A Randomized, Double-blind, Placebo Controlled, Multi-center Study to Evaluate the Pharmacokinetics, Safety and Efficacy of Albiglutide for the Treatment of Type 2 Diabetes Mellitus in Pediatric Patients

Registration

Registration

NCT03015519

Study type

INTERVENTIONAL

Allocation

RANDOMIZED

Phase

PHASE3

Masking

DOUBLE

Status

WITHDRAWN

Enrollment

0

Start

2017-08-14

Primary completion

2020-04-20

Lead sponsor

GlaxoSmithKline

Conditions

Diabetes Mellitus, Type 2

Interventions

DRUG:Albiglutide; DRUG:Placebo

Results posted

FALSE

Registered primary outcomes

• Area under the curve (AUC) of albiglutide: Part A [Up to 28 days post-dose]
• Maximum Plasma Concentration (Cmax) of albiglutide: Part A [Up to 28 days post-dose]
• Apparent clearance (CL/F) of albiglutide: Part A [Up to 28 days post-dose]
• Apparent volume of distribution (V/F) of albiglutide: Part A [Up to 28 days post-dose]
• Number of subjects with adverse events (AEs): Part A [Up to Week 8 post dose]
• Change from Baseline in Glycosylated Hemoglobin A1c (HbA1c) at Week 24: Part B [Up to Week 24]
• Time to reach maximum plasma concentration (tmax) of albiglutide: Part A [Up to 28 days post-dose]
• Time to reach half of the maximum plasma concentration (t1/2) of albiglutide: Part A [Up to 28 days post-dose]