A Research Study to See How Much CagriSema Lowers Blood Sugar and Body Weight Compared to Tirzepatide in People With Type 2 Diabetes Treated With Metformin, SGLT2 Inhibitor or Both
- Conditions
- Diabetes Mellitus, Type 2
- Interventions
- Registration Number
- NCT06534411
- Lead Sponsor
- Novo Nordisk A/S
- Brief Summary
This study will look at how much CagriSema lowers blood sugar and body weight in people with type 2 diabetes. CagriSema is a new investigational medicine. Doctors cannot yet prescribe CagriSema. CagriSema will be compared to a medicine called tirzepatide. Doctors can prescribe tirzepatide in some countries. Participants will either receive CagriSema or tirzepatide. Which treatment the participant will receive is decided by chance. For each participant, the study will last for up to 1 year and 4 months.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 1023
- Male or female (sex at birth).
- Age 18 years or above at the time of signing the informed consent.
- Diagnosed with type 2 diabetes mellitus greater than or equal to (>=) 180 days before screening.
- Stable daily dose(s) >= 90 days before screening of any of the following antidiabetic drug(s) or combination regimen(s) at effective or maximum tolerated dose as judged by the investigator:
- Metformin
- sodium-glucose co-transporter 2 inhibitor (SGLT2i)
- Glycated haemoglobin (HbA1c) 7.0-10.5 percent (53-91 millimoles per mol [mmol/mol]) (both inclusive) as determined by central laboratory at screening.
- Body mass index (BMI) >= 30 kilogram per square meter (kg/m^2) at screening. BMI will be calculated in the electronic case report form (eCRF) based on height and body weight at screening.
- Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using a highly effective contraceptive method.
- Renal impairment with estimated Glomerular Filtration Rate less than < 30 milliliter per minute per 1.73 square meter (mL/min/1.73 m^2) as determined by central laboratory at screening.
- Treatment with any anti-diabetic or anti-obesity medication (irrespective of indication) other than stated in the inclusion criteria within 90 days before screening. However, short term insulin treatment for a maximum of 14 consecutive days is allowed.
- Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by an eye examination performed within 90 days before screening or in the period between screening and randomisation. Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Tirzepatide Tirzepatide Participants will receive once-weekly s.c injections of tirzepatide at escalating dose in a 4-week dose escalating period and maintained up to 56 weeks. CagriSema Semaglutide Participants will receive once-weekly subcutaneous (s.c) injections of CagriSema (cagrilintide and semaglutide) at escalating doses every 4 weeks in a 8-week dose escalation period until target dose of CagriSema is achieved and maintained for 52 weeks. CagriSema Cagrilintide Participants will receive once-weekly subcutaneous (s.c) injections of CagriSema (cagrilintide and semaglutide) at escalating doses every 4 weeks in a 8-week dose escalation period until target dose of CagriSema is achieved and maintained for 52 weeks.
- Primary Outcome Measures
Name Time Method Change in Glycated Haemoglobin (HbA1c) From baseline (week 0) to end of treatment (week 60) Measured in percentage points.
Relative Change in Body Weight From baseline (week 0) to end of treatment (week 60) Measured in percentage (%).
- Secondary Outcome Measures
Name Time Method Number of Participants Who Achieve HbA1c Target Values of Less Than or Equal to (<=) 6.5% (<= 48 mmol/mol) At end of treatment (week 60) Measured as count of participants.
Ratio to Baseline in Lipids: Low Density Lipoprotein (LDL) Cholesterol From baseline (week 0) to end of treatment (week 60) Measured as ratio.
Number of Participants Who Achieve Greater Than or Equal to (>=) 5% Weight Reduction From baseline (week 0) to end of treatment (week 60) Measured as count of participants.
Change in Waist Circumference From baseline (week 0) to end of treatment (week 60) Measured in centimeter (cm).
Ratio to Baseline in Lipids: Total Cholesterol From baseline (week 0) to end of treatment (week 60) Measured as ratio.
Ratio to Baseline in Lipids: Triglycerides From baseline (week 0) to end of treatment (week 60) Measured as ratio.
Number of Participants Who Achieve >= 10% Weight Reduction From baseline (week 0) to end of treatment (week 60) Measured as count of participants.
Change in Systolic Blood Pressure (SBP) From baseline (week 0) to end of treatment (week 60) Measured in millimeter of mercury (mmHg).
