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

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ClinicalTrials.gov Identifier: NCT02443714
Recruitment Status : Completed
First Posted : May 14, 2015
Last Update Posted : September 28, 2015
Sponsor:
Information provided by (Responsible Party):
Qifu Li, 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.

Condition or disease Intervention/treatment Phase
Healthy Device: Needle-free jet injection with insulin lispro Device: Conventional pen injection with insulin lispro Phase 4

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  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Pharmacokinetic and Pharmacodynamic Profile of Insulin Lispro Using Needle-Free Jet Injection Technology
Study Start Date : April 2015
Actual Primary Completion Date : September 2015
Actual Study Completion Date : September 2015

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Early insulin exposure [ Time Frame: The area under the curve (AUC) of insulin from 0 to 30min (AUCins, 0-30min) ]

Secondary Outcome Measures :
  1. Pharmacodynamics [ Time Frame: AUC of GIR for 0-30 min, 30-60 min, 60-90 min, 90-120 min, 0-420 min,respectively ]
  2. Pharmacodynamics [ Time Frame: 50% glucose clearance time (GIR- TAUC50%) ]
  3. Pharmacodynamics [ Time Frame: Time to maximum GIR (GIR-Tmax) ]
  4. Pharmacodynamics [ Time Frame: Maximum GIR (GIRmax) ]
  5. Pharmacokinetics [ Time Frame: AUC of insulin concentration for 30-60 min, 60-90 min, 90-120 min, 0-420 min,respectively ]
  6. Pharmacokinetics [ Time Frame: The time to peak plasma insulin concentrations (Ins-Tmax) ]
  7. Pharmacokinetics [ Time Frame: The maximal insulin levels (Ins-Cmax) ]
  8. Pharmacokinetics [ Time Frame: 50% insulin absorption time (Ins-TAUC50%) ]


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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02443714


Locations
China, Chongqing
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing, China, 400016
Sponsors and Collaborators
Chongqing Medical University