Study on the Effectiveness of Weekly IcoSema (Insulin Icodec and Semaglutide) vs. Daily Insulin Glargine for Adults with Type 2 Diabetes Not Controlled by Oral Drugs

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What is this study about?

This clinical trial is focused on studying the effects of a new treatment for type 2 diabetes, a condition where the body struggles to regulate blood sugar levels effectively. The study will compare a new weekly medication called IcoSema, which combines two substances, insulin icodec and semaglutide, with a daily medication known as insulin glargine. Participants in the study will have their blood sugar levels monitored to see how well these treatments work in controlling their diabetes.

The purpose of the study is to determine if the weekly IcoSema is more effective than the daily insulin glargine in managing blood sugar levels in people with type 2 diabetes who are not adequately controlled with oral anti-diabetic drugs. The study will last for 40 weeks, during which participants will receive either the weekly or daily treatment. Throughout the study, participants will continue their usual oral diabetes medications, which may include drugs like metformin, pioglitazone, dapagliflozin, and others, unless specified otherwise by the study protocol.

Participants will be monitored for changes in their blood sugar levels, body weight, and overall satisfaction with their diabetes treatment. The study will also track the occurrence of any low blood sugar episodes, known as hypoglycemia, and other health indicators. This research aims to provide valuable insights into the effectiveness and safety of the new weekly treatment option for managing type 2 diabetes.

1 joining the study

Upon joining the study, informed consent is required. This means agreeing to participate after understanding the study’s purpose and procedures.

Eligibility is confirmed based on criteria such as age, type 2 diabetes diagnosis, and current treatment with oral anti-diabetic drugs (OADs).

2 baseline assessment

Initial health assessments are conducted to establish baseline measurements. This includes checking blood sugar levels (HbA1c) and body weight.

Participants must have an HbA1c level of 8.0% or higher to qualify.

3 randomization and treatment allocation

Participants are randomly assigned to one of two treatment groups: once weekly IcoSema or daily insulin glargine.

IcoSema is a combination of insulin icodec and semaglutide, administered subcutaneously once a week.

Insulin glargine is administered subcutaneously daily using a pre-filled pen.

4 treatment period

The treatment period lasts for 40 weeks. Participants continue their assigned treatment while maintaining their current OADs, unless otherwise instructed.

Regular monitoring of blood sugar levels and body weight is conducted throughout the study.

5 continuous glucose monitoring

From week 36 to week 40, participants use a continuous glucose monitoring (CGM) system to track blood sugar levels.

The CGM system helps assess the time spent within target blood sugar ranges.

6 final assessments

At the end of the 40-week period, final assessments are conducted to measure changes in blood sugar levels (HbA1c) and body weight.

Participants complete a questionnaire to evaluate their satisfaction with the diabetes treatment.

7 follow-up

A follow-up period extends to week 45 to monitor any hypoglycemic episodes and ensure participant safety.

Participants continue to report any significant changes in their health status.

Who Can Join the Study?

Provide informed consent before any study-related activities. This means you agree to participate after understanding the study details.
Can be either male or female.
Must be at least 18 years old at the time of signing the informed consent.
Have been diagnosed with type 2 diabetes for at least 180 days before the screening.
Have an HbA1c level of 8.0% or higher. HbA1c is a blood test that shows your average blood sugar level over the past 2 to 3 months.
Have not used insulin before, except for short-term use (up to 14 days) or for gestational diabetes (diabetes during pregnancy).
Currently taking 1 to 3 oral anti-diabetic drugs (OADs) with stable doses for at least 90 days before screening. These drugs can include Metformin, Sulfonylureas, Meglitinides, DPP 4 inhibitors, Sodium glucose co-transporter 2 inhibitors, Alpha glucosidase inhibitors, Thiazolidinediones, or certain combination products.
Have a body mass index (BMI) of 40.0 kg/m² or less. BMI is a measure of body fat based on height and weight.

Who Cannot Join the Study?

