A Research Study to See How Well the New Weekly Medicine IcoSema, Which is a Combination of Insulin Icodec and Semaglutide, Controls Blood Sugar Level in People With Type 2 Diabetes Compared to Insulin Glargine Taken Daily With Insulin Aspart (COMBINE 3)
- Conditions
- Diabetes Mellitus, Type 2
- Interventions
- Registration Number
- NCT05013229
- Lead Sponsor
- Novo Nordisk A/S
- Brief Summary
This study will compare the new medicine IcoSema, which is a combination of insulin icodec and semaglutide, taken once a week, to insulin glargine taken daily with insulin aspart in people with type 2 diabetes.The study will look at how well IcoSema controls blood sugar level in people with type 2 diabetes compared to insulin glargine taken with insulin aspart. Participants will either get IcoSema or insulin glargine taken with insulin aspart. Which treatment participants get is decided by chance. IcoSema is a new medicine that doctors cannot prescribe. Doctors can already prescribe insulin glargine and insulin aspart in many countries.
Participants will get IcoSema or insulin glargine together with insulin aspart. Participants must inject IcoSema once a week or inject insulin glargine once daily and insulin aspart 2-4 times a day. Participants will inject the medicines with a pen, which has a small needle, in a skin fold in the thigh, upper arm, or stomach. The study will last for about 1 year and 1 month. Participants will be asked to wear a sensor that measures participants blood sugar level all the time during an 8 week period at the beginning of the study and a 4 week period at the end of the study.
Women cannot take part if pregnant, breast-feeding or plan to get pregnant during the study period.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 679
-
Male or female and age above or equal to 18 years at the time of signing informed consent.
-
Diagnosed with type 2 diabetes mellitus 180 days or more before screening.
-
HbA1c of 7.0-10.0 percentage (53.- 85.8 mmol/mol) (both inclusive) as assessed by central laboratory on the day of screening.
-
Treated with once daily or twice-daily basal insulin (neutral protamine hagedorn insulin, insulin degludec, insulin detemir, insulin glargine 100 units/mL, or insulin glargine 300 units/mL) 20-80 units/day 90 days or more before screening. Short term bolus insulin treatment for a maximum of 14 days before screening is allowed, as is prior insulin treatment for gestational diabetes. The treatment can be with or without any of the following anti diabetic drugs with stable doses 90 days or more before screening:
- Metformin
- Sulfonylureas(a)
- Meglitinides (glinides)(a)
- DPP-4 inhibitors(a)
- Sodium-glucose co-transporter 2 inhibitors
- Alpha-glucosidase-inhibitors
- Thiazolidinediones
- Marketed oral combination products only including the products listed above.
-
Body mass index (BMI) less than or equal to 40.0 kg/m^2.
- Sulfonylureas, meglitinides (glinides) and DPP-4 inhibitors must be discontinued at randomisation.
- Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using a highly effective contraceptive method.
- Anticipated initiation or change in concomitant medication (for more than 14 consecutive days) known to affect weight or glucose metabolism (e.g. treatment with orlistat, thyroid, hormones, or systemic corticosteroids).
- Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria within 90 days before screening.
- Any episodes of diabetic ketoacidosis within 90 days before screening. As declared by the participant or in the medical records.
- Presence or history of pancreatitis (acute or chronic) within 180 days before screening.
- Any of the following: Myocardial infarction, stroke, hospitalization for unstable angina pectoris or transient ischaemic attack within 180 days before screening.
- Chronic heart failure classified as being in New York Heart Association Class IV at screening.
- Recurrent severe hypoglycaemic episodes within the last year (12 months) as judged by the investigator.
- Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a fundus examination performed within the past 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 IcoSema IcoSema Participants will receive once weekly subcutaneous (s.c) injections of IcoSema during the 52-week treatment period. Insuling glargine/insulin aspart Insulin glargine Participants will receive subcutaneous (s.c) injections of insulin glargine once daily combined with 2-4 times daily injections of insulin aspart. Insuling glargine/insulin aspart insulin aspart Participants will receive subcutaneous (s.c) injections of insulin glargine once daily combined with 2-4 times daily injections of insulin aspart.
- Primary Outcome Measures
Name Time Method Change in HbA1c From baseline week 0 (V2) to week 52 (V54) Percent-points
- Secondary Outcome Measures
Name Time Method Change in Diabetes Treatment Satisfaction Questionnaire (DTSQs) in total treatment satisfaction From baseline week 0 (V2) to week 52 (V54) Score 0-36. The higher the score the greater the satisfaction with treatment.
