Trial Outcomes & Findings for 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 NCT02750930)
NCT ID: NCT02750930
Last Updated: 2019-07-12
Results Overview
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.
TERMINATED
PHASE4
8 participants
Up to Week 34
2019-07-12
Participant Flow
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.
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).
Participant milestones
| Measure |
Albiglutide Liquid
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.
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Overall Study
STARTED
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8
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Overall Study
COMPLETED
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0
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Overall Study
NOT COMPLETED
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8
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Reasons for withdrawal
| Measure |
Albiglutide Liquid
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.
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Overall Study
Study closed/terminated
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8
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Baseline Characteristics
Extension to Study 200952 to Evaluate the Long-term Safety, Tolerability and Pharmacodynamics of Albiglutide Liquid Drug Product in Type 2 Diabetes Mellitus Subjects
Baseline characteristics by cohort
| Measure |
Albiglutide Liquid
n=8 Participants
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.
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Age, Continuous
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53.1 Years
STANDARD_DEVIATION 7.86 • n=5 Participants
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Sex: Female, Male
Female
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3 Participants
n=5 Participants
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Sex: Female, Male
Male
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5 Participants
n=5 Participants
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Race/Ethnicity, Customized
White
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7 Participants
n=5 Participants
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Race/Ethnicity, Customized
American Indian or Alaskan native
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1 Participants
n=5 Participants
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PRIMARY outcome
Timeframe: Up to Week 34Population: Safety Population comprised of all enrolled participants who received at least 1 dose of study medication.
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.
Outcome measures
| Measure |
Albiglutide Liquid
n=8 Participants
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.
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Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Any SAE
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0 Participants
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Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Any AE
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2 Participants
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PRIMARY outcome
Timeframe: Up to Week 34Population: Safety Population.
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.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Up to Week 34Population: Safety Population.
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.
Outcome measures
| Measure |
Albiglutide Liquid
n=8 Participants
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.
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Number of Participants With Hematology Values of Potential Clinical Importance (PCI)
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1 Participants
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PRIMARY outcome
Timeframe: Up to Week 34Population: Safety population
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.
Outcome measures
| Measure |
Albiglutide Liquid
n=8 Participants
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.
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Number of Participants With Clinical Chemistry Parameters of PCI
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1 Participants
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PRIMARY outcome
Timeframe: Up to 26 weeksPopulation: Safety Population
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.
Outcome measures
| Measure |
Albiglutide Liquid
n=8 Participants
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.
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Number of Participants With Clinically Significant Urinalysis Abnormalities by Dipstick Method
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0 Participants
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PRIMARY outcome
Timeframe: Up to Week 34Population: Safety population
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.
Outcome measures
| Measure |
Albiglutide Liquid
n=8 Participants
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.
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Number of Participants With Pulse Rate Values of PCI
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0 Participants
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PRIMARY outcome
Timeframe: Up to Week 34Population: Safety population
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.
Outcome measures
| Measure |
Albiglutide Liquid
n=8 Participants
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.
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Number of Participants With Systolic and Diastolic Blood Pressure of PCI
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0 Participants
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PRIMARY outcome
Timeframe: Up to Week 34Population: Safety population.
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.
Outcome measures
| Measure |
Albiglutide Liquid
n=8 Participants
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.
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|---|---|
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Number of Participants With Clinically Significant Findings for 12-lead ECG
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0 Participants
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PRIMARY outcome
Timeframe: Up to Week 34Population: Safety population.
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.
Outcome measures
Outcome data not reported
Adverse Events
Albiglutide Liquid
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Albiglutide Liquid
n=8 participants at risk
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.
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Respiratory, thoracic and mediastinal disorders
Sleep apnoea syndrome
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12.5%
1/8 • From start of study treatment (Week 1 of this extension study) to upto follow-up (Up to Week 34)
Safety population was used. On treatment AEs and SAEs were reported.
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Metabolism and nutrition disorders
Vitamin D deficiency
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12.5%
1/8 • From start of study treatment (Week 1 of this extension study) to upto follow-up (Up to Week 34)
Safety population was used. On treatment AEs and SAEs were reported.
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Infections and infestations
Tooth abscess
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12.5%
1/8 • From start of study treatment (Week 1 of this extension study) to upto follow-up (Up to Week 34)
Safety population was used. On treatment AEs and SAEs were reported.
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER