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Efficacy and Safety of Alogliptin Plus Empagliflozin Compared with Alogliptin Alone or Empagliflozin Alone in Adults with Type 2 Diabetes on Metformin

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What is this trial about?

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

The study focuses on adults who have type 2 diabetes mellitus that is not well controlled even though they are taking metformin and following diet and exercise advice. The research compares taking a tablet of alogliptin (a medicine that helps the body release more insulin after meals) together with a tablet of empagliflozin (a medicine that helps the kidneys remove extra sugar in the urine) versus taking each medicine alone.

The main aim is to find out which treatment lowers the average blood‑sugar level best, measured by the change in HbA1c, a blood test that reflects sugar control over the past two to three months.

Participants will be assigned to one of the treatment groups and will take the study tablets once a day for several months. They will attend regular clinic visits where blood samples are taken and basic health checks are performed to watch for any side effects. Some participants may receive a tablet that looks the same but does not contain active medicine (placebo), and the study staff will not know which tablets each person receives until the study is finished.

The research process

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

  1. Step 1

    Randomization and receipt of study medication

    After you join the study, you will be randomly placed into one of the treatment groups. each group receives a different set of tablets that look the same.

    The possible groups are: alogliptin 25 mg alone, empagliflozin 10 mg alone, empagliflozin 25 mg alone, or a combination of alogliptin 25 mg plus empagliflozin (10 mg or 25 mg) as assigned.

  2. Step 2

    Start of daily medication

    You will begin taking the tablets once each day, usually in the morning, with or without food.

    The dosage is exactly as listed in the assignment: 25 mg for alogliptin and either 10 mg or 25 mg for empagliflozin. if you are in a combination group, you will take both tablets at the same time.

    The medication will be continued for the entire duration of the study, which may last up to 18 months.

  3. Step 3

    Regular follow‑up visits

    Throughout the study you will attend scheduled clinic visits. at each visit blood samples will be taken to measure hbA1c (a test that shows average blood sugar over the past few months) and fasting plasma glucose (fpg).

    The visits also include checks of vital signs, a brief physical exam, and questions about any side effects you may have experienced.

  4. Step 4

    Monitoring of safety and side effects

    At every visit you will be asked about any new symptoms, especially signs of low blood sugar (hypoglycemia) or other unexpected problems.

    Any adverse events will be recorded and evaluated by the study team.

  5. Step 5

    Final assessment and end of study

    At the last study visit, final measurements of hbA1c and fpg will be taken, and a complete safety review will be performed.

    After this assessment the study medication will be stopped and you will receive instructions for any further care.

Who can join the trial?

10 criteria

  • Age 18 or older and either male or a female who is not pregnant or breastfeeding, with a diagnosis of Type 2 Diabetes.
  • Having consistently high blood sugar while taking a stable dose of the medicine metformin (1500 mg per day or the highest dose you can tolerate) together with diet and exercise for at least 12 weeks before screening.
  • Blood test result called HbA1c must be 7.0% or higher but not more than 10.5% (this test shows average blood sugar over the past three months).
  • Body weight relative to height, measured as BMI, must be 45 kg/m² or lower.
  • Kidney function, measured by eGFR, must be 60 mL/min/1.73 m² or higher (eGFR estimates how well the kidneys are working).
  • Must be able to swallow pills taken by mouth.
  • If you are a female of child‑bearing age, you must have a negative pregnancy test before randomization and another negative test before starting the study medication.
  • Women who could become pregnant must agree to use a highly effective form of birth control during the study and for at least two weeks after the last dose.
  • Men do not need any special birth‑control measures for this study.
  • Must be able to sign a written informed consent form before any study procedures begin.

Who cannot join the trial?

