A study comparing cagrilintide and semaglutide combination to semaglutide, cagrilintide, and placebo in adults with type 2 diabetes on metformin

3 1 1

What is this study about?

This study is looking at people with type 2 diabetes whose blood sugar levels are not well controlled with their current medication. Type 2 diabetes is a condition where the body does not properly use insulin, a hormone that helps control blood sugar levels. The study will test different combinations and doses of medications given as injections under the skin. These medications include cagrilintide, semaglutide, a combination of both called CagriSema, and placebo. Some participants may also continue taking their regular diabetes medications, which could include metformin taken by mouth, with or without a type of medication called an SGLT2 inhibitor such as dapagliflozin.

The main goal of the study is to see how well CagriSema works at lowering blood sugar levels compared to semaglutide alone, as measured by a blood test called HbA1c that shows average blood sugar over several months. The study will also look at how these medications affect body weight, blood pressure, cholesterol levels, and other health measurements. Researchers want to understand if the combination medication works better than the individual medications at helping people reach target blood sugar levels and lose weight. The study will also measure how much time blood sugar levels stay within a healthy range using a continuous glucose monitor, which is a small device that tracks sugar levels throughout the day.

Participants will receive their assigned treatment for 68 weeks, with the entire study lasting about 75 weeks. During this time, they will have regular visits to check their blood sugar, weight, blood pressure, and overall health. The study will also ask participants questions about their quality of life and satisfaction with their diabetes treatment. Safety will be carefully monitored throughout the study, including checking for side effects and episodes of low blood sugar, which can occur when blood sugar drops too low and may cause symptoms like shakiness or confusion.

1 Treatment period begins

The treatment period starts at week 0, which serves as the baseline for all measurements.

At this point, initial measurements will be taken, including HbA1c (a blood test that shows average blood sugar levels over the past 2-3 months), body weight, waist circumference, blood pressure, and blood samples for cholesterol and other fats in the blood.

A device called a continuous glucose monitor (a small sensor that measures sugar levels in the blood throughout the day and night) will be used starting from week -3 to collect baseline data.

Several questionnaires will be completed to assess quality of life and satisfaction with diabetes treatment.

2 Receiving assigned treatment

One of the following treatment options will be assigned: CagriSema (a combination of cagrilintide and semaglutide) at doses of 2.4 mg/2.4 mg or 1.0 mg/1.0 mg, semaglutide alone at 2.4 mg or 1.0 mg, cagrilintide alone at 2.4 mg, or placebo (an inactive substance with no medication).

The assigned medication will be administered as an injection under the skin (subcutaneous injection) once weekly.

Current diabetes medications (metformin taken by mouth and possibly an SGLT2 inhibitor, which is a type of diabetes medication that helps remove sugar through urine, also taken by mouth) will be continued at the same stable dose throughout the trial.

3 Ongoing treatment and monitoring

The treatment will continue for 68 weeks.

Regular visits will occur throughout this period to monitor progress and safety.

Blood sugar levels will be continuously monitored using the continuous glucose monitor device.

Any side effects or health changes will be recorded and assessed during the treatment period.

Blood pressure will be measured regularly, including both systolic blood pressure (the pressure when the heart beats) and diastolic blood pressure (the pressure when the heart rests between beats).

4 End of treatment assessments

At week 68, final treatment measurements will be taken.

These measurements include HbA1c, body weight, waist circumference, blood pressure, and blood samples for fats such as triglycerides (a type of fat in the blood), total cholesterol, HDL cholesterol (good cholesterol), LDL cholesterol (bad cholesterol), VLDL cholesterol (another type of cholesterol), non-HDL cholesterol, and free fatty acids.

Blood samples will also be taken to measure fasting plasma glucose (blood sugar level after not eating overnight) and high sensitivity C-reactive protein (a marker of inflammation in the body).

The continuous glucose monitor data will be analyzed to determine time spent in different blood sugar ranges: tight target range (3.9-7.8 mmol/L or 70-140 mg/dL), target range (3.9-10.0 mmol/L or 70-180 mg/dL), above range (over 10.0 mmol/L or over 180 mg/dL, and over 13.9 mmol/L or over 250 mg/dL).

The within-day glycaemic variability (how much blood sugar levels fluctuate during a single day) will be calculated.

Quality of life questionnaires will be completed again, including the SF-36v2 (a general health survey), Diabetes Treatment Satisfaction Questionnaire, and Treatment Related Impact Measure for Diabetes.

5 Follow-up period

After treatment ends at week 68, a follow-up period of 7 weeks will occur.

The study will be completed at week 75.

During this follow-up period, any remaining side effects or health changes will continue to be monitored and recorded.

