NCT02443714

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for phase_4 healthy

Timeline
Completed

Started Apr 2015

Shorter than P25 for phase_4 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2015

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 1, 2015

Completed
13 days until next milestone

First Posted

Study publicly available on registry

May 14, 2015

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
Last Updated

September 28, 2015

Status Verified

September 1, 2015

Enrollment Period

5 months

First QC Date

May 1, 2015

Last Update Submit

September 24, 2015

Conditions

Healthy

Keywords

Needle-Free Jet InjectionInsulin Lispropharmacokineticspharmacodynamics

Outcome Measures

Primary Outcomes (1)

  • Early insulin exposure

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

Secondary Outcomes (8)

  • 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

  • +3 more secondary outcomes

Study Arms (2)

Needle-free jet injection

EXPERIMENTAL

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

Conventional pen

EXPERIMENTAL

Conventional insulin administration with insulin pens.

Device: Conventional pen injection with insulin lispro

Interventions

Needle-free jet injection with insulin lisproDEVICE

Subjects injected by jet injectors which deliver insulin lispro

Needle-free jet injection
Conventional pen injection with insulin lisproDEVICE

Subjects injected by conventional insulin pens which deliver insulin lispro

Conventional pen

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The First Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, 400016, China

Location

Related Publications (3)

  • 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.

    PMID: 12614490RESULT

  • 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.

    PMID: 24089542RESULT

  • 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.

    PMID: 21715522RESULT

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 1, 2015

First Posted

May 14, 2015

Study Start

April 1, 2015

Primary Completion

September 1, 2015

Study Completion

September 1, 2015

Last Updated

September 28, 2015

Record last verified: 2015-09

Locations

CN(1)