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Study on the Effects of Ertugliflozin and Semaglutide on Heart Health in Patients 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 study focuses on Type 2 Diabetes and its effects on heart function, particularly a condition called Cardiovascular Autonomic Neuropathy (CAN), which is damage to the nerves that control heart rate and blood pressure. The research investigates how a type of medication known as SGLT-2 inhibitors (SGLT-2i) might improve heart function in people with diabetes. These medications were originally developed to help lower blood sugar levels by causing the kidneys to remove excess sugar through urine, but they have shown benefits for heart health as well.

The purpose of the study is to determine whether SGLT-2 inhibitors can improve the nervous system's control of heart function and slow the progression of cardiovascular autonomic neuropathy in people with type 2 diabetes. Participants in the study will receive SGLT-2 inhibitor treatment for 6 months. During this time, they will undergo tests to measure heart rate variability (changes in time between heartbeats) and other indicators of nerve function related to the heart. Some tests will include monitoring blood sugar levels using a flash glucose monitoring system worn for 2 weeks, and a mixed meal test to assess how the body processes food.

The study is designed for adults over 45 years old with type 2 diabetes whose blood sugar levels are not optimally controlled despite current treatments. Participants will need to be on stable medication regimens for at least 3 months before joining the study.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Study enrollment and initial assessment
You will sign an informed consent form after the study has been explained to you.
Your eligibility will be confirmed based on your type 2 diabetes diagnosis, age (over 45 years), stable medication use for at least 3 months, and HbA1c levels between 7.0% and 8.5%.
Initial tests will be performed to establish your baseline health status, including heart function tests.
Step 2
Flash glucose monitoring setup
You will receive a flash glucose monitoring device that continuously tracks your blood sugar levels.
You'll wear this device for 2 weeks at the beginning of the study to establish your baseline glycemic variability (how much your blood sugar levels fluctuate).
Step 3
Cardiovascular autonomic testing
You will undergo Cardiovascular Autonomic Reflex Tests (CARTs) to assess the function of nerves that control your heart rate and blood vessels.
These tests include measuring your heart rate during different breathing patterns (expiration/inspiration ratio), when standing up from a lying position (30:15 ratio), and during a specific breathing exercise called the Valsalva maneuver.
Heart Rate Variability (HRV) will also be measured, which shows how well your nervous system is regulating your heart.
Step 4
Mixed Meal Test
You will take a Mixed Meal Test where you'll consume a specific meal, and your blood will be sampled to measure how your body responds to food.
This test helps evaluate your pancreatic beta cell function (how well your pancreas produces insulin).
Step 5
Beginning medication treatment
You will start taking an SGLT-2 inhibitor medication. This could be one of the following: dapagliflozin, empagliflozin, canagliflozin, or ertugliflozin.
Your doctor will determine the specific medication and dosage based on your individual needs.
This medication works by helping your kidneys remove excess sugar through your urine.
You will continue taking this medication daily for 6 months.
Step 6
Regular monitoring during 6-month treatment period
You will have regular check-up appointments to monitor your response to the medication.
Your doctor will assess your overall health, diabetes control, and any potential side effects.
Your current diabetes medications (which may include metformin, insulin, or others) will continue as prescribed.
Step 7
End-of-study assessments
After 6 months of treatment, you will repeat the same tests done at the beginning of the study:
Flash glucose monitoring for 2 weeks to measure changes in your blood sugar patterns
Cardiovascular autonomic testing to check for improvements in heart nerve function
Mixed Meal Test to reassess your pancreatic function
These final assessments will help determine how the SGLT-2 inhibitor medication has affected your heart's nervous system control and diabetes management.

Who can join the trial?

11 criteria

You must give your informed consent (agreement) before joining the study, understanding and signing a written form
You must have type 2 diabetes (a condition where your body doesn't use insulin properly)
You must be over 45 years old
You must be unable to tolerate metformin (a common diabetes medication), or metformin isn't working for you, or you have conditions like heart failure or diabetic kidney disease that indicate you should be on SGLT2 inhibitor therapy (a type of diabetes medication)
Your diabetes medications must have been stable for at least 3 months before screening
If you use insulin, your daily dose must not have changed by more than 30% in the 3 months before screening
Your HbA1c (a blood test that measures your average blood sugar over the past 3 months) must be between 7.0% and 8.5% at screening
If you're a woman who can become pregnant, you must have a negative pregnancy test at the baseline visit
If you're a woman who can become pregnant, you must be willing to use an adequate contraception method throughout the study
You must be able to take oral medications (by mouth)
You must be willing and able to follow the study protocol

Who cannot join the trial?

10 criteria

You cannot participate if you are unable to give your informed consent
You cannot participate if you have a known allergy or sensitivity to the study drug
You cannot participate if you have a medical condition that makes you unfit for the study, as determined by the investigators
You cannot participate if you have severe kidney problems
You cannot participate if you have type 1 diabetes (the study is only for type 2 diabetes)
You cannot participate if you have diabetic ketoacidosis (a serious complication where your body produces high levels of blood acids)
You cannot participate if you have heart failure with severely reduced heart function
You cannot participate if you are pregnant, breastfeeding, or planning to become pregnant
You cannot participate if you are already taking similar medications to the study drug
You cannot participate if you have a history of not following medical advice or treatment plans

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Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Rome, Italy

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Investigated drugs

SGLT-2 inhibitors are medications used to treat type 2 diabetes. They work by preventing the kidneys from reabsorbing sugar back into the blood, which helps lower blood sugar levels. In this study, researchers are investigating whether these medications can also improve heart function by affecting the nervous system that controls the heart (autonomic nervous system) in people with type 2 diabetes.

What is already known about the treatment

SGLT-2 inhibitors - This class of medications is used for treating type 2 diabetes by preventing the kidneys from reabsorbing glucose back into the blood, allowing it to be excreted in urine and reducing blood sugar levels. SGLT-2 inhibitors have shown significant cardiovascular benefits beyond glucose control, including reduced risk of heart failure and cardiovascular death in patients with type 2 diabetes. These medications, typically taken as oral tablets once daily, work by blocking the sodium-glucose cotransporter-2 protein in the kidneys, which is responsible for glucose reabsorption. Recent clinical research suggests that SGLT-2 inhibitors may also improve cardiovascular autonomic neuropathy (CAN), a serious complication of diabetes that affects the nerves controlling heart function.

Investigated diseases

Type 2 diabetes mellitus
A chronic metabolic disorder characterized by high blood sugar levels due to insulin resistance and relative insulin deficiency. In this condition, cells do not respond properly to insulin, and the pancreas cannot produce enough insulin to overcome this resistance. The disease typically develops gradually, with symptoms including increased thirst, frequent urination, unexplained weight loss, fatigue, and blurred vision. Over time, type 2 diabetes can affect multiple body systems, potentially leading to complications in the cardiovascular, nervous, and renal systems. The condition is often associated with obesity, physical inactivity, and genetic factors.
Cardiac autonomic neuropathy (CAN)
A diabetic complication affecting the autonomic nerve fibers that innervate the heart and blood vessels. It results in abnormalities in heart rate control and vascular dynamics. CAN progresses silently over years and may initially manifest as reduced heart rate variability. As the condition advances, patients may experience resting tachycardia, exercise intolerance, orthostatic hypotension, and silent myocardial ischemia. CAN represents a significant cause of morbidity in diabetic patients and often coexists with peripheral neuropathy.