Patients who do not have Type 2 diabetes cannot participate. Type 2 diabetes is a condition where the body does not use insulin properly, leading to high blood sugar levels.
Patients who are not in the specified age range cannot participate. The age range includes adults and older adults.
Patients who are not male or female cannot participate.
Patients who are not considered part of a vulnerable population cannot participate. A vulnerable population includes groups that may need special protection or care.
Patients who are not inadequately controlled with OADs cannot participate. OADs are oral anti-diabetic drugs, which are pills taken to help control blood sugar levels.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
ClinHouse Centrum Medyczne	Zabrze	Poland
GABINET LEKARSKI MALGORZATA SARYUSZ-WOLSKA	Lodz	Poland
NBR Polska Tomasz Klodawski	Warsaw	Poland
General Hospital Of Messinia	Kalamata	Greece
Centrum Terapii Wspolczesnej J.M. Jasnorzewska S.K.A.	Lodz	Poland
Legeartis Poradnie Specjalistyczne Sp. z o.o.	Bialystok	Poland
Niepublicznego Zakladu Opieki Zdrowotnej Specjalistyczny Osrodek Internistyczno Diabetologiczny	Bialystok	Poland
Casa della Salute	Ceccano	Italy

Other Sites

Site Name	City	Country
Evangelismos S.A.	Athens	Greece
General University Hospital Of Larissa	Larissa	Greece
ASST Grande Ospedale Metropolitano Niguarda	Milan	Italy
Centrum Medyczne All-Med Badania Kliniczne	Cracow	Poland
Ko-Med Centra Kliniczne Sp. z o.o.	Zamosc	Poland
Casa Sollievo Della Sofferenza	San Giovanni Rotondo	Italy
Hospital Santa Maria Della Misericordia	Perugia	Italy
Thermi Clinic S.A.	Thessaloniki	Greece
Azienda Sociosanitaria Ligure N 4 Sistema Sanitario Regione Liguria	Chiavari	Italy
Pohalwyfg Iifiqyya Mrrpqlay Mneezsntijrt Srznk Wavzbdybtzaw I Amifzqsoswvfy	Warsaw	Poland
Ijqgcbaxkr Izuqxkww Nyormpjpe Dk Rgxnak E Cymg Pby Gnv Aalfjkw	Ancona	Italy
Lsscp Gsfpabh Hcpuppun Og Ahqzqn	Athens	Greece
Uyehfqcewmgyhx Cvcpkzc Kjablkzra	Gdansk	Poland
Uqjqnskxmc Dsyiw Skbwh Df Rvgs Lc Sepjjqwo	Rome	Italy
Asyhazc Saxjtdpim Lwelng Adrpzorm Sduoalz Lybwbzbhagtmrf	L'aquila	Italy

Trial status

Country	Status	Recruitment Start
Greece	Not recruiting	15.02.2024
Italy	Not recruiting	15.02.2024
Poland	Not recruiting	15.02.2024

Trial locations

Investigated drugs:

IcoSema is a medication being tested in this study. It is given once a week to help control blood sugar levels in people with type 2 diabetes who are not managing well with their current oral diabetes medications. The goal is to see if IcoSema can better control blood sugar compared to another treatment.

Insulin Glargine is a long-acting insulin used daily to help manage blood sugar levels in people with type 2 diabetes. In this study, it is being compared to IcoSema to see which one is more effective in controlling blood sugar when oral diabetes medications are not enough.

Type 2 Diabetes – This is a chronic condition that affects the way the body processes blood sugar (glucose). In type 2 diabetes, the body either resists the effects of insulin, a hormone that regulates the movement of sugar into cells, or doesn’t produce enough insulin to maintain normal glucose levels. Over time, high blood sugar levels can lead to various complications, including damage to the eyes, kidneys, and nerves. The disease often develops slowly, and individuals may not notice symptoms initially. Common symptoms include increased thirst, frequent urination, hunger, fatigue, and blurred vision. As the condition progresses, it may require lifestyle changes and medication to manage blood sugar levels effectively.

Trial ID:

2022-502484-38-00

Protocol code:

NN1535-4988

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on the Effectiveness of Weekly IcoSema (Insulin Icodec and Semaglutide) vs. Daily Insulin Glargine for Adults with Type 2 Diabetes Not Controlled by Oral Drugs

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?