Any episodes of hypoglycaemia (low blood sugar) will be documented, including clinically significant hypoglycaemia (blood sugar below 3.0 mmol/L or 54 mg/dL confirmed by a blood glucose meter) and severe hypoglycaemia (low blood sugar causing confusion or loss of consciousness requiring assistance from another person).

Who Can Join the Study?

  • You must be male or female, based on sex assigned at birth.
  • You must be 18 years of age or older at the time you sign the consent form.
  • You must have been diagnosed with type 2 diabetes, which is a condition where your body does not use insulin properly and your blood sugar levels are too high, at least 180 days (about 6 months) before joining the study.
  • You must have been taking the same daily dose of diabetes medication for at least 90 days (about 3 months) before joining the study. This medication must be metformin, which is a common diabetes medicine that helps lower blood sugar, either alone or combined with SGLT2 inhibitors, which are medicines that help your kidneys remove sugar through urine. Your doctor must consider your dose to be effective or the highest dose you can tolerate.
  • Your HbA1c level must be between 7.0% and 10.5%. HbA1c is a blood test that shows your average blood sugar levels over the past 2 to 3 months. This will be measured by a laboratory when you are screened for the study.
  • Your BMI must be 25 or higher at the time of screening. BMI stands for Body Mass Index, which is a number calculated from your height and weight that indicates if you are underweight, normal weight, overweight, or obese.

Who Cannot Join the Study?

  • The source data does not provide specific exclusion criteria, which are the reasons why a patient cannot participate in the study
  • Without detailed information about who cannot join this trial, it is not possible to list the specific conditions or situations that would prevent participation
  • Typically, exclusion criteria may include things like other health conditions, certain medications being taken, recent medical procedures, or laboratory test results that fall outside acceptable ranges, but these specific details are not available in the provided information

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Azienda Ospedaliera Universitaria Federico II Di Napoli Naples Italy
Athens Medical Center S.A. Athens Greece
Spitalul Clinic Judetean De Urgenta Cluj Cluj Napoca Romania
NBR Polska Tomasz Klodawski Warsaw Poland
Die Praxis am Ludwigsplatz Ludwigshafen Am Rhein Germany
Osteo-Medic s.c. Artur Racewicz, Jerzy Supronik Bialystok Poland
Bispebjerg Hospital Copenhagen Denmark
Azienda Ospedaliero Universitaria Careggi Florence Italy
Technische Universitaet Dresden Dresden Germany
Fondazione Policlinico Universitario Agostino Gemelli IRCCS Rome Italy
Hospital Universitario Y Politecnico La Fe Valencia Spain
Niepublicznego Zakladu Opieki Zdrowotnej Specjalistyczny Osrodek Internistyczno Diabetologiczny Bialystok Poland
Diabetes-Zentrum-Wilhelmsburg GbR Hamburg Germany
Etela-Pohjanmaan Sairaanhoitopiiri Seinajoki Finland
Diahaza s.r.o. Zlin Czechia
Individual Practice For Specialized Medical Care Dr. Nikolay Kostadinov EOOD Burgas Bulgaria
Poliklinika SLAVONIJA OSIJEK za opcu kirurgiju radiologiju baromedicinu ginekologiju i porodiljstvo i internu medicinu Osijek Croatia
Dialipid s.r.o. Presov Slovakia
SPLOSNA BOLNISNICA DR. FRANCA DERGANCA Nova Gorica Sempeter Pri Gorici Slovenia
Diabetologische Schwerpunktpraxis Dr. Staudenmeyer & Dr. Schiwietz Lingen (Ems) Germany
Prywatna Praktyka Lekarska Anna Chudoba Zyrardow Poland
Institutul National de Diabet, Nutritie si Boli Metabolice “N.C. Paulescu” Bucharest Romania
Dr. Tatyana Metalova Ambulatoria Za Individualna Praktika Za Spetsializirana Meditsinska EOOD Gotse Delchev Bulgaria
Urodiamed S.R.L. Craiova Romania
Cabinet Medical de Diabet, Nutritie si Boli Metabolice-Dr. Zaharie Daniela Gabriela Zalău Romania
Zdravstveni dom Koper Koper Slovenia
Dermatologija Bartenjev Ljubljana Slovenia
Razgrad Medical Center Ltd. Razgrad Bulgaria
iDia s.r.o. Nova Bana Slovakia
DEImedi s. r. o. Hul Slovakia
Medical Center Zdrave Lom EOOD Lom Bulgaria
Pihlajalinna Laeaekaerikeskukset Oy Tampere Finland
ZD Kocevje Kocevje Slovenia
ZDRAVSTVENI DOM Osnovno varstvo Nova Gorica Nova Gorica Slovenia

