DelfaGLP-1 Atlas

← Trials/Trial dossier/NCT02092597

SAFEGUARD

CompletedPhase 4

Safety Evaluation of Adverse Reactions in Diabetes

Assets

Exenatide / GLP-1 / incretin class catch-all

Listed sites

1

Recruiting sites

—

Enrollment

42

actual

Study population

Obesity / overweight, Type 2 diabetes

Key I/E criterion

•BMI 25-40

Primary endpoints

•Heart rate, change•Gastric evacuation velocity•Blood pressure

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 IDNCT02092597
Org study IDHEALTH-282521-CUNI

Timeline

Milestones

Study first posted2014-03-20estimated
Last update posted2018-02-07actual
Study start2013-10 (month precision)
Primary completion2015-10actual (month precision)
Study completion2016-09actual (month precision)

Assets

Investigational agents

ExenatideGLP-1 / incretin class catch-all

Study populations

Who this study enrolls

Obesity / overweightType 2 diabetes

Eligibility

Who can enroll

Minimum age35 Years
Maximum age70 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

•Type 2 diabetes mellitus
•Metformin monotherapy - stable dose during last 3 months
•HbA1C 48-75 mmol/mol (IFCC)
•BMI 25-40 kg/m2
•Age 35-70 years (women postmenopausal)
•Use of ACE inhibitors or ATII receptor blockers for at least 3 months before enrollment

Exclusion criteria

•eGFR<30 ml/min/1.73m2 (MDRD)
•Treatment with incretin mimetics during 3 months before enrollment
•Chronic insulin therapy
•Chronic use of loop diuretics, glucocorticoids, NSAID, immune suppressants, antimicrobial agents, chemotherapeutics, bile acid sequestrants (colestyramin, colesevelam)
•History of pancreatic disease or impaired pancreatic function (defined as the need to use pancreatic enzymes)
•Active liver disease or a 3-fold elevation of liver transaminases (ALT, AST)
•Active malignancy
•History of severe cardiovascular disease including acute coronary syndrome, stroke or transient ischemic neurologic disorder during previous 6 months, atrial fibrillation or other arrhythmia requiring chronic antiarrhythmic medication, chronic heart failure (New York Heart Association grade III/IV)
•History of alcohol abuse, defined as >4 units of alcohol/day (32 g or 40 ml of 100% alcohol)
•History of allergy for GLP-1 receptor agonists or DPP-4 inhibitors
•Any disease that could interfere with study procedures (e.g. decreased mobility, mental incapacity)
•Inability to give informed consent

Endpoints (10)

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

Cardiometabolic biomarkers
4
Renal / kidney
3
Heart failure
1
Safety / tolerability / PK
1
Other clinical outcomes
1

Heart failure

1 endpoint
Primary/protocol endpoint

Left ventricular ejection fraction

Time frame:90 days after treatment initiation

change from baseline, improvement

Renal / kidney

3 endpoints
Primary/protocol endpoint

Glomerular filtration rate

Time frame:90 days after treatment initiation

eGFR, change

change from baseline, improvement

Primary/protocol endpoint/low confidence

Tubular function

Time frame:90 days after treatment initiation

descriptive

Primary/protocol endpoint

KIM-1

Time frame:90 days after treatment initiation

change from baseline, improvement

Cardiometabolic biomarkers

4 endpoints
Primary/protocol endpoint

Heart rate

Time frame:90 days after treatment initiation

Heart rate, change

change from baseline, improvement

Primary/protocol endpoint

Blood pressure

Time frame:90 days after treatment initiation

change from baseline, improvement

Primary/protocol endpoint

Intimomedial thickness

Time frame:90 days after treatment initiation

change from baseline, improvement

Primary/protocol endpoint

Pulse wave velocity

Time frame:90 days after treatment initiation

change from baseline, improvement

Safety / tolerability / PK

1 endpoint
Primary/protocol endpoint/low confidence

Exocrine pancreas function

Time frame:90 days after treatment initiation

descriptive

Other clinical outcomes

1 endpoint
Primary/protocol endpoint/low confidence

Gastric evacuation velocity

Time frame:90 days after treatment initiation

change from baseline, descriptive

Publications (2)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

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.