Change in body weight From baseline week 0 (V2) to week 52 (V54) Kg
Number of clinically significant hypoglycaemic episodes (level 2) (less than 3.0 mmol/L (54 mg/dL), confirmed by BG meter) or severe hypoglycaemic episodes (level 3) From week 0 (V52) to week 52 (V54) Number of episodes
Time spent less than 3.0 mmol/L (54 mg/dL) using continuous glucose monitoring (CGM) system, Dexcom G6 From week 48 (V50) to week 52 (V54) Percentage of readings
Change in fasting plasma glucose (FPG) From baseline week 0 (V2) to week 52 (V54) mmol/L
Weekly insulin dose (total) From week 50 (V52) to week 52 (V54) Units
Number of severe hypoglycaemic episodes (level 3) From baseline week 0 (V2) to week 57 (V56) Number of episodes
Number of clinically significant hypoglycaemic episodes (level 2) (less than 3.0 mmol/L (54 mg/dL), confirmed by BG meter) From baseline week 0 (V2) to week 57 (V56) Number of episodes
Time in range 3.9 - 10.0 mmol/L (70 - 180 mg/dL) using continuous glucose monitoring (CGM) system, Dexcom G6 From week 48 (V50) to week 52 (V54) Percentage of readings
Time spent more than 10.0 mmol/L (180 mg/dL) using continuous glucose monitoring (CGM) system, Dexcom G6 From week 48 (V50) to week 52 (V54) Percentage of readings
Trial Locations
- Locations (129)
Endeavor Health
🇺🇸Skokie, Illinois, United States
Andres Garcia-Zuniga, MD, P.A
🇺🇸Laredo, Texas, United States
Centre de Recherche Clinique Portes Du Sud
🇫🇷Venissieux, France
University Technology MARA (UiTM) - Sg Buloh
🇲🇾Sungai Buloh, Selangor, Malaysia
Centrum Terapii Współczesnej J.M. Jasnorzewska S.K.A.
🇵🇱Lodz, Poland
Scripps Wht Diab Inst La Jolla
🇺🇸La Jolla, California, United States
Downtown LA Res Ctr. Inc.
🇺🇸Los Angeles, California, United States
San Diego Family Care
🇺🇸San Diego, California, United States
Creekside Endocrine Associates
🇺🇸Denver, Colorado, United States
Northeast Research Institute
🇺🇸Fleming Island, Florida, United States
Northeast Res Inst. Inc.
🇺🇸Jacksonville, Florida, United States
South Broward Research LLC
🇺🇸Miramar, Florida, United States
Adult Medicine of Lake County, Inc.
🇺🇸Mount Dora, Florida, United States
Florida Inst For Clin Res
🇺🇸Orlando, Florida, United States
Endo Res Solutions Inc
🇺🇸Roswell, Georgia, United States
Saltzer Medical Group Research
🇺🇸Nampa, Idaho, United States
Iowa Diab & Endo Res Center
🇺🇸West Des Moines, Iowa, United States
The Research Group of Lexington LLC
🇺🇸Lexington, Kentucky, United States
MedStar Hlth Res Institute
🇺🇸Hyattsville, Maryland, United States
Northern Pines Hlth Ctr, PC
🇺🇸Buckley, Michigan, United States
Palm Research Center Inc-Vegas
🇺🇸Las Vegas, Nevada, United States
Southern NH Diabetes and Endocrinology
🇺🇸Nashua, New Hampshire, United States
Southgate Medical Group, LLP
🇺🇸West Seneca, New York, United States
Piedmont Healthcare/Research
🇺🇸Statesville, North Carolina, United States
Accellacare
🇺🇸Wilmington, North Carolina, United States
Diab & Endo Assoc of Stark Co
🇺🇸Canton, Ohio, United States
Prestige Clinical Research
🇺🇸Franklin, Ohio, United States
New Venture Medical Research
🇺🇸Wadsworth, Ohio, United States
Hillcrest Clinical Research
🇺🇸Simpsonville, South Carolina, United States
AM Diabetes And Endocrinology Center
🇺🇸Bartlett, Tennessee, United States
Univ Diab & Endo Consultants
🇺🇸Chattanooga, Tennessee, United States
HealthStar Physicians PC
🇺🇸Morristown, Tennessee, United States
Amarillo Med Spec LLP
🇺🇸Amarillo, Texas, United States
Velocity Clinical Res-Dallas
🇺🇸Dallas, Texas, United States
PlanIt Research, PLLC
🇺🇸Houston, Texas, United States
Protenium Clinical Research
🇺🇸Hurst, Texas, United States
Clinical Investigations Of Texas
🇺🇸Plano, Texas, United States
Briggs Clinical Research, LLC
🇺🇸San Antonio, Texas, United States
NE Clin Res of San Antonio
🇺🇸San Antonio, Texas, United States
Simcare Medical Research, LLC
🇺🇸Sugar Land, Texas, United States
Chrysalis Clinical Research
🇺🇸Saint George, Utah, United States
Rainier Clin Res Ctr Inc
🇺🇸Renton, Washington, United States
Fakultni nemocnice Plzen
🇨🇿Plzen, Czech Republic, Czechia
University Hospital U sv. Anny
🇨🇿Brno, Czechia
FN Hradec Kralove
🇨🇿Hradec Kralove, Czechia
Diabet2 s.r.o.
