Not recruiting

Study comparing semaglutide with insulin glargine in overweight adults with type 2 diabetes: effectiveness of combined treatment versus insulin alone

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 focuses on people with Type 2 Diabetes who are overweight and currently using insulin. The study examines the effectiveness of combining two medications: semaglutide (Ozempic) and a reduced dose of insulin glargine (Lantus), compared to using a higher dose of insulin glargine alone.

The trial investigates whether using semaglutide along with a lower dose of insulin can control blood sugar levels just as effectively as using a higher dose of insulin by itself. Both medications are given through subcutaneous injection (under the skin) using pre-filled injection pens. The semaglutide is given once weekly, while insulin glargine is administered once daily.

The study lasts for 40 weeks and involves measuring changes in HbA1c (a measure of average blood sugar levels over the past 2-3 months). Participants will receive either a combination of semaglutide with reduced insulin glargine or insulin glargine alone. The study also looks at changes in body weight and how satisfied participants are with their treatment.

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
Initial treatment period
You will be assigned to one of two treatment groups. Both groups will receive insulin glargine (Lantus SoloStar) through under-skin injection.
If you're in the first group, you will receive a reduced dose of insulin glargine along with semaglutide (Ozempic) 2 mg once weekly through under-skin injection.
If you're in the second group, you will receive only insulin glargine at an adjusted dose through under-skin injection.
Step 2
Treatment duration
The treatment period will last for 40 weeks.
During this time, you will need to continue taking your regular diabetes medication (metformin, with or without SGLT-2 inhibitors).
Step 3
Measurements and monitoring
Your blood sugar control (HbA1c) will be measured at the start of the study and after 40 weeks.
Your body weight will be monitored throughout the study.
The amount of insulin you use daily will be tracked.
You will complete a questionnaire about your satisfaction with the diabetes treatment at week 40.
Step 4
Study completion
The study is expected to end in July 2025.
At the end of the study, your blood sugar control, weight changes, and insulin use will be evaluated.
You will provide feedback about your treatment experience through a satisfaction questionnaire.

Who can join the trial?

10 criteria

Must be diagnosed with type 2 diabetes for at least 180 days before screening
Must have a HbA1c level (a measure of average blood sugar over the past 2-3 months) between 7% and 10% at screening
Must have a Body Mass Index (BMI) of 25 or higher at screening (BMI is a measure of body fat based on height and weight)
Must be taking stable doses of diabetes medications for at least 90 days before screening, including either:
- Metformin at least 1500 mg daily or highest tolerated dose
- Metformin combination medications at least 1500 mg daily or highest tolerated dose
- Must be using a once-daily long-acting insulin at a dose of 40 units or less per day for at least 90 days before screening
- Can be either male or female
- Must be an adult (18 years or older)
- Can be taking SGLT-2 inhibitors (a type of diabetes medication) along with other treatments
- May have received short-term rapid-acting insulin treatment for up to 14 days before screening

Who cannot join the trial?

14 criteria

Known or suspected hypersensitivity to semaglutide or any of its components
History of diabetic ketoacidosis (a serious complication of diabetes where the body produces high levels of blood acids)
History of pancreatitis (inflammation of the pancreas)
Personal or family history of medullary thyroid carcinoma (a type of thyroid cancer)
Current treatment with other GLP-1 receptor agonists (diabetes medications similar to semaglutide)
Pregnancy or breastfeeding
Severe kidney or liver disease
History of gastroparesis (delayed stomach emptying)
Any serious medical condition that could interfere with study participation
Current participation in other clinical trials
History of alcohol or drug abuse within the past 12 months
Mental condition that could interfere with study compliance
Use of weight loss medications within 90 days before study entry
Major surgery planned during the study period

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Verified sites

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

Alexandra Hospital
Verified
Athens, Greece
Azienda Ospedaliera Papa Giovanni XXIII
Verified
Bergamo, Italy
Unidade Local De Saude De Lisboa Ocidental E.P.E.
Responsive
Carnaxide, Portugal

Trial locations

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Investigated drugs

Semaglutide
is a medication used to treat type 2 diabetes and help with weight management. It's taken as an injection under the skin once a week. This medication works by helping control blood sugar levels and can help reduce appetite and body weight.
Insulin glargine
is a long-acting insulin that is injected under the skin. It works by helping to control blood sugar levels throughout the day and night. It's designed to work slowly to provide day-long blood sugar control for people with diabetes.

What is already known about the treatment

Semaglutide
A once-weekly injectable medication used for treating type 2 diabetes and managing weight in overweight patients, administered subcutaneously (under the skin). This GLP-1 receptor agonist works by mimicking a natural hormone that helps regulate blood sugar levels, reduces appetite, and slows down digestion, making it effective for both blood glucose control and weight management. The medication is classified as an incretin mimetic and has shown significant effectiveness in clinical trials when used in combination with insulin therapy, particularly with insulin glargine.
Insulin glargine
A long-acting synthetic insulin administered once daily via subcutaneous injection, designed to provide steady blood sugar control over 24 hours. This basal insulin analog works by slowly releasing insulin into the bloodstream, helping maintain consistent glucose levels throughout the day and night, making it particularly useful for managing type 2 diabetes. As a modified form of human insulin, it belongs to the class of long-acting insulin analogs and is commonly used as a foundation therapy in diabetes treatment, either alone or in combination with other diabetes medications.

Investigated diseases

Type 2 Diabetes (T2D)
A chronic metabolic disorder characterized by high blood sugar levels due to the body's ineffective use of insulin or reduced insulin production. The condition typically develops gradually, often in adults, and is strongly associated with lifestyle factors and genetic predisposition. The body either becomes resistant to insulin or doesn't produce enough insulin to maintain normal glucose levels. Over time, this leads to various metabolic changes and can affect how the body processes carbohydrates, fats, and proteins. The disease usually progresses slowly, and symptoms may include increased thirst, frequent urination, fatigue, and blurred vision.
Overweight
A condition where a person's body weight is higher than what is considered healthy for their height, typically measured by body mass index (BMI) between 25 and 29.9. It occurs when the body accumulates excess fat due to an imbalance between calorie intake and energy expenditure. The condition can develop gradually over time and is influenced by various factors including diet, physical activity levels, genetics, and metabolism. This condition often coexists with other metabolic disorders and can affect overall health status.