Ratio to Baseline in Lipids: Very Low Density Lipoprotein (VLDL) Cholesterol From baseline (week 0) to end of treatment (week 60) Measured as ratio.
Change in HbA1c From baseline (week 0) to end of treatment (week 60) Measured in percentage points.
Change in Fasting Plasma Glucose (FPG) From baseline (week 0) to end of treatment (week 60) Measured as millimole per liter (mmol/L).
Number of Participants Who Achieve HbA1c Target Values of Less Than (<) 7.0 (Percent [%]) (< 53 millimole per mole [mmol/mol]) At end of treatment (week 60) Measured as count of participants.
Number of Participants Who Achieve >= 15% Weight Reduction From baseline (week 0) to end of treatment (week 60) Measured as count of participants.
Ratio to Baseline in Lipids: High Density Lipoprotein (HDL) Cholesterol From baseline (week 0) to end of treatment (week 60) Measured as ratio.
Number of Participants Who Achieve >= 20% Weight Reduction From baseline (week 0) to end of treatment (week 60) Measured as count of participants.
Change in Diastolic Blood Pressure (DBP) From baseline (week 0) to end of treatment (week 60) Measured in mmHg.
Ratio to Baseline in Lipids: Non-HDL cholesterol From baseline (week 0) to end of treatment (week 60) Measured as ratio.
Change in SF-36v2 Score: Vitality Subscale From baseline (week 0) to end of treatment (week 60) Measured as score points. SF-36v2 Acute measures Health-Related Quality of Life (HRQOL). The measure consists of 36 items yielding 8 health domain scores and 2 component summary scores. SF-36v2. Acute scores are norm-based scores, i.e. transformed to a scale where the 2009 US general population has a mean of 50 and a standard deviation of 10. Vitality score ranges from 25.6 to 69.1 with higher scores indicating better functional health and well-being.
Number of Treatment Emergent Adverse Events (TEAEs) From baseline (week 0) to end of study (week 66) Measured as count of events.
Number of Clinically Significant Hypoglycaemic Episodes (Level 2) (<3.0 mmol/L (<54 Milligram per Deciliter [mg/dL]), Confirmed by Blood Glucose (BG) Meter From baseline (week 0) to end of study (week 66) Measured as count of episodes.
Change in Short Form (SF) -36v2 Score: Physical Component Summary Score From baseline (week 0) to end of treatment (week 60) Measured as score points. SF-36v2 Acute measures Health-Related Quality of Life (HRQOL). The measure consists of 36 items yielding 8 health domain scores and 2 component summary scores. SF-36v2. Acute scores are norm-based scores, i.e. transformed to a scale where the 2009 US general population has a mean of 50 and a standard deviation of 10. Physical component summary scores ranges from 6.1 to 79.7 with higher scores indicating better functional health and well-being.
Change in Impact of Weight on Quality of Life Lite for Clinical Trials Version (IWQOL-Lite-CT) : Physical Function score From baseline (week 0) to end of treatment (week 60) Measured as score points. IWQOL-Lite-CT measures weight-related physical and psychosocial functioning. The measure consists of 20 items yielding 3 composite scores, and 1 total score. Higher scores indicate better levels of functioning. Physical functioning score ranges from 0 to 100, with higher scores reflecting better levels of functioning.
Change in SF-36v2 Score: Mental Component Summary Score From baseline (week 0) to end of treatment (week 60) Measured as score points. SF-36v2 Acute measures Health-Related Quality of Life (HRQOL). The measure consists of 36 items yielding 8 health domain scores and 2 component summary scores. SF-36v2. Acute scores are norm-based scores, i.e. transformed to a scale where the 2009 US general population has a mean of 50 and a standard deviation of 10. Mental component summary scores ranges from -3.8 to 78.7 with higher scores indicating better functional health and well-being.
Change in IWQOL-Lite-CT: Total score From baseline (week 0) to end of treatment (week 60) Measured as score points. IWQOL-Lite-CT measures weight-related physical and psychosocial functioning. The measure consists of 20 items yielding 3 composite scores, and 1 total score. Higher scores indicate better levels of functioning. Total score ranges from 0 to 100, with higher scores reflecting better levels of functioning.
Number of Severe Hypoglycaemic Episodes (Level 3): Hypoglycaemia Associated With Severe Cognitive Impairment Requiring External Assistance for Recovery, With no Specific Glucose Threshold From baseline (week 0) to end of study (week 66) Measured as count of episodes.
