GLP-1 Peptide Atlas, by Delfa

CompletedPhase 3

A Study of Taspoglutide in Patients With Inadequately Controlled Diabetes Mellitus Type 2 and Cardiovascular Disease

A Randomized Double Blind, Placebo-controlled Clinical Trial to Assess the Effects of Taspoglutide (RO5073031) on Cardiovascular Outcomes in Subjects With Inadequately Controlled Type 2 Diabetes and Established Cardiovascular Disease

Lead sponsor

Hoffmann-La Roche

Asset

Taspoglutide

Subcutaneous · GLP-1 agonist

Listed sites

288

Recruiting sites

—

Enrollment

2,118

actual

Study population

Cardiovascular disease, Type 2 diabetes

Key I/E criterion

—

Primary endpoint

•Expanded / custom MACE composite

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT01018173

Org study IDNC25113

Secondary ID2009-014986-22

Timeline

Milestones

Study first posted2009-11-23estimated

Last update posted2016-11-02estimated

Study start2010-01 (month precision)

Primary completion2011-01actual (month precision)

Study completion2011-01actual (month precision)

Assets

Investigational agents

Taspoglutide

Study populations

Who this study enrolls

Cardiovascular diseaseType 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•adult patients, >18 years of age

•diabetes mellitus type 2

•HbA1c >/=6.5% and </=10% at screening

•BMI >/=23kg/m2

•cardiovascular disease with onset >/=1 month prior to screening

Exclusion criteria

•diagnosis or history of type 1 diabetes or secondary forms of diabetes

•acute metabolic diabetic complications within past 6 months

•severe hypoglycemia </=1 month prior to screening

•clinically significant gastrointestinal disease

•history of chronic or acute pancreatitis

•current New York Heart Association (NYHA) class IV heart failure or post-transplantation cardiomyopathy

•severely impaired renal function

Endpoints (5)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Cardiovascular outcomes

Other (unclassified)

Cardiovascular outcomes

4 endpoints

Primary/protocol endpoint/low confidence

Time to cardiovascular composite primary endpoints

Time frame:event-driven, cardiovascular assessments weeks 1,4,12 and every 3 to 4 months thereafter

Expanded / custom MACE composite

time to event, event

Secondary/protocol endpoint/low confidence

Secondary cardiovascular composite endpoints

Time frame:event-driven, cardiovascular assessments weeks 1,4,12 and every 3 to 4 months thereafter

Expanded / custom MACE composite

composite event, event

Secondary/protocol endpoint/low confidence

Individual components of primary cardiovascular composite endpoints

Time frame:event-driven, cardiovascular assessments weeks 1,4,12 and every 3 to 4 months thereafter

descriptive

Secondary/protocol endpoint

Total mortality

Time frame:assessed at end of study, week 104

All-cause death

event count, event

SNOMED 419620001

Other (unclassified)

1 endpoint

Secondary/protocol endpoint/low confidence

Metabolic and renal function parameters: HbA1c, fasting plasma glucose, body weight, lipid profile, albumin/creatinine ratio (ACR), albuminuria, glomerular filtration rate (GFR)

Time frame:laboratory assessments weeks 4 and 12, and every 3 to 6 months thereafter

descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 1, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.