HealthyPhase 4NCT02443714
Pharmacokinetic and Pharmacodynamic Profile of Insulin Lispro Using Needle-Free Jet Injection Technology
A Phase 4 study testing Needle-free jet injection with insulin lispro and Conventional pen injection with insulin lispro in people with Healthy, run by Chongqing Medical University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Needle-free jet injection with insulin lispro and Conventional pen injection with insulin lispro
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteChina
- Study dates
- Apr 2015to Sep 2015
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, 400016
About this study
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.
Read the 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.
- Conditions
- Healthy
- Being tested
- Needle-free jet injection with insulin lispro, Conventional pen injection with insulin lispro
- Keywords
- Needle-Free Jet Injection, Insulin Lispro, pharmacokinetics, pharmacodynamics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Needle-free jet injection with insulin lisproDevice
Subjects injected by jet injectors which deliver insulin lispro
Conventional pen injection with insulin lisproDevice
Subjects injected by conventional insulin pens which deliver insulin lispro
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Needle-free jet injection with insulin lispro |
| Conventional pen | Experimental | Conventional insulin administration with insulin pens. Receives: Device: Conventional pen injection with insulin lispro |
What is being measured
The primary outcome is the main question the study is designed to answer.
Early insulin exposure
Measured: The area under the curve (AUC) of insulin from 0 to 30min (AUCins, 0-30min)
Secondary outcomes (8)
Pharmacodynamics
Measured: AUC of GIR for 0-30 min, 30-60 min, 60-90 min, 90-120 min, 0-420 min,respectively
Pharmacodynamics
Measured: 50% glucose clearance time (GIR- TAUC50%)
Pharmacodynamics
Measured: Time to maximum GIR (GIR-Tmax)
Pharmacodynamics
Measured: Maximum GIR (GIRmax)
Pharmacokinetics
Measured: AUC of insulin concentration for 30-60 min, 60-90 min, 90-120 min, 0-420 min,respectively
Pharmacokinetics
Measured: The time to peak plasma insulin concentrations (Ins-Tmax)
Pharmacokinetics
Measured: The maximal insulin levels (Ins-Cmax)
Pharmacokinetics
Measured: 50% insulin absorption time (Ins-TAUC50%)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2015 (estimated)
- Study startApr 2015
- Primary completionSep 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chongqing Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Qifu Li, Chongqing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02443714
- Sponsor's protocol ID
- NFJI-2015
- Status last verified
- Sep 2015
- First submitted
- 1 May 2015
- Last updated
- 28 Sep 2015
- Results posted
- No
- Data monitoring committee
- Yes
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.
PubMed 12614490Engwerda 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.
PubMed 24089542Engwerda 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.
PubMed 21715522
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetic and Pharmacodynamic Profile of Insulin Lispro Using Needle-Free Jet Injection Technology
- ClinicalTrials.gov ID
- NCT02443714
- Acronym / sponsor ID
- NFJI-2015
- Conditions
- Healthy
- Keywords
- Needle-Free Jet Injection, Insulin Lispro, pharmacokinetics, pharmacodynamics
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Chongqing Medical UniversityUniversity, hospital or other
- Study start
- Apr 2015
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 14 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Needle-free jet injection | Experimental | Device: Needle-free jet injection with insulin lisproJet 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. |
| Conventional pen | Experimental | Device: Conventional pen injection with insulin lisproConventional insulin administration with insulin pens. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Needle-free jet injection with insulin lisproSubjects injected by jet injectors which deliver insulin lispro | Device | Needle-free jet injection |
| Conventional pen injection with insulin lisproSubjects injected by conventional insulin pens which deliver insulin lispro | Device | Conventional pen |
Primary outcome
Early insulin exposure
Time frame: The area under the curve (AUC) of insulin from 0 to 30min (AUCins, 0-30min)
8 secondary outcomes
Pharmacodynamics
Time frame: AUC of GIR for 0-30 min, 30-60 min, 60-90 min, 90-120 min, 0-420 min,respectively
Pharmacodynamics
Time frame: 50% glucose clearance time (GIR- TAUC50%)
Pharmacodynamics
Time frame: Time to maximum GIR (GIR-Tmax)
Pharmacodynamics
Time frame: Maximum GIR (GIRmax)
Pharmacokinetics
Time frame: AUC of insulin concentration for 30-60 min, 60-90 min, 90-120 min, 0-420 min,respectively
Pharmacokinetics
Time frame: The time to peak plasma insulin concentrations (Ins-Tmax)
Pharmacokinetics
Time frame: The maximal insulin levels (Ins-Cmax)
Pharmacokinetics
Time frame: 50% insulin absorption time (Ins-TAUC50%)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2015.
- Results publication: PubMed 12614490Sarno 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.
- Results publication: PubMed 24089542Engwerda 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.
- Results publication: PubMed 21715522Engwerda 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Needle-free jet injection with insulin lispro and Conventional pen injection with insulin lispro in people with Healthy, run by Chongqing Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Early insulin exposure (time frame: The area under the curve (AUC) of insulin from 0 to 30min (AUCins, 0-30min)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02443714, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2015.