Trial Locations
- Locations (144)
South Broward Research LLC
🇺🇸Miramar, Florida, United States
West Orange Endocrinology
🇺🇸Ocoee, Florida, United States
Optimal Research Sites
🇺🇸Orange City, Florida, United States
Aeres Clinical Research
🇺🇸Laredo, Texas, United States
RGV Endocrine Center
🇺🇸McAllen, Texas, United States
G.A. Research Associates Ltd.
🇨🇦Moncton, New Brunswick, Canada
New Horizon Research Center
🇺🇸Miami, Florida, United States
Cahaba Research
🇺🇸Pelham, Alabama, United States
Velocity Clinical Research-Phoenix
🇺🇸Phoenix, Arizona, United States
AES Tucson DRS
🇺🇸Tucson, Arizona, United States
Woodland Int. Research Group
🇺🇸Little Rock, Arkansas, United States
John Muir Physicians Network
🇺🇸Concord, California, United States
Diabetes & Endocrine Specialists - La Mesa
🇺🇸La Mesa, California, United States
Desert Oasis Healthcare
🇺🇸Palm Springs, California, United States
Velocity Clin Res - Panorama
🇺🇸Van Nuys, California, United States
Optumcare Colorado Springs
🇺🇸Colorado Springs, Colorado, United States
FEME Medical LLC
🇺🇸Washington, District of Columbia, United States
Tampa Bay Medical Research
🇺🇸Clearwater, Florida, United States
AGA Clinical Trial
🇺🇸Hialeah, Florida, United States
Clinical Trial Services Corp
🇺🇸Miami, Florida, United States
Bioclinical Research Alliance
🇺🇸Miami, Florida, United States
Javara Inc. / Privia Medical Group Georgia LLC
🇺🇸Fayetteville, Georgia, United States
Clinical Invest Special_Gurnee
🇺🇸Gurnee, Illinois, United States
Iowa Diabetes & Endo Res Ctr
🇺🇸West Des Moines, Iowa, United States
Cotton-Oneill Diabetes and End
🇺🇸Topeka, Kansas, United States
AES Minneapolis DRS
🇺🇸Richfield, Minnesota, United States
Univ of Nebraska Medical CTR
🇺🇸Omaha, Nebraska, United States
Albany Medical College
🇺🇸Albany, New York, United States
Carteret Medical Group
🇺🇸Morehead City, North Carolina, United States
Piedmont Healthcare/Research
🇺🇸Statesville, North Carolina, United States
Lillestol Research LLC
🇺🇸Fargo, North Dakota, United States
Triad Research Institute
🇺🇸Norman, Oklahoma, United States
Circuit Clinical - PMSI
🇺🇸Pottstown, Pennsylvania, United States
Clinical Res Collaborative
🇺🇸Cumberland, Rhode Island, United States
Velocity Clin Res Providence
🇺🇸East Greenwich, Rhode Island, United States
Holston Medical Group
🇺🇸Kingsport, Tennessee, United States
Clinical Research Associates
🇺🇸Nashville, Tennessee, United States
Velocity Clin Res Austin
🇺🇸Austin, Texas, United States
UT Southwestern Medical Center - Lingvay
🇺🇸Dallas, Texas, United States
Juno Research, LLC_Houston
🇺🇸Houston, Texas, United States
Discovery MM Services - Houston - Broadway Street
🇺🇸Houston, Texas, United States
PlanIt Research, PLLC
🇺🇸Houston, Texas, United States
Sante Clinical Research
🇺🇸Kerrville, Texas, United States
Privia Health Javara Clin Res.
🇺🇸Stephenville, Texas, United States
Chrysalis Clinical Research
🇺🇸Saint George, Utah, United States
J.Lewis Research Inc
🇺🇸Salt Lake City, Utah, United States
TPMG Clinical Research
🇺🇸Newport News, Virginia, United States
Centro Médico CIMEL
🇦🇷Lanus Este, Buenos Aires, Argentina
Centro de Investigaciones Médicas Clínica de Fracturas y Or
🇦🇷Mar del Plata, Buenos Aires, Argentina
Fundación CESIM
🇦🇷Santa Rosa, La Pampa, Argentina
Centro de Investigaciones Médicas Tucumán
🇦🇷San Miguel De Tucuimán, Tucumán, Argentina
IMOBA
🇦🇷City of Buenos Aires, Argentina
Instituto de Investigaciones Clinicas San Nicolás
🇦🇷San Nicolás, Argentina
Paratus Clinical
🇦🇺Herston, Queensland, Australia
Hunter Diabetes Centre
🇦🇺Merewether, New South Wales, Australia
Austrials
🇦🇺St Leonards, New South Wales, Australia
Momentum Clinical Research
🇦🇺St Leonards, New South Wales, Australia
Roger Chih Yu Chen
🇦🇺Sydney, New South Wales, Australia
Townsville University Hospital
🇦🇺Douglas, Queensland, Australia
Centro de Diabetes Curitiba
🇧🇷Curitiba, Parana, Brazil
Núcleo de Pesquisa Clínica do Rio Grande do Sul Ltda.
