Study comparing cagrilintide and semaglutide versus tirzepatide in people with type 2 diabetes taking metformin or SGLT2 inhibitor

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What is this study about?

This study is looking at type 2 diabetes, a condition where the body does not properly control blood sugar levels. The study will test a combination medication called cagrilintide semaglutide, which contains two active substances that work together to help lower blood sugar and reduce body weight. This medication will be compared to another diabetes medicine called tirzepatide, which is available under the brand name Mounjaro. Both medications are given as injections under the skin once a week. The study will include people with type 2 diabetes who are already taking metformin, an SGLT2 inhibitor, or both of these medications, but whose blood sugar levels are not well controlled with these treatments alone.

The purpose of the study is to find out if cagrilintide semaglutide is at least as good as tirzepatide at lowering blood sugar levels, and whether it might be better at helping people lose weight. The study will also look at other health measures such as blood pressure, waist size, cholesterol levels, and overall quality of life. Additionally, the study will check how safe these medications are and what side effects people may experience while taking them.

People taking part in this study will receive either cagrilintide semaglutide or tirzepatide for 60 weeks. During this time, they will continue taking their current diabetes medications. Throughout the study, participants will have regular visits where their blood sugar levels, body weight, blood pressure, and other health measurements will be checked. Blood tests will be done to measure a substance called HbA1c, which shows average blood sugar levels over the past few months, as well as cholesterol and other blood fats. Participants will also be asked to complete questionnaires about their physical health and quality of life. The study team will monitor for any side effects, including episodes of low blood sugar, which can happen when blood sugar drops too much.

1 Starting treatment

At the beginning of the trial (week 0), baseline measurements will be taken. These include HbA1c (a measure of average blood sugar levels over the past 2-3 months), body weight, blood pressure (both systolic and diastolic), waist circumference, and blood lipid levels (cholesterol and triglycerides).

Quality of life questionnaires will also be completed at this point.

The trial medication will be assigned. This will be either CagriSema (a combination of cagrilintide and semaglutide at 1.0 mg/1.0 mg) or tirzepatide (starting at 5 mg).

All medications are administered as an injection under the skin (subcutaneous injection) once weekly.

Current diabetes medication (metformin, SGLT2 inhibitor, or both) will be continued at the same stable dose throughout the trial.

2 Treatment period

The treatment period lasts 60 weeks in total.

Throughout this period, weekly injections of the assigned medication will be self-administered under the skin.

Regular monitoring visits will occur to assess blood sugar control, body weight, blood pressure, and other health parameters.

Blood samples will be taken periodically to measure fasting plasma glucose (blood sugar level after not eating overnight) and other laboratory values.

Any side effects or health changes will be recorded during scheduled visits.

3 End of treatment assessment

At week 60, the final treatment assessments will be performed.

Measurements will include HbA1c, body weight, blood pressure, waist circumference, and blood lipid levels.

Blood sugar targets will be evaluated, including whether HbA1c has reached levels of 6.5% or below, or below 7.0%.

Weight loss will be assessed to determine if there has been a reduction of 5%, 10%, 15%, or 20% or more from the starting weight.

Quality of life questionnaires will be completed again to compare with baseline scores.

The number and type of any adverse events, including episodes of low blood sugar (hypoglycemia), will be reviewed.

Who Can Join the Study?

  • You can be male or female.
  • You must be 18 years old or older when you sign the consent form to join the study.
  • You must have been diagnosed with type 2 diabetes at least 180 days (about 6 months) before the screening visit. Type 2 diabetes is a condition where your body does not use insulin properly, causing high blood sugar levels.
  • Your HbA1c level must be between 7.0% and 10.5% at the screening visit. HbA1c is a blood test that shows your average blood sugar level over the past 2 to 3 months.
  • Your BMI must be 30 or higher at the screening visit. BMI stands for body mass index, which is a measure that uses your height and weight to estimate body fat.
  • You must have been taking a stable daily dose of diabetes medication for at least 90 days (about 3 months) before the screening visit. This medication must be either metformin, an SGLT2 inhibitor, or both. Metformin is a common diabetes medicine that helps lower blood sugar. SGLT2 inhibitors are medications that help your kidneys remove sugar from your body through urine.
  • The dose of your diabetes medication must be at an effective level or the maximum amount you can tolerate, as determined by your doctor.

Who Cannot Join the Study?

