Ongoing, recruitingTherapeutic use (Phase IV)Interventional

Intraclass safety and efficacy comparison among SGLT-2 inhibitors in elderly patients with type 2 diabetes. A pragmatic, phase IV, multicenter, open-label, randomised controlled trial.

This study, called a clinical trial, is comparing several common medicines used to treat type 2 diabetes in older patients. These medicines, known as SGLT-2 inhibitors and including brand names like Invokana, Forxiga, and Jardiance, help control blood sugar. Researchers want to understand if these different medicines are equally good at keeping blood sugar stable without causing severe drops (low blood sugar), which can be very serious. They will also look at other important health factors like weight, blood pressure, and kidney health, as well as checking for any side effects. This research aims to help doctors choose the best and safest treatment for older adults with type 2 diabetes.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic use (Phase IV)

Sponsor

Center For Outcomes Research And Clinical Epidemiology S.r.l.

Enrolment target

1,167

Start

13 Nov 2024

Type 2 diabetes mellitus

What is this study about?

Imagine you have type 2 diabetes, and your doctor prescribes medication to help manage your blood sugar. There are several different types of medicines available, and this study is focusing on a group called SGLT-2 inhibitors. These medicines work in a specific way to help your body get rid of sugar through your urine, which can lower your blood sugar levels. This particular study wants to compare many of the commonly used SGLT-2 inhibitor medicines, like Invokana, Jardiance, and Forxiga, to see how well they work and how safe they are, especially for older people with type 2 diabetes.

The main thing the researchers are looking for is whether these medicines can control your blood sugar effectively without causing *severe* low blood sugar. Severe low blood sugar, sometimes called 'level 3 hypoglycemia,' is a serious condition where your blood sugar drops so much that you might need help from another person. This study will also check if these medicines affect your weight, blood pressure, and kidney function, as these are all important aspects of managing diabetes.

Ultimately, this study is being done to help doctors and patients make more informed choices about which medication might be best for older individuals with type 2 diabetes. By understanding the safety and effectiveness of different SGLT-2 inhibitors, the aim is to improve care and reduce the risk of serious complications.

Key takeaways

Compares different well-known diabetes medicines (SGLT-2 inhibitors).
Focuses on older people with type 2 diabetes.
Aims to find out which medicines are safest and most effective for controlling blood sugar without severe drops.
Also looks at effects on weight, blood pressure, and kidney health.
Participation involves taking a study medicine and regular check-ups.
You can discuss this study with your doctor to see if it's right for you.

Who may be eligible?

To be considered for this study, individuals must have been diagnosed with type 2 diabetes.

There are no age limits for this study, so people of all adult ages are welcome to inquire. Both men and women can take part.

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.

I have been diagnosed with type 2 diabetes.
I am an adult.
I am considering a new or adjusted diabetes medication.
I am willing to attend regular clinic appointments.
I am comfortable taking one of the specified SGLT-2 inhibitor medications.

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would be prescribed one of the study medications for your type 2 diabetes. Which exact medicine you receive would be chosen randomly, a bit like drawing names from a hat. You would have regular appointments at a clinic where doctors and nurses would monitor your health. These visits would involve checking your blood sugar, weight, and blood pressure. You might also have blood tests to check your kidney function and other health markers. The study team will track how often you need to adjust your other medicines, and how you feel about your treatment. The total duration of your participation in the study, including all visits and follow-ups, would be explained to you in detail by the study team.

Potential risks and benefits

Taking part in any study has potential benefits and risks. A potential benefit could be receiving close medical monitoring and access to widely used diabetes medications. The information gathered might also help future patients. Potential risks include experiencing side effects from the medication, such as mild low blood sugar, infections, dehydration, or, less commonly, bone fractures or other serious issues, all of which the study team would carefully monitor. You would always have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Italy

Common questions

What is type 2 diabetes?

Type 2 diabetes is a condition where your body doesn't produce enough insulin or doesn't use insulin effectively, leading to high blood sugar levels.

What are SGLT-2 inhibitors?

These are a type of medicine for type 2 diabetes that helps your kidneys remove more sugar from your body through your urine, which helps lower your blood sugar.

What does a 'clinical trial' mean?

A clinical trial is a research study that looks at new ways to prevent, detect, or treat diseases. This particular study is comparing existing medications.

What is 'low blood sugar'?

Low blood sugar, or hypoglycemia, is when your blood sugar levels drop too low. Severe low blood sugar means you might need help from another person.

Will I know which medicine I'm taking?

Yes, this is an 'open-label' study, which means both you and the study team will know which specific study medication you are receiving.