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NCT Number: NCT02443714

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.

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Key information

Conditions

Healthy

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

The First Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, 400016, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Needle-free jet injection with insulin lispro

Device

Subjects injected by jet injectors which deliver insulin lispro

Conventional pen injection with insulin lispro

Device

Subjects injected by conventional insulin pens which deliver insulin lispro

Primary outcomes

  1. Early insulin exposure

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

Secondary outcomes

  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%)

Sponsors and collaborators

Lead sponsor

Chongqing Medical University

Other

Registry information

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
May 14, 2015
Registry last updated
Sep 28, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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