Gene-Guided diabetes care shows promise in new trial
NCT ID NCT06851962
First seen Jun 27, 2026 · Last updated Sep 04, 2026 · Updated 1 time
Summary
This study tests whether choosing diabetes medications based on a person's genetic profile helps control blood sugar better than standard treatment. About 500 adults with type 2 diabetes that is not well controlled will be randomly assigned to either gene-guided or standard care. Researchers will compare how many patients reach their blood sugar goal after 24 weeks and track any side effects.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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92 people
The number who actually took part.
- Started
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May 2025
- Finished
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Jun 2026
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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40 to 70 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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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Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Hospital Clínico Universitario de Valencia
Valencia, 46010, Spain
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Hospital General Universitario de Valencia (HGUV)
Valencia, 46014, Spain
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Hospital Universitario Regional de Málaga
Málaga, 29010, Spain
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