Study on the Effects of Switching from Daily Basal Insulin to Weekly Insulin Icodec Compared to Daily Insulin Glargine in Adults with Type 2 Diabetes

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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 does not use insulin properly, leading to high blood sugar levels. The study will compare a new weekly insulin called insulin icodec with a commonly used daily insulin known as insulin glargine. Insulin icodec is administered once a week using a special pen-injector, while insulin glargine is given daily through a pre-filled pen.

The purpose of the study is to see how well the new weekly insulin helps in controlling blood sugar levels compared to the daily insulin. Participants in the study will switch from their current daily insulin to either the weekly insulin icodec or continue with the daily insulin glargine. The study will last for 26 weeks, during which participants will receive regular injections and have their blood sugar levels monitored.

Throughout the study, researchers will observe changes in blood sugar control, as well as any side effects or safety concerns. The goal is to determine if the weekly insulin is as effective as the daily insulin in managing blood sugar levels in adults with Type 2 Diabetes. Participants will also be asked about their satisfaction with the treatment to understand how the new insulin fits into their daily lives.

1 joining the study

Upon joining the study, the participant will be assessed to ensure they meet the inclusion criteria. This includes having been diagnosed with Type 2 Diabetes for at least 180 days, having an HbA1c level between 7.0% and 10.0%, and having been treated with basal insulin for at least 90 days prior to the study.

2 initial assessment

An initial assessment will be conducted to establish baseline measurements. This includes measuring HbA1c levels, body weight, and other relevant health indicators.

3 treatment phase

Participants will be randomly assigned to receive either insulin icodec or insulin glargine. Insulin icodec is administered once weekly at a concentration of 700 U/mL, while insulin glargine is administered once daily at a concentration of 100 units/mL.

The treatment phase will last for 26 weeks. During this time, participants will continue their usual non-insulin anti-diabetic medications, if applicable.

4 monitoring and follow-up

Participants will attend regular follow-up visits to monitor their health and the effectiveness of the treatment. This includes measuring changes in HbA1c levels, time spent in target blood sugar range, and any hypoglycemic episodes.

Participants will also complete the Diabetes Treatment Satisfaction Questionnaire to assess their satisfaction with the treatment.

5 end of study assessment

At the end of the 26-week treatment period, a final assessment will be conducted. This will include measuring changes in HbA1c levels, body weight, and other health indicators compared to baseline measurements.

Who Can Join the Study?

Must have been diagnosed with Type 2 Diabetes at least 180 days before the screening day.
Must have an HbA1c level between 7.0% and 10.0% at screening. HbA1c is a blood test that shows your average blood sugar levels over the past 2 to 3 months.
Must have been treated with once-daily or twice-daily basal insulin for at least 90 days before screening. Basal insulin is a type of insulin that helps control blood sugar levels throughout the day and night.
Can be taking other anti-diabetic medications, such as metformin or sulfonylureas, as long as the doses have been stable for at least 90 days before screening.
Must 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.
Both males and females are eligible to participate.

Who Cannot Join the Study?

Patients who have a different type of diabetes other than Type 2 Diabetes cannot participate.
Patients who are not currently using a daily basal insulin are excluded. Basal insulin is a type of insulin that helps control blood sugar levels throughout the day and night.
Patients who are not within the specified age range for the study cannot participate. The age range is typically defined by the study but is not specified here.
Patients who are part of a vulnerable population, which may include groups like pregnant women or those with certain health conditions, are excluded.
Patients who are not able to switch from their current insulin to the study insulin as required by the trial cannot participate.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

Site Name	City	Country	Status
Niepublicznego Zakladu Opieki Zdrowotnej Specjalistyczny Osrodek Internistyczno Diabetologiczny	Bialystok	Poland

Other Sites

Site Name	City	Country
Hospital Universitario Basurto	Bilbao	Spain
Medcenter Nova Clinic Ltd.	Varna	Bulgaria
InnoDiab Forschung GmbH	Essen	Germany
R.E.D. Institut fuer medizinische Studien und Fortbildung GmbH	Oldenburg In Holstein	Germany
Medical Institute Ministry Of Interior	Sofia	Bulgaria
Multiprofile Hospital For Active Treatment Knyaginya Klementina Sofia EAD	Sofia	Bulgaria
Diagnostic-consultative center “Aleksandrovska” EOOD	Sofia	Bulgaria
Hospital Clinic De Barcelona	Barcelona	Spain
Hospital Universitario Quironsalud Madrid	Pozuelo De Alarcon	Spain
Pratia S.A.	Skorzewo	Poland
Uniwersytecki Szpital Kliniczny W Opolu	Opole	Poland
Medical Center Viva Phoenix OOD	Dobrich	Bulgaria
Institut fuer Diabetesforschung Muenster GmbH	Munster	Germany
Hospital Universitario Virgen De La Victoria	Malaga	Spain
Zentrum für klinische Forschung Allgäu Oberschwaben	Wangen	Germany
Schwerpunktpraxis für Diabetes und Ernährungsmedizin	Munster	Germany
Ttulfzig Sgw z oayt	Piotrkow Trybunalski	Poland
Isbgsjka fli Dnfqpahejqheqhkrh Oekfckamb	Osnabrück	Germany
Paqjsrpoi Swhmalwsj I Szuflds Shfc	Barcelona	Spain
Msqwgum Crbcpv Bgmxggcu Ldkj	Yambol	Bulgaria
Pjgdxuqds Idzqjhiq Mdcgjdst Mbagyaqgzjfv Sofly Wrmycxocnkda I Axbmbepgevwhq	Warsaw	Poland
Nlmg Vsfi Dqkmzubwi Mibclkmunh Bkatyqqj	Bialystok	Poland

Trial status

Country	Status	Recruitment Start
Bulgaria	Not recruiting	19.04.2024
Germany	Not recruiting	19.04.2024
Poland	Not recruiting	19.04.2024
Spain	Not recruiting	19.04.2024

Trial locations

Investigated drugs:

Insulin Icodec is a new type of insulin that is taken once a week. It is being studied to see how well it controls blood sugar levels in people with type 2 diabetes who are switching from their daily insulin. The goal is to find out if it works as well as other daily insulin treatments.

Insulin Glargine U100 is a long-acting insulin that is taken once a day. It is used to help control blood sugar levels in people with type 2 diabetes. In this study, it is being compared to the new once-weekly insulin to see if the new treatment is just as effective.

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, affecting the heart, kidneys, nerves, and eyes. The disease often develops slowly, and individuals may not notice symptoms initially. Common symptoms include increased thirst, frequent urination, hunger, fatigue, and blurred vision. Lifestyle factors such as obesity and inactivity are significant contributors to the development of type 2 diabetes.

Trial ID:

2023-506084-34-00

Protocol code:

NN1436-7724

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on the Effects of Switching from Daily Basal Insulin to Weekly Insulin Icodec Compared to Daily Insulin Glargine in Adults with Type 2 Diabetes

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?