Overview

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

Status:
Terminated

Trial end date:
2017-03-21

Target enrollment:
0

Participant gender:
All

Summary

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.

Phase:

Phase 4

Accepts Healthy Volunteers?

Details

Lead Sponsor:

GlaxoSmithKline

Treatments:

Glucagon-Like Peptide 1
rGLP-1 protein

Criteria

Inclusion Criteria:

- Subjects who have completed the 26 week Treatment Phase of Study 200952

- Male or female

- Able and willing to provide informed consent.

Exclusion Criteria:

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