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Study on the Effects of Ertugliflozin and Sodium Intake on Blood Pressure in Overweight Adults with Type 2 Diabetes

Verified siteRegistered drugNo placebo

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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 the effects of a medication called ertugliflozin on people with type 2 diabetes. Type 2 diabetes is a condition where the body does not use insulin properly, leading to high blood sugar levels. The medication being tested, ertugliflozin, is taken as a 15 mg film-coated tablet. The study will compare the effects of ertugliflozin with a placebo, which is a substance with no active medication, to see how it affects blood pressure and other health markers in people with type 2 diabetes.

The purpose of the study is to understand how different levels of sodium intake in the diet can change the effects of ertugliflozin on blood pressure over a 24-hour period. Participants will follow either a diet with sodium levels recommended by the World Health Organization or a higher sodium diet. The study will observe changes in blood pressure, kidney function, and other health indicators in overweight or obese adults with type 2 diabetes.

Throughout the study, participants will take part in a series of tests and assessments to monitor their health. These will include measuring blood pressure, kidney function, and other factors like blood sugar levels and body measurements. The study aims to provide insights into how ertugliflozin works in combination with different dietary sodium levels, which could help improve treatment strategies for managing type 2 diabetes.

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
Initial assessment
Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes verifying a diagnosis of type 2 diabetes, age between 35 and 80 years, and a body mass index (BMI) greater than 25 kg/m².
Additional criteria include stable diabetes medication and sodium intake below 200 mmol/day at baseline.
Step 2
Medication administration
Participants receive ertugliflozin 15 mg in the form of film-coated tablets, taken orally once daily.
The study involves a comparison between the effects of ertugliflozin and a placebo on blood pressure over 24 hours.
Step 3
Dietary sodium intake adjustment
Participants follow two different sodium intake regimens: one with the World Health Organization (WHO)-recommended sodium intake of 90 mmol per day, and another with a high sodium intake targeted at 250 mmol per day.
The effects of these sodium intake levels on the medication's impact are observed.
Step 4
Monitoring and evaluation
Throughout the study, various health parameters are monitored, including blood pressure, kidney function, and glucose levels.
Specific tests include measuring glomerular filtration rate (GFR), hematocrit, and kidney oxygenation, among others.
Step 5
Completion and follow-up
The study is expected to conclude by December 31, 2025.
Upon completion, participants may undergo a final assessment to evaluate the overall effects of the treatment and dietary adjustments.

Who can join the trial?

12 criteria

Adults who have been previously diagnosed with Type 2 diabetes according to the American Diabetes Association (ADA) criteria.
Have a blood sugar level, measured as HbA1c, between 6.5% and 10%. HbA1c is a test that shows your average blood sugar level over the past 2 to 3 months.
Are between 35 and 80 years old.
Are overweight or obese with a Body Mass Index (BMI) greater than 25 kg/m². BMI is a measure of body fat based on height and weight.
Participants of all races and ethnicities are encouraged to join.
Both men and women can participate. Women must be post-menopausal, meaning they haven't had a menstrual period for more than a year. If there's uncertainty, a hormone test called Follicle-Stimulating Hormone (FSH) will be done, and the level should be greater than 31 U/L.
Must be able to provide signed and dated written consent before any study procedures begin.
Have an estimated Glomerular Filtration Rate (eGFR) between 60 and 90 ml/min/1.73m². eGFR is a test that checks how well your kidneys are working.
Have a sodium intake at the start of the study of less than 200 mmol per day.
Have a Urine Albumin-to-Creatinine Ratio (UACR) of less than 30 mg/mmol. UACR is a test that checks for protein in your urine, which can be a sign of kidney problems.
Must be on a stable dose of diabetes medication, which can include Metformin, SU, DPP4-inhibitors, or insulin.
Must be on a stable dose of a Renin-Angiotensin System (RAS) blocker, which is a type of medication that helps control blood pressure.

Who cannot join the trial?

4 criteria

Individuals who do not have Type 2 diabetes cannot participate. Type 2 diabetes is a condition where the body does not use insulin properly, leading to high blood sugar levels.
Participants must be adults, meaning they are 18 years or older.
Both men and women can participate, so gender is not a reason for exclusion.
Participants should not be part of a vulnerable population, which means they should not be in a situation where they are unable to protect their own interests.

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Amsterdam UMC
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Amsterdam, The Netherlands

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Investigated drugs

Ertugliflozin is a medication used in this study to help manage blood sugar levels in people with type 2 diabetes. It works by helping the kidneys remove glucose from the bloodstream through urine. The study aims to see how different levels of sodium intake affect the medication's ability to change kidney function, oxygen levels in the kidneys, and blood pressure.

Ertugliflozin

What is already known about the treatment

Ertugliflozin – Ertugliflozin is administered orally in tablet form. It is currently being studied in clinical trials for its effects on type 2 diabetes, particularly in relation to dietary sodium intake. The main therapeutic indication for ertugliflozin is the management of type 2 diabetes by helping to control blood sugar levels. At the molecular level, it works by inhibiting the sodium-glucose co-transporter 2 (SGLT2) in the kidneys, which reduces glucose reabsorption and increases glucose excretion in the urine. Ertugliflozin is classified as an SGLT2 inhibitor, a type of medication used to improve glycemic control in adults with type 2 diabetes.

Investigated diseases

Type 2 diabetes – This is a chronic condition that affects the way the body processes blood sugar (glucose). In type 2 diabetes, 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, including damage to the eyes, kidneys, and nerves. The disease often develops slowly, and individuals may not notice symptoms initially. Common symptoms include increased thirst, frequent urination, hunger, fatigue, and blurred vision. It is more common in adults, but increasing numbers of children are being diagnosed with the disorder.