Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Conventional pen | Experimental | Conventional insulin administration with insulin pens. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Needle-free jet injection with insulin lispro | Device | Subjects injected by jet injectors which deliver insulin lispro |
|
| Measure | Description | Time Frame |
|---|---|---|
| Early insulin exposure | The area under the curve (AUC) of insulin from 0 to 30min (AUCins, 0-30min) |
| Measure | Description | Time Frame |
|---|---|---|
| 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%) | |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Chongqing Medical University | Chongqing | Chongqing Municipality | 400016 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12614490 | Result | 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. | |
| 24089542 | Result | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Conventional pen injection with insulin lispro | Device | Subjects injected by conventional insulin pens which deliver insulin lispro |
|
| 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 |
| Pharmacokinetics | The time to peak plasma insulin concentrations (Ins-Tmax) |
| Pharmacokinetics | The maximal insulin levels (Ins-Cmax) |
| Pharmacokinetics | 50% insulin absorption time (Ins-TAUC50%) |
| 21715522 | Result | 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. |