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A Phase III Randomized Double‑Blind Study of Elecoglipron for Adults with Type 2 Diabetes on Insulin

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What is this trial about?

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

The study looks at adults who have type 2 diabetes mellitus and are already using insulin to control their blood sugar. The medication being tested is called elecoglipron, which is taken as a small tablet taken by mouth. The main goal of the study is to find out whether elecoglipron can improve blood sugar control compared with a harmless pill called placebo.

Participants will be randomly assigned to receive either elecoglipron at one of two dose levels or the placebo, while continuing their usual insulin therapy. Over about 40 weeks, they will visit the clinic several times for simple blood tests, including a test called HbA1c that shows the average blood sugar level over the past few months. The study will also check changes in body weight and blood pressure, but no detailed procedures are described here.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Randomization
After you join the study you will be assigned by a computer to receive either elecoglipron tablets or a placebo tablet. the assignment is double‑blind, so you will not know which one you receive.
Step 2
Baseline assessments
Before starting the study medication you will have a series of measurements taken. these include a blood test for hbA1c (a measure of average blood sugar), body weight, and blood pressure. the results provide a starting point for later comparison.
Step 3
Start of study medication
You will begin taking one oral tablet each day. the tablet is a film‑coated tablet taken by mouth. the exact amount of elecoglipron or placebo is specified by the study and will be the same each day.
You will continue your regular insulin therapy as prescribed by your doctor while taking the study tablet.
Step 4
Regular follow‑up visits
Throughout the 40‑week treatment period you will attend scheduled clinic visits. during each visit the study staff will check your safety, record any side effects, and repeat measurements such as hbA1c, weight, and blood pressure.
The visits also allow the study team to give you any needed instructions and to collect the study tablets you have taken.
Step 5
Final assessment at week 40
At the end of week 40 you will have a final set of measurements. these include a blood test for hbA1c, a weight check, and a blood pressure reading. the results will be compared with the baseline values to evaluate the effect of the study medication.
Step 6
Completion of study medication
After the week 40 visit you will stop taking the study tablet. any further follow‑up will be according to the study protocol, but no additional study medication will be given.

Who can join the trial?

6 criteria

Diagnosed with type 2 diabetes (also called T2DM) at least 90 days before the screening visit.
Currently taking insulin and no more than two oral medicines that lower blood sugar (oral glucose‑lowering medications).
Recent lab test showing an HbA1c value of 7% or higher but not above 10.5% (HbA1c reflects average blood sugar over the past 2‑3 months).
Body mass index (BMI) of 23 kg/m² or higher at the screening visit (BMI is a calculation that relates weight to height).
Weight has been stable (no major gain or loss) for at least 90 days before screening, based on self‑report or medical records.
Both men and women are eligible to participate.

Who cannot join the trial?

7 criteria

People with type 1 diabetes (a condition where the body cannot make insulin), any other secondary or congenital forms of diabetes, or who have had a serious episode of ketoacidosis (dangerously high blood acids) or hyperosmolar coma (very high blood sugar leading to loss of consciousness) cannot join the study.
Anyone who is currently receiving or is expected to receive treatment for diabetic retinopathy (damage to the eye’s blood vessels caused by diabetes) or macular edema (swelling in the central part of the retina) cannot participate.
People who have had more than one serious episode of low blood sugar (severe hypoglycemia) in the past 180 days, or who cannot recognize or feel the symptoms of low blood sugar (hypoglycemia unawareness), are not eligible.
Those with a significant medical problem affecting the upper part of the digestive system (upper GI tract) or who regularly take medicines that change how the stomach moves food (gastric motility) or empties (gastric emptying) cannot join.
Anyone with a past history of pancreatitis (inflammation of the pancreas), whether recent (acute) or long‑term (chronic), is excluded.
People with very severe heart failure classified as NYHA IV (the most advanced stage, where symptoms occur even at rest) cannot take part.
Individuals who have had or have a family history of medullary thyroid cancer (a rare thyroid gland tumor) or multiple endocrine neoplasia type 2 (a genetic condition that can cause tumors in several glands) are not allowed to participate.

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Verified sites

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

CRS Clinical Research Services Mannheim GmbH
Verified
Mannheim, Germany
Donmed s.r.o.
Verified
Ostrava, Czechia
Herz Und Diabeteszentrum NRW Bad Oeynhausen Universitaetsklinik Der Ruhr-Universitaet Bochum
Responsive
Bad Oeynhausen, Germany

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Investigated drugs

Elecoglipron is an oral, film‑coated tablet taken by mouth. In this study it is being tested as an additional medicine for adults with type 2 diabetes who are already using insulin. The drug is intended to help lower blood‑sugar levels and improve overall glucose control when used together with insulin. Participants receive the tablet in a double‑blind fashion, meaning neither they nor the researchers know whether they are getting the active drug or a placebo, so the true effect of Elecoglipron on blood sugar can be measured safely.

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What is already known about the treatment

Elecoglipron - Elecoglipron is taken as a film‑coated tablet swallowed by mouth. It is an experimental drug that is currently in Phase III clinical trials and has not yet been approved for general medical use. It is being studied to help adults with type 2 diabetes improve blood‑sugar control while they are already using insulin. It works by activating the GLP‑1 receptor, which raises insulin release and reduces appetite, placing it in the class of GLP‑1 receptor agonists.

Investigated diseases

Type 2 diabetes mellitus - It is a chronic condition where the body does not use insulin properly, leading to high blood sugar. Over time, the pancreas may produce less insulin. Persistent high glucose can cause blood sugar levels to rise gradually. The disease often develops slowly and may become more difficult to control as it progresses. It can affect various organs as the condition continues.