A Study to Compare the Effect of Giving Dulaglutide Using an Auto-injector Versus a Manual Syringe

Part of paid clinical trials in Daytona Beach, Florida.

Sponsor
Eli Lilly and Company
Study ID
NCT01524770
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Dulaglutide — BIOLOGICAL
    Administered by subcutaneous (SC) injection

Study Details

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.

Key Dates

Start date
Mar 31, 2012
Status verified
Oct 2014
Primary completion
Jun 30, 2012
Completion
Jun 30, 2012

Study Design

Enrollment
50 participants (actual)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • 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

Primary Outcome Measure

Pharmacokinetics: Area Under the Concentration Curve (AUC[0-336]) for Dulaglutide [ Time Frame: Predose to 336 hours postdose ]

Locations (1)

FacilityCityStateZIPSite coordinators
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.Daytona BeachFlorida32117-

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By research site
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.· Daytona Beach, FL

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