Impact of Pharmacogenetic-Guided Treatment on Type 2 Diabetes.
EPHIC-DIA2
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.
2 other identifiers
interventional
504
1 country
3
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4 diabetes-mellitus-type-2
Started May 2025
Shorter than P25 for phase_4 diabetes-mellitus-type-2
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 30, 2025
CompletedFirst Posted
Study publicly available on registry
February 28, 2025
CompletedStudy Start
First participant enrolled
May 26, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 30, 2026
February 23, 2026
February 1, 2026
1.1 years
January 30, 2025
February 20, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Comparison of HbA1c ≤7% goal at Week 24 between Pharmacogenetic-Guided and Standard Treatment in Type 2 Diabetes
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.
From baseline to the end of treatment at 24 weeks
Secondary Outcomes (1)
Comparison of Pharmacogenetic Markers and Treatment Response Pre-Randomization
Before randomization to the end of treatment at 24 weeks
Other Outcomes (13)
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)
From baseline to the end of treatment at 24 weeks
Exploratory Objective (3): percentage of patients achieving the goal of <140/90 mmHg systolic and diastolic pressure
From baseline to the end of treatment at 24 weeks
Exploratory Objective (4): glucose-lowering drugs' adverse events
From baseline to the end of treatment at 24 weeks
- +10 more other outcomes
Study Arms (2)
Pharmacogenetic-guided treatment
EXPERIMENTALPatient 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.
Standard treatment
ACTIVE COMPARATORPatient 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.
Interventions
Eligibility Criteria
You may qualify if:
- Age 40-70 years old, included.
- Body Mass Index (BMI) between 25-40 kg/m².
- Diagnosis of Type 2 Diabetes (T2D) according to the American Diabetes Association (ADA) criteria.
- Patients with T2D insufficiently controlled (Hemoglobin A1c (HbA1c) 7-9.5%) with current (≥6 months) "standard of care" treatment, excluding the use of insulin.
- The subject has provided written informed consent prior to any study-specific procedure.
- Able and willing to comply with requested study visits and procedures.
- 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.
You may not qualify if:
- Treatment with insulin at the time of screening.
- HbA1c \>9.5% at screening.
- Treatment with more than 3 glucose-lowering drugs at the time of screening.
- 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.
- Hepatic insufficiency, which contraindicates the use of glucose-lowering drugs.
- Currently receiving treatment in another investigational drug study, or less than 30 days since ending treatment in another investigational drug study.
- Pregnancy or lactation.
- Women of childbearing potential with no effective contraceptive methods.
- New York Heart Association (NYHA) Class III or IV congestive heart failure.
- 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.
- Subject is study staff directly involved with the study or is a family member of the investigational study staff.
- Life expectancy predicted to be \<2 years.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Hospital Universitario Regional de Málaga
Málaga, 29010, Spain
Hospital Clínico Universitario de Valencia
Valencia, 46010, Spain
Hospital General Universitario de Valencia (HGUV)
Valencia, 46014, Spain
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sergio Martínez Hervás, Doctor
Hospital Clínico Universitario de Valencia
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 30, 2025
First Posted
February 28, 2025
Study Start
May 26, 2025
Primary Completion (Estimated)
June 30, 2026
Study Completion (Estimated)
June 30, 2026
Last Updated
February 23, 2026
Record last verified: 2026-02