Phase
Condition
Diabetes Mellitus, Type 2
Diabetic Macular Edema
Diabetic Vitreous Hemorrhage
Treatment
Insulin Degludec
Insulin Efsitora Alfa
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Have diagnosis of Type 2 diabetes (T2D) according to the World Health OrganizationCriteria
Have an Hemoglobin A1c (HbA1c) of 7.0 percent (%) - 10.5% inclusive, at screening
Are on a stable treatment with 1 to 3 antihyperglycemic medication for at least 3months prior to screening and willing to continue the stable treatment for theduration of the study
These antihyperglycemic medications are accepted in the study
dipeptidyl peptidase-4 (DPP-4) inhibitors
sodium-glucose cotransporter 2 (SGLT2) inhibitors
biguanides, such as metformin
alpha-glucosidase inhibitors
glucagon-like peptide-1 (GLP-1) receptor agonists, oral or injectable
Sulfonylureas, or
Thiazolidinediones.
Are insulin naïve.
Exceptions:
short-term insulin treatment for a maximum of 14 days, prior to screening, and priorinsulin treatment for gestational diabetes
Have a body mass index of less than or equal to (≤) 45 kilogram/square meter (kg/m²).
Exclusion
Exclusion Criteria:
Have a diagnosis of Type 1 diabetes (T1D), latent autoimmune diabetes, or a specifictype of diabetes other than T2D, for example, monogenic diabetes, diseases of theexocrine pancreas, or drug-induced or chemical-induced diabetes.
Have a history of greater than (>) 1 episode of ketoacidosis or hyperosmolar stateor coma requiring hospitalization within 6 months prior to screening. Have hadsevere hypoglycemia episodes within 6 months prior to screening. Have a history ofrenal transplantation, are currently receiving renal dialysis, or have an estimatedglomerular filtration rate.
Have known hemoglobinopathy, hemolytic anemia or sickle cell anemia, or any othertraits of hemoglobin abnormalities known to interfere with the measurement of HbA1c.
Have had New York Heart Association Class IV heart failure or any of thesecardiovascular conditions within 3 months prior to screening
Acute myocardial infarction
Cerebrovascular accident (stroke), or
Coronary bypass surgery.
Have had gastric bypass (bariatric) surgery, restrictive bariatric surgery, forexample Lap-Band, or sleeve gastrectomy within 1 year prior to screening
Have had significant weight gain or loss within 3 months prior to screening,for example, greater than or equal to (≥) 5%.
Study Design
Connect with a study center
CEDOES
Vitória, Espírito Santo 29055450
BrazilSite Not Available
Cline Research Center
Curitiba, Paraná 80030-480
BrazilSite Not Available
CPCLIN
Natal, Rio Grande Do Norte 01228-200
BrazilSite Not Available
Centro de Pesquisa Sao Lucas
Campinas, São Paulo 13034-685
BrazilSite Not Available
Hospital São Lucas Copacabana
Rio de Janeiro, 22061-080
BrazilSite Not Available
Hospital São Lucas de Copacabana
Rio de Janeiro, 22061-080
BrazilSite Not Available
CPCLIN
Sao Paulo, 01228-200
BrazilSite Not Available
CEPIC - Centro Paulista de Investigação Clínica
São Paulo, 04266-010
BrazilSite Not Available
CPQuali Pesquisa Clínica
São Paulo, 01228-000
BrazilSite Not Available
Hospital das Clinicas FMUSP
São Paulo, 04266-010
BrazilSite Not Available
LMC Clinical Research Inc. (Calgary)
Calgary, Alberta T2H 2G4
CanadaSite Not Available
LMC Diabetes & Endocrinology
Calgary, Alberta T2H 2G4
CanadaSite Not Available
Aggarwal and Associates Limited
Brampton, Ontario L6T 0G1
CanadaSite Not Available
LMC Clinical Research Inc. (Brampton)
Brampton, Ontario L6S 0C6
CanadaSite Not Available
LMC Diabetes & Endocrinology
Brampton, Ontario L6S 0C6
CanadaSite Not Available
LMC Clinical Research Inc. (Oakville)
Oakville, Ontario L6M 1M1
CanadaSite Not Available
LMC Clinical Research Inc. (Ottawa)
Ottawa, Ontario K2J 0V2
CanadaSite Not Available
LMC Manna Research
Ottawa, Ontario K2J 0V2
CanadaSite Not Available
Bluewater Clinical Research Group Inc.
