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 Weekly Semaglutide (COMBINE 2)
- Registration Number
- NCT05259033
- 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 semaglutide taken once a week 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 semaglutide.
Participants will either get IcoSema or semaglutide. Which treatment participants get is decided by chance. IcoSema is a new medicine that doctors cannot prescribe. Doctors can already prescribe semaglutide in many countries.
Participants will get IcoSema or semaglutide, which they must inject once a week 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 have 18 clinic visits, 34 phone/video calls with the study doctor, and 4 contacts with the site that can either be clinic visits or phone/video calls.
At 11 clinic visits participants will have blood samples taken. At 7 clinic visits participants cannot eat or drink (except for water) for 8 hours before the visit.
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
- 683
- 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% (53.0 - 85.8 mmol/mol) (both inclusive) as assessed by central laboratory on the day of screening.
- Insulin naïve. The following exceptions are permitted: short term insulin treatment for a maximum of 14 days before screening and/or prior insulin treatment for gestational diabetes.
- Treated with stable doses of daily or weekly GLP-1 receptor agonist (excluding once weekly semaglutide with doses higher than 1.0 mg) according to local label for the treatment of diabetes for 90 days or more before screening. The treatment can be with or without any of the following anti diabetic drugs with stable doses for 90 days or more before screening: Metformin - Sulfonylureas (Sulfonylureas, meglitinides (glinides) and DPP 4 inhibitors must be discontinued at randomisation) - Meglitinides (glinides)(Sulfonylureas, meglitinides (glinides) and DPP 4 inhibitors must be discontinued at randomisation) - DPP 4 inhibitors (Sulfonylureas, meglitinides (glinides) and DPP 4 inhibitors must be discontinued at randomisation) - Sodium glucose co transporter 2 inhibitors - Alpha-glucosidase inhibitors - Thiazolidinediones - Marketed oral combination products only including the products listed above.
- Body mass index (BMI) below or equal to 40.0 kg/m^2.
- 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 (as declared by the participant or in the medical records) of diabetic ketoacidosis within 90 days before screening.
- 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.
- 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 get once weekly dose Semaglutide Semaglutide 1 mg Participants will get once weekly dose
- Primary Outcome Measures
Name Time Method Change From Baseline in Glycosylated Haemoglobin (HbA1c) Baseline (week 0), (week 52) Change from baseline (week 0) to week 52 in HbA1c is presented.The outcome measure was evaluated based on the data from in study period, where all data from randomisation until last date of any of the following: 1) last direct participant-site contact; 2) participants who withdrew their informed consent; 3) last participant-investigator contact as defined by the investigator for participants who lost to follow-up (i.e. possibly an unscheduled phone visit); 4) death of participants who died before any of the above.
- Secondary Outcome Measures
Name Time Method Change From Baseline in Fasting Plasma Glucose (FPG) Baseline (week 0), (week 52) Change from baseline (week 0) to week 52 in FPG is presented.The outcome measure was evaluated based on the data from in study period, where all data from randomisation until last date of any of the following: 1) last direct participant-site contact; 2) participants who withdrew their informed consent; 3) last participant-investigator contact as defined by the investigator for participants who lost to follow-up (i.e. possibly an unscheduled phone visit); 4) death of participants who died before any of the above.
Change From Baseline in Body Weight Baseline (week 0), (week 52) Change from baseline (week 0) to week 52 in body weight is presented. The outcome measure was evaluated based on the data from in study period, where all data from randomisation until last date of any of the following: 1) last direct participant-site contact; 2) participants who withdrew their informed consent; 3) last participant-investigator contact as defined by the investigator for participants who lost to follow-up (i.e. possibly an unscheduled phone visit); 4) death of participants who died before any of the above.
Number of Clinically Significant Hypoglycaemic Episodes (Level 2) (<3.0 mmol/L (54 mg/dL), Confirmed by BG Meter) Week 0 to Week 57 Hypoglycaemic episodes were classified according to the American Diabetes Association/ International Hypoglycaemia Study Group, where glycemic criteria for level 2 was \< 3.0 mmol/L (54 mg/dL). The outcome measure was evaluated based on data from on treatment period, where all data from date of first dose of randomised treatment as recorded on the electronic case report form (eCRF) until the first date of any of the following: 1)last follow-up visit (V56); 2) last date on randomised treatment +6 weeks (corresponding to 5 weeks after the end of the dosing interval for both treatment arms); 3) end-date for the in-study data points sets.
