Clinical trial NCT02750930: Extension to Study 200952 to Evaluate the Long-term Safety, Tolerability and Pharmacodynamics of Albiglutide Liquid Drug Product in Type 2 Diabetes Mellitus Subjects
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Diabetes Mellitus, Type 2
Keywords: Extension
Long-term Safety
Pharmacodynamics
Albiglutide
Type 2 Diabetes Mellitus
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2016-04-26
Enrollment: 8
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


Eligibility 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)

Primary outcomes:
measure: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: Up to Week 34
measure: Number of Participants With Physical Examination Abnormalities
timeFrame: Up to Week 34
measure: Number of Participants With Hematology Values of Potential Clinical Importance (PCI)
timeFrame: Up to Week 34
measure: Number of Participants With Clinical Chemistry Parameters of PCI
timeFrame: Up to Week 34
measure: Number of Participants With Clinically Significant Urinalysis Abnormalities by Dipstick Method
timeFrame: Up to 26 weeks
measure: Number of Participants With Pulse Rate Values of PCI
timeFrame: Up to Week 34
measure: Number of Participants With Systolic and Diastolic Blood Pressure of PCI
timeFrame: Up to Week 34
measure: Number of Participants With Clinically Significant Findings for 12-lead ECG
timeFrame: Up to Week 34
measure: Number of Participant With Positive Results of Anti-albiglutide Antibody Production Over Time
timeFrame: Up to Week 34
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: GSK Investigational Site
state: Arizona
city: Fresno
country: United States
facility: GSK Investigational Site
state: California
city: Lomita
country: United States
facility: GSK Investigational Site
state: California
city: Sacramento
country: United States
facility: GSK Investigational Site
state: California
city: Spring Valley
country: United States
facility: GSK Investigational Site
state: California
city: Tustin
country: United States
facility: GSK Investigational Site
state: California
city: West Hills
country: United States
facility: GSK Investigational Site
state: California
city: Littleton
country: United States
facility: GSK Investigational Site
state: Colorado
city: Bradenton
country: United States
facility: GSK Investigational Site
state: Florida
city: Clearwater
country: United States
facility: GSK Investigational Site
state: Florida
city: Hallandale Beach
country: United States
facility: GSK Investigational Site
state: Florida
city: Miami
country: United States
facility: GSK Investigational Site
state: Florida
city: Miami
country: United States
facility: GSK Investigational Site
state: Florida
city: Orlando
country: United States
facility: GSK Investigational Site
state: Florida
city: Conyers
country: United States
facility: GSK Investigational Site
state: Georgia
city: Evansville
country: United States
facility: GSK Investigational Site
state: Indiana
city: Kalamazoo
country: United States
facility: GSK Investigational Site
state: Michigan
city: Chesterfield
country: United States
facility: GSK Investigational Site
state: Missouri
city: Columbia
country: United States
facility: GSK Investigational Site
state: North Carolina
city: Columbus
country: United States
facility: GSK Investigational Site
state: Ohio
city: Columbia
country: United States
facility: GSK Investigational Site
state: South Carolina
city: Arlington
country: United States
facility: GSK Investigational Site
state: Texas
city: Dallas
country: United States
facility: GSK Investigational Site
state: Texas
city: Houston
country: United States
facility: GSK Investigational Site
state: Texas
city: Houston
country: United States
facility: GSK Investigational Site
state: Texas
city: Schertz
country: United States
facility: GSK Investigational Site
state: Texas
city: Shavano Prk
country: United States
facility: GSK Investigational Site
state: Texas
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: