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

NCT02465515 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 9463

Last updated 2019-03-06

Study results available
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Summary

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.

Conditions

Interventions

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.

BIOLOGICAL

Albiglutide matching placebo

Once weekly subcutaneous injection. Matched to 30 mg and 50 mg albiglutide.

Sponsors & Collaborators

  • Duke Clinical Research Institute

    collaborator OTHER

  • GlaxoSmithKline

    lead INDUSTRY

Principal Investigators

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

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-07-01
Primary Completion
2018-02-20
Completion
2018-03-14

Countries

  • United States
  • Argentina
  • Belgium
  • Bulgaria
  • Canada
  • Czechia
  • Denmark
  • France
  • Germany
  • Greece
  • Hong Kong
  • Hungary
  • Italy
  • Mexico
  • Netherlands
  • Norway
  • Peru
  • Philippines
  • Poland
  • Russia
  • South Africa
  • South Korea
  • Spain
  • Sweden
  • Taiwan
  • Thailand
  • Ukraine
  • United Kingdom

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02465515 on ClinicalTrials.gov