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 |
|---|---|
| Conditions: | Diabetes, Diabetes |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 4/17/2018 |
| Start Date: | October 7, 2016 |
| End Date: | March 21, 2017 |
An Open-label Extension to Study 200952 to Evaluate the Long-term Safety, Tolerability and Pharmacodynamics of Albiglutide Liquid Drug Product in Subjects With Type 2 Diabetes Mellitus
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.
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.
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)
We found this trial at
25
sites
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