🇨🇿Praha 1, Czechia
Diabetologická a internà ambulance Diabet2
🇨🇿Praha 1, Czechia
Fledip s.r.o.
🇨🇿Praha, Czechia
ResTrial s.r.o.
🇨🇿Praha 8, Czechia
III. interni klinika VFN a 1. LK UK v Praze
🇨🇿Praha, Czechia
Institut klinicke a experimentalni mediciny_Praha
🇨🇿Praha, Czechia
Centre Hospitalier Departemental Vendee- La Roche Sur Yon
🇫🇷LA ROCHE-sur-YON cedex 9, France
Groupe Sos Sante-Hopital Le Creusot-Hotel Dieu-2
🇫🇷Le Creusot, France
Aphp-Hopital Lariboisiere-1
🇫🇷Paris, France
Centre Hospitalier Universitaire de Bordeaux-Hopital Haut Leveque-2
🇫🇷Pessac, France
InnoDiab Forschung GmbH
🇩🇪Essen, Germany
Wendisch/Dahl Hamburg
🇩🇪Hamburg, Germany
Institut für Diabetesforschung GmbH Münster - Dr. med. Rose
🇩🇪Münster, Germany
RED-Institut für medizinische Forschung und Fortbildung GmbH
🇩🇪Oldenburg in Holstein, Germany
Zentrum für klinische Studien Alexander Segner
🇩🇪Saint Ingbert-Oberwürzbach, Germany
Clinexpert Egészségügyi Szolgáltató és Kereskedelmi Kft.
ðŸ‡ðŸ‡ºBudapest, Hungary
Szőcs Depot Egészségügyi Szolgáltató Kft.
ðŸ‡ðŸ‡ºBudapest, Hungary
Semmelweis Egyetem II. Belgyógyászati Klinika
ðŸ‡ðŸ‡ºBudapest, Hungary
ClinDiab Egészségügyi Szolgáltató és Kereskedelmi Kft.
ðŸ‡ðŸ‡ºBudapest, Hungary
Békés Megyei Központi Kórház - dr. Réthy Pál Tagkórház
ðŸ‡ðŸ‡ºBékéscsaba, Hungary
Apollo Hospital, Ahmedabad
🇮🇳Ahmedabad, Gujarat, India
Apollo Hospital International Ltd
🇮🇳Gandhinagar, Gujarat, India
Diacon Hospital Private Limited
🇮🇳Bangalore, Karnataka, India
TOTALL Diabetes Hormone Institute
🇮🇳Indore, Madhya Pradesh, India
Sahyadri Speciality Hospital
🇮🇳Pune, Maharashtra, India
Sahyadri Super Speciality Hospital
🇮🇳Pune, Maharashtra, India
chelleram Diabetes Institute
🇮🇳Pune, Maharashtra, India
Post Graduate Institute of Medical Education & Research
🇮🇳Chandigarh, Punjab, India
Christian Medical College and Hospital
🇮🇳Ludhiana, Punjab, India
Fortis Heart Institute and Multispeciality Hospital
🇮🇳Mohali, Punjab, India
Diabetes, Thyroid and Endocrine Centre
🇮🇳Jaipur, Rajasthan, India
Madras Diabetes Research Foundation
🇮🇳Chennai, Tamil Nadu, India
Christian Medical College Hospital, Vellore
🇮🇳Vellore, Tamil Nadu, India
Medanta Lucknow Hospital
🇮🇳Lucknow, Uttar Pradesh, India
Swasthya Diabetes Care
🇮🇳Ahmedabad, India
Azienda Ospedaliero-Universitaria Renato Dulbecco
🇮🇹Catanzaro, CZ, Italy
Pol. Uni. Campus Biomedico UOC Endocrinologia e Diabetologia
🇮🇹Roma, RM, Italy
Azienda Ospedaliera Luigi Sacco
🇮🇹Milano, Italy
Ospedale Civico Partinico di Palermo
🇮🇹Partinico, Italy
IRCCS Multimedica
🇮🇹Sesto San Giovanni (MI), Italy
Heiwadai Hospital
🇯🇵Miyazaki-shi, Miyazaki, Japan
Asano Clinic
