Clinical trial NCT02443714: Pharmacokinetic and Pharmacodynamic Profile of Insulin Lispro Using Needle-Free Jet Injection Technology
Official title: Pharmacokinetic and Pharmacodynamic Profile of Insulin Lispro Using Needle-Free Jet Injection Technology
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Healthy
Keywords: Needle-Free Jet Injection
Insulin Lispro
pharmacokinetics
pharmacodynamics
Lead sponsor: Chongqing Medical University
Sponsor class: OTHER
First posted: 2015-05-14
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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.

Eligibility 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.

Primary outcomes:
measure: Early insulin exposure
timeFrame: The area under the curve (AUC) of insulin from 0 to 30min (AUCins, 0-30min)
Secondary outcomes:
measure: Pharmacodynamics
timeFrame: AUC of GIR for 0-30 min, 30-60 min, 60-90 min, 90-120 min, 0-420 min,respectively
measure: Pharmacodynamics
timeFrame: 50% glucose clearance time (GIR- TAUC50%)
measure: Pharmacodynamics
timeFrame: Time to maximum GIR (GIR-Tmax)
measure: Pharmacodynamics
timeFrame: Maximum GIR (GIRmax)
measure: Pharmacokinetics
timeFrame: AUC of insulin concentration for 30-60 min, 60-90 min, 90-120 min, 0-420 min,respectively
measure: Pharmacokinetics
timeFrame: The time to peak plasma insulin concentrations (Ins-Tmax)
measure: Pharmacokinetics
timeFrame: The maximal insulin levels (Ins-Cmax)
measure: Pharmacokinetics
timeFrame: 50% insulin absorption time (Ins-TAUC50%)
Other outcomes:
Locations:
city: Chongqing
country: China
facility: The First Affiliated Hospital of Chongqing Medical University
state: Chongqing
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.