🇧🇷Porto Alegre, Rio Grande Do Sul, Brazil
CPQuali Pesquisa Clínica Ltda
🇧🇷São Paulo, Sao Paulo, Brazil
Hilltop Medical Clinic
🇨🇦Surrey, British Columbia, Canada
Centricity Research Brampton
🇨🇦Brampton, Ontario, Canada
Centricity Research Etobicoke
🇨🇦Etobicoke, Ontario, Canada
Wharton Med Clin Trials
🇨🇦Hamilton, Ontario, Canada
London Road Diagnostic Clinic and Medical Centre
🇨🇦Sarnia, Ontario, Canada
Diabetes Heart Research Centre
🇨🇦Toronto, Ontario, Canada
Ctr de rech Clin de Laval
🇨🇦Laval, Quebec, Canada
Alpha Recherche Clinique - Clinique de Levis
🇨🇦Levis, Quebec, Canada
Centre Medical Acadie
🇨🇦Montreal, Quebec, Canada
Ctr de Med Metab de Lanaudiere
🇨🇦Terrebonne, Quebec, Canada
Herz- und Diabeteszentrum NRW - Bad Oeynhausen
🇩🇪Bad Oeynhausen, Germany
Klinik für Endokrinologie, Diabetologie und Stoffwechsel - Uniklinik Essen
🇩🇪Essen, Germany
Praxis am Markt Dr. Becker
🇩🇪Essen, Germany
Wendisch/Dahl Hamburg
🇩🇪Hamburg, Germany
Medicover Neuroendokrinologie MVZ
🇩🇪München, Germany
MedicalCenter am Clemenshospital - Schwerpunktpraxis für Diabetologie und Ernährungsmedizin
🇩🇪Münster, Germany
Zentrum für klinische Studien Allgäu Oberschwaben
🇩🇪Wangen, Germany
Alexandra General Hospital, Therapeutic Clinic
🇬🇷Athens, Attiki, Greece
Venizeleio Pananeio
🇬🇷Heraklion, Crete, Greece
Evangelismos Hospital
🇬🇷Athens, Greece
Iatriko Athinon 'Palaiou Falirou'
🇬🇷Athens, Greece
"Laiko" General Hospital of Athens
🇬🇷Goudi/Athens, Greece
University General Hospital of Ioannina,Internal Medicine
🇬🇷Ioannina, Greece
General Hospital of Thessaloniki 'G. Gennimatas
🇬🇷Thessaloniki, Greece
'Ippokrateio' General Hospital of Thessaloniki
🇬🇷Thessaloniki, Greece
Szegedi Tudomanyegyetem St Györgyi Albert Klinikai Központ
🇭🇺Szeged, Csongrád-Csanád, Hungary
Selye János Kórház és Rendelőintézet
🇭🇺Komárom, Komárom-Esztergom, Hungary
QUALICLINIC Egészségügyi Szolgáltató és Kutatásszervező Kft
🇭🇺Budapest, Pest, Hungary
Óbudai Egészségügyi Centrum
🇭🇺Budapest, Hungary
Szőcs Depot Egészségügyi Szolgáltató Kft.
🇭🇺Budapest, Hungary
Semmelweis Egyetem
🇭🇺Budapest, Hungary
ClinDiab Egészségügyi Szolgáltató és Kereskedelmi Kft.
🇭🇺Budapest, Hungary
PVN Kutato Kft.
🇭🇺Budapest, Hungary
MED-TIMA Kft.
