Last updated: 07/17/2024 17:18:29
Extension to Study 200952 to Evaluate the Long-term Safety, Tolerability and Pharmacodynamics of Albiglutide Liquid Drug Product in Type 2 Diabetes Mellitus Subjects
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Terminated (halted prematurely)
Terminated (halted prematurely)
Trial overview
Official title: 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
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Single Group Assignment
Masking:
None (Open Label)
Allocation:
Not applicable
Primary outcomes:
Number of participants with adverse events (AEs) and serious adverse events (SAEs)
Timeframe: Up to Week 34
Number of participants with physical examination abnormalities
Timeframe: Up to Week 34
Number of participants with hematology values of potential clinical importance (PCI)
Timeframe: Up to Week 34
Number of participants with clinical chemistry parameters of PCI
Timeframe: Up to Week 34
Number of participants with clinically significant urinalysis abnormalities by dipstick method
Timeframe: Up to 26 weeks
Number of participants with pulse rate values of PCI
Timeframe: Up to Week 34
Number of participants with systolic and diastolic blood pressure of PCI
Timeframe: Up to Week 34
Number of participants with clinically significant findings for 12-lead ECG
Timeframe: Up to Week 34
Number of participant with positive results of anti-albiglutide antibody production over time
Timeframe: Up to Week 34
Secondary outcomes:
Not applicable
Interventions:
Drug: Albiglutide
Device: Auto-injector
Enrollment:
8
Observational study model:
Not applicable
Primary completion date:
2017-21-03
Time perspective:
Not applicable
Clinical publications:
Bonnie C. Shaddinger, Joseph Soffer, Georgios Vlasakakis, Mayadah Shabbout, Cynthia Weston, Antonio Nino. Efficacy and Safety of an Albiglutide Liquid Formulation Compared With the Lyophilized Formulation: A 26-Week Randomized, Double-Blind, Repeat-Dose Study in Patients With Type 2 Diabetes Mellitus. Diabetes Res Clin Pract. 2019;31627-9
DOI: 10.1016/j.diabres.2019.04.018
PMID: 31004676
Medical condition
Diabetes Mellitus, Type 2
Product
albiglutide
Collaborators
Not applicable
Study date(s)
October 2016 to March 2017
Type
Interventional
Phase
4
Participation criteria
Sex
Female & Male
Age
Not applicable
Accepts healthy volunteers
No
- Subjects who have completed the 26 week Treatment Phase of Study 200952
- Male or female
- Subject meets one or more of the withdrawal stopping criteria at Visit 1 (Week 26)
Inclusion and exclusion 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)
Trial location(s)
Location
GSK Investigational Site
Columbiana, North Carolina, United States, 28150
Status
Study Complete
Location
GSK Investigational Site
Fresno, California, United States, 93720
Status
Study Complete
Study documents
Clinical study report
Available language(s): English
Protocol
Available language(s): English
Statistical analysis plan
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Terminated (halted prematurely)
Actual primary completion date
2017-21-03
Actual study completion date
2017-21-03
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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