Number of Clinically Significant Hypoglycaemic Episodes (Level 2) (<3.0 mmol/L (54 Milligram Per Decilitre [mg/dL]) , Confirmed by Blood Glucose [BG] Meter) or Severe Hypoglycaemic Episodes (Level 3) Week 0 to Week 57 Hypoglycaemic episodes were classified according to the American Diabetes Association/ International Hypoglycaemia Study Group, where glycemic criteria for level 2 was less than (\<) 3.0 mmol/L (54 mg/dL) and level 3 had no specific glucose threshold. The outcome measure was evaluated based on data from on treatment period, where all data from date of first dose of randomised treatment as recorded on the electronic case report form (eCRF) until the first date of any of the following: 1)last follow-up visit (V56); 2) last date on randomised treatment +6 weeks (corresponding to 5 weeks after the end of the dosing interval for both treatment arms); 3) end-date for the in-study data points sets.
Number of Severe Hypoglycaemic Episodes (Level 3) Week 0 to Week 57 Hypoglycaemic episodes were classified according to the American Diabetes Association/ International Hypoglycaemia Study Group, where glycemic criteria for level 3 had no specific glucose threshold.The outcome measure was evaluated based on data from on treatment period, where all data from date of first dose of randomised treatment as recorded on the electronic case report form (eCRF) until the first date of any of the following: 1)last follow-up visit (V56); 2) last date on randomised treatment +6 weeks (corresponding to 5 weeks after the end of the dosing interval for both treatment arms); 3) end-date for the in-study data points sets.
Trial Locations
- Locations (133)
Endeavor Health
🇺🇸Skokie, Illinois, United States
Zhu Xianyi Memorial Hospital of Tianjin Medical University-Endocrinology
🇨🇳Tianjin, Tianjin, China
Pri Med Grp dba/Gil Ctr Fam
🇺🇸Gilbert, Arizona, United States
Clinical Research Institute of Arizona
🇺🇸Sun City West, Arizona, United States
LMC Clinical Res Thornhill
🇨🇦Concord, Ontario, Canada
Premier Medical Center, Inc.
🇺🇸Toluca Lake, California, United States
Northeast Research Institute
🇺🇸Fleming Island, Florida, United States
Northeast Res Inst. Inc.
🇺🇸Jacksonville, Florida, United States
Est Cst Inst for Rsrch,Jksnvil
🇺🇸Jacksonville, Florida, United States
Anhui Provincial Hospital-Endocrinology
🇨🇳Hefei, Anhui, China
Peking University People's Hospital-Endocrinology
🇨🇳Beijing, Beijing, China
The Second Affiliated Hospital of Nanjing Medical University-Endocrinology
🇨🇳Nanjing, Jiangsu, China
Shanghai Fifth People's Hospital-Endocrinology
🇨🇳Shanghai, Shanghai, China
Valley Clinical Trials, Inc.
🇺🇸Northridge, California, 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
Florida Institute For Clinical Research
🇺🇸Orlando, Florida, United States
Oviedo Medical Research, LLC
🇺🇸Oviedo, Florida, United States
Metabolic Research Institute Inc
🇺🇸West Palm Beach, Florida, United States
Huizhou Central People's Hospital-Endocrinology
🇨🇳Huizhou, Guangdong, China
Huashan Hospital Fudan University-Endocrinology
🇨🇳Shanghai, Shanghai, China
General Hospital of Tianjin Medical University-Endocrinology
🇨🇳Tianjin, Tianjin, China
Univ of AL at Birmingham_BRM
🇺🇸Birmingham, Alabama, United States
John Muir Physicians Network
🇺🇸Concord, California, United States
Velocity Clin Res Wstlke
🇺🇸Los Angeles, California, United States
Javara/Privia Med Grp GA,LLC
🇺🇸Albany, Georgia, United States
East West Med Res Inst
🇺🇸Honolulu, Hawaii, United States
Saltzer Medical Group Research
🇺🇸Nampa, Idaho, United States
Ileana J Tandron APMC
🇺🇸Slidell, Louisiana, United States
MedStar Hlth Res Institute
🇺🇸Hyattsville, Maryland, United States
Northern Pines Hlth Ctr, PC
🇺🇸Buckley, Michigan, United States
PharmQuest Life Sciences LLC
🇺🇸Greensboro, North Carolina, United States
New Venture Medical Research
🇺🇸Wadsworth, Ohio, United States
Thomas Jefferson Univ Di Rsrch Ctr
🇺🇸Philadelphia, Pennsylvania, United States
Palm Research Center Inc-Vegas
🇺🇸Las Vegas, Nevada, United States
John J Shelmet, MD
🇺🇸Lawrenceville, New Jersey, United States
Southgate Medical Group, LLP
🇺🇸West Seneca, New York, United States
Albuquerque Clin Trials, Inc.
