Effect of Albiglutide, When Added to Standard Blood Glucose Lowering Therapies, on Major Cardiovascular Events in Subjects With Type 2 Diabetes Mellitus

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02465515
• Date of registration: 04/06/2015
• Prospective Registration: Yes
• Primary sponsor: GlaxoSmithKline
• Public title: Effect of Albiglutide, When Added to Standard Blood Glucose Lowering Therapies, on Major Cardiovascular Events in Subjects With Type 2 Diabetes Mellitus
• Scientific title: A Long Term, Randomised, Double Blind, Placebo-controlled Study to Determine the Effect of Albiglutide, When Added to Standard Blood Glucose Lowering Therapies, on Major Cardiovascular Events in Patients With Type 2 Diabetes Mellitus
• Date of first enrolment: July 1, 2015
• Target sample size: 9463
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02465515
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 4

Countries of recruitment

Argentina, Belgium, Bulgaria, Canada, Czech Republic, Czechia, Denmark, France, Germany, Greece, Hong Kong, Hungary, Italy, Korea, Republic of, Mexico, Netherlands, Norway, Peru, Philippines, Poland, Russian Federation, South Africa, Spain, Sweden, Taiwan, Thailand, Ukraine, United Kingdom, United States

Contacts

• Name: GSK Clinical Trials
• Affiliation: GlaxoSmithKline (for GlaxoSmithKline; Human Genome Sciences Inc., a GSK Company; Sirtris, a GSK Company; Stiefel, a GSK Company; ViiV Healthcare)

Key inclusion & exclusion criteria

Inclusion Criteria:

- Men or women at least 40 years old. Women must be post-menopausal or using a highly
effective method for avoidance of pregnancy.

- Diagnosis of type 2 diabetes.

- Established cardiovascular disease with at least one of the following: coronary artery
disease, cerebrovascular disease, or peripheral arterial disease.

- HbA1c >7.0% (53 mmol/mol) (based on the most recent documented laboratory measurement
within 6 months).

- Able and willing to provide informed consent.

Exclusion Criteria:

- Severely reduced kidney function: eGFR <30 ml/min/1.73 m^2 (based on the last measured
and documented laboratory measurement within 6 months) or renal replacement therapy.

- Use of a GLP-1 receptor agonist at Screening.

- Severe gastroparesis

- History of pancreatitis or considered clinically at significant risk of developing
pancreatitis during the course of the study.

- Personal or family history of medullary carcinoma of the thyroid or subject with
multiple endocrine neoplasia type 2 (MEN-2). Personal history of pancreatic
neuroendocrine tumours.

- Medical history which might limit the subject's ability to take trial treatments for
the duration of the study or to otherwise complete the study.

- Breastfeeding, pregnancy, or planning a pregnancy during the course of the study.
Note: a pregnancy test will be performed on all women of child bearing potential prior
to study entry.

- Known allergy to any GLP-1 receptor agonist or excipients of albiglutide.

- Use of another investigational product within 30 days or according to local
regulations, or currently enrolled in a study of an investigational device.

- Any other reason the investigator deems the subject to be unsuitable for the study.



Age minimum: 40 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Diabetes Mellitus

Intervention(s)

Biological: Albiglutide 50 mg

Biological: Albiglutide matching placebo

Biological: Albiglutide 30 mg

Primary Outcome(s)

Time to First Occurrence of Major Adverse Cardiovascular Events (MACE) During Cardiovascular (CV) Follow-up Time Period [Time Frame: Median of 1.65 person years for CV follow-up time period]

Secondary Outcome(s)

Change From Baseline in Heart Rate [Time Frame: Baseline and Months 8, 16, 24 and end of study (up to 2.7 years)]

Number of Participants With Non-fatal Serious Adverse Events (SAEs) [Time Frame: Up to 2.7 years]

Change From Baseline in HbA1c [Time Frame: Baseline and Months 8 and 16]

Change From Baseline in Treatment Related Impact Measures-Diabetes (TRIM-D) Total Score [Time Frame: Baseline and Months 8 and 16]

Percentage of Participants Achieving Composite Metabolic Endpoint [Time Frame: Months 8, 16, 24 and final assessment (up to 2.7 years)]

Change From Baseline in EuroQol- 5 Dimension (EQ-5D) Visual Analogue Scale (VAS) Score [Time Frame: Baseline and Months 8 and 16]

Number of Participants With Adverse Events (AEs) Leading to Discontinuation of Investigational Product (AELD) [Time Frame: Up to 2.7 years]

Time to Adjudicated CV Death [Time Frame: Median of 1.65 person years for the CV follow-up time period]

Time to First Occurrence of Adjudicated MI [Time Frame: Median of 1.65 person years for CV follow-up time period]

Number of Participants With AEs of Special Interest [Time Frame: Up to 2.7 years]

Time to Death [Time Frame: Median of 1.73 years for the Vital Status follow-up time period]

Time to First Occurrence of Adjudicated CV Death or Hospitalization for Heart Failure (HF) [Time Frame: Median of 1.65 person years for CV follow-up time period]

Time to First Occurrence of a Clinically Important Microvascular Event [Time Frame: Up to 2.7 years]

Change in Estimated Glomerular Filtration Rate (eGFR) Calculated Using Modification of Diet in Renal Disease (MDRD) Formula [Time Frame: Baseline and Months 8 and 16]

Time to First Occurrence of MACE or Urgent Revascularization for Unstable Angina [Time Frame: Median of 1.65 person years for CV follow-up time period]

Time to First Occurrence of Adjudicated Stroke [Time Frame: Median of 1.65 person years for CV follow-up time period]

Change From Baseline in Blood Pressure [Time Frame: Baseline and Months 8,16,24 and end of study (up to 2.7 years)]

Time to Initiation of Insulin of More Than 3 Months Duration for Those Participants Not Treated With Insulin at Study Start [Time Frame: Up to 2.7 years]

Change From Baseline in Body Weight [Time Frame: Baseline and Months 8 and 16]

Time to Initiation of Prandial Insulin in Those Participants on Basal Insulin at Study Start [Time Frame: Up to 2.7 years]

Secondary ID(s)

116174

2014-001824-32

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Duke Clinical Research Institute

Results

• Results available: Yes
• Date Posted: 06/03/2019
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02465515