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

• ClinicalTrials.gov Identifier: NCT02750930
• Recruitment Status: Terminated
• First Posted: April 26, 2016
• Results First Posted: March 14, 2018
• Last Update Posted: July 12, 2019
• Sponsor: GlaxoSmithKline
• Information provided by (Responsible Party): GlaxoSmithKline

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Diabetes Mellitus, Type 2	Drug: Albiglutide; Device: Auto-injector	Phase 4

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 8 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: 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
• Actual Study Start Date: October 7, 2016
• Actual Primary Completion Date: March 21, 2017
• Actual Study Completion Date: March 21, 2017

Arms and Interventions

Arm

Intervention/treatment

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.

Outcome Measures

Primary Outcome Measures :

1. 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.
2. 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.
3. 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.
4. 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.
5. 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.
6. 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.
7. 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.
8. 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.
9. 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.

Eligibility Criteria

• Ages Eligible for Study: Child, Adult, Older Adult
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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)

Contacts and Locations

Locations

United States, Arizona

GSK Investigational Site

Phoenix, Arizona, United States, 85018

United States, California

GSK Investigational Site

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

United States, Colorado

GSK Investigational Site

Littleton, Colorado, United States, 80128

United States, Florida

GSK Investigational Site

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

United States, Georgia

GSK Investigational Site

Conyers, Georgia, United States, 30094

United States, Indiana

GSK Investigational Site

Evansville, Indiana, United States, 47714

United States, Michigan

GSK Investigational Site

Kalamazoo, Michigan, United States, 49009

United States, Missouri

GSK Investigational Site

Chesterfield, Missouri, United States, 63017

United States, North Carolina

GSK Investigational Site

Columbia, North Carolina, United States, 28150

United States, Ohio

GSK Investigational Site

Columbus, Ohio, United States, 43201

United States, South Carolina

GSK Investigational Site

Columbia, South Carolina, United States, 29204

United States, Texas

GSK Investigational Site

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

Sponsors and Collaborators

GlaxoSmithKline

Investigators

• Study Director: GSK Clinical Trials; GlaxoSmithKline

  Study Documents (Full-Text)

Documents provided by GlaxoSmithKline:

Study Protocol  [PDF] October 28, 2015

Statistical Analysis Plan  [PDF] March 6, 2017

More Information

• Responsible Party: GlaxoSmithKline
• ClinicalTrials.gov Identifier: NCT02750930
• Other Study ID Numbers: 204682
• First Posted: April 26, 2016
• Results First Posted: March 14, 2018
• Last Update Posted: July 12, 2019
• Last Verified: July 2019

Keywords provided by GlaxoSmithKline:

Extension; Long-term Safety; Pharmacodynamics; Albiglutide; Type 2 Diabetes Mellitus

Additional relevant MeSH terms:

Diabetes Mellitus; Diabetes Mellitus, Type 2; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; rGLP-1 protein; Incretins; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs