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EPHIC-DIA2

Active not recruitingPhase 4

Impact of Pharmacogenetic-Guided Treatment on Type 2 Diabetes.

Open-label, Double-arm, Controlled, Randomized, Multicentre Clinical Trial to Evaluate the Impact of Pharmacogenetic-guided Treatment in Patients With Insufficiently Controlled Type 2 Diabetes.

Lead sponsor

Fundación para la Investigación del Hospital Clínico de Valencia

Assets

Dulaglutide / Semaglutide

Listed sites

Recruiting sites

—

Enrollment

504

estimated

Study population

Obesity / overweight, Type 2 diabetes

Key I/E criteria

•BMI 25-40•HbA1c 7-9.5%

Primary endpoint

•HbA1c <7.0% achievement

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 IDNCT06851962

Org study IDEPHIC-DIA2

Secondary ID2025-520686-46-00

Timeline

Milestones

Study first posted2025-02-28actual

Study start2025-05-26actual

Last update posted2026-02-23actual

Primary completion2026-06-30estimated

Study completion2026-06-30estimated

Assets

Investigational agents

Dulaglutide Semaglutide

Study populations

Who this study enrolls

Obesity / overweightType 2 diabetes

Eligibility

Who can enroll

Minimum age40 Years

Maximum age70 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

1. Age 40-70 years old, included.

2. Body Mass Index (BMI) between 25-40 kg/m².

3. Diagnosis of Type 2 Diabetes (T2D) according to the American Diabetes Association (ADA) criteria.

4. Patients with T2D insufficiently controlled (Hemoglobin A1c (HbA1c) 7-9.5%) with current (≥6 months) "standard of care" treatment, excluding the use of insulin.

5. The subject has provided written informed consent prior to any study-specific procedure.

6. Able and willing to comply with requested study visits and procedures.

7. Contraceptive measures, only for female participants:

–A female participant is eligible to participate if she is not pregnant or breastfeeding, and one of the following conditions applies:

–Is a woman of non-childbearing potential (WONCBP) OR

–Is a woman of childbearing potential (WOCBP) and agrees to use a contraceptive method that is highly effective, with a failure rate of <1%, during the study intervention period (to be effective before starting the intervention).

A WOCBP must have a negative urine pregnancy test before the first administration of study intervention.

Exclusion criteria

1. Treatment with insulin at the time of screening.

2. HbA1c >9.5% at screening.

3. Treatment with more than 3 glucose-lowering drugs at the time of screening.

4. Chronic renal disease defined as estimated glomerular filtration rate (eGFR) <30 mL/min/1.73m² (many glucose-lowering drugs are not approved or require dosage adjustments for use in these patients) at the screening visit.

5. Hepatic insufficiency, which contraindicates the use of glucose-lowering drugs.

6. Currently receiving treatment in another investigational drug study, or less than 30 days since ending treatment in another investigational drug study.

7. Pregnancy or lactation.

8. Women of childbearing potential with no effective contraceptive methods.

9. New York Heart Association (NYHA) Class III or IV congestive heart failure.

10. Subject likely to not be available to complete all protocol-required study visits or procedures, and/or to comply with all required study procedures to the best of the subject and investigator's knowledge.

11. Subject is study staff directly involved with the study or is a family member of the investigational study staff.

12. Life expectancy predicted to be <2 years.

Endpoints (15)

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

Glycemic / diabetes

Safety / tolerability / PK

Renal / kidney

MASH / liver

Glycemic / diabetes

4 endpoints

Primary/protocol endpoint

Comparison of HbA1c ≤7% goal at Week 24 between Pharmacogenetic-Guided and Standard Treatment in Type 2 Diabetes

Time frame:From baseline to the end of treatment at 24 weeks

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

Comparison of Pharmacogenetic Markers and Treatment Response Pre-Randomization

Time frame:Before randomization to the end of treatment at 24 weeks

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Other/protocol endpoint

Safety Objective (4): Changes in biochemistry parameters (glucose)

Time frame:From baseline to the end of treatment at 24 weeks

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Other/protocol endpoint

Safety Objective (5): Changes in biochemistry parameters (insulin)

Time frame:From baseline to the end of treatment at 24 weeks

change from baseline, descriptive

MASH / liver

1 endpoint

Other/protocol endpoint

Safety Objective (1): Changes in hepatic function

Time frame:From baseline to the end of treatment at 24 weeks

change from baseline, improvement

Renal / kidney

2 endpoints

Other/protocol endpoint

Safety Objective (2): Changes in renal function (eGFR)

Time frame:From baseline to the end of treatment at 24 weeks

eGFR, change

change from baseline, improvement

LOINC 98979-8

Other/protocol endpoint

Safety Objective (3): Changes in renal function (creatinine)

Time frame:From baseline to the end of treatment at 24 weeks

change from baseline, improvement

Cardiometabolic biomarkers

5 endpoints

Other/protocol endpoint

Exploratory Objective (1): percentage of patients achieving the dyslipidemia goal (LDL colesterol/LDL-C <70 mg/dL or <55 mg/Dl) in patients with or without cardiovascular disease (CVD)

Time frame:From baseline to the end of treatment at 24 weeks

threshold achievement, improvement

LOINC 13457-7

Other/protocol endpoint

Exploratory Objective (3): percentage of patients achieving the goal of <140/90 mmHg systolic and diastolic pressure

Time frame:From baseline to the end of treatment at 24 weeks

threshold achievement, improvement

componentsSystolic BP, change, Diastolic BP, change

Other/protocol endpoint

Safety Objective (6): Changes in biochemistry parameters (lipid panel)

Time frame:From baseline to the end of treatment at 24 weeks

change from baseline, improvement

Other/protocol endpoint

Safety Objective (7): Changes in heart rate

Time frame:From baseline to the end of treatment at 24 weeks

Heart rate, change

change from baseline, improvement

Other/protocol endpoint

Safety Objective (8): Changes in blood pressure

Time frame:From baseline to the end of treatment at 24 weeks

change from baseline, improvement

Safety / tolerability / PK

3 endpoints

Other/protocol endpoint

Exploratory Objective (4): glucose-lowering drugs' adverse events

Time frame:From baseline to the end of treatment at 24 weeks

Treatment-emergent AEs (any)

event count, event

Other/protocol endpoint

Safety Objective (1): Incidence of Treatment-Emergent Adverse Events (AEs)

Time frame:From baseline to the end of treatment at 24 weeks

Treatment-emergent AEs (any)

event count, event

Other/protocol endpoint

Safety Objective (2): Incidence of Serious Adverse Events (SAEs)

Time frame:From baseline to the end of treatment at 24 weeks

Serious AEs (any)

threshold achievement, event

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.