A phase III, randomized, prospective, double-blind, parallel design, multi-arm, multicenter study to compare the efficacy and safety of alogliptin and empagliflozin combination therapy versus alogliptin alone and empagliflozin alone in metformin-treated participants with type 2 diabetes mellitus and insufficient glycemic control despite diet and exercise (ODISSEIA 2026).
Living with type 2 diabetes often means finding the right balance of treatments to keep blood sugar in a healthy range. Many people already take a common medication called metformin, alongside eating well and staying active, but still find their blood sugar remains too high. This clinical trial is looking at whether combining two other established diabetes tablets—alogliptin and empagliflozin—works better than taking just one of them. Both medicines help lower blood sugar in different ways. Researchers will measure changes in HbA1c (a standard blood test showing average blood sugar over recent months) and check fasting blood sugar levels. They will also closely monitor safety, tracking side effects such as low blood sugar episodes. By comparing the treatments, the study aims to find out if this dual combination is safe, effective, and a helpful option for managing type 2 diabetes.
At a glance
What is this study about?
Type 2 diabetes is a common condition where the body struggles to keep blood sugar levels in check. Over time, high blood sugar can lead to complications affecting the heart, eyes, kidneys, and nerves. While eating a healthy diet, exercising, and taking a daily tablet called metformin helps many people, it is not always enough to keep blood sugar levels where they need to be.
When one medicine is not doing enough, doctors often consider adding other treatments. In this study, called the ODISSEIA trial, researchers are testing two diabetes medicines: alogliptin and empagliflozin. Alogliptin helps your pancreas make more insulin when you eat, while empagliflozin helps your kidneys remove extra sugar through your urine.
The trial aims to find out if taking both of these tablets together lowers blood sugar more effectively than taking either tablet alone. Researchers will track this by checking HbA1c, which is a blood test that shows your average blood sugar levels over the past two to three months. They will also look at safety and side effects to see how well people tolerate the combination.
Good diabetes care is about finding treatments that are both effective and easy to live with. If the combination proves safe and successful, it could offer doctors and patients a valuable option to improve long-term diabetes management.
Key takeaways
- Tests whether combining two diabetes drugs (alogliptin and empagliflozin) works better than taking either one alone.
- Designed for adults aged 18 and over with type 2 diabetes who already take metformin.
- Aims to safely lower blood sugar levels measured by standard HbA1c blood tests.
- Involves regular health visits, blood tests, and close monitoring by medical specialists.
- Taking part is entirely voluntary, and you can leave at any time.
Who may be eligible?
This study is open to adults aged 18 and older who have been diagnosed with type 2 diabetes. To take part, you should already be taking metformin to manage your condition, alongside following healthy diet and lifestyle advice.
Participants must have blood sugar levels that remain higher than ideal despite taking their regular metformin. This means the study doctor will test your blood sugar to confirm whether it falls into the range needed for this research.
Because your safety comes first, certain health conditions or medicines may mean the trial is not suitable for you. The study team will review your full medical history, run routine tests, and check your kidney function and overall health before deciding if you can join.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- You are aged 18 or older.
- You have a confirmed diagnosis of type 2 diabetes.
- You currently take metformin to help manage your blood sugar.
- Your blood sugar is still higher than your target despite diet and exercise.
- You are happy to attend regular clinic appointments and have routine health checks.
What does participation involve?
If you choose to join, you will be placed into a treatment group by chance, similar to tossing a coin. You will receive either both study medicines, or just one of them alongside dummy tablets (placebos), so everyone takes the same number of pills. Neither you nor your study doctor will know which specific group you are in, which keeps the results fair. You will continue taking your usual metformin throughout. During the trial, you will attend regular clinic visits for health checks. These include blood tests (such as HbA1c and fasting blood sugar), urine tests, blood pressure checks, and heart traces (ECGs). You will also be asked about any side effects or low blood sugar symptoms. The study team will provide all study tablets and closely monitor your health from start to finish.
Potential risks and benefits
Locations (5)
- —UnverifiedPoland
- —UnverifiedGermany
- —UnverifiedPortugal
- —UnverifiedItaly
- —UnverifiedSpain
Common questions
What is the main goal of this study?
The trial aims to find out if taking two diabetes medicines (alogliptin and empagliflozin) together lowers blood sugar better and as safely as taking either medicine on its own.
Will I have to stop taking metformin?
No. This study is specifically for people who continue to take their regular metformin treatment alongside the study tablets.
What is a placebo?
A placebo is a dummy tablet that looks identical to the real medicine but contains no active drug. It is used so that all participants take the same number of pills without knowing which group they are in.
How will the doctors monitor my blood sugar?
They will use standard blood tests, including an HbA1c test (which measures your average blood sugar over the last two to three months) and fasting blood sugar checks.
Can I leave the trial if I change my mind?
Yes. Taking part is completely voluntary. You are free to withdraw at any point, and your normal medical care will continue as usual.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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