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Randomized trial of elecoglipron with dapagliflozin versus placebo in adults with type 2 diabetes mellitus and impaired renal function

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What is this trial about?

A plain-language summary of the goals, design and what participants do

The study focuses on adults who have Type 2 diabetes mellitus and reduced kidney function. The condition means that the body has difficulty controlling blood sugar and the kidneys do not filter waste as well as they should. Participants will continue taking a daily tablet of dapagliflozin, a medicine that helps the kidneys remove extra sugar, and will be given either the experimental drug Elecoglipron at two different dose levels or a matching placebo. The purpose of the study is to determine whether adding Elecoglipron to dapagliflozin improves blood‑sugar control.

During the trial, each person will take the assigned tablets every day for about 40 weeks. Regular visits will include simple blood tests, such as the HbA1c test, which shows the average blood‑sugar level over the past few months, measurements of body weight, and checks of blood pressure. The schedule is designed to monitor how the medicines affect blood sugar, weight, and overall health while watching for any side effects.

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
Baseline assessment and start of medication
On the first day you join the study, a series of measurements are taken. these include blood tests to determine your current hbA1c level (a measure of average blood sugar over the past few months), fasting plasma glucose, body weight, and blood pressure. after these measurements, you begin taking the study medicines.
Step 2
Daily oral intake of dapagliflozin
You will take one dapagliflozin tablet each day. each tablet contains 10 mg of the active ingredient. the tablet is taken by mouth and can be taken with or without food. this medication is continued for the entire 40‑week study period.
Step 3
Daily oral intake of study medication (elecoglipron or placebo)
Each day you will also take one tablet that contains either elecoglipron (the investigational drug) or a matching placebo (a tablet with no active drug). the tablet is film‑coated and taken by mouth. the exact dose of elecoglipron is not disclosed in the study information, but the tablet is taken once daily for the full 40 weeks.
Step 4
Continue daily medication for 40 weeks
You will keep taking both the dapagliflozin tablet and the study tablet every day for a total of 40 weeks. missing doses may affect the study results, so it is important to follow the daily schedule.
Step 5
Regular study visits for safety and efficacy checks
Throughout the 40‑week period you will attend study visits where health professionals will repeat the measurements taken at baseline. these visits include checking your hbA1c, fasting plasma glucose, body weight, and blood pressure (both systolic and diastolic). the visits allow the study team to monitor how well the medication works and whether any side effects occur.
Step 6
Possible use of rescue medication
If your blood sugar becomes dangerously low (a condition called hypoglycemia, defined as glucose below 54 mg/dL) or if other problems arise, the study protocol allows the addition of a rescue medication. the time when rescue medication is started is recorded as part of the study data.
Step 7
Final evaluation at week 40
At the end of week 40 you will undergo a final set of assessments. these include the same blood tests and measurements as at baseline, allowing comparison of changes in hbA1c, fasting plasma glucose, body weight, and blood pressure. the results determine whether the investigational drug provided benefit compared with placebo.

Who can join the trial?

6 criteria

Be diagnosed with type 2 diabetes mellitus (a common type of diabetes) for at least 90 days before the screening visit.
Either be taking a medication called SGLT2i (a drug that helps the kidneys remove extra sugar) or not taking it, but you may use no more than one other medicine to lower blood sugar.
Your blood test called HbA1c (shows average blood sugar over the past 2‑3 months) must be between 7.0% and 10.5% (53‑91.3 mmol/mol) if you are on a stable dose of SGLT2i, or between 7.5% and 10.5% (58‑91.3 mmol/mol) if you have never taken SGLT2i.
Have some level of reduced renal function (the kidneys are the organs that filter waste from the blood).
Have a BMI (body mass index, a measure of weight compared to height) of 23 kg/m² or higher at the screening visit.
Maintain a stable body weight for the 90 days before screening, based on what you report or documented records.

Who cannot join the trial?

7 criteria

You must not have type 1 diabetes, any secondary forms of diabetes (including those you are born with), or a past episode of ketoacidosis (a dangerous buildup of acid from high blood sugar) or hyperosmolar coma (extremely high blood sugar leading to loss of consciousness).
You cannot be currently receiving or planning to receive treatment for diabetic retinopathy (eye damage caused by diabetes) or macular edema (swelling in the central part of the retina).
You must not have had more than one episode of severe hypoglycemia (very low blood sugar that needs help) in the past 180 days, and you should not have a history of hypoglycemia unawareness (not feeling the warning signs of low blood sugar) or trouble recognizing low‑sugar symptoms.
You cannot have a significant problem affecting the upper GI tract (the upper part of your digestive system such as the esophagus, stomach, or duodenum) or be using medicines on a long‑term basis that change gastric motility or gastric emptying (how the stomach moves and empties its contents).
You must not have a history of pancreatitis (inflammation of the pancreas), whether it was a sudden (acute) episode or a long‑lasting (chronic) condition.
You cannot have severe congestive heart failure classified as NYHA IV (the most serious level, where everyday activities cause significant shortness of breath or fatigue).
You must not have a personal or family history of medullary thyroid cancer (a specific type of thyroid gland cancer) or multiple endocrine neoplasia type 2 (a genetic condition that can cause tumors in several hormone‑producing glands).

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Verified sites

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

Herz Und Diabeteszentrum NRW Bad Oeynhausen Universitaetsklinik Der Ruhr-Universitaet Bochum
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Bad Oeynhausen, Germany
Klinikum Der Landeshauptstadt Stuttgart gKAöR
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Stuttgart, Germany
Region Midtjylland
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Aarhus, Denmark

Trial locations

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Investigated drugs

Elecoglipron
is the new medicine being tested in this study. Participants will take this drug to see if it can help lower blood sugar in adults with type 2 diabetes who also have reduced kidney function. The trial compares two different strengths of Elecoglipron with a placebo, while all participants also receive a standard diabetes medication. Researchers are looking at how well Elecoglipron works, whether it is safe, and how well patients can tolerate it.
Dapagliflozin
is a well‑known diabetes medicine that is already approved for use. In this trial, every participant continues to take dapagliflozin as part of their regular treatment. The study adds Elecoglipron on top of dapagliflozin to find out if the new drug can provide extra benefit in controlling blood sugar when used together with this established therapy.

What is already known about the treatment

Elecoglipron
This investigational drug is taken as a film‑coated tablet taken by mouth. It is currently being studied in clinical trials and is not yet approved for general medical use. The medication is aimed at treating type 2 diabetes, especially in people whose kidneys do not work well. It works by helping the body use insulin more effectively and by lowering the amount of sugar the liver releases, and it is classified as an oral glucose‑lowering agent under investigation.
Dapagliflozin (Forxiga)
Dapagliflozin is provided as a 10 mg film‑coated tablet for oral use. It is an approved medicine that is widely used and described in medical literature for the treatment of type 2 diabetes. The drug lowers blood sugar by blocking the SGLT2 protein in the kidneys, which allows excess glucose to be removed in the urine. It belongs to the pharmacological class of SGLT2 inhibitors, a type of oral antidiabetic agent.

Investigated diseases

Type 2 diabetes mellitus - a chronic condition where the body does not use insulin properly, leading to higher blood sugar levels. Over time, the pancreas may produce less insulin as it becomes exhausted. Persistent high sugar can cause the kidneys to filter more fluid, resulting in increased urination. Blood vessels may become less flexible, which can affect circulation. Nerves can be damaged, leading to tingling or loss of feeling in the feet and hands. The condition usually develops slowly and may worsen if blood sugar remains uncontrolled.