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Trial · Interventional

TerminatedPhase 4Results postedRegistry data

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

NCTNCT02750930 (opens ClinicalTrials.gov in a new tab)Other id204682
Open at ClinicalTrials.govAsk about this trial

This trial does not test a peptide that PepBank tracks.

  • Names Glucagon, does not test it. It appears in the description.

Overview

Status
Terminated
Phase
Phase 4
Enrollment
8 participants (actual)
Sponsor
GlaxoSmithKline · Industry
Design
Allocation not applicable · Open label (no masking)
Countries
1 country

United States

Start
7 Oct 2016
Primary completion
21 Mar 2017
Completion
21 Mar 2017
First posted
26 Apr 2016 (estimated)
Last update posted
12 Jul 2019
Conditions
Diabetes Mellitus, Type 2

Timeline

1 trial · 1 stopped early · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
201620172018
  1. Ph 4

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

    NCT02750930

    7 Oct 2016 to 21 Mar 2017

    Terminated

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • AlbiglutideDrug
  • Auto-injectorDevice

Arms1

  • Experimental

    Albiglutide arm

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

Primary outcomes9

Outcomes the sponsor listed as primary.

  1. Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

    Time frame · Up to Week 34

    Registry description

    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.

  2. Number of Participants With Physical Examination Abnormalities

    Time frame · Up to Week 34

    Registry description

    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.

  3. Number of Participants With Hematology Values of Potential Clinical Importance (PCI)

    Time frame · Up to Week 34

    Registry description

    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.

  4. Number of Participants With Clinical Chemistry Parameters of PCI

    Time frame · Up to Week 34

    Registry description

    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.

  5. Number of Participants With Clinically Significant Urinalysis Abnormalities by Dipstick Method

    Time frame · Up to 26 weeks

    Registry description

    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.

  6. Number of Participants With Pulse Rate Values of PCI

    Time frame · Up to Week 34

    Registry description

    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.

  7. Number of Participants With Systolic and Diastolic Blood Pressure of PCI

    Time frame · Up to Week 34

    Registry description

    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.

  8. Number of Participants With Clinically Significant Findings for 12-lead ECG

    Time frame · Up to Week 34

    Registry description

    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.

  9. Number of Participant With Positive Results of Anti-albiglutide Antibody Production Over Time

    Time frame · Up to Week 34

    Registry description

    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.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeNumber· Up to Week 34

Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

GroupValue (Participants)
Albiglutide Liquid0
Primary outcome· Up to Week 34

Number of Participants With Physical Examination Abnormalities

GroupValue
Albiglutide Liquidnot posted
Primary outcomeNumber· Up to Week 34

Number of Participants With Hematology Values of Potential Clinical Importance (PCI)

GroupValue (Participants)
Albiglutide Liquid1
Primary outcomeNumber· Up to Week 34

Number of Participants With Clinical Chemistry Parameters of PCI

GroupValue (Participants)
Albiglutide Liquid1
Primary outcomeNumber· Up to 26 weeks

Number of Participants With Clinically Significant Urinalysis Abnormalities by Dipstick Method

GroupValue (Participants)
Albiglutide Liquid0
Primary outcomeNumber· Up to Week 34

Number of Participants With Pulse Rate Values of PCI

GroupValue (Participants)
Albiglutide Liquid0
Primary outcomeNumber· Up to Week 34

Number of Participants With Systolic and Diastolic Blood Pressure of PCI

GroupValue (Participants)
Albiglutide Liquid0
Primary outcomeNumber· Up to Week 34

Number of Participants With Clinically Significant Findings for 12-lead ECG

GroupValue (Participants)
Albiglutide Liquid0

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Albiglutide LiquidThe participants in this arm, self-administered, albiglutide liquid drug product 50 mg at a volume of 1 mL, as a single dose subcutaneous injection in the abdomen, thigh or upper arm region, once weekly, for 26-weeks. It was administered on the same day each week, anytime during the day without regards to meals. The first dose was self-administered by the participant in the supervision from clinic staff. All further doses of study treatment were self-administered by the participant.0 / 80 / 82 / 8

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
Not stated
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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)

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