  • The study does not list specific exclusion criteria in the provided information, which means detailed reasons why patients cannot participate are not available in this document
  • Generally, clinical trials may exclude patients who do not meet certain health or medical requirements, but these specific details would need to be obtained from the complete study documentation
  • Patients should discuss with their doctor whether they are suitable candidates for this study based on their individual medical history and current health condition

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
Central Hospital Of Northern Pest Military Hospital Budapest Hungary
Herz Und Diabeteszentrum NRW Bad Oeynhausen Universitaetsklinik Der Ruhr-Universitaet Bochum Bad Oeynhausen Germany
Nutrilife S.R.L. Bucharest Romania
Clinica Korall S.R.L. Satu Mare Romania
Mediab S.R.L. Targu Mures Romania
Qualiclinic Kft. Budapest Hungary
Ippokratio General Hospital Of Thessaloniki Thessaloniki Greece
Centrum Medyczne Oporow Wroclaw Poland
Hospital Clinico Universitario De Valladolid Valladolid Spain
Komaromi Selye Janos Korhaz Komarom Hungary
Etyka Osrodek Badan Klinicznych Tomasz Pesta S.K.A. Olsztyn Poland
Diabdana S.R.L. Oradea Romania
General Hospital Of Thessloniki G Gennimatas Thessaloniki Greece
Obudai Egeszseguegyi Centrum Kft. Dunaújváros Hungary
Evangelismos S.A. Athens Greece
University General Hospital Of Ioannina Ioannina Greece
Uniwersytecki Szpital Kliniczny W Bialymstoku Bialystok Poland
Alexandra Hospital Athens Greece
Semmelweis University Budapest Hungary
Medical Center – University Of Freiburg Freiburg Im Breisgau Germany
University Of Szeged Szeged Hungary
ClinDiab Kft. Budapest Hungary
Med-Tima Kft. Budapest Hungary
PVN Kutato Kft. Budapest Hungary
Zentrum für klinische Forschung Allgäu Oberschwaben Wangen Germany
Schwerpunktpraxis für Diabetes und Ernährungsmedizin Munster Germany
Medicover Neuroendokrinologie MVZ Munich Germany
Kiepury Clinic MALGORZATA JARNOT Specjalistyczna Praktyka Ginekologiczno-Poloznicza Sosnowiec Poland
Cabinet Medical Individual Diabet, Nutritie, Boli Metabolice Dr. Pop Lavinia Baia Mare Romania
Ufpdfbitbsvdgpabnwkjk Elrrr Aqk Essen Germany
Sjvqsxqjixq Ptfogppyv Swgjssk Knnrclxsf Ns 1 Iouyqcwhfvwtqksqvl Sfxmsvb Skpdhydib Ugkitpabthvz Mtalagzpjs W Kfhbjghwop Zabrze Poland
Swisr Dgbst Esihtguoaejw Soqhgnlzssf Kyql Budapest Hungary
Sjlrewdadsfihca Gpwjmia Ditgmuvrdztqvrz Rzoeczxg Rkrrmsbaiac Gorzów Wielkopolski Poland
Dfidea Mbo Smlniy Bucharest Romania
Lwmyh Gqupslw Helgfczc Oq Aysxpm Athens Greece
Afrsho Mosanom Caxjjs Saoq Thessaloniki Greece
Hsbrbksj Vtqf dukirbzs Barcelona Spain
Sotcokv Hfnkattg Szyrfp Bucharest Romania

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

Trial status

Country Status Recruitment Start
Germany Germany
Not recruiting
20.08.2024
Greece Greece
Not recruiting
20.08.2024
Hungary Hungary
Not recruiting
20.08.2024
Poland Poland
Not recruiting
20.08.2024
Romania Romania
Recruiting
20.08.2024
Spain Spain
Recruiting
20.08.2024

Trial locations

CagriSema is a combination medication that contains two medicines given together: cagrilintide and semaglutide. This treatment is given as an injection under the skin once a week. It is being tested to help people with type 2 diabetes better control their blood sugar levels and lose weight. The medication works by helping your body manage blood sugar and reducing appetite.

Tirzepatide is a medication given as an injection under the skin once a week. It is used to help people with type 2 diabetes control their blood sugar levels and can also help with weight loss. This medication works by helping your body release insulin when blood sugar is high and by reducing your appetite.

Metformin is a pill taken by mouth that is commonly used to treat type 2 diabetes. It helps lower blood sugar levels by reducing the amount of sugar your liver makes and helping your body use insulin better. Some people in this study may already be taking this medication before joining the trial.

SGLT2 inhibitor is a type of medication taken by mouth that helps lower blood sugar in people with type 2 diabetes. It works by helping your kidneys remove extra sugar from your body through urine. Some people in this study may already be taking this type of medication before joining the trial.

Investigated diseases:

Type 2 Diabetes – Type 2 diabetes is a chronic condition that affects the way the body processes blood sugar, also known as glucose. In this disease, the body either resists the effects of insulin, a hormone that regulates the movement of sugar into cells, or does not produce enough insulin to maintain normal glucose levels. Over time, high blood sugar levels can develop and persist in the bloodstream. The condition typically develops gradually, often beginning with a state called prediabetes where blood sugar levels are elevated but not yet high enough to be classified as diabetes. As the disease progresses, the body’s ability to control blood sugar becomes increasingly impaired. This leads to elevated levels of a marker called HbA1c, which reflects average blood sugar levels over several months.

Trial ID:
2023-509600-15-00
Protocol code:
NN9388-7741
Trial Phase:
Therapeutic confirmatory (Phase III)

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