Sarnia, Ontario N7T 4X3
CanadaSite Not Available
Centricity Research Etobicoke Endocrinology
Toronto, Ontario M9R 4E1
CanadaSite Not Available
LMC Etobicoke
Toronto, Ontario M9R 4E1
CanadaSite Not Available
Fadia El Boreky Medicine
Waterloo, Ontario N2J 1C4
CanadaSite Not Available
9109-0126 Quebec Inc.
Montreal, Quebec H4N 2W2
CanadaSite Not Available
Beijing Hospital
Beijing, Beijing 100005
ChinaSite Not Available
Beijing Pinggu District Hospital
Beijing, Beijing 101200
ChinaSite Not Available
Beijing Tsinghua Changgung Hospital
Changping, Beijing 102202
ChinaSite Not Available
Chongqing General Hospital
Chongqing, Chongqing 400014
ChinaSite Not Available
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, Guangdong 510120
ChinaSite Not Available
Cangzhou People's Hospital Medical College
Cangzhou, Hebei 061600
ChinaSite Not Available
Hebei Medical University - Harrison International Peace Hospital
Hengshui Shi, Hebei 053000
ChinaSite Not Available
The First Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang 150001
ChinaSite Not Available
The First Hospital of Harbin Medical University
Harbin, Heilongjiang 150001
ChinaSite Not Available
The Fourth Hospital of Harbin Medical University
Harbin, Heilongjiang 150001
ChinaSite Not Available
The First Affiliated Hospital of Henan University of Science &Technology
Luoyang, Henan 471003
ChinaSite Not Available
The First Affiliated Hospital of Henan University of Science &Technology
Luoyang Shi, Henan 471003
ChinaSite Not Available
The Second Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan 450014
ChinaSite Not Available
The Second Xiangya Hospital of Central South University
Changsha, Hunan 410011
ChinaSite Not Available
Xiangya Hospital Central South University
Changsha, Hunan 410008
ChinaSite Not Available
The First People's Hospital of Yueyang
Yueyang, Hunan 414000
ChinaSite Not Available
Changzhou No.2 People's Hospital
Changzhou, Jiangsu 213164
ChinaSite Not Available
Nanjing First Hospital
Nanjing, Jiangsu 210006
ChinaSite Not Available
Nanjing Medical University - Nanjing Jiangning Hospital
Nanjing, Jiangsu 211100
ChinaSite Not Available
The Second Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu 210011
ChinaSite Not Available
Nanjing First Hospital
Nanjing Shi, Jiangsu 210012
ChinaSite Not Available
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu 215006
ChinaSite Not Available
Wuxi People's Hospital
Wuxi, Jiangsu 214023
ChinaSite Not Available
The Affiliated Jiangyin Hospital of Southeast University Medical College
Wuxi Shi, Jiangsu 214400
ChinaSite Not Available
Affiliated Hospital of Jiangsu University
Zhenjiang, Jiangsu 212000
ChinaSite Not Available
The Third Hospital of Nanchang
Nanchang, Jiangxi 330009
ChinaSite Not Available
The First Hospital of Jilin University
Changchun, Jilin 130021
ChinaSite Not Available
Shengjing Hospital of China Medical University
Shenyang, Liaoning 110004
ChinaSite Not Available
Jinan Central Hospital
Jinan, Shandong 250013
ChinaSite Not Available
Shanghai 9th People hospital
Shanghai, Shanghai 200023
ChinaSite Not Available
Shanghai Putuo District Center Hospital
Shanghai, Shanghai 200062
ChinaSite Not Available
West China Hospital of Sichuan University
Cheng Du, Sichuan 610041
ChinaSite Not Available
West China Hospital, Sichuan University
Cheng Du, Sichuan 610041
ChinaSite Not Available
Chengdu Fifth People's Hospital
Chengdu, Sichuan 611130
ChinaSite Not Available
Tianjin Medical University General Hospital
Tianjin, Tianjin 300052
ChinaSite Not Available
Tianjin Medical University Zhu Xianyi Memorial Hospital
Tianjin, Tianjin 300070
ChinaSite Not Available
Zhejiang Hospital
Hangzhou, Zhejiang 310013
ChinaSite Not Available
Ningbo First Hospital
Ningbo, Zhejiang 315010
ChinaSite Not Available
INTENDIA klinika s.r.o.
