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Study on Switching to Insulin Glargine 300 U/ml from Insulin Glargine 100 U/ml for Patients with Type 2 Diabetes and Kidney Problems

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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 in patients who also have kidney problems. The study is looking at the effects of switching from a lower dose of insulin glargine 100 U/ml to a higher dose of insulin glargine 300 U/ml. Insulin glargine is a type of insulin used to help control blood sugar levels in people with diabetes. The purpose of the study is to evaluate how effective and safe this switch is for patients.

Participants in the study will use a device called Continuous Glucose Monitoring (CGM) to track their blood sugar levels. This device helps to provide a detailed picture of how blood sugar changes throughout the day and night. The study will last for several months, during which time participants will have their blood sugar levels closely monitored. The goal is to see if the higher dose of insulin glargine helps keep blood sugar levels within a healthy range more effectively than the lower dose.

Throughout the study, researchers will also keep an eye on any side effects or health issues that might arise from the change in insulin dosage. This includes monitoring for episodes of low blood sugar, known as hypoglycemia, and any other adverse events. The study aims to provide valuable information on whether the higher dose of insulin glargine is a better option for managing blood sugar in people with Type 2 Diabetes and kidney problems.

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
Enrollment
Upon joining the study, the participant provides signed informed consent, confirming understanding and agreement to participate.
Eligibility is confirmed based on criteria such as age, diagnosis of type 2 diabetes for at least three years, current treatment with insulin glargine 100 U/ml for at least four months, and specific health parameters like HbA1c levels and kidney function.
Step 2
Initial assessment
An initial assessment is conducted to establish baseline health metrics. This includes measuring HbA1c levels, fasting plasma glucose, and other relevant health indicators.
Participants are introduced to the use of the Freestyle IQ Pro device for continuous glucose monitoring (CGM).
Step 3
Treatment switch
Participants switch from insulin glargine 100 U/ml to insulin glargine 300 U/ml. This change is administered subcutaneously, meaning the medication is injected under the skin.
The dosage and frequency of insulin administration are adjusted as per the study protocol to ensure safety and efficacy.
Step 4
Monitoring and follow-up
Participants are monitored regularly using the CGM device to track glucose levels continuously.
Regular follow-up visits are scheduled to assess the participant's health, adjust treatment if necessary, and collect data on glucose levels, including time in range, mean glucose profile, and any hypoglycemia events.
Step 5
Final assessment
At the end of the study period, a final assessment is conducted to evaluate changes in health metrics from baseline, including HbA1c levels and fasting plasma glucose.
The study aims to determine the efficacy and safety of the insulin switch by comparing these final results with the initial baseline data.

Who can join the trial?

8 criteria

Must provide a signed informed consent, which means you agree to participate after understanding the study details.
Must be 18 years of age or older.
Must have been diagnosed with **Type 2 Diabetes Mellitus** for at least 3 years before joining the study.
Must have been treated with **Gla-100** (a type of insulin) for at least 4 months before joining, with or without other diabetes pills.
Must have an **HbA1c** level (a measure of blood sugar control) between 7.5% and less than 9% within 3 months before joining.
Must have an **Estimated Glomerular Filtration Rate (eGFR)**, which measures kidney function, between 30-60 ml/min at least 4 weeks before joining.
Must have a **Body Mass Index (BMI)**, which is a measure of body fat based on height and weight, between 25 and 40 kg/m².
Must be able and willing to wear the **Freestyle IQ Pro**, a device used to monitor blood sugar, as required by the study.

Who cannot join the trial?

5 criteria

Patients who have a different type of diabetes other than Type 2 Diabetes Mellitus (T2DM) cannot participate. T2DM is a condition where the body doesn't use insulin properly.
Patients who do not have renal impairment cannot participate. Renal impairment means the kidneys are not working as well as they should.
Patients who are not using insulin glargine 100U/ml (Gla-100) cannot participate. This is a specific type of insulin used to control blood sugar levels.
Patients who are not willing to switch to insulin glargine 300U/ml (Gla-300) cannot participate. This is another type of insulin that will be used in the study.
Patients who are not able to use a Continuous Glucose Monitor (CGM) cannot participate. A CGM is a device that tracks blood sugar levels throughout the day and night.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Bellvitge University Hospital
Verified
L'hospitalet De Llobregat, Spain
Hospital Clinic De Barcelona
Verified
Barcelona, Spain
Hospital Universitario De Salamanca
Verified
Salamanca, Spain

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Investigated drugs

Insulin Glargine 100 U/ml
is a long-acting insulin used to help control blood sugar levels in people with Type 2 Diabetes. It is typically administered once a day to provide a steady level of insulin throughout the day and night. In this study, patients are initially using this form of insulin before switching to a different dosage.
Insulin Glargine 300 U/ml
is another form of long-acting insulin, similar to the 100 U/ml version, but it is more concentrated. This means that a smaller volume of insulin is needed to achieve the same effect, which can be beneficial for patients who require higher doses of insulin. The study aims to evaluate the effectiveness and safety of switching patients from the 100 U/ml version to this more concentrated form, especially in those with Type 2 Diabetes and kidney problems.

What is already known about the treatment

Insulin Glargine 300 U/ml – This medication is administered via subcutaneous injection and is used to manage blood sugar levels in individuals with Type 2 Diabetes Mellitus, particularly those with renal impairment. It is currently being studied in clinical trials to assess its efficacy and safety when switching from a lower concentration insulin glargine formulation. The main therapeutic indication is to improve blood sugar control in diabetes patients. At the molecular level, insulin glargine works by mimicking the action of natural insulin, promoting glucose uptake by cells and reducing glucose production by the liver. It is classified as a long-acting insulin analog.

Investigated diseases

Type 2 Diabetes Mellitus – This is a chronic condition that affects the way the body processes blood sugar (glucose). In this disease, the body either resists the effects of insulin, a hormone that regulates the movement of sugar into cells, or doesn't produce enough insulin to maintain normal glucose levels. Over time, high blood sugar levels can lead to various complications, affecting the heart, kidneys, nerves, and eyes. The progression of the disease can be gradual, often starting with insulin resistance and eventually leading to decreased insulin production. Lifestyle factors such as diet and physical activity play a significant role in its development and progression. Managing blood sugar levels is crucial to prevent complications associated with this condition.