Extension to Study 200952 to Evaluate the Long-term Safety, Tolerability and Pharmacodynamics of Albiglutide Liquid Drug Product in Type 2 Diabetes Mellitus Subjects

Stopped early · Phase 4

Conditions studied: Diabetes Mellitus, Type 2

In brief

Albiglutide has been developed for the treatment of type 2 diabetes mellitus (T2DM) as an adjunct to diet and exercise, as monotherapy, or in combination with existing therapies and has been approved by the United States (US) Food and Drug Administration (FDA), the European Medicines Agency (EMA) and other regulatory agencies. This is a 26 week, open-label, single group, multicenter, extension study to Study 200952. This extension study will provide extended safety, tolerability and immunogenicity data for the albiglutide liquid drug product. This extension study will comprise 2 study periods: treatment (26 weeks) and post-treatment follow-up (8 weeks). A maximum of 300 subjects will be eligible to take part in this extension study.

Key facts

Study ID

NCT02750930

Run by

GlaxoSmithKline

People needed

8

Starts

2016-10-07

Expected to finish

2017-03-21

Last updated by the study team

2019-07-12

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subjects who have completed the 26 week Treatment Phase of Study 200952
• Male or female
• Able and willing to provide informed consent.

You may not qualify if…

• Subject meets one or more of the withdrawal stopping criteria at Visit 1 (Week 26)

Where it is running

• GSK Investigational Site — Phoenix, Arizona, United States
• GSK Investigational Site — Fresno, California, United States
• GSK Investigational Site — Lomita, California, United States
• GSK Investigational Site — Sacramento, California, United States
• GSK Investigational Site — Spring Valley, California, United States
• GSK Investigational Site — Tustin, California, United States
• GSK Investigational Site — West Hills, California, United States
• GSK Investigational Site — Littleton, Colorado, United States
• GSK Investigational Site — Bradenton, Florida, United States
• GSK Investigational Site — Clearwater, Florida, United States
• GSK Investigational Site — Hallandale, Florida, United States
• GSK Investigational Site — Miami, Florida, United States
• GSK Investigational Site — Miami, Florida, United States
• GSK Investigational Site — Orlando, Florida, United States
• GSK Investigational Site — Conyers, Georgia, United States
• GSK Investigational Site — Evansville, Indiana, United States
• GSK Investigational Site — Kalamazoo, Michigan, United States
• GSK Investigational Site — Chesterfield, Missouri, United States
• GSK Investigational Site — Columbia, North Carolina, United States
• GSK Investigational Site — Columbus, Ohio, United States
• GSK Investigational Site — Columbia, South Carolina, United States
• GSK Investigational Site — Arlington, Texas, United States
• GSK Investigational Site — Dallas, Texas, United States
• GSK Investigational Site — Houston, Texas, United States
• GSK Investigational Site — Houston, Texas, United States

Full record on ClinicalTrials.gov

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