DelfaGLP-1 Atlas

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UnknownPhase 4

Prognostic Predictors of Response to Hypoglycemic Therapy

Search for Highly Specific Predictors of Response to Different Hypoglycemic Therapy for Cardiovascular Prognosis

Assets

Exenatide / Liraglutide

Listed sites

1

Recruiting sites

1

Enrollment

800

estimated

Study population

Type 2 diabetes

Key I/E criterion

•HbA1c ≤1%

Primary endpoints

•HbA1c, change•BMI, change

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 IDNCT03804411
Org study ID11/2017

Timeline

Milestones

Study start2017-08-01actual
Study first posted2019-01-15actual
Last update posted2020-02-10actual
Primary completion2020-03estimated (month precision)
Study completion2020-05estimated (month precision)

Assets

Investigational agents

ExenatideLiraglutide

Study populations

Who this study enrolls

Type 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years
Maximum age70 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

1. Male and female aged 17-70 years

2. Type 2 diabetes mellitus with non-target HbA1c exciding less than 1% (<1%)

3. Initiation of the treatment by SGLT- 2 inhibitors, dipeptidyl peptidase-4 inhibitors, GLP-1 analogues

4. Stable hypoglycemic therapy for 12 weeks before enrollment

5. Signed informed consent

Exclusion criteria

1. Type 1 diabetes mellitus

2. Recent acute coronary syndrome or acute disturbance of cerebral blood circulation (less than 2 months ago)

3. Decompensation of chronic heart failure, chronic heart failure class IV (NYHA), acute heart failure

4. Confirmed non-diabetic kidney disease (glomerulonephritis, pyelonephritis, amyloidosis)

5. Chronic kidney disease requiring hemodialysis and/or urinary albumin concentration (morning spot) >1000 mg/L

6. Regular nephrotoxic drugs intake (long-term intake of NSAIDs, aminoglycosides, sulfonamides, cyclosporine, lithium preparations)

7. Anamnesis of malignancy.

8. Diabetic foot ulcer and neuropathic osteoarthropathy

9. Anamnesis of bariatric surgery or surgical interventions on the gastrointestinal tract leading to malabsorption.

10. Treatment with drugs reducing body weight less than 3 months ago or any other drugs use that can lead to a change in body weight.

11. Liver disorders with elevation of ALT/AST exceeding three-fold the upper limit of normal

12. Immunosuppressive therapy or regular nonsteroidal anti-inflammatory drugs intake

13. Change in the dosage of thyroid hormones less than 6 weeks ago.

Endpoints (16)

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
6
Other (unclassified)
3
Glycemic / diabetes
2
Heart failure
2
Renal / kidney
2
Weight & body composition
1

Weight & body composition

1 endpoint
Primary/protocol endpoint

Body mass index

Time frame:baseline and 3, 12, and 24 months after intervention

BMI, change

change from baseline, improvement

Glycemic / diabetes

2 endpoints
Primary/protocol endpoint

HbA1c

Time frame:baseline and 3, 12, and 24 months after intervention

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

HOMA-IR index

Time frame:baseline, 6 and 12 months after intervention

HOMA-IR (insulin sensitivity)

change from baseline, improvement

Heart failure

2 endpoints
Secondary/protocol endpoint

NT-proBNP

Time frame:baseline, 6 and 12 months after intervention

NT-proBNP, change

change from baseline, improvement

Secondary/protocol endpoint

LV ejection fraction

Time frame:baseline, 6 and 12 months after intervention

change from baseline, improvement

Renal / kidney

2 endpoints
Secondary/protocol endpoint

Estimated glomerular filtration rate

Time frame:baseline, 12 and 24 months after intervention

eGFR, change

change from baseline, improvement

LOINC 98979-8

Secondary/protocol endpoint

Urinary creatinine-adjusted excretion of albumin

Time frame:baseline, 12 and 24 months after intervention

uACR, change

change from baseline, improvement

LOINC 9318-7

Cardiometabolic biomarkers

6 endpoints
Secondary/protocol endpoint

LDL cholesterol

Time frame:baseline, 6 and 12 months after intervention

LDL-C, change

change from baseline, improvement

LOINC 13457-7

Secondary/protocol endpoint

Triglycerides

Time frame:baseline, 6 and 12 months after intervention

Triglycerides, change

change from baseline, improvement

LOINC 2571-8

Secondary/protocol endpoint

hsCRP

Time frame:baseline, 6 and 12 months after intervention

hs-CRP, change

change from baseline, improvement

LOINC 30522-7

Secondary/protocol endpoint/low confidence

PAT

Time frame:baseline, 6 and 12 months after intervention

change from baseline, improvement

Secondary/protocol endpoint

IMT

Time frame:baseline, 6 and 12 months after intervention

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Molecular-genetic markers of endothelial damage

Time frame:baseline, 6 and 12 months after intervention

change from baseline, improvement

Other (unclassified)

3 endpoints
Secondary/protocol endpoint/low confidence

Cardiovascular parameters of PAT and IMT

Time frame:baseline, 6 and 12 months after intervention

change from baseline, improvement

Secondary/protocol endpoint/low confidence

LV mass index

Time frame:baseline, 6 and 12 months after intervention

change from baseline, improvement

Secondary/protocol endpoint/low confidence

GLS by 2D-STE

Time frame:baseline, 6 and 12 months after intervention

change from baseline, improvement

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.