An Open-Label Exploratory Study to Investigate the Feasibility of Administering Exenatide by Continuous Subcutaneous Infusion to Healthy Subjects

Registration

Registration

NCT01857895

Study type

INTERVENTIONAL

Allocation

RANDOMIZED

Phase

PHASE1

Masking

NONE

Status

COMPLETED

Enrollment

10

Start

2013-05-16

Primary completion

2013-11-01

Lead sponsor

GlaxoSmithKline

Conditions

Obesity

Interventions

DRUG:Exenatide

Results posted

FALSE

Individual participant data sharing

YES

Registered primary outcomes

• Characterization of interruptions or deviations from prescribed exenatide infusion in Part A [2 days]
• Characterization of interruptions or deviations from prescribed exenatide infusion in Part B [8 days]
• Infusion rate adjustments when nausea/vomiting occurs in Part B [8 days]
• Number of participants with adverse events (AEs) in Part A [17 days]
• Number of participants with AEs in Part B [23 days]
• Laboratory parameter assessment in Part A [17 days]
• Laboratory parameter assessment in Part B [23 days]
• Vital sign assessment in Part A [17 days]
• Vital sign assessment in Part B [23 days]