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
NCT ID: NCT01777282
Last Updated: 2017-05-03
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
374 participants
INTERVENTIONAL
2013-02-23
2015-01-27
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Albiglutide + Sulfonylurea
Albiglutide in combination with background sulfonylurea
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.
Sulfonylurea
Single oral antidiabetic drug as a background therapy, to be continued as previously prescribed.
Albiglutide + Biguanide
Albiglutide in combination with background biguanide
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.
Biguanide
Single oral antidiabetic drug as a background therapy, to be continued as previously prescribed.
Albiglutide + Glinide
Albiglutide in combination with background glinide
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.
Glinide
Single oral antidiabetic drug as a background therapy, to be continued as previously prescribed.
Albiglutide + Thiazolidinedione
Albiglutide in combination with background thiazolidinedione
Thiazolidinedione
Single oral antidiabetic drug as a background therapy, to be continued as previously prescribed.
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.
Albiglutide + Alpha-glucosidase inhibitor
Albiglutide in combination with background alpha-glucosidase inhibitor
Alpha-glucosidase inhibitor
Single oral antidiabetic drug as a background therapy, to be continued as previously prescribed.
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.
Interventions
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Thiazolidinedione
Single oral antidiabetic drug as a background therapy, to be continued as previously prescribed.
Alpha-glucosidase inhibitor
Single oral antidiabetic drug as a background therapy, to be continued as previously prescribed.
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.
Sulfonylurea
Single oral antidiabetic drug as a background therapy, to be continued as previously prescribed.
Biguanide
Single oral antidiabetic drug as a background therapy, to be continued as previously prescribed.
Glinide
Single oral antidiabetic drug as a background therapy, to be continued as previously prescribed.
Eligibility Criteria
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Inclusion Criteria
* Body mass index (BMI) 17 to 40 kg/ m2 inclusive
* Subjects with an HbA1c between 7.0% and 10.0% at Screening
* Creatinine clearance \>30 mL/min (calculated using the Cockcroft-Gault formula)
Exclusion Criteria
* Female subject is pregnant, lactating, or \<6 weeks postpartum
* Clinically significant cardiovascular and/or cerebrovascular disease
* Current ongoing symptomatic biliary disease, clinical signs or symptoms of pancreatitis, or a history of chronic or acute pancreatitis, as determined by the investigator
* Serum amylase \>=3 ×ULN and/or serum lipase \>=2 × ULN and/or subject is experiencing any symptoms possibly related to pancreatitis
* Prior use of a GLP-1R agonist or DPP-IV inhibitor within 6 months before Screening
20 Years
ALL
No
Sponsors
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GlaxoSmithKline
INDUSTRY
Responsible Party
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Principal Investigators
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GSK Clinical Trials
Role: STUDY_DIRECTOR
GlaxoSmithKline
Locations
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GSK Investigational Site
Aichi, , Japan
GSK Investigational Site
Chiba, , Japan
GSK Investigational Site
Ehime, , Japan
GSK Investigational Site
Fukuoka, , Japan
GSK Investigational Site
Fukuoka, , Japan
GSK Investigational Site
Fukuoka, , Japan
GSK Investigational Site
Fukushima, , Japan
GSK Investigational Site
Fukushima, , Japan
GSK Investigational Site
Gunma, , Japan
GSK Investigational Site
Gunma, , Japan
GSK Investigational Site
Hokkaido, , Japan
GSK Investigational Site
Hokkaido, , Japan
GSK Investigational Site
Ibaraki, , Japan
GSK Investigational Site
Ibaraki, , Japan
GSK Investigational Site
Kagawa, , Japan
GSK Investigational Site
Kagoshima, , Japan
GSK Investigational Site
Kanagawa, , Japan
GSK Investigational Site
Kanagawa, , Japan
GSK Investigational Site
Kanagawa, , Japan
GSK Investigational Site
Kanagawa, , Japan
GSK Investigational Site
Kochi, , Japan
GSK Investigational Site
Kumamoto, , Japan
GSK Investigational Site
Kumamoto, , Japan
GSK Investigational Site
Kyoto, , Japan
GSK Investigational Site
Kyoto, , Japan
GSK Investigational Site
Kyoto, , Japan
GSK Investigational Site
Miyagi, , Japan
GSK Investigational Site
Miyagi, , Japan
GSK Investigational Site
Nagano, , Japan
GSK Investigational Site
Nagano, , Japan
GSK Investigational Site
Okinawa, , Japan
GSK Investigational Site
Osaka, , Japan
GSK Investigational Site
Osaka, , Japan
GSK Investigational Site
Osaka, , Japan
GSK Investigational Site
Osaka, , Japan
GSK Investigational Site
Osaka, , Japan
GSK Investigational Site
Ōita, , Japan
GSK Investigational Site
Saitama, , Japan
GSK Investigational Site
Saitama, , Japan
GSK Investigational Site
Saitama, , Japan
GSK Investigational Site
Saitama, , Japan
GSK Investigational Site
Saitama, , Japan
GSK Investigational Site
Saitama, , Japan
GSK Investigational Site
Shizuoka, , Japan
GSK Investigational Site
Tochigi, , Japan
GSK Investigational Site
Tokyo, , Japan
GSK Investigational Site
Tokyo, , Japan
GSK Investigational Site
Tokyo, , Japan
GSK Investigational Site
Tokyo, , Japan
Countries
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References
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Okuda I, Wilson TH, Yue L, Nakajima H, Carr MC, Tsuboi M, Nino A, Seino Y. Albiglutide, a weekly GLP-1 receptor agonist, improves glycemic parameters in Japanese patients with type 2 diabetes over 1 year when added to single oral antidiabetic drugs. Curr Med Res Opin. 2017 Mar;33(3):431-438. doi: 10.1080/03007995.2016.1261817. Epub 2016 Dec 21.
Study Documents
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Document Type: Dataset Specification
For additional information about this study please refer to the GSK Clinical Study Register
View DocumentDocument Type: Informed Consent Form
For additional information about this study please refer to the GSK Clinical Study Register
View DocumentDocument Type: Individual Participant Data Set
For additional information about this study please refer to the GSK Clinical Study Register
View DocumentDocument Type: Study Protocol
For additional information about this study please refer to the GSK Clinical Study Register
View DocumentDocument Type: Clinical Study Report
For additional information about this study please refer to the GSK Clinical Study Register
View DocumentDocument Type: Statistical Analysis Plan
For additional information about this study please refer to the GSK Clinical Study Register
View DocumentRelated Links
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Other Identifiers
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116170
Identifier Type: -
Identifier Source: org_study_id
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