Ongoing, recruitingTherapeutic use (Phase IV)Interventional

Prospective study to assess with Continuous Glucose Monitoring (CGM) the efficacy and safety of switching to insulin glargine 300 U/ml from insulin glargine 100 U/ml in Type 2 Diabetes (T2DM) patients with renal impairment

This research study is for people with Type 2 diabetes who are already using a long-acting insulin called insulin glargine 100 U/ml and also have kidney problems. The study aims to look at how blood sugar levels change when people switch to a different, more concentrated version of the same insulin, called insulin glargine 300 U/ml. Researchers will use special devices called Continuous Glucose Monitors (CGM) to track blood sugar closely. They want to see if switching helps keep blood sugar within a healthy range for longer periods and to check for any side effects. This is to understand if this change in insulin could be a good option for managing Type 2 diabetes in people with kidney issues.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic use (Phase IV)

Sponsor

Sanofi Aventis S.A.

Enrolment target

100

Start

13 Jan 2025

Diabetes mellitus II

What is this study about?

This study is designed for individuals living with Type 2 diabetes who also have some form of kidney impairment. If you're currently using a specific type of long-acting insulin called insulin glargine 100 U/ml, this research might be relevant to you. The main goal is to understand what happens to your blood sugar control when you switch to a more concentrated version of the same insulin, called insulin glargine 300 U/ml.

Researchers will be looking closely at how much time your blood sugar levels stay within a healthy target range. They will use small, wearable devices called Continuous Glucose Monitors (CGM) which track your blood sugar throughout the day and night. This helps them get a very clear picture of your sugar levels and how they respond to the change in insulin. They will compare your blood sugar control before and after switching to the new insulin.

Beyond just looking at how much time your blood sugar is in range, the study will also check several other important things. This includes your average blood sugar levels, whether your blood sugar goes too high or too low, and your overall HbA1c (a long-term measure of blood sugar control). They will also keep a close eye on any side effects you might experience, especially low blood sugar (hypoglycemia), and how the change in insulin impacts your overall quality of life. This research is part of a larger effort to find the best ways to help people with Type 2 diabetes and kidney problems manage their condition effectively and safely.

Key takeaways

This study evaluates switching to a stronger long-acting insulin for Type 2 diabetes with kidney issues.
It aims to see if the new insulin helps keep blood sugar levels stable within a healthy range.
Continuous Glucose Monitors (CGM) will be used for detailed blood sugar tracking.
Researchers will also monitor safety, side effects, and overall well-being.
The study takes about 5 months and includes regular clinic visits.

Who may be eligible?

This study is looking for adults who are aged 18 or older. There is no upper age limit, so people of all adult ages are welcome to be considered.

To be eligible, you must have Type 2 diabetes. You also need to have some kidney problems, as this is a key focus of the study. Importantly, you should already be taking a long-acting insulin called insulin glargine 100 U/ml. Both men and women can take part in this research.

The research team will have a more detailed list of criteria to make sure the study is right for you and safe. This might include checking other medications you're taking or certain health conditions you have. If you meet these general points, the study doctors can talk through all the specific requirements with you.

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.

Are you 18 years old or older?
Do you have Type 2 diabetes?
Do you also have kidney problems?
Are you currently using insulin glargine 100 U/ml?
Are you able to attend regular clinic appointments for about 5 months?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will switch from your current insulin glargine 100 U/ml to insulin glargine 300 U/ml. The study will last for about 5 months. During this time, you'll have regular visits to the clinic where the study team will monitor your health and gather information about your diabetes management. You will wear a Continuous Glucose Monitor (CGM) which is a small device that painlessly measures your blood sugar levels throughout the day and night. This device will give the study team detailed insights into how the new insulin is affecting your blood sugar.

At your visits, the study team will take blood samples to check your HbA1c and other markers. They will also ask you about your general well-being, any side effects you might be experiencing, especially low blood sugar events, and how you feel about your diabetes treatment. You might also complete questionnaires about your quality of life linked to your diabetes. The study team will provide all the necessary medication and support throughout your participation.

Potential risks and benefits

Taking part in any medical study has potential benefits and risks. A possible benefit of this study is that switching to insulin glargine 300 U/ml might lead to improved blood sugar control for your Type 2 diabetes, especially if you have kidney problems. This could potentially reduce your risk of diabetes complications. As with any medication, there's always a risk of side effects, such as low blood sugar (hypoglycemia) or reactions at the injection site. The study team will closely monitor you for any adverse events. Remember, your participation is completely voluntary, and you have the right to withdraw from the study at any time, for any reason, without affecting your regular 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
Spain

Common questions

What is insulin glargine?

Insulin glargine is a type of long-acting insulin used to help manage blood sugar levels in people with diabetes. It releases slowly into your body to provide a steady effect.

What does 'renal impairment' mean?

'Renal impairment' is a medical term for reduced kidney function, meaning your kidneys aren't working as well as they should.

What is a Continuous Glucose Monitor (CGM)?

A CGM is a small sensor placed on your skin that continuously measures your blood sugar levels, giving you and your doctor a much clearer picture than just occasional finger-prick tests.

Will I have to pay to join this study?

No, you will not have to pay to participate in the study. All study-related medication, tests, and medical care will be provided by the study.

How long will I be in the study?

The study will involve a change in your insulin and will last for about 5 months, with regular check-ups during that time.