Not recruiting

Study on Personalized Treatment Using Dapagliflozin, Dulaglutide, and Metformin for Patients with Uncontrolled Type 2 Diabetes

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying Type 2 Diabetes Mellitus, a condition where the body struggles to regulate blood sugar levels effectively. The study aims to see if a personalized treatment approach based on a person's genetic makeup can improve diabetes control compared to the usual treatment methods. Several medications are involved in this study, including Forxiga (dapagliflozin), Trulicity (dulaglutide), Glucophage (metformin hydrochloride), Jardiance (empagliflozin), Pioglitazone Mylan (pioglitazone), Ozempic (semaglutide), Trajenta (linagliptin), Invokana (canagliflozin), Galvus (vildagliptin), and Sitagliptin (sitagliptin). Some of these medications are taken orally as tablets, while others are administered as injections.

The purpose of the study is to evaluate the effectiveness of this genetic-based treatment approach. Participants will be randomly assigned to either the experimental group, receiving the personalized treatment, or the control group, receiving the optimized standard treatment. The study will last for 24 weeks, during which participants will be monitored to see if they achieve better control of their blood sugar levels. The study will also look at other health factors, such as cholesterol levels and blood pressure, to see if they improve with the treatment.

Throughout the study, the safety of the medications will be closely monitored, and any side effects will be recorded. The goal is to determine if this new approach can help more people with Type 2 Diabetes Mellitus reach their health goals and improve their overall well-being.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, participants will be randomly assigned to one of two groups. This process is called randomization and ensures that each participant has an equal chance of being placed in either group.
Step 2
Initial assessment
Participants will undergo an initial assessment to evaluate their current health status. This includes measuring blood sugar levels, blood pressure, and other relevant health indicators.
Step 3
Medication administration
Participants will receive medications based on their assigned group. The medications include Forxiga 10 mg film-coated tablets, Trulicity 1.5 mg solution for injection in pre-filled pen, GLUCOPHAGE 1000 mg film-coated tablets, Jardiance 10 mg film-coated tablets, Pioglitazone Mylan 15 mg tablets, Ozempic 0.5 mg solution for injection in pre-filled pen, Trajenta 5 mg film-coated tablets, Invokana 100 mg film-coated tablets, Galvus 50 mg tablets, and Sitagliptin 50 mg film-coated tablets.
The medications will be administered either orally or by injection, depending on the specific drug. The frequency and dosage will be determined by the study protocol and communicated to each participant.
Step 4
Ongoing monitoring
Participants will attend regular follow-up visits to monitor their health and the effects of the medication. These visits will include blood tests and other assessments to track progress and any side effects.
Step 5
Final assessment
At the end of the study period, participants will undergo a final assessment to evaluate the overall impact of the treatment. This will include measuring blood sugar levels and other health indicators to determine the effectiveness of the treatment.

Who can join the trial?

15 criteria

Age between 40 and 70 years old.
Body Mass Index (BMI) between 25 and 40 kg/m². BMI is a measure of body fat based on height and weight.
Diagnosed with Type 2 Diabetes (T2D) according to the American Diabetes Association (ADA) criteria.
Have Type 2 Diabetes that is not well controlled, with an HbA1c level between 7% and 9.5%. HbA1c is a blood test that shows average blood sugar levels over the past 2 to 3 months.
Currently receiving standard diabetes treatment for at least 6 months, without using insulin.
Have provided written informed consent before any study-specific procedures.
Able and willing to attend study visits and follow study procedures.
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For female participants: Must not be pregnant or breastfeeding. If of childbearing potential, must agree to use a highly effective contraceptive method during the study. Acceptable methods include:
- Male or female condom
- Contraceptive implant
- IUD (intrauterine device)
- Surgical sterilization (tubal ligation or partner's vasectomy)
- Birth control pill
- Contraceptive patch
- Vaginal ring
- Contraceptive injections

Who cannot join the trial?

10 criteria

Patients with a history of severe allergic reactions to any medication.
Patients who are currently participating in another clinical trial.
Patients with a history of drug or alcohol abuse within the past year.
Patients with any other medical condition that the study doctors believe would make it unsafe for them to participate.
Patients who are pregnant or breastfeeding.
Patients who have had a major surgery within the past 3 months.
Patients with uncontrolled high blood pressure.
Patients with severe kidney disease.
Patients with severe liver disease.
Patients with a history of heart attack or stroke within the past 6 months.

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Verified sites

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Hospital General Universitario De Valencia
Valencia, Spain

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Investigated drugs

Pharmacogenetic-Guided Treatment
is a personalized approach to treating type 2 diabetes. This therapy uses information about a person's genetic makeup to help doctors choose the most effective medication for managing their blood sugar levels. The goal is to find the right medication that works best for each individual, potentially leading to better control of diabetes and fewer side effects.
Optimized Standard Treatment
refers to the best possible use of existing diabetes medications based on current medical guidelines. This approach involves adjusting the type and amount of medication a patient takes to achieve the best possible control of their blood sugar levels. The aim is to improve diabetes management by using the most effective treatment strategies available.

What is already known about the treatment

Pharmacogenetic-Guided Treatment – This treatment is administered orally and is designed to help manage type 2 diabetes by tailoring medication choices based on a patient's genetic makeup. Currently, it is being studied in clinical trials to determine its effectiveness compared to standard diabetes treatments. The main goal is to improve blood sugar control in patients whose diabetes is not well-managed with existing therapies. At the molecular level, this approach aims to optimize drug selection and dosing by considering genetic factors that affect how a patient responds to medication. It falls under the pharmacological classification of personalized medicine, which seeks to customize healthcare based on individual characteristics.

Investigated diseases

Type 2 Diabetes Mellitus – Type 2 Diabetes Mellitus is a chronic condition characterized by insulin resistance and relative insulin deficiency, leading to elevated blood glucose levels. Over time, the pancreas may produce less insulin, exacerbating the condition. The disease often develops gradually and is commonly associated with obesity, physical inactivity, and genetic predisposition. As the condition progresses, individuals may experience increased thirst, frequent urination, and fatigue. Long-term complications can affect various organs, including the eyes, kidneys, and nerves. The progression of the disease can lead to cardiovascular issues and other metabolic disorders.