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

GlaxoSmithKline (GSK) logo

GlaxoSmithKline (GSK)

Status and phase

Terminated
Phase 4

Conditions

Diabetes Mellitus, Type 2

Treatments

Device: Auto-injector
Drug: Albiglutide

Study type

Interventional

Funder types

Industry

Identifiers

NCT02750930
204682

Details and patient eligibility

About

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.

Enrollment

8 patients

Sex

All

Volunteers

No Healthy Volunteers

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)

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

8 participants in 1 patient group

Albiglutide arm
Experimental group
Description:
Subjects will receive 50 milligrams (mg) albiglutide liquid drug product once weekly via auto-injector for 26 weeks.
Treatment:
Drug: Albiglutide
Device: Auto-injector

Trial documents
2

Trial contacts and locations

27

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Data sourced from clinicaltrials.gov

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