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Trial record 15 of 36 for:    albiglutide

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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Duke Clinical Research Institute
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT02465515
First received: June 4, 2015
Last updated: August 25, 2017
Last verified: August 2017
  Purpose
Albiglutide is an analogue of glucagon-like peptide-1 (GLP-1), used to treat type 2 diabetes This study will test whether albiglutide affects the occurrence of major cardiovascular events such as heart attacks or strokes and other important medical outcomes in persons with type 2 diabetes, when used alone or added to other diabetes treatments.

Condition Intervention Phase
Diabetes Mellitus Biological: Albiglutide 30 mg Biological: Albiglutide 50 mg Biological: Albiglutide matching placebo Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official 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 (HARMONY Outcomes)

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Time to first occurrence of major adverse cardiovascular events (MACE; cardiovascular death, myocardial infarction, or stroke) [Non-inferiority] [ Time Frame: Subjects will remain in the study until a specified number of MACE events have occurred. The maximum time subjects will be in the study is estimated to be between 3 and 5 years. ]

Secondary Outcome Measures:
  • Time to first occurrence of MACE [Superiority] [ Time Frame: Subjects will remain in the study until a specified number of MACE events have occurred. The maximum time subjects will be in the study is estimated to be between 3 and 5 years. ]
  • Time to first occurrence of MACE or urgent revascularisation for unstable angina [ Time Frame: Subjects will remain in the study until a specified number of MACE events have occurred. The maximum time subjects will be in the study is estimated to be between 3 and 5 years. ]
  • Time to first occurrence of the individual components of the primary endpoint [ Time Frame: Subjects will remain in the study until a specified number of MACE events have occurred. The maximum time subjects will be in the study is estimated to be between 3 and 5 years. ]
  • Time to first occurrence of cardiovascular death or hospitalization due to heart failure [ Time Frame: Subjects will remain in the study until a specified number of MACE events have occurred. The maximum time subjects will be in the study is estimated to be between 3 and 5 years. ]
  • All cause mortality [ Time Frame: Subjects will remain in the study until a specified number of MACE events have occurred. The maximum time subjects will be in the study is estimated to be between 3 and 5 years. ]
  • Time to initiation of insulin of more than 3 months duration for those subjects not treated with insulin at study start [ Time Frame: Subjects will remain in the study until a specified number of MACE events have occurred. The maximum time subjects will be in the study is estimated to be between 3 and 5 years. ]
  • The proportion of subjects achieving glycemic control (HbA1c <=7.0% at final assessment) with no severe hypoglycemic incidents and weight gain <5% of body weight [ Time Frame: Subjects will remain in the study until a specified number of MACE events have occurred. The maximum time subjects will be in the study is estimated to be between 3 and 5 years. ]

Estimated Enrollment: 9400
Study Start Date: July 1, 2015
Estimated Study Completion Date: March 22, 2018
Estimated Primary Completion Date: February 8, 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Albiglutide
Albiglutide once weekly by subcutaneous injection. Starting dose 30 mg may be increased to 50 mg if needed. Albiglutide will be administered in addition to standard therapy for diabetes and cardiovascular health.
Biological: Albiglutide 30 mg
Once weekly subcutaneous injection. Starting dose 30 mg may be increased to 50 mg if needed.
Biological: Albiglutide 50 mg
Once weekly subcutaneous injection. Starting dose 30 mg may be increased to 50 mg if needed.
Placebo Comparator: Placebo
Placebo once weekly by subcutaneous injection. Placebo will be administered in addition to standard therapy for diabetes and cardiovascular health.
Biological: Albiglutide matching placebo
Once weekly subcutaneous injection. Matched to 30 mg and 50 mg albiglutide.

  Eligibility

Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02465515

  Show 633 Study Locations
Sponsors and Collaborators
GlaxoSmithKline
Duke Clinical Research Institute
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT02465515     History of Changes
Other Study ID Numbers: 116174
Study First Received: June 4, 2015
Last Updated: August 25, 2017

Keywords provided by GlaxoSmithKline:
cardiovascular events /outcomes
Type 2 diabetes mellitus
albiglutide
glucagon-like peptide-1 receptor agonist

Additional relevant MeSH terms:
rGLP-1 protein
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Glucagon-Like Peptide 1
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 21, 2017