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

NCT ID: NCT02750930

Last Updated: 2019-07-12

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-10-07

Study Completion Date

2017-03-21

Brief Summary

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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.

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Detailed Description

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Conditions

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Diabetes Mellitus, Type 2

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Albiglutide arm

Subjects will receive 50 milligrams (mg) albiglutide liquid drug product once weekly via auto-injector for 26 weeks.

Group Type EXPERIMENTAL

Albiglutide

Intervention Type DRUG

Albiglutide liquid drug product is provided as a fixed-dose, disposable auto-injector containing albiglutide liquid drug product (50 mg). Subjects will receive albiglutide 50 mg through subcutaneous injection in the abdomen, thigh or upper arm region via auto-injector. Albiglutide is a glucagon-like peptide-1 agonist (GLP-1 agonist).

Auto-injector

Intervention Type DEVICE

The auto-injector delivers the albiglutide liquid drug product in an injection volume of 1.0 mL for the 50 mg dose.

Interventions

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Albiglutide

Albiglutide liquid drug product is provided as a fixed-dose, disposable auto-injector containing albiglutide liquid drug product (50 mg). Subjects will receive albiglutide 50 mg through subcutaneous injection in the abdomen, thigh or upper arm region via auto-injector. Albiglutide is a glucagon-like peptide-1 agonist (GLP-1 agonist).

Intervention Type DRUG

Auto-injector

The auto-injector delivers the albiglutide liquid drug product in an injection volume of 1.0 mL for the 50 mg dose.

Intervention Type DEVICE

Eligibility Criteria

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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)
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Investigational Site

Phoenix, Arizona, United States

Site Status

GSK Investigational Site

Fresno, California, United States

Site Status

GSK Investigational Site

Lomita, California, United States

Site Status

GSK Investigational Site

Sacramento, California, United States

Site Status

GSK Investigational Site

Spring Valley, California, United States

Site Status

GSK Investigational Site

Tustin, California, United States

Site Status

GSK Investigational Site

West Hills, California, United States

Site Status

GSK Investigational Site

Littleton, Colorado, United States

Site Status

GSK Investigational Site

Bradenton, Florida, United States

Site Status

GSK Investigational Site

Clearwater, Florida, United States

Site Status

GSK Investigational Site

Hallandale, Florida, United States

Site Status

GSK Investigational Site

Miami, Florida, United States

Site Status

GSK Investigational Site

Miami, Florida, United States

Site Status

GSK Investigational Site

Orlando, Florida, United States

Site Status

GSK Investigational Site

Conyers, Georgia, United States

Site Status

GSK Investigational Site

Evansville, Indiana, United States

Site Status

GSK Investigational Site

Kalamazoo, Michigan, United States

Site Status

GSK Investigational Site

Chesterfield, Missouri, United States

Site Status

GSK Investigational Site

Columbia, North Carolina, United States

Site Status

GSK Investigational Site

Columbus, Ohio, United States

Site Status

GSK Investigational Site

Columbia, South Carolina, United States

Site Status

GSK Investigational Site

Arlington, Texas, United States

Site Status

GSK Investigational Site

Dallas, Texas, United States

Site Status

GSK Investigational Site

Houston, Texas, United States

Site Status

GSK Investigational Site

Houston, Texas, United States

Site Status

GSK Investigational Site

Schertz, Texas, United States

Site Status

GSK Investigational Site

Shavano Prk, Texas, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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204682

Identifier Type: -

Identifier Source: org_study_id

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