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

July 11, 2019 updated by: GlaxoSmithKline

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
8

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85018
        • GSK Investigational Site
    • California
      • Fresno, California, United States, 93720
        • GSK Investigational Site
      • Lomita, California, United States, 90717
        • GSK Investigational Site
      • Sacramento, California, United States, 95831
        • GSK Investigational Site
      • Spring Valley, California, United States, 91978
        • GSK Investigational Site
      • Tustin, California, United States, 92780
        • GSK Investigational Site
      • West Hills, California, United States, 91307
        • GSK Investigational Site
    • Colorado
      • Littleton, Colorado, United States, 80128
        • GSK Investigational Site
    • Florida
      • Bradenton, Florida, United States, 34201
        • GSK Investigational Site
      • Clearwater, Florida, United States, 33765
        • GSK Investigational Site
      • Hallandale Beach, Florida, United States, 33009
        • GSK Investigational Site
      • Miami, Florida, United States, 33156
        • GSK Investigational Site
      • Miami, Florida, United States, 33176
        • GSK Investigational Site
      • Orlando, Florida, United States, 32825
        • GSK Investigational Site
    • Georgia
      • Conyers, Georgia, United States, 30094
        • GSK Investigational Site
    • Indiana
      • Evansville, Indiana, United States, 47714
        • GSK Investigational Site
    • Michigan
      • Kalamazoo, Michigan, United States, 49009
        • GSK Investigational Site
    • Missouri
      • Chesterfield, Missouri, United States, 63017
        • GSK Investigational Site
    • North Carolina
      • Columbia, North Carolina, United States, 28150
        • GSK Investigational Site
    • Ohio
      • Columbus, Ohio, United States, 43201
        • GSK Investigational Site
    • South Carolina
      • Columbia, South Carolina, United States, 29204
        • GSK Investigational Site
    • Texas
      • Arlington, Texas, United States, 76012
        • GSK Investigational Site
      • Dallas, Texas, United States, 75230
        • GSK Investigational Site
      • Houston, Texas, United States, 77036
        • GSK Investigational Site
      • Houston, Texas, United States, 77058
        • GSK Investigational Site
      • Schertz, Texas, United States, 782154
        • GSK Investigational Site
      • Shavano Prk, Texas, United States, 78231
        • GSK Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Albiglutide arm
Subjects will receive 50 milligrams (mg) albiglutide liquid drug product once weekly via auto-injector for 26 weeks.
Drug: 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).
Device: Auto-injector
The auto-injector delivers the albiglutide liquid drug product in an injection volume of 1.0 mL for the 50 mg dose.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time Frame: Up to Week 34
An AE is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product whether or not it is considered drug related. This would include any side effect, injury, toxicity, sensitivity reaction, abnormal or worsening of a laboratory value, concurrent illness or sudden death. Pre-existing conditions that worsen during a study will be reported as AEs. SAE is any AE that results in death, is life-threatening, requires inpatient hospitalization or extends a current hospital stay, results in an ongoing or significant incapacity or interferes substantially with normal life functions, or causes a congenital anomaly or birth defect, or is associated with liver injury or impaired liver function. Number of participants who reported any AE or SAE during this extension study or who had ongoing AE or SAE from study 200952 have been presented.
Up to Week 34
Number of Participants With Physical Examination Abnormalities
Time Frame: Up to Week 34
A full physical examination was planned to be done, at a minimum, assessment of the skin (including injection site), head, eyes, ears, nose, throat, thyroid, respiratory system cardiovascular system, abdomen (liver and spleen), lymph nodes, central nervous system and extremities was planned. The evaluation of skin (including injection site), respiratory system, cardiovascular system, abdomen (liver, spleen), and central nervous system was planned; however, it was not performed due to early termination of the study.
Up to Week 34
Number of Participants With Hematology Values of Potential Clinical Importance (PCI)
Time Frame: Up to Week 34
