Diabetes Mellitus Type 2Phase 4EPHIC-DIA2NCT06851962
Impact of Pharmacogenetic-Guided Treatment on Type 2 Diabetes.
A Phase 4 study testing Metformin, Dulaglutide and Semaglutide 1.0 mg in people with Diabetes Mellitus Type 2, run by Fundación para la Investigación del Hospital Clínico de Valencia at 3 sites in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Diabetes Mellitus Type 2
- What is being tested?
- Metformin, Dulaglutide and Semaglutide 1.0 mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 3 sitesSpain
- Study dates
- 26 May 2025to 30 Jun 2026
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 11Show fewer
- 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.
Who cannot join
- 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.
Show all 12Show fewer
- 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.
Trial locations and contacts
3 sites in 1 country.
Spain3 sites
Hospital Universitario Regional de Málaga
Málaga, 29010
Hospital Clínico Universitario de Valencia
Valencia, 46010
Hospital General Universitario de Valencia (HGUV)
Valencia, 46014
About this study
Official title: 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.
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.
Read the detailed description
Rationale:
Type 2 diabetes (T2D) is a growing disease that causes serious complications and represents a significant public health burden. Despite current therapies, many patients fail to achieve adequate glycemic control, highlighting the need for more personalized approaches. This study seeks to demonstrate that pharmacogenetics, which tailors treatments according to patients' genetic variations, can improve disease control, reduce adverse effects, and ultimately optimize healthcare resources, improving patients' quality of life.
Study Design:
This is a Phase IV, multicenter, randomized, controlled, two-arm, crossover clinical trial. The study will include at least 504 patients, who will be randomized in a 1:1 ratio to receive pharmacogenetics-guided treatment or standard treatment for type 2 diabetes. Once proven to meet eligibility criteria, patients will be assigned to a treatment arm and will participate in the study for the next 24 weeks.
Primary Objective:
To evaluate the efficacy of pharmacogenetics-guided treatment, compared to optimized standard treatment, in patients with inadequately controlled type 2 diabetes.
Secondary Objective:
To evaluate pharmacogenetic markers with the effect of treatment administered prior to randomization.
Exploratory Objectives:
- To evaluate the percentage of patients achieving the target of dyslipidemia and its relationship with the genetic variations present in these subjects.
- To evaluate the percentage of patients reaching the blood pressure target and its relationship with the genetic variations present in these subjects.
- To evaluate the incidence and relationship of adverse events of glucose control drugs with genetic variations.
Safety Objective:
To evaluate the safety and tolerability of the glucose control drugs prescribed in each group of patients.
Target Population:
Patients between 40 and 70 years old, with a body mass index (BMI) between 25 and 40 kg/m² and with a diagnosis of type 2 diabetes inadequately controlled (HbA1c between 7% and 9.5%) and receiving standard non-insulin treatment for at least 6 months will be included. Patients will be visited at 12 and 24 weeks from the start of the study.
Statistical Methods:
The sample size was calculated with an alpha risk of 0.05 and a beta risk of 0.1, using a bilateral test. A total of 252 subjects in each group (standard and pharmacogenetics-guided treatment) are required to detect a significant difference in the proportion of patients achieving HbA1c ≤7%. A dropout rate of 10% is expected. Follow-up of patients will be 24 weeks, sufficient time to observe improvements in glycemic control. The goal is to achieve an HbA1c ≤7%, as recommended by the American Diabetes Association. It is estimated that 50% of patients will achieve the target with antidiabetic treatment, and it is assumed that pharmacogenetics-guided treatment will have at least a 15% greater response than conventional treatment, due to genetic variations.
The main objective is to evaluate the impact of pharmacogenetics-guided treatment in patients with type 2 diabetes, comparing proportions between groups. Analyses will be performed according to the type of variable: Student's t-test or Mann-Whitney for quantitative variables and Fisher's exact test or chi-square tests for qualitative variables. The software used will be R (version 3.6.1), with two-way tests and an alpha risk of 0.05, verifying normality with the Shapiro-Wilk test.
- Conditions
- Diabetes Mellitus Type 2
- Being tested
- Metformin, Dulaglutide, Semaglutide 1.0 mg, Empagliflozin (BI 10773), Canagliflozin
- Keywords
- Pharmacogenetics, Diabetes type 2, uncontrolled diabetes, hyperglycemia, hypoglycemia, dyslipemia, personalized medicine, genomics, Precision Medicine
- Medical subject headings
- Diabetes Mellitus, Type 2, Hyperglycemia, Hypoglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MetforminDrug
Metformin maximum daily dose 2000 mg
DulaglutideDrug
Dulaglutide
Semaglutide 1.0 mgDrug
Semaglutide
Empagliflozin (BI 10773)Drug
Empagliflozin
CanagliflozinDrug
Canagliflozin
DapagliflozinDrug
Dapagliflozin
pioglitazoneDrug
Pioglitazone
SitagliptinDrug
Sitagliptin
Vildagliptin (Galvus)Drug
vildagliptin
linagliptinDrug
linagliptin
| Study group | Role | What they receive |
|---|---|---|
| Pharmacogenetic-guided treatment | Experimental | 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. Receives: Drug: Metformin; Drug: Dulaglutide; Drug: Semaglutide 1.0 mg; Drug: Empagliflozin (BI 10773); Drug: Canagliflozin; Drug: Dapagliflozin; Drug: pioglitazone; Drug: Sitagliptin; Drug: Vildagliptin (Galvus); Drug: linagliptin |
| Standard treatment | Active comparator | 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. Receives: Drug: Metformin; Drug: Dulaglutide; Drug: Semaglutide 1.0 mg; Drug: Empagliflozin (BI 10773); Drug: Canagliflozin; Drug: Dapagliflozin; Drug: pioglitazone; Drug: Sitagliptin; Drug: Vildagliptin (Galvus); Drug: linagliptin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From baseline to the end of treatment at 24 weeks
Secondary outcomes (1)
Comparison of Pharmacogenetic Markers and Treatment Response Pre-Randomization
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).
Measured: Before randomization to the end of treatment at 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2025
- Study start26 May 2025
- Primary completion30 Jun 2026
- Study completion30 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus Type 2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundación para la Investigación del Hospital Clínico de Valencia
- Sponsor type
- University, hospital or other
- Collaborators
- Instituto de Salud Carlos III, European Union
- Responsible party
- Sponsor
- Investigators
- Sergio Martínez Hervás, Doctor, Principal investigator, Hospital Clínico Universitario de Valencia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06851962
- Sponsor's protocol ID
- EPHIC-DIA2
- Other IDs
- 2025-520686-46-00, 2025
- Acronym
- EPHIC-DIA2
- Status last verified
- Sep 2026
- First submitted
- 30 Jan 2025
- Last updated
- 4 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT06851962
- Acronym / sponsor ID
- EPHIC-DIA2 / EPHIC-DIA2
- Conditions
- Diabetes Mellitus Type 2
- Keywords
- Pharmacogenetics, Diabetes type 2, uncontrolled diabetes, hyperglycemia, hypoglycemia, dyslipemia, personalized medicine, genomics
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Fundación para la Investigación del Hospital Clínico de ValenciaUniversity, hospital or other
- Collaborators
- Instituto de Salud Carlos III, European Union
- Study start
- 26 May 2025 (actual)
- Primary completion
- 30 Jun 2026 (actual)
- Study completion
- 30 Jun 2026 (actual)
- First posted
- 28 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Rationale:
Type 2 diabetes (T2D) is a growing disease that causes serious complications and represents a significant public health burden. Despite current therapies, many patients fail to achieve adequate glycemic control, highlighting the need for more personalized approaches. This study seeks to demonstrate that pharmacogenetics, which tailors treatments according to patients' genetic variations, can improve disease control, reduce adverse effects, and ultimately optimize healthcare resources, improving patients' quality of life.
Study Design:
This is a Phase IV, multicenter, randomized, controlled, two-arm, crossover clinical trial. The study will include at least 504 patients, who will be randomized in a 1:1 ratio to receive pharmacogenetics-guided treatment or standard treatment for type 2 diabetes. Once proven to meet eligibility criteria, patients will be assigned to a treatment arm and will participate in the study for the next 24 weeks.
Primary Objective:
To evaluate the efficacy of pharmacogenetics-guided treatment, compared to optimized standard treatment, in patients with inadequately controlled type 2 diabetes.
Secondary Objective:
To evaluate pharmacogenetic markers with the effect of treatment administered prior to randomization.
Exploratory Objectives:
- To evaluate the percentage of patients achieving the target of dyslipidemia and its relationship with the genetic variations present in these subjects.