🇺🇸Albuquerque, New Mexico, United States
Diab & Endo Assoc of Stark Co
🇺🇸Canton, Ohio, United States
Palmetto Clinical Research
🇺🇸Summerville, South Carolina, United States
AM Diabetes And Endocrinology Center
🇺🇸Bartlett, Tennessee, United States
Chattanooga Medical Research, LLC
🇺🇸Chattanooga, Tennessee, United States
Amarillo Med Spec LLP
🇺🇸Amarillo, Texas, United States
Texas Diab & Endo, P.A.
🇺🇸Austin, Texas, United States
Texas Diabetes & Endocrinology
🇺🇸Austin, Texas, United States
Osvaldo A. Brusco MD PA
🇺🇸Corpus Christi, Texas, United States
North Texas Endocrine Center
🇺🇸Dallas, Texas, United States
UT Southwestern Med Cntr
🇺🇸Dallas, Texas, United States
Diabetes and Thyroid Ctr of FW
🇺🇸Fort Worth, Texas, United States
DCOL Ctr for Clin Res
🇺🇸Longview, Texas, United States
Texas Diabetes & Endocrinology_Round Rock
🇺🇸Round Rock, Texas, United States
NE Clin Res of San Antonio
🇺🇸San Antonio, Texas, United States
Sugar Lakes Family Practice PA
🇺🇸Sugar Land, Texas, United States
Chrysalis Clinical Research
🇺🇸Saint George, Utah, United States
Javara Inc. / Privia Medical Group LLC_Forest
🇺🇸Forest, Virginia, United States
Javara Inc/Privia Md GpLLC Fst
🇺🇸Forest, Virginia, United States
TPMG Clinical Research
🇺🇸Newport News, Virginia, United States
Centro de Diabetes Metabolismo e Endocrinologia
🇧🇷Fortaleza, Ceara, Brazil
Western Univ. Cnt for Studies in Fam Med
🇨🇦London, Ontario, Canada
Centre Hospitalier Universitaire de Rouen - Hopital de Bois Guillaume
🇫🇷Bois-Guillaume, France
Les Hopitaux de Chartres-Hopital Louis Pasteur
🇫🇷Le Coudray, France
Instituto de Ciências Farmacêuticas de Estudos e Pesquisas
🇧🇷Aparecida de Goiania, Goias, Brazil
Quanta Diagnóstico Nuclear / Medicina Nuclear Alto da XV
🇧🇷Curitiba, Parana, Brazil
Instituto São José dos Campos em Pesquisas Médicas
🇧🇷São José dos Campos, Sao Paulo, Brazil
Centro de Diabetes Curitiba
🇧🇷Curitiba, Parana, Brazil
BR Trials - Ensaios Clínicos e Consultoria Ltda.
🇧🇷São Paulo, Sao Paulo, Brazil
Medical Trust Clinics, Inc.
🇨🇦Courtice, Ontario, Canada
Wharton Med Clin Trials
🇨🇦Hamilton, Ontario, Canada
Bluewater Clin Res Group,Inc
🇨🇦Sarnia, Ontario, Canada
Recherche GCP Research
🇨🇦Montreal, Quebec, Canada
Recherche Clinique Sigma inc
🇨🇦Quebec, Canada
Iatriko Psychicou Private Clinic
🇬🇷Athens, Greece
Evangelismos Hospital
🇬🇷Athens, Greece
LMC Endo Centres Ltd.(Bayview)
🇨🇦Toronto, Ontario, Canada
LMC Clin Rsrch Inc. (Montreal)
🇨🇦Saint-Laurent, Quebec, Canada
Chongqing University Three Gorges Hospital
🇨🇳ChongQing, Chongqing, China
Changzhou No.2 People's Hospital, Yanghu Branch
🇨🇳Changzhou, Jiangsu, China
Jinan Central Hospital
🇨🇳Ji'nan, Shandong, China
Shanghai Huashan Hospital, Affiliated to Fudan University
🇨🇳Shanghai, Shanghai, China
Centre Hospitalier Universitaire de Nantes-Hopital Nord Laennec-1
🇫🇷Saint Herblain, France
Groupe Sos Sante-Hopital Le Creusot-Hotel Dieu-1
🇫🇷Le Creusot, France
Centre Hospitalier Universitaire de Toulouse-Hopital Rangueil-2
🇫🇷Toulouse, France
Centre de Recherche Clinique Portes Du Sud
🇫🇷Venissieux, France
'G. Gennimatas' General Hospital of Athens
🇬🇷Athens, Greece
Univ Gen Hospital Larisa, Endocrinology & Metabolic Disease
🇬🇷Larissa, Greece
General Hospital of Thessaloniki 'G. Gennimatas
🇬🇷Thessaloniki, Greece
"Ippokrateio" G.H. of Thessaloniki
🇬🇷Thessaloniki, Greece
"Thermi" Private Hosital
🇬🇷Thessaloniki, Greece
General Hospital of Thessaloniki "G.Papanikolaou"
🇬🇷Thessaloniki, Greece
PTE-AOK II. Belgyogyaszati Klinika es Nephrologiai Centrum
🇭🇺Pécs, Baranya Vármegye, Hungary
Debreceni Egyetem Belgyógyászati Klinika
🇭🇺Debrecen, Hajdu-Bihar, Hungary
Debreceni Egyetem Klinikai Központ Belgyógyászati Klinika D épület
🇭🇺Debrecen, Hajdu-Bihar, Hungary
MED-TIMA Kft.
