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Study on Ertugliflozin for Children and Teens with Type 2 Diabetes

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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 Mellitus in children and teenagers aged 10 to 17 years. The study is testing a medication called ertugliflozin, which is also known by its code name MK-8835. This medication is taken as a film-coated tablet and is being compared to a placebo. The purpose of the study is to evaluate the safety and effectiveness of ertugliflozin in managing blood sugar levels in young people with Type 2 Diabetes Mellitus.

Participants in the study will be randomly assigned to receive either ertugliflozin or a placebo. The study will last for a total of 54 weeks, with key assessments taking place at 24 weeks and 54 weeks. During this time, researchers will monitor changes in a blood marker called hemoglobin A1C, which reflects average blood sugar levels over the past few months. The study will also track any side effects experienced by participants to ensure the medication is safe and well-tolerated.

The trial aims to provide valuable information on how ertugliflozin can help manage Type 2 Diabetes Mellitus in young people. By understanding the effects of this medication, researchers hope to improve treatment options for children and teenagers living with this condition. Participants will be closely monitored throughout the study to ensure their safety and well-being.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, participants will be randomly assigned to receive either the study medication, ertugliflozin, or a placebo. A placebo is a tablet that looks like the medication but does not contain the active ingredient.
The study is designed to be double-blind, meaning neither the participants nor the researchers will know who is receiving the actual medication or the placebo.
Step 2
Medication administration
Participants will take the assigned tablets orally. The dosage will be either 5 mg or 15 mg of ertugliflozin, or a matching placebo, once daily.
The medication will be taken for a period of 24 weeks initially, with some participants continuing for up to 54 weeks to further assess safety and tolerability.
Step 3
Regular check-ups
Participants will attend regular check-ups to monitor their health and the effects of the medication. These check-ups will include blood tests to measure hemoglobin A1C levels, which indicate blood sugar control.
Participants will also be monitored for any side effects or adverse events throughout the study duration.
Step 4
End of study
At the end of the study period, participants will have a final evaluation to assess the overall impact of the medication on their diabetes management.
The results will help determine the effectiveness and safety of ertugliflozin in managing type 2 diabetes in pediatric participants.

Who can join the trial?

7 criteria

Has been diagnosed with Type 2 Diabetes Mellitus by a doctor using specific criteria.
Has a body mass index (BMI) at or above the 85th percentile, which means they are in the higher range for their age and height, or has a history of being overweight or obese when diagnosed with Type 2 diabetes.
Has had Type 2 diabetes for 2 years or more, or if less than 2 years, has a fasting C-peptide value greater than 0.6 ng/mL. C-peptide is a substance made in the pancreas, and its level can help show how much insulin the body is making.
Is taking a stable dose of metformin (at least 1500 mg per day) for at least 8 weeks before the study starts. Metformin is a common medication used to control blood sugar levels in people with diabetes. If also taking insulin, the dose must also be stable for at least 8 weeks before the study.
Male participants must use contraception methods that follow local guidelines for clinical studies.
Female participants who are not sterilized must either not be sexually active, agree to abstain from heterosexual activity, or agree to start using contraception before becoming sexually active. The method of contraception should follow local guidelines for clinical studies.
Must have a family member or adult who will be actively involved in their daily activities and treatment during the study, as determined by the study investigator.

Who cannot join the trial?

10 criteria

Patients with a history of severe allergic reactions to the study medication cannot participate.
Patients with uncontrolled high blood pressure are not eligible.
Individuals with severe kidney disease or on dialysis cannot join the study.
Patients with a history of heart attack or stroke in the last 6 months are excluded.
Pregnant or breastfeeding women are not allowed to participate.
Patients with a history of drug or alcohol abuse in the past year are not eligible.
Individuals currently participating in another clinical trial are excluded.
Patients with certain types of cancer or undergoing cancer treatment cannot join.
Individuals with a history of certain mental health disorders may not be eligible.
Patients with any other medical condition that the study doctors believe would make participation unsafe are excluded.

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Verified sites

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Azienda Ospedaliera Universitaria Citta' Della Salute E Della Scienza Di Torino
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Turin, Italy
Azienda Ospedaliera Universitaria Federico II Di Napoli
Verified
Naples, Italy
Ospedale Pediatrico Bambino Gesu'
Verified
Rome, Italy

Trial locations

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Investigated drugs

Ertugliflozin is a medication used in this clinical trial to help manage blood sugar levels in children and teenagers with type 2 diabetes. It works by helping the kidneys remove sugar from the body through urine, which can help lower blood sugar levels. The trial aims to see how well this medication works and how safe it is for young people over a period of 24 to 54 weeks.

Ertugliflozin

What is already known about the treatment

Ertugliflozin – Ertugliflozin is a medication administered orally, typically in the form of a tablet, and is currently being studied in clinical trials for its effectiveness and safety in treating Type 2 Diabetes Mellitus in children aged 10 to 17. It is already used in adults for managing blood sugar levels in Type 2 Diabetes. The main therapeutic indication for ertugliflozin is to help control high blood sugar, which can prevent complications such as nerve damage and kidney problems. At the molecular level, it works by blocking a protein in the kidneys called SGLT2, which helps remove excess sugar from the body through urine. Ertugliflozin belongs to a class of drugs known as SGLT2 inhibitors.

Investigated diseases

Type 2 Diabetes Mellitus – Type 2 Diabetes Mellitus is a chronic condition that affects the way the body processes blood sugar (glucose). It is characterized by insulin resistance, where the body's cells do not respond properly to insulin, and a relative lack of insulin production. Over time, high blood sugar levels can lead to various complications affecting the heart, blood vessels, nerves, eyes, and kidneys. The disease often develops gradually and may initially present with symptoms such as increased thirst, frequent urination, and fatigue. As the condition progresses, individuals may experience more severe symptoms and complications. Management of blood sugar levels is crucial to prevent further progression and complications.