Blood samples were collected from the participants to evaluate the hematology paramaters. The following hematology parameters were measured: platelet count, red blood cell (RBC) count, hemoglobin, hematocrit, mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH), white blood cell (WBC) count, neutrophils, lymphocytes, monocytes, eosinophils, and basophils, at the specified timepoints (Week 0, 4, 10, 22, 26 and Week 34). Number of participants with hematology paramaters with PCI values has been reported.
Up to Week 34
Number of Participants With Clinical Chemistry Parameters of PCI
Time Frame: Up to Week 34
The following clinical chemistry parameters were measured: blood urea nitrogen (BUN), creatinine, calcium, bicarbonate, potassium, sodium, chloride, uric acid, aspartate amino transferase (AST), alanine amino transferase (ALT), alkaline phosphatase, gamma glutamyl transferase (GGT), total and direct bilirubin, total protein, and albumin at the specified timepoints (Week 0, 4, 10, 22, 26 and Week 34). Number of participants with clinical chemistry paramaters with PCI values has been reported.
Up to Week 34
Number of Participants With Clinically Significant Urinalysis Abnormalities by Dipstick Method
Time Frame: Up to 26 weeks
Urine samples were collected early morning from the participants at specified timepoints (Weeks 26 to 52). The following urinalysis parameters were measured: specific gravity, power of hydrogen (pH), glucose, protein, blood and ketones by dipstick; microscopic examination (if blood or protein was abnormal). Number of participants with no clinically significant abnormalities in urinalysis dipstick results were reported.
Up to 26 weeks
Number of Participants With Pulse Rate Values of PCI
Time Frame: Up to Week 34
The pulse rate, was measured after completion of the electrocardiogram (ECG) sampling at specified timepoints (Week 0, 4, 10, 22, 26 and Week 34). The participants were asked to be either in semi-recumbent or sitting position. During blood withdraws the vitals were performed prior to blood collection. Number of participants with pulse rate values of PCI has been reported.
Up to Week 34
Number of Participants With Systolic and Diastolic Blood Pressure of PCI
Time Frame: Up to Week 34
The systolic and diastolic blood pressure, were measured after completion of the ECG sampling at specified timepoints (Week 0, 4, 10, 22, 26 and Week 34). The participants were asked to be either in semi-recumbent or sitting position. During blood withdraws the vitals were performed prior to blood collection. Number of participants with systolic and diastolic blood pressure values of PCI has been reported.
Up to Week 34
Number of Participants With Clinically Significant Findings for 12-lead ECG
Time Frame: Up to Week 34
A single 12-lead ECG was performed at the specified timepoints (Weeks 0, 26 and 34) during the study where the participant was instructed to be in semi-recumbent position for 10 to 15 minutes before obtaining the ECG. An ECG machine that automatically calculated the heart rate and measures like the PR, QRS, QT, and corrected QT intervals. Number of participants with clinically significant findings in ECG results has been reported.
Up to Week 34
Number of Participant With Positive Results of Anti-albiglutide Antibody Production Over Time
Time Frame: Up to Week 34
Anti-albiglutide antibodies were planned to be assessed using a validated enzyme-linked immunosorbent assay, which utilized a tiered testing approach. It was to be collected at specified timepoints at Week 0, Week 4, Week 10, Week 26 and Week 34 (follow-up). Confirmed positive samples were to be titrated to obtain the titer of anti-albiglutide antibodies. The number of participants with positive results of anti-albiglutide antibody production was to be reported. However, due to early termination only limited number of key safety data was analyzed. This study 204682 was planned as an extension of the main study, 200952 and was supposed to end well after the main study. However, the 204682 extension study was terminated prior to completion of the main study 200952, which is a double-blind study. To preserve the integrity of the main study 200952, results of anti-albiglutide antibody were not completed after the termination.
Up to Week 34

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
GlaxoSmithKline

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 7, 2016

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 21, 2017

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 21, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 14, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 21, 2016

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 26, 2016

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 12, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 11, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 204682

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