Other Sites

Site Name City Country Status
General University Hospital Of Larissa Larissa Greece
Areteus s.r.o. Trebisov Slovakia
Bajcsy-Zsilinszky Korhaz Es Rendelointezet Budapest Hungary
American Heart Of Poland S.A. Dabrowa Gornicza Poland
Ospedale San Raffaele S.r.l. Milan Italy
Region Skane Skanes Universitetssjukhus Lund Sweden
Karolinska University Hospital Solna Sweden
Fakultni Nemocnice U Sv Anny V Brne Brno-Stred Czechia
Zala Megyei Szent Rafael Korhaz Zalaegerszeg Hungary
Poliklinika Solmed d.o.o. Zagreb Croatia
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Palermo Italy
Diabeteszentrum-Do Dres. K U. Ch. Busch GbR Dortmund Germany
Mariodiab Clinic S.R.L. Brasov Romania
Hippokration Hospital Athens Greece
University Of Debrecen Debrecen Hungary
Somogy Varmegyei Kaposi Mor Oktato Korhaz Kaposvar Hungary
University Teaching Hospital Markusovszky Szombathely Hungary
Diagnostic Consultative Centre Ascendent OOD Sofia Bulgaria
Università degli studi Gabriele D’Annunzio Chieti-Pescara Centro di Studi e tecnologie avanzate Chieti Italy
University General Hospital Of Thessaloniki Ahepa Thessaloniki Greece
General Hospital Dr. Josip Bencevic Slavonski Brod Croatia
General Hospital Of Thessaloniki Papageorgiou Thessaloniki Greece
Thalassotherapia Specijalna bolnica za medicinsku rehabilitaciju bolesti srca pluca i reumatizma Opatija Croatia
Obudai Egeszseguegyi Centrum Kft. Dunaújváros Hungary
Diabet2 s.r.o. Prague Czechia
Universita’ Degli Studi Di Verona Verona Italy
Turku University Hospital Turku Finland
CTC Clinical Trial Consultants AB Uppsala Sweden
Pratia S.A. Skorzewo Poland
Ko-Med Centra Kliniczne Sp. z o.o. Zamosc Poland
Zentrum fuer klinische Studien Suedbrandenburg GmbH Elsterwerda Germany
Azienda USL Toscana Sud Est Arezzo Italy
Centrum Medyczne Medyk Sp. z o.o. Rzeszow Poland
ASST Fatebenefratelli Sacco Milan Italy
Region Oerebro Laen Orebro Sweden
MBAL Sveta Marina EAD Varna Bulgaria
University Of Luebeck Luebeck Germany
Euromedica General Clinic Of Thessaloniki Thessaloniki Greece
UNIVERZITETNI KLINICNI CENTER MARIBOR Maribor Slovenia
InnoDiab Forschung GmbH Essen Germany
R.E.D. Institut fuer medizinische Studien und Fortbildung GmbH Oldenburg In Holstein Germany
Milena Sante S.R.L. Galati Romania
Praxis Fuer Innere Medizin Zwenkau Germany
Steno Diabetes Center Copenhagen Herlev Denmark
Instytut Diabetologii Sp. z o.o. Warsaw Poland
Medizinisches Versorgungszentrum Am Bahnhof Spandau GbR Berlin Germany
Medcenter Nova Clinic Ltd. Varna Bulgaria
Kalthus Heart & Horse AB Lund Sweden
Bella Praxis S.R.L. Pascani Romania
Medi-Dia s.r.o. Sabinov Slovakia
Sc Cmi Dr. Pletea Noemi S.R.L. Bacau Romania
Opca Bolnica Varazdin Varazdin Croatia
University Of Szeged Szeged Hungary
Odense University Hospital Odense Denmark
MUDr. Michala Pelikanova s.r.o. Prague Czechia
Athens Medical Center S.A. Athens Greece
MVZ Diabeteszentrum Dr. Tews GmbH Gelnhausen Germany
Edumed s.r.o. Nove Mesto Czechia
Medical Centre Hungarian Defence Forces Budapest Hungary
Nordsjaellands Hospital Hillerød Denmark
Suomen Terveystalo Oy Tampere Finland
Anapkbbq Hdcaw Ov Pfcnoo Sxhl Zgierz Poland
Dpzjhpixkntierz Sxeciwcxlxmihankz Djgznt Daaden Germany
Sreojj Tmtasvqgdqz Oa Jyvaskyla Finland
Cfz Drk Bxorjxlop Mojvybb Maprlbqpm Ploiesti Romania
Dvkjdbi Dae Pxunchz Acjjzovwmnh Sphzph Ploiesti Romania
Lpzdx Ghhqmje Hvanfuyv Om Adbcic Athens Greece
Aewxhnuh Hrwah Od Ppyody Swsb Tychy Poland
Myqbvbkrwct Cjxrbkw Sfigxjnpyqyedcqivr Afqy Chrzanow Poland
Pnfbdnnnc Srtafxibu I Skxrksy Svua Barcelona Spain
Mnxbsisqt Mxcyhhy ggjuu Munich Germany
Dvjpa sjbahr Kosice Slovakia
Kiyujydw bgivfawo chgmjp Ruehah (oqchbinf Hkgndjhr Cvdbcd Rnoawjz Rijeka Croatia
Aokeuf Ujggeotxmz Huschbgw Aarhus Denmark
Pyoeetnem Iwvumaqo Mwrlwnom Mrhuxvfgeoqi Sfxoj Wlkexshhaunh I Aegvyhftwjrnd Warsaw Poland
Aigdoyu Oaschwevcby Pltb Gjqwyhla Xzktp Bergamo Italy
Uimyxutxnl Dfhif Shkti Dh Reoh Le Symgmwim Rome Italy
Iwokhcltx Fuf Cizlknaw Alo Ehxdcnitzfht Mqbfzluk Prague Czechia
Hwzxhwas Hbvgptyo Hvidovre Denmark
Cnneioz Mqlzokn Dd Dmgoywmoib Sp Tsmpgxmhh Aohxolgaf Ngtnkf Somizv Brasov Romania
Wybkajdvytl Wgjckiefqcfjqgurosbd Cghvbov Otqkbrkem I Twsrjbfdzdpju Ie Mesrvwfaphs W Lzpog Lodz Poland
Klcitvcb Djksrvbf Kxxmvx Nagykanizsa Hungary
Dfixla Mhc Shhbkv Bucharest Romania
Mjklaxg sccmrq Malacky Slovakia
Mydxz Jog Cwrnv stgwjf Prievidza Slovakia
Dlxwabbz Zyhsqnv Wxcfbaew Dfbqrjvjguxflof Ssecwnkmgdsozqlya Bbzojqbbjpyykgogwxjagngfzrin Gup Hamburg Germany
Swqmdzalvbwgrvq Gkzvopk Dlqqsxyflpoldmp Rbefcudq Rjqvfxcxncb Gorzów Wielkopolski Poland
Hrmvnxfu Viud dzxdtcxz Barcelona Spain
Hfwheqzn Uluixryejzvmz ds A Chpjjr A Coruna Galicia Spain
Ujvgdzqskp Gxnhdhk Htovusgp Ayhtlda Athens Greece
Dgryl snoana Bardejov Slovakia
Dnpyqzd skpkdb Plzen Czechia
Mjsebcp Cftkcq Meysc Mfl Ekvc Sofia Bulgaria
Pdlf Chdsodyl Mnk Sndxcp Reghin Romania
Bmawgnrfrv Taczsfcxf Topolsica Slovenia
Dyiwapqoxf sjgqop Ruzomberok Slovakia

