Impact of Pharmacogenetic-Guided Treatment on Type 2 Diabetes.

Short name EPHIC-DIA2

NCTNCT06851962Other idEPHIC-DIA2Other id2025-520686-46-00Other id2025

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Overview

Status: Completed
Phase: Phase 4
Enrollment: 92 participants (actual)
Sponsor: Fundación para la Investigación del Hospital Clínico de Valencia · Other
Design: Randomized · Single masking
Countries: 1 country
Spain
Start: 26 May 2025
Primary completion: 30 Jun 2026
Completion: 30 Jun 2026
First posted: 28 Feb 2025
Last update posted: 4 Sept 2026
Conditions: Diabetes Mellitus Type 2

Timeline

1 trial · 1 completed

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

202520262027

Ph 4
EPHIC-DIA2
NCT06851962
26 May 2025 to 30 Jun 2026

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

The goal of this clinical trial is to assess the efficacy of a pharmacogenetics-guided treatment, compared to standard optimized treatment, in patients with inadequately controlled type 2 diabetes. The main questions it aims to answer are: * Is the disease better controlled when the treatment prescribed is based on the participant's pharmacogenetic profile? * What medical problems do participants experience while taking the treatment? Participants will: * Take the treatment described according to the Summary of Product Characteristics (SmPC). * Visit the clinic once every 12 weeks for checkups and tests. * Keep a diary of their symptoms to inform the Investigator.

Interventions

MetforminDrug
DulaglutideDrug
Semaglutide 1.0 mgDrug
Empagliflozin (BI 10773)Drug
CanagliflozinDrug
DapagliflozinDrug
pioglitazoneDrug
SitagliptinDrug
Vildagliptin (Galvus)Drug
linagliptinDrug

Arms2

Experimental
Pharmacogenetic-guided treatment
Patient treatment will be selected according to previously identified genetic variations. Study treatments and posology from enrollment to the end of treatment at Week 24 can be: 1. Metformin (daily dose 2000 mg). 2. GLP1 receptor analogs: dulaglutide and semaglutide. 3. SGLT2 inhibitors: empagliflozin, canagliflozin and dapagliflozin. 4. Pioglitazone. 5. DPP4 inhibitors: sitagliptin, vildagliptin and linagliptin. Or a combination of these drugs. Except of metformin, which 2000 mg is the daily dose stablished in this study, for the rest of treatment options, SmPCs guidelines of each treatment will be followed to stablished the daily dose.
Active comparator
Standard treatment
Patient treatment will be selected according to clinical guidelines. Study treatments and posology from enrollment to the end of treatment at Week 24 can be: 1. Metformin (daily dose 2000 mg). 2. GLP1 receptor analogs: dulaglutide and semaglutide. 3. SGLT2 inhibitors: empagliflozin, canagliflozin and dapagliflozin. 4. Pioglitazone. 5. DPP4 inhibitors: sitagliptin, vildagliptin and linagliptin. Or a combination of these drugs. Except of metformin, which 2000 mg is the daily dose stablished in this study, for the rest of treatment options, SmPCs guidelines of each treatment will be followed to stablished the daily dose.

Primary outcomes1

Outcomes the sponsor listed as primary.

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
Registry description
The primary objective is to compare the proportion of patients achieving HbA1c ≤7% at Week 24 between pharmacogenetic-guided treatment arm and standard treatment arm in subjects with insufficiently controlled type 2 diabetes. The null hypothesis is that the proportion of patients achieving this goal is equal in both the pharmacogenetic-guided and standard treatment groups.

Secondary outcomes(1)

Comparison of Pharmacogenetic Markers and Treatment Response Pre-Randomization
Time frame · Before randomization to the end of treatment at 24 weeks
Registry description
Comparison of pharmacogenetic markers with the effect of pre-randomization treatment. This will be measured by analyzing the pharmacogenetic markers before randomization and their relationship to the treatment response. The endpoint will be the comparison between the proportion of patients who achieved HbA1c ≤7% at baseline (excluded from randomization) and those who did not (included for randomization).

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex: All
Age: from 40 Years up to 70 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

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.

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