23 criteria

  • Severe allergy to the study medicines, the groups of medicines they belong to, or any inactive ingredients (excipients) that are part of the pills.
  • Moderate to severe kidney problems, measured by a test called eGFR. An eGFR between 30 and 60 means moderate impairment, and below 30 means severe impairment.
  • Serious liver disease, judged by a score called the Child‑Pugh score. A score higher than 9 (range 10‑15) means very advanced liver damage.
  • High blood pressure that is still uncontrolled despite medication, defined as a systolic pressure (top number) of 160 mmHg or higher, or a diastolic pressure (bottom number) of 100 mmHg or higher.
  • Recent serious heart or brain problems, such as a heart attack, unstable chest pain, stroke, or a mini‑stroke (TIA) that happened within the last three months.
  • Severe or unstable heart failure (heart’s pumping ability is weak), especially classification NYHA class III or IV, or certain moderate heart failure (class II) with other heart disease unless a specific diabetes medicine (GLP‑1 receptor agonist) cannot be used.
  • Important heart rhythm or electrical problems seen on an electrocardiogram (ECG), such as dangerous irregular beats, a high‑grade heart block (second‑ or third‑degree atrioventricular block) unless a working pacemaker is present, or a prolonged QT interval (>500 ms) that could lead to abnormal heartbeats.
  • Any cancer diagnosed in the past five years, except for very early skin cancers (in situ) or basal/squamous cell skin cancer.
  • Active infection with hepatitis B (HBV), hepatitis C (HCV), or HIV (human immunodeficiency virus), meaning the virus is still present in the blood.
  • Any medical, mental health, behavioral, or social situation that would make it hard to finish the study, follow the rules, or give reliable results.
  • Use of any diabetes medicines other than metformin within the 12 weeks before screening.
  • Smoking more than 10 cigarettes, or more than 3 cigars or 3 pipes per day at the time of screening.
  • Taking any other drug that could interact in an important way with the study medicines.
  • History of alcohol or drug misuse within the past year.
  • Kidney disease caused by diabetes, shown by an albumin‑to‑creatinine ratio (ACR) of 30 mg/g or higher on two separate tests before randomisation.
  • Needing a special diabetes medicine called a GLP‑1 receptor agonist unless that medicine cannot be used, is not tolerated, or the person chooses not to take it after counseling.
  • Any other significant medical or psychiatric condition not listed above that the investigator thinks would increase risk, prevent following the study plan, or make the results unclear.
  • Participation in a weight‑loss program or use of weight‑loss drugs within the last 12 weeks.
  • Being in another clinical trial that used an experimental (investigational) drug within the past 90 days, or currently taking part in another trial.
  • Being institutionalised (living in a prison, nursing home, or similar facility).
  • Having Type 1 diabetes or a form of diabetes caused by another condition (secondary diabetes).
  • Being pregnant or breastfeeding.
  • Having a fasting blood sugar level (fasting plasma glucose, FPG) higher than 240 mg/dL (13.3 mmol/L) after at least an 8‑hour fast, confirmed by two separate tests before randomisation.
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Investigated drugs

  • Empagliflozin

    is a tablet taken by mouth that helps the kidneys remove extra sugar from the blood. It belongs to a class of medicines called SGLT2 inhibitors. In this study it is added to participants who are already taking metformin to see how well it can lower blood sugar.

  • Alogliptin

    is an oral tablet that works by increasing hormones that tell the pancreas to release insulin after meals. It is a DPP‑4 inhibitor. The trial tests how well it controls blood sugar when used together with metformin.

  • Empagliflozin + Alogliptin combination therapy

    means participants take both medicines at the same time. The two drugs act in different ways—one helps the kidneys clear sugar and the other helps the pancreas release more insulin—so together they may lower blood sugar better than either drug alone.

What is already known about the treatment

  • Empagliflozin

    This medication is taken as a film‑coated tablet taken by mouth, typically in 10 mg or 25 mg strengths. It is an approved drug that is widely used and studied for treating type 2 diabetes. Empagliflozin belongs to the class of sodium‑glucose co‑transporter‑2 (SGLT2) inhibitors and works by blocking the kidney’s ability to re‑absorb sugar, so more sugar leaves the body in the urine, helping to lower blood sugar levels. It is used to improve blood glucose control in adults with type 2 diabetes, often together with other diabetes medicines.

  • Alogliptin

    This drug is an oral tablet, usually taken at a dose of 25 mg once daily. It is an approved and well‑documented treatment for type 2 diabetes that has been studied in many clinical trials. Alogliptin is classified as a dipeptidyl peptidase‑4 (DPP‑4) inhibitor and works by preventing the breakdown of natural hormones that increase insulin release after meals, thereby helping to lower blood glucose. It is prescribed to improve blood sugar control in adults with type 2 diabetes, often as an addition to other diabetes medicines.

Investigated diseases

Type 2 Diabetes mellitus - Type 2 Diabetes mellitus is a chronic condition in which the body does not use insulin properly, leading to higher blood sugar levels. Over time, the pancreas may produce less insulin as the disease progresses. Persistent high blood sugar can cause the body’s cells to become less responsive, requiring more insulin to achieve the same effect. The condition often develops gradually, starting with mild elevations in blood sugar that may not cause symptoms. As it advances, people may notice increased thirst, frequent urination, and fatigue.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2025-524606-15-00Protocol code240207Estimated enrolment940 patientsSponsorTecnimede-Sociedade Tecnico-Medicinal S.A.

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