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

Trial status

Country Status Recruitment Start
Bulgaria Bulgaria
Not recruiting
15.11.2023
Croatia Croatia
Not recruiting
15.11.2023
Czechia Czechia
Not recruiting
15.11.2023
Denmark Denmark
Not recruiting
15.11.2023
Finland Finland
Not recruiting
15.11.2023
Germany Germany
Not recruiting
15.11.2023
Greece Greece
Not recruiting
15.11.2023
Hungary Hungary
Not recruiting
15.11.2023
Italy Italy
Not recruiting
15.11.2023
Poland Poland
Not recruiting
15.11.2023
Romania Romania
Not recruiting
15.11.2023
Slovakia Slovakia
Not recruiting
15.11.2023
Slovenia Slovenia
Not recruiting
15.11.2023
Spain Spain
Not recruiting
15.11.2023
Sweden Sweden
Not recruiting
15.11.2023

Trial locations

CagriSema is a combination medication that contains two medicines given together: cagrilintide and semaglutide. This medication is given as an injection under the skin once a week. It is being tested to help people with type 2 diabetes lower their blood sugar levels when metformin alone or metformin with another diabetes medicine is not working well enough.

Semaglutide is a medication used to treat type 2 diabetes. It is given as an injection under the skin once a week. This medicine helps lower blood sugar levels and may also help with weight loss. In this study, it is being compared to the combination medication to see which works better.

Cagrilintide is a medication being studied for the treatment of type 2 diabetes. It is given as an injection under the skin once a week. This medicine works to help control blood sugar levels in people with diabetes.

Metformin is a commonly used pill for treating type 2 diabetes. It helps lower blood sugar levels by reducing the amount of sugar made by the liver and helping the body use insulin better. All participants in this study are already taking this medication.

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 over many years, and may go unnoticed in its early stages. As the disease progresses, the body’s ability to control blood sugar becomes increasingly impaired. This leads to elevated levels of glucose in the blood, which can affect various body systems if not properly managed.

Trial ID:
2022-502678-18-00
Protocol code:
NN9388-4896
Trial Phase:
Therapeutic confirmatory (Phase III)

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