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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

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ClinicalTrials.gov Identifier: NCT02750930
Recruitment Status : Terminated (The termination was result of GSK business considerations and not due to quality, safety or efficacy concerns with any albiglutide formulations or study conduct)
First Posted : April 26, 2016
Results First Posted : March 14, 2018
Last Update Posted : July 12, 2019
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Diabetes Mellitus, Type 2
Interventions Drug: Albiglutide
Device: Auto-injector
Enrollment 8
Recruitment Details A total of 8 participants with Diabetes Mellitus type II, were enrolled in the study from 3 centres in United States of America. The study was conducted from 07 October 2016 to 21 March 2017. The study was terminated prematurely as a reflection of GlaxoSmithKline business considerations.
Pre-assignment Details The participants who completed study 200952 and who were eligible, were included in this open-label extension study 204682. This was an extension study, hence visit 1 of this study was also a last treatment visit of study 200952 (NCT02683746).
Arm/Group Title Albiglutide Liquid
Hide Arm/Group Description The participants in this arm, self-administered, albiglutide liquid drug product 50 milligram (mg) at a volume of 1 millilitre (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.
Period Title: Overall Study
Started 8
Completed 0
Not Completed 8
Reason Not Completed
Study closed/terminated             8
Arm/Group Title Albiglutide Liquid
Hide Arm/Group Description The 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.
Overall Number of Baseline Participants 8
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 8 participants
53.1  (7.86)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants
Female
3
  37.5%
Male
5
  62.5%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 8 participants
White 7
American Indian or Alaskan native 1
1.Primary Outcome
Title Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Hide 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.
Time Frame Up to Week 34
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population comprised of all enrolled participants who received at least 1 dose of study medication.
Arm/Group Title Albiglutide Liquid
Hide Arm/Group Description:
The 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.
Overall Number of Participants Analyzed 8
Measure Type: Number
Unit of Measure: Participants
Any SAE 0
Any AE 2
2.Primary Outcome
Title Number of Participants With Physical Examination Abnormalities
Hide 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.
Time Frame Up to Week 34
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population.
Arm/Group Title Albiglutide Liquid
Hide Arm/Group Description:
The 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.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
3.Primary Outcome
Title Number of Participants With Hematology Values of Potential Clinical Importance (PCI)
Hide 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.
Time Frame Up to Week 34
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population.
Arm/Group Title Albiglutide Liquid
Hide Arm/Group Description:
The 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.
Overall Number of Participants Analyzed 8
Measure Type: Number
Unit of Measure: Participants
1
4.Primary Outcome
Title Number of Participants With Clinical Chemistry Parameters of PCI
Hide 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.
Time Frame Up to Week 34
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population
Arm/Group Title Albiglutide Liquid
Hide Arm/Group Description:
The 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.
Overall Number of Participants Analyzed 8
Measure Type: Number
Unit of Measure: Participants
1
5.Primary Outcome
Title Number of Participants With Clinically Significant Urinalysis Abnormalities by Dipstick Method
Hide 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.
Time Frame Up to 26 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population
Arm/Group Title Albiglutide Liquid
Hide Arm/Group Description:
The 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.
Overall Number of Participants Analyzed 8
Measure Type: Number
Unit of Measure: Participants
0
6.Primary Outcome
Title Number of Participants With Pulse Rate Values of PCI
Hide 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.
Time Frame Up to Week 34
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population
Arm/Group Title Albiglutide Liquid
Hide Arm/Group Description:
The 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.
Overall Number of Participants Analyzed 8
Measure Type: Number
Unit of Measure: Participants
0
7.Primary Outcome
Title Number of Participants With Systolic and Diastolic Blood Pressure of PCI
Hide 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.
Time Frame Up to Week 34
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population
Arm/Group Title Albiglutide Liquid
Hide Arm/Group Description:
The 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.
Overall Number of Participants Analyzed 8
Measure Type: Number
Unit of Measure: Participants
0
8.Primary Outcome
Title Number of Participants With Clinically Significant Findings for 12-lead ECG
Hide 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.
Time Frame Up to Week 34
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population.
Arm/Group Title Albiglutide Liquid
Hide Arm/Group Description:
The 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.
Overall Number of Participants Analyzed 8
Measure Type: Number
Unit of Measure: Participants
0
9.Primary Outcome
Title Number of Participant With Positive Results of Anti-albiglutide Antibody Production Over Time
Hide 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.
Time Frame Up to Week 34
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population.
Arm/Group Title Albiglutide Liquid
Hide Arm/Group Description:
The 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.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame From start of study treatment (Week 1 of this extension study) to upto follow-up (Up to Week 34)
Adverse Event Reporting Description Safety population was used. On treatment AEs and SAEs were reported.
 
Arm/Group Title Albiglutide Liquid
Hide Arm/Group Description The 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.
All-Cause Mortality
Albiglutide Liquid
Affected / at Risk (%)
Total   0/8 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Albiglutide Liquid
Affected / at Risk (%)
Total   0/8 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Albiglutide Liquid
Affected / at Risk (%)
Total   2/8 (25.00%) 
Infections and infestations   
Tooth abscess  1  1/8 (12.50%) 
Metabolism and nutrition disorders   
Vitamin D deficiency  1  1/8 (12.50%) 
Respiratory, thoracic and mediastinal disorders   
Sleep apnoea syndrome  1  1/8 (12.50%) 
1
Term from vocabulary, MedDRA 19.1
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
Phone: 866-435-7343
EMail: GSKClinicalSupportHD@gsk.com
Layout table for additonal information
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT02750930     History of Changes
Other Study ID Numbers: 204682
First Submitted: April 14, 2016
First Posted: April 26, 2016
Results First Submitted: December 6, 2017
Results First Posted: March 14, 2018
Last Update Posted: July 12, 2019