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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)
Sponsor: Novo Nordisk A/S
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.
Official title: A 52 Week Study Comparing the Efficacy and Safety of Once Weekly IcoSema and Once Weekly Semaglutide, Both Treatment Arms With or Without Oral Anti Diabetic Drugs, in Participants With Type 2 Diabetes Inadequately Controlled With a GLP 1 Receptor Agonist. COMBINE 2
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
683
Start Date
2022-04-11
Completion Date
2024-01-16
Last Updated
2026-06-12
Healthy Volunteers
No
Conditions
Interventions
IcoSema
IcoSema once weekly subcutaneously (s.c., under the skin) using a needle and a pen. For about 1 year and 1 month.
Semaglutide 1 mg
Semaglutide once weekly subcutaneously (s.c., under the skin). Dose titrated to 1mg over 8 weeks (0.25 mg for 4 weeks, 0.5 mg for 4 weeks). For about 1 year and 1 month.
Locations (193)
Univ of AL at Birmingham_BRM
Birmingham, Alabama, United States
Pri Med Grp dba/Gil Ctr Fam
Gilbert, Arizona, United States
Phoenician Centers for Research & Innovation PCRI
Phoenix, Arizona, United States
Clinical Research Institute of Arizona
Sun City West, Arizona, United States
John Muir Physicians Network
Concord, California, United States
Scripps Whittier Diabetes Inst
La Jolla, California, United States
Clinical Trials Research_Sacramento
Lincoln, California, United States
Downtown LA Res Ctr. Inc.
Los Angeles, California, United States
Velocity Clin Res Los Angeles
Los Angeles, California, United States
Velocity Clin Res Wstlke
Los Angeles, California, United States
Valley Clinical Trials, Inc.
Northridge, California, United States
San Diego Family Care_San Diego
San Diego, California, United States
Premier Medical Center, Inc.
Toluca Lake, California, United States
Northeast Research Institute
Fleming Island, Florida, United States
Encore Medical Research LLC
Hollywood, Florida, United States
Northeast Res Inst. Inc.
Jacksonville, Florida, United States
Est Cst Inst for Rsrch,Jksnvil
Jacksonville, Florida, United States
University Of Miami
Miami, Florida, United States
South Broward Research LLC
Miramar, Florida, United States
Adult Medicine of Lake County, Inc.
Mt. Dora, Florida, United States
Clinical Neuroscience Solution
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
Javara/Privia Med Grp GA,LLC
Albany, Georgia, United States
Endo Res Solutions Inc
Roswell, Georgia, United States
East West Med Res Inst
Honolulu, Hawaii, United States
Saltzer Medical Group Research
Nampa, Idaho, United States
Cedar-Crosse Research Center
Chicago, Illinois, United States
Macoupin Research Group
Gillespie, Illinois, United States
Endeavor Health
Skokie, Illinois, United States
Central Illinois Diabetes and Clinical Research
Springfield, Illinois, United States
Velocity Clin. Res Valparaiso
Valparaiso, Indiana, United States
Iowa Diab & Endo Res Center
West Des Moines, Iowa, United States
Cotton-O'Neil Diab & Endo Ctr
Topeka, Kansas, United States
L-MARC Research Center
Louisville, Kentucky, United States
Four Rivers Clinical Research Inc
Paducah, Kentucky, United States
Ileana J Tandron APMC
Slidell, Louisiana, United States
MedStar Hlth Res Institute
Hyattsville, Maryland, United States
ActivMed Practice & Research LLC
Methuen, Massachusetts, United States
Northern Pines Hlth Ctr, PC
Buckley, Michigan, United States
Univ of Nebraska Medical CTR
Omaha, Nebraska, United States
Palm Research Center Inc-Vegas
Las Vegas, Nevada, United States
Southern New Hampshire Diabete
Nashua, New Hampshire, United States
John J Shelmet, MD
Lawrenceville, New Jersey, United States
Albuquerque Clin Trials, Inc.
Albuquerque, New Mexico, United States
Endocrine Associates of Long Island, PC
Smithtown, New York, United States
Southgate Medical Group, LLP
West Seneca, New York, United States
PharmQuest Life Sciences LLC
Greensboro, North Carolina, United States
Accellacare
Wilmington, North Carolina, United States
Diab & Endo Assoc of Stark Co
Canton, Ohio, United States
New Venture Medical Research
Wadsworth, Ohio, United States
Thomas Jefferson Univ Di Rsrch Ctr
Philadelphia, Pennsylvania, United States
Hillcrest Clinical Research
Simpsonville, South Carolina, 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
Corpus Christi, Texas, United States
Cedar Research
Dallas, 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
PrimeCare Medical Group
Houston, 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
Hillcrest Family Health Center
Waco, Texas, United States
Wade Family Medicine
Bountiful, Utah, United States
Chrysalis Clinical Research
St. 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 Estudos Em Diabetes E Hipertensão
Fortaleza, Ceará, Brazil
Centro de Diabetes Metabolismo e Endocrinologia
Fortaleza, Ceará, Brazil
Instituto de Ciências Farmacêuticas de Estudos e Pesquisas
Aparecida de Goiânia, Goiás, Brazil
Quanta Diagnóstico Nuclear / Medicina Nuclear Alto da XV
Curitiba, Paraná, Brazil
Centro de Diabetes Curitiba
Curitiba, Paraná, Brazil
Instituto São José dos Campos em Pesquisas Médicas
São José dos Campos, São Paulo, Brazil
BR Trials - Ensaios Clínicos e Consultoria Ltda.
São Paulo, São Paulo, Brazil
BC Diabetes Canada
Vancouver, British Columbia, Canada
Rivergrove Medical Clinic
Winnipeg, Manitoba, Canada
Winnipeg Clinic
Winnipeg, Manitoba, Canada
G.A. Research Associates Ltd.
Moncton, New Brunswick, Canada
Commonwealth Medical Clinic
Mount Pearl, Newfoundland and Labrador, Canada
Dawson Clinical Research
Cambridge, Ontario, Canada
LMC Clinical Res Thornhill
Concord, Ontario, Canada
Medical Trust Clinics, Inc.
Courtice, Ontario, Canada
Wharton Medical Clinic Clinical Trials (Hamilton)
Hamilton, Ontario, Canada
Premier Clinical Trial Research Network (PCTRN)
Hamilton, Ontario, Canada
Western Univ. Cnt for Studies in Fam Med
London, Ontario, Canada
Bluewater Clin Res Group,Inc
Sarnia, Ontario, Canada
LMC Endo Centres Ltd.(Bayview)
Toronto, Ontario, Canada
ViaCar Recherche Clinique Inc
Brossard, Quebec, Canada
Recherche GCP Research
Montreal, Quebec, Canada
Recherche GCP Research
Montreal, Quebec, Canada
Recherche GCP Research_Montreal
Montreal, Quebec, Canada