A Randomized, Double-blind, Single-dose, Placebo Controlled, 2-way Cross-over Study Evaluating Effect of Albiglutide on Cholecystokinin-induced Gallbladder Emptying in Fasting Healthy Subjects

Registration

Registration

NCT02496221

Study type

INTERVENTIONAL

Allocation

RANDOMIZED

Phase

PHASE4

Masking

QUADRUPLE

Status

COMPLETED

Enrollment

20

Start

2015-06-11

Primary completion

2015-10-13

Lead sponsor

GlaxoSmithKline

Conditions

Diabetes Mellitus, Type 2

Interventions

DRUG:Albiglutide 50 mg; DRUG:Placebo; DRUG:CCK (Kinevac)

Results posted

TRUE

Individual participant data sharing

YES

Registered primary outcomes

• Maximum Absolute Value of Gallbladder Ejection Fraction (Emax GEF) During Cholecystokinin (CCK) Infusion, as a Measure of Maximum Effect [Day 4 in each treatment period]
• Area Under the Effect Curve for Gallbladder Ejection Fraction (AUEC GEF) [Day 4 in each treatment period]
• Time at Which the Maximum Effect (Emax GEF) Occurred (TEMAXEF) During the CCK Infusion [Day 4 in each treatment period]
• Maximum Gallbladder Ejection Fraction Value During CCK Infusion [Day 1 and Day 4 in each treatment period]
• Area Under the Effect Curve for Gallbladder Volume (AUEC VL) [Day 4 in each treatment period]
• Maximum Absolute Change From Baseline in Value of Gallbladder Volume (Emax VL) During CCK Infusion, as a Measure of Maximum Effect [Day 4 in each treatment period]
• Time at Which the Maximum Effect (Emax VL) Occurred (TEmax VL) During the CCK Infusion [Day 4 in each treatment period]
• Maximum Change From Baseline in Main Pancreatic Duct Diameter During CCK Infusion [Day 4 in each treatment period]
• Maximum Change From Baseline in Common Bile Duct Diameter During CCK Infusion [Day 4 in each treatment period]