MedTrace Logo

A Study to Determine the Long Term Safety and Efficacy of Albiglutide in Combination With Oral Monotherapy Antihyperglycemic Medications in Japanese Patients With Type 2 Diabetes Mellitus

NCT01777282 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 374

Last updated 2017-05-03

Study results available
· View outcomes & findings →

Summary

This study is designed to examine the long term safety and efficacy of weekly subcutaneously injected albiglutide in combination with a single oral antidiabetic drug for 52 weeks in Japanese subjects with type 2 diabetes mellitus.

Conditions

Interventions

DRUG

Albiglutide

Albiglutide is a fixed-dose, fully disposable pen injector system for delivery of albiglutide from a prefilled dual chamber glass cartridge that is an integral part of the pen. It is intended for single use by the subject. It is designed for manual reconstitution of the dose, priming, and insertion of the pen needle, and manual injection by the subject. The subject will inject albiglutide 30 mg weekly for 52 weeks (with optional uptitration to 50 mg weekly) subcutaneously into the abdomen, alternating between left and right sides. The pen is designed to work with standard pen needles.

DRUG

Sulfonylurea

Single oral antidiabetic drug as a background therapy, to be continued as previously prescribed.

DRUG

Biguanide

Single oral antidiabetic drug as a background therapy, to be continued as previously prescribed.

DRUG

Glinide

Single oral antidiabetic drug as a background therapy, to be continued as previously prescribed.

DRUG

Thiazolidinedione

Single oral antidiabetic drug as a background therapy, to be continued as previously prescribed.

DRUG

Alpha-glucosidase inhibitor

Single oral antidiabetic drug as a background therapy, to be continued as previously prescribed.

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-02-23
Primary Completion
2015-01-27
Completion
2015-01-27

Countries

  • Japan

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01777282 on ClinicalTrials.gov