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

PHASE3CompletedINTERVENTIONAL
Enrollment

374

Participants

Timeline

Start Date

February 23, 2013

Primary Completion Date

January 27, 2015

Study Completion Date

January 27, 2015

Conditions
Diabetes Mellitus
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.

Trial Locations (49)

456-0058

GSK Investigational Site, Aichi

263-0043

GSK Investigational Site, Chiba

792-8586

GSK Investigational Site, Ehime

810-0014

GSK Investigational Site, Fukuoka

815-8588

GSK Investigational Site, Fukuoka

819-0168

GSK Investigational Site, Fukuoka

960-0418

GSK Investigational Site, Fukushima

963-8851

GSK Investigational Site, Fukushima

370-3573

GSK Investigational Site, Gunma

379-0116

GSK Investigational Site, Gunma

040-8585

GSK Investigational Site, Hokkaido

070-0002

GSK Investigational Site, Hokkaido

300-0835

GSK Investigational Site, Ibaraki

311-0113

GSK Investigational Site, Ibaraki

760-0076

GSK Investigational Site, Kagawa

890-0061

GSK Investigational Site, Kagoshima

232-0064

GSK Investigational Site, Kanagawa

235-0045

GSK Investigational Site, Kanagawa

252-0302

GSK Investigational Site, Kanagawa

253-0044

GSK Investigational Site, Kanagawa

780-0088

GSK Investigational Site, Kochi

862-0960

GSK Investigational Site, Kumamoto

867-0041

GSK Investigational Site, Kumamoto

600-8558

GSK Investigational Site, Kyoto

601-1495

GSK Investigational Site, Kyoto

601-8325

GSK Investigational Site, Kyoto

980-0021

GSK Investigational Site, Miyagi

985-0852

GSK Investigational Site, Miyagi

399-0006

GSK Investigational Site, Nagano

399-0036

GSK Investigational Site, Nagano

900-0029

GSK Investigational Site, Okinawa

530-0012

GSK Investigational Site, Osaka

536-0023

GSK Investigational Site, Osaka

538-0044

GSK Investigational Site, Osaka

577-0803

GSK Investigational Site, Osaka

582-0019

GSK Investigational Site, Osaka

870-0039

GSK Investigational Site, Ōita

332-0012

GSK Investigational Site, Saitama

350-0035

GSK Investigational Site, Saitama

350-0851

GSK Investigational Site, Saitama

354-0031

GSK Investigational Site, Saitama

355-0321

GSK Investigational Site, Saitama

358-0011

GSK Investigational Site, Saitama

424-0855

GSK Investigational Site, Shizuoka

329-0433

GSK Investigational Site, Tochigi

103-0002

GSK Investigational Site, Tokyo

103-0027

GSK Investigational Site, Tokyo

125-0054

GSK Investigational Site, Tokyo

143-0015

GSK Investigational Site, Tokyo

Sponsors

Lead Sponsor

All Listed Sponsors
lead

GlaxoSmithKline

INDUSTRY

NCT01777282 - 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 | Biotech Hunter | Biotech Hunter