors which deliver insulin lispro
Experimental: Conventional pen; Conventional insulin administration with insulin pens.	Device: Conventional pen injection with insulin lispro; Subjects injected by conventional insulin pens which deliver insulin lispro

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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%)

Collaborators and Investigators

• Sponsor: Chongqing Medical University

Publications and helpful links

General Publications

• Sarno MJ, Bell J, Edelman SV. Pharmacokinetics and glucodynamics of rapid-, short-, and intermediate-acting insulins: comparison of jet injection to needle syringe. Diabetes Technol Ther. 2002;4(6):863-6. doi: 10.1089/152091502321118865. No abstract available.
• Engwerda EE, Tack CJ, de Galan BE. Needle-free jet injection of rapid-acting insulin improves early postprandial glucose control in patients with diabetes. Diabetes Care. 2013 Nov;36(11):3436-41. doi: 10.2337/dc13-0492. Epub 2013 Oct 2.
• Engwerda EE, Abbink EJ, Tack CJ, de Galan BE. Improved pharmacokinetic and pharmacodynamic profile of rapid-acting insulin using needle-free jet injection technology. Diabetes Care. 2011 Aug;34(8):1804-8. doi: 10.2337/dc11-0182. Epub 2011 Jun 29.

Study record dates

Study Major Dates

• Study Start: April 1, 2015
• Primary Completion (Actual): September 1, 2015
• Study Completion (Actual): September 1, 2015

Study Registration Dates

• First Submitted: May 1, 2015
• First Submitted That Met QC Criteria: May 13, 2015
• First Posted (Estimate): May 14, 2015

Study Record Updates

• Last Update Posted (Estimate): September 28, 2015
• Last Update Submitted That Met QC Criteria: September 24, 2015
• Last Verified: September 1, 2015

More Information

Terms related to this study

• Keywords: pharmacokinetics; pharmacodynamics; Insulin Lispro; Needle-Free Jet Injection
• Additional Relevant MeSH Terms: Hypoglycemic Agents; Physiological Effects of Drugs; Insulin; Insulin, Globin Zinc; Insulin Lispro
• Other Study ID Numbers: NFJI-2015