- To evaluate the percentage of patients reaching the blood pressure target and its relationship with the genetic variations present in these subjects.
- To evaluate the incidence and relationship of adverse events of glucose control drugs with genetic variations.
Safety Objective:
To evaluate the safety and tolerability of the glucose control drugs prescribed in each group of patients.
Target Population:
Patients between 40 and 70 years old, with a body mass index (BMI) between 25 and 40 kg/m² and with a diagnosis of type 2 diabetes inadequately controlled (HbA1c between 7% and 9.5%) and receiving standard non-insulin treatment for at least 6 months will be included. Patients will be visited at 12 and 24 weeks from the start of the study.
Statistical Methods:
The sample size was calculated with an alpha risk of 0.05 and a beta risk of 0.1, using a bilateral test. A total of 252 subjects in each group (standard and pharmacogenetics-guided treatment) are required to detect a significant difference in the proportion of patients achieving HbA1c ≤7%. A dropout rate of 10% is expected. Follow-up of patients will be 24 weeks, sufficient time to observe improvements in glycemic control. The goal is to achieve an HbA1c ≤7%, as recommended by the American Diabetes Association. It is estimated that 50% of patients will achieve the target with antidiabetic treatment, and it is assumed that pharmacogenetics-guided treatment will have at least a 15% greater response than conventional treatment, due to genetic variations.
The main objective is to evaluate the impact of pharmacogenetics-guided treatment in patients with type 2 diabetes, comparing proportions between groups. Analyses will be performed according to the type of variable: Student's t-test or Mann-Whitney for quantitative variables and Fisher's exact test or chi-square tests for qualitative variables. The software used will be R (version 3.6.1), with two-way tests and an alpha risk of 0.05, verifying normality with the Shapiro-Wilk test.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pharmacogenetic-guided treatment | Experimental | Drug: Metformin, Drug: Dulaglutide, Drug: Semaglutide 1.0 mg, Drug: Empagliflozin (BI 10773), Drug: Canagliflozin, Drug: Dapagliflozin, Drug: pioglitazone, Drug: Sitagliptin, Drug: Vildagliptin (Galvus), Drug: linagliptinPatient 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 comparator | Drug: Metformin, Drug: Dulaglutide, Drug: Semaglutide 1.0 mg, Drug: Empagliflozin (BI 10773), Drug: Canagliflozin, Drug: Dapagliflozin, Drug: pioglitazone, Drug: Sitagliptin, Drug: Vildagliptin (Galvus), Drug: linagliptinPatient 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. |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MetforminMetformin maximum daily dose 2000 mg | Drug | Pharmacogenetic-guided treatment, Standard treatment |
| DulaglutideDulaglutide | Drug | Pharmacogenetic-guided treatment, Standard treatment |
| Semaglutide 1.0 mgSemaglutide | Drug | Pharmacogenetic-guided treatment, Standard treatment |
| Empagliflozin (BI 10773)Empagliflozin | Drug | Pharmacogenetic-guided treatment, Standard treatment |
| CanagliflozinCanagliflozin | Drug | Pharmacogenetic-guided treatment, Standard treatment |
| DapagliflozinDapagliflozin | Drug | Pharmacogenetic-guided treatment, Standard treatment |
| pioglitazonePioglitazone | Drug | Pharmacogenetic-guided treatment, Standard treatment |
| SitagliptinSitagliptin | Drug | Pharmacogenetic-guided treatment, Standard treatment |
| Vildagliptin (Galvus)vildagliptin | Drug | Pharmacogenetic-guided treatment, Standard treatment |
| linagliptinlinagliptin | Drug | Pharmacogenetic-guided treatment, Standard treatment |
Primary outcome
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
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.
1 secondary outcome
Comparison of Pharmacogenetic Markers and Treatment Response Pre-Randomization
Time frame: Before randomization to the end of treatment at 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2026.
Related trials for Diabetes Mellitus Type 2
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
Not yet recruiting
Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
Type 2 Diabetes Mellitus (T2D), Obesity (BMI>30)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sergio Martínez Hervás, Doctor principal investigator
Hospital Clínico Universitario de Valencia
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Metformin, Dulaglutide and Semaglutide 1.0 mg in people with Diabetes Mellitus Type 2, run by Fundación para la Investigación del Hospital Clínico de Valencia at 3 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2026.