🇯🇵Kawagoe-shi, Saitama, Japan, Japan
Tokyo Medical Univ. Hospital_Diabetes, Metabolism and Endocrinology
🇯🇵Shinjuku-ku, Tokyo, Japan
TOSAKI Clinic for Diabetes and Endocrinology_Diabetes and Endocrinology
🇯🇵Aichi, Japan
Akaicho Clinic
🇯🇵Chiba-shi, Chiba, Japan
The Institute of Medical Science, Asahi Life Foundation
🇯🇵Chuo-ku, Tokyo, Japan
Naka Kinen Clinic
🇯🇵Ibaraki, Japan
Minami Akatsuka Clinic
🇯🇵Mito-shi, Ibaraki, Japan
Takatsuki Red Cross Hospital
🇯🇵Osaka, Japan
Tokyo-Eki Center-building Clinic
🇯🇵Tokyo, Japan
Fukuwa Clinic
🇯🇵Tokyo, Japan
Hospital Universiti Sains Malaysia_Kota Bharu, Kelantan
🇲🇾Kota Bharu, Kelantan, Malaysia
Hospital Universiti Kebangsaan Malaysia
🇲🇾Cheras, Kuala Lumpur, Malaysia
Hospital Seri Manjung
🇲🇾Seri Manjung, Perak, Malaysia
University Technology MARA (UiTM) - Puncak Alam
🇲🇾Sungai Buloh, Selangor, Malaysia
University Malaya Medical Centre
🇲🇾Kuala Lumpur, Wilayah Persekutuan Kuala Lumpur, Malaysia
Klinik Kesihatan Simpang Kuala
🇲🇾Alor Setar, Malaysia
Miri Hospital
🇲🇾Miri, Sarawak, Malaysia
NZOZ Specjalistyczny Osrodek Internistyczno-Diabetologiczny Małgorzata Arciszewska
🇵🇱Bialystok, Podlaskie, Poland
Centrum Medyczne Pratia Gdynia
🇵🇱Gdynia, Pomorskie, Poland
SNZOZ Lege Artis
🇵🇱Bialystok, Poland
Gabinet Lekarski Malgorzata Saryusz-Wolska
🇵🇱Lodz, Poland
NBR Polska Tomasz Klodawski
🇵🇱Warszawa, Poland
Healthcare centre Kocevje
🇸🇮Kocevje, Slovenia
Healthcare Centre Koper
🇸🇮Koper, Slovenia
UKC Ljubljana, Endocrinology and Diabetes
🇸🇮Ljubljana, Slovenia
General Hospital Murska Sobota
🇸🇮Murska Sobota, Slovenia
General Hospital Nova Gorica_Diabetes
🇸🇮Nova Gorica, Slovenia
Medi-Clinic Bloemfontein
🇿🇦Bloemfontein, Free State, South Africa
Lenasia Clinical Trial Centre
🇿🇦Lenasia, Gauteng, South Africa
Prof P. Joshi
🇿🇦Pretoria, Gauteng, South Africa
Spoke Research Inc
🇿🇦Cape Town, Western Cape, South Africa
Siriraj Hospital_Bangkoknoi, Bangkok
🇹ðŸ‡Bangkoknoi, Bangkok, Bangkok, Thailand
Maharaj Nakorn Chiang Mai Hospital
🇹ðŸ‡Chiang Mai, Mueang Chiang Mai District, Thailand
Rajavithi Hospital
🇹ðŸ‡Bangkok, Thailand
Srinagarind Hospital
🇹ðŸ‡Khon Kaen, Thailand
Maharat Nakhon Ratchasima Hospital
🇹ðŸ‡Nakhon Ratchasima, Thailand
Baskent Universitesi Adana
🇹🇷Adana, Turkey
Gulhane Egitim Arastirma Hastanesi
🇹🇷Ankara, Turkey
Akdeniz University Tip Fakultesi Hastanesi
🇹🇷Antalya, Turkey
Adnan Menderes Universitesi Uygulama ve Arastirma Hastanesi
🇹🇷Aydin, Turkey
Pamukkale Universitesi Tip Fakultesi
🇹🇷Denizli, Turkey
TC SB Ist.İl Sag.Müd.Prof.Dr.Cemil Tascioglu Sehir Hastanesi
🇹🇷Istanbul, Turkey
Dokuz Eylul University Medical Faculty
🇹🇷Izmir, Turkey