🇭🇺Budapest, Hungary
Linn clinic - Clalit Health Services
🇮🇱Haifa, Israel
Clalit sick fund Herzlia
🇮🇱Herzlia, Israel
Diabetes Clinic Wolfson MC
🇮🇱Holon, Israel
Diabetes Unit Hadassah Ein Karem MC
🇮🇱Jerusalem, Israel
Diabetes Clinic Meir MC
🇮🇱Kfar Saba, Israel
Endrocrinolgy Clinic - Sheba Medical Center
🇮🇱Tel Hashomer, Israel
Heiwadai Hospital
🇯🇵Miyazaki-shi, Miyazaki, Japan
The Institute of Medical Science, Asahi Life Foundation
🇯🇵Chuo-ku, Tokyo, Japan
Futata Tetsuhiro Clinic Meinohama
🇯🇵Fukuoka-shi, Fukuoka, Japan
Gifu University Hospital
🇯🇵Gifu, Japan
Naka Kinen Clinic
🇯🇵Ibaraki, Japan
Takatsuki Red Cross Hospital
🇯🇵Osaka, Japan
Shimizu Clinic Fusa
🇯🇵Saitama, Japan
Soka Sugiura Internal Medicine Clinic_Internal Medicine
🇯🇵Saitama, Japan
Shinden Higashi Clinic
🇯🇵Sendai-shi, Miyagi, Japan
Irkutsk State Medical Academy of Postgraduate Education
🇷🇺Irkutsk, Russian Federation
National Medical Research Center of Endocrinology
🇷🇺Moscow, Russian Federation
Limited Law Company "Healthy Family" Medicine Center"
🇷🇺Novosibirsk, Russian Federation
BHI of Omsk Region "City Hospital № 3"
🇷🇺Omsk, Russian Federation
Penza Regional Clinical Hospital named after N.N. Burdenko
🇷🇺Penza, Russian Federation
Rostov State Medical University_Rostov-on-Don
🇷🇺Rostov-on-Don, Russian Federation
Polyclinic #2 in Yoshkar-Ola
🇷🇺Yoshkar-Ola, Russian Federation
DIOLI s.r.o.
🇸🇰Kosice, Slovakia
HUMAN-CARE s.r.o.
🇸🇰Kosice, Slovakia
Diabetologicka ambulancia DIADAN, s.r.o. Kosice
🇸🇰Kosice, Slovakia
FNsP L. Pasteura
🇸🇰Kosice, Slovakia
DIA - KONTROL s.r.o.
🇸🇰Levice, Slovakia
MUDr. Alena Lomencikova, s.r.o
🇸🇰Turcianske Teplice, Slovakia
Primary Care Trial Center, PTC ,Gothia Forum
🇸🇪Göteborg, Sweden
Centrum for Diabetes, Academical Specialist Centrum
🇸🇪Stockholm, Sweden
Enheten för Kliniska Studier (EKS), Örebro
🇸🇪Örebro, Sweden
Luzerner Kantonsspital
🇨🇭Luzern 16, Switzerland
Kantonsspital Olten
🇨🇭Olten, Switzerland
Diabetes Adipositas Zentrum Zürich
🇨🇭Zollikerberg, Switzerland
Chung Shan Medical University Hospital
🇨🇳Taichung City, Taiwan
National Cheng Kung University Hospital
🇨🇳Tainan City, Taiwan
Chi Mei Medical Center
🇨🇳Tainan City, Taiwan
Taipei Veterans General Hospital
🇨🇳Taipei, Taiwan
Chang Gung Medical Foundation - Linkou Branch
🇨🇳Taoyuan city, Taiwan