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

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What is this study about?

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.

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.

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).

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.

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 Study?

  • 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 Study?

  • 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

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Other Sites

Site Name City Country Status
ResTrial s.r.o. Prague Czechia
Hospital Santa Maria Della Misericordia Perugia Italy
Euromedica General Clinic Of Thessaloniki Thessaloniki Greece
Geniko Nosokomeio Thessalonikis George Papanikolaou Thessaloniki Greece
Clinica Korall S.R.L. Satu Mare Romania
Hospital Universitario Infanta Leonor Madrid Spain
CCAB Centro Clinico Academico Braga Associacao Braga Portugal
Unidade Local De Saude De Matosinhos E.P.E. Senhora Da Hora Portugal
Edumed s.r.o. Nachod Czechia
Medispektrum s.r.o. Petrzalka Slovakia
Diabet2 s.r.o. Prague Czechia
Consultmed S.R.L. Iasi Romania
MuDr. Jitka Zemanova Diabetologie A Interna s.r.o. Plzen 2-Slovany Czechia
Grandmed S.R.L. Oradea Romania
Spitalul Clinic Judetean De Urgenta Sf. Apostol Andrei Galati Galati Romania
Thermi Clinic S.A. Thessaloniki Greece
Ospedale Santa Maria Goretti Latina Latina Italy
MediTask s.r.o. Bratislava Slovakia
Universita Degli Studi Di Brescia Brescia Italy
University General Hospital Of Thessaloniki Ahepa Thessaloniki Greece
Ospedale San Raffaele S.r.l. Milan Italy
Alexandra Hospital Athens Greece
Spitalul Clinic Judetean De Urgenta Sfantul Apostol Andrei Constanta Constanta Romania
University General Hospital Of Alexandroupoli Alexandroupoli Greece
Centro Hospitalar Do Baixo Vouga E.P.E. (CHBV E.P.E.) Aveiro Portugal
Geniko Nosokomeio Peiraia Tzaneio Piraeus Greece
Servei De Salut De Les Illes Balears Palma Spain
Unidade Local De Saude Do Alto Minho E.P.E. Ponte De Lima Portugal
DIAB s.r.o. Roznava Slovakia
MUDr. Michala Pelikanova s.r.o. Prague Czechia
Diahelp s.r.o. Pardubice Czechia
Dwbvhkaicbqlzd Slpect Targu Mures Romania
Cjtclqp Mevmzxd Dh Dopiiiayau Sy Ttigljkzf Aomjjptje Nckabj Shcwws Brasov Romania
Dxeiurgleypcdjyayil Scptpk Bucharest Romania
Cvokxag Mwhhhsl Scu Szmeae Sxjsky Timisoara Romania
Nuiux Mcvekts Ctwsabp Sximhu Ploiesti Romania
Spjgoqrr Jlazewnr dh Uekytjh Tadhhjmnpr Targoviste Romania
Mwunhsm Pwbnsryc Stxyod Oradea Romania
Pmusqcpkb Slniarzkk I Shuxmbl Sari Barcelona Spain
Dnovtfknyv smrthl Bojnice Slovakia
Buzvnb smtzce Sturovo Slovakia
Dzjryw sgmha s rgck Poprad Slovakia
Lssmd Gkpzkew Hgxwsgce Oc Afzuai Athens Greece
Acygtgb Uez Tlpxqhr npcu oahyl Leghorn Italy
Fnjklglqfn suzgx Nove Zamky Slovakia
Aqbjplz Oleohyaimgf Prqt Gozubiek Xwfoh Bergamo Italy
Uzgjnkavsf Mmtlp Gtgzgyd Os Czfijiits Catanzaro Italy
Uafzbautxf Gqtqrpn Hdqynyga Asxlgzv Athens Greece

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Czechia Czechia
Not recruiting
01.09.2022
Greece Greece
Not recruiting
01.09.2022
Italy Italy
Not recruiting
01.09.2022
Portugal Portugal
Not recruiting
01.09.2022
Romania Romania
Not recruiting
01.09.2022
Slovakia Slovakia
Not recruiting
01.09.2022
Spain Spain
Not recruiting
01.09.2022

Trial locations

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.

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.

Trial ID:
2024-510612-75-00
Protocol code:
NN9535-4801
Trial Phase:
Therapeutic confirmatory (Phase III)

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