Pharmacokinetics: Area Under the Concentration Curve (AUC[0-336]) for Dulaglutide
| Group | Value (nanograms times hours per milliliters) | Spread |
|---|---|---|
| Auto-injector | 14700 | 22 |
| Manual Syringe | 14300 | 24 |
Trial · Interventional
CompletedPhase 1Results postedRegistry dataUnited States
1 trial · 1 completed · 1 with posted results
A Study to Compare the Effect of Giving Dulaglutide Using an Auto-injector Versus a Manual Syringe
NCT01524770Mar 2012 to Jun 2012
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
The study involves 2 injections of 1.5 milligrams (mg) dulaglutide, 1 given by a pre-filled manual syringe, the other given by an auto-injector. Injections will be separated by a minimum 28-day washout period. The study will evaluate if the levels of drug in the blood are similar when given by each method. Participation in the study is likely to take approximately 7 weeks, not including screening.
Active comparator
Manual syringe
Dulaglutide: Single dose of 1.5 milligrams (mg) dulaglutide administered subcutaneously (SC) by manual syringe in one of two study periods separated by a 28-day minimum washout period.
Experimental
Auto-injector
Dulaglutide: Single dose of 1.5 milligrams (mg) dulaglutide administered subcutaneously (SC) by auto-injector in one of two study periods separated by a minimum 28-day washout period
Outcomes the sponsor listed as primary.
Pharmacokinetics: Area Under the Concentration Curve (AUC[0-336]) for Dulaglutide
Time frame · Predose to 336 hours postdose
Pharmacokinetics: Maximum Concentration (Cmax) for Dulaglutide
Time frame · Predose to 336 hours postdose
Pharmacokinetics: Time to Maximum Concentration (Tmax) for Dulaglutide
Time frame · Predose to 336 hours postdose
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
| Group | Value (nanograms times hours per milliliters) | Spread |
|---|---|---|
| Auto-injector | 14700 | 22 |
| Manual Syringe | 14300 | 24 |
| Group | Value (nanograms per milliliter (ng/mL)) | Spread |
|---|---|---|
| Auto-injector | 91.1 | 31 |
| Manual Syringe | 88.2 | 32 |
| Group | Value (hours) |
|---|---|
| Auto-injector | 48.0 |
| Manual Syringe | 48.0 |
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| Auto-injectorDulaglutide: Single dose of 1.5 milligrams (mg) dulaglutide administered subcutaneously (SC) by auto-injector in one of two study periods separated by a minimum 28 day washout period | – | 0 / 47 | 18 / 47 |
| Manual SyringeDulaglutide: Single dose of 1.5 milligrams (mg) dulaglutide administered subcutaneously (SC) by manual syringe in one of two study periods separated by a 28 day minimum washout period. | – | 0 / 49 | 18 / 49 |
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