🇭🇺Budapest, Hungary
Észak-Pesti Centrumkórház Honvédkórház
🇭🇺Budapest, Hungary
Endolife Specialty Hospitals
🇮🇳Guntur, Andhra Pradesh, India
All India Institute of Medical Sciences (AIIMS)
🇮🇳New Delhi, Delhi, India
Ramaiah Memorial Hospital
🇮🇳Bengaluru, Karnataka, India
Excel Endocrine Centre
🇮🇳Kolhapur, Maharashtra, India
Acharya Vinoba Bhave Rural Hospital, Sawangi Meghe, Wardha
🇮🇳Wardha, Maharashtra, India
Jawahar Lal Nehru Govt. Medical College
🇮🇳Ajmer, Rajasthan, India
SMS Hospital
🇮🇳Jaipur, Rajasthan, India
Diabetes, Thyroid and Endocrine Centre
🇮🇳Jaipur, Rajasthan, India
Arthur Asirvatham hospital,
🇮🇳Madurai, Tamil Nadu, India
AIG Hospitals,Hyderabad
🇮🇳Hyderabad, Telangana, India
Udyaan Health Care
🇮🇳Lucknow, Uttar Pradesh, India
IPGME&R and SSKM Hospital
🇮🇳Kolkata, West Bengal, India
Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER)
🇮🇳Puducherry, India
Diabetes and obesity center of excellence, Rambam MC
🇮🇱Haifa, Israel
Clalit sick fund Herzlia
🇮🇱Herzlia, Israel
Diabetes Clinic Wolfson MC
🇮🇱Holon, Israel
Diabetes Unit Hadassah Ein Karem MC
🇮🇱Jerusalem, Israel
Rabin MC Beilinson Campus Endo
🇮🇱Petah-Tikva, Israel
Endrocrinolgy Clinic - Sheba Medical Center
🇮🇱Tel Hashomer, Israel
Institute of Endocrinology, metabolism and hypertension
🇮🇱Tel-Aviv, Israel
Uniwersytecki Szpital Kliniczny w Bialymstoku
🇵🇱Bialystok, Poland
Diab Serwis Popenda Spółka Jawna
🇵🇱Chorzów, Poland
Specjalistyczny Gabinet Diabetologiczny Rumianowski Radosław
🇵🇱Gorzow Wielkopolski, Poland
Centrum Terapii Wspolczesnej J.M. Jasnorzewska S.K.A.
🇵🇱Lodz, Poland
Etyka Ośrodek Badań Klinicznych Tomasz Pesta S.K.A.
🇵🇱Olsztyn, Poland
Kiepury Clinic MAŁGORZATA JARNOT SPECJALISTYCZNA PRAKTYKA GINEKOLOGICZNO-POŁOŻNICZA
🇵🇱Sosnowiec, Poland
Centrum Medyczne Oporow
🇵🇱Wroclaw, Poland
Samodzielny Publiczny Szpital Kliniczny Nr 1 im. Prof. Szyszko
🇵🇱Zabrze, Poland
Diabdana S.R.L.
🇷🇴Oradea, Bihor, Romania
Institutul National De Diabet Nutritie Si Boli Metabolice Prof.Dr.N.Paulescu Bucuresti- Ion Movila
🇷🇴Bucharest, Bucurestii, Romania
CMI Dr Pop Lavinia
🇷🇴Baia Mare, Maramures, Romania
Sc Mediab Srl
🇷🇴Tirgu Mures, Mures, Romania
SC Nutrilife SRL
🇷🇴Bucharest, Romania
Diabet Med SRL
🇷🇴Bucuresti, Romania
Sanamed Hospital SRL
🇷🇴Bucuresti, Romania
Clinica Korall S.R.L. Satu Mare
🇷🇴Satu-Mare, Romania
Clinica Universitaria de Navarra
🇪🇸Pamplona, Navarra, Spain
Centro Periferico De Especialidades Bola Azul
🇪🇸Almeria, Spain
Hospital Vall d'Hebron
🇪🇸Barcelona, Spain
Hospital Universitario San Cecilio
🇪🇸Granada, Spain
Clínica Nuevas Tecnologías en Diabetes y Endocrinología
🇪🇸Sevilla, Spain
Hospital Clínico de Valladolid
🇪🇸Valladolid, Spain
Kaohsiung Medical University Chung-Ho Memorial Hospital
🇨🇳Kaoshiung, Taiwan
China Medical University Hospital
🇨🇳Taichung City, Taiwan
Taichung Veterans General Hospital
🇨🇳Taichung City, Taiwan
National Cheng Kung University Hospital
🇨🇳Tainan City, Taiwan
Chang Gung Memorial Hospital Linkou
🇨🇳Taoyuan City, Taiwan