Chrudim III, Chrudim 537 01
CzechiaSite Not Available
MUDr. Alena Vachova
Ceske Budejovice, Jihočeský 37011
CzechiaSite Not Available
MUDr. Tomas Edelsberger
Krnov, Moravskoslezský Kraj 79401
CzechiaSite Not Available
Diahelp s.r.o
Pardubice V, Pardubice 530 02
CzechiaSite Not Available
Milan Kvapil s.r.o., Diabetologicka ambulance
Praha, Praha 4 14900
CzechiaSite Not Available
Diacentrum Brandys n.L. s.r.o.
Brandys nad Labem, Praha-vých 25001
CzechiaSite Not Available
MUDr. Tomas Hrdina
Opocno, Rychnov Nad Kněžnou 517 73
CzechiaSite Not Available
INTENDIA klinika s.r.o.
Chrudim, 537 01
CzechiaSite Not Available
Diahelp s.r.o
Pardubice, 530 02
CzechiaSite Not Available
Praxis Sauter & Sauter & Vorbach
Wangen im Allgäu, Baden-Württemberg 88239
GermanySite Not Available
InnoDiab Forschung Gmbh
Essen, Nordrhein-Westfalen 45136
GermanySite Not Available
Medizentrum Essen Borbeck
Essen, Nordrhein-Westfalen 45355
GermanySite Not Available
Diabetologikum Ludwigshafen/Die Praxis am Ludwigsplatz
Ludwigshafen am Rhein, Rheinland-Pfalz 67059
GermanySite Not Available
Zentrum für klinische Studien
Saint Ingbert, Saarland 66386
GermanySite Not Available
Zentrum für klinische Studien
Sankt Ingbert, Saarland 66386
GermanySite Not Available
Universitaetsklinikum Carl Gustav Carus Dresden
Dresden, Sachsen 01307
GermanySite Not Available
RED-Institut GmbH
Oldenburg, Schleswig-Holstein 23758
GermanySite Not Available
Diabeteszentrum Hamburg West
Hamburg, 22607
GermanySite Not Available
Praxis Sauter & Sauter & Vorbach
Wangen, 88239
GermanySite Not Available
Alexandra General Hospital of Athens
Athens, Attikí 11528
GreeceSite Not Available
Alexandra Hospital
Athens, Attikí 11528
GreeceSite Not Available
Iatriko Paleou Falirou Medical Center
Palaió Fáliro, Attikí (Region) 17562
GreeceSite Not Available
Iatriko Paleou Falirou Medical Center
Paleo Faliro, Attikí (Region) 17562
GreeceSite Not Available
Thermi Clinic
Thermi,Thessaloniki, Thessaloníki 570 01
GreeceSite Not Available
Thermi Clinic
Thessaloniki, Thessaloníki 570 01
GreeceSite Not Available
Athens Euroclinic
Athens, 115 21
GreeceSite Not Available
Tosaki Clinic for Diabetes and Endocrinology
Nagoya, Aichi 468-0009
JapanSite Not Available
Tosaki Clinic for Diabetes and Endocrinology
Nagoya-shi, Aichi 468-0009
JapanSite Not Available
Kashiwa City Hospital
Kashiwa, Chiba 277-0825
JapanSite Not Available
Tokuyama Clinic
Mihama-ku,Chiba City, Chiba 261-0004
JapanSite Not Available
Nippon Kokan Fukuyama Hospital
Fukuyama-shi, Hiroshima 721-0927
JapanSite Not Available
Hasegawa Medical Clinic
Chitose, Hokkaido 066-0032
JapanSite Not Available
Manda Memorial Hospital
Sapporo, Hokkaido 060-0062
JapanSite Not Available
MinamiAkatsukaClinic
Mito, Ibaraki 311-4153
JapanSite Not Available
Nakakinen clinic
Naka, Ibaraki 311-0113
JapanSite Not Available
Hayashi Diabetes Internal Medicine Clinic
Chigasaki, Kanagawa 253-0044
JapanSite Not Available
Medical Corporation Yuga Tsuruma Kaneshiro Diabetes Clinic
Yamato-shi, Kanagawa 242-0004
JapanSite Not Available
Shimizu Clinic Fusa
Saitama-shi, Saitama 336-0967
JapanSite Not Available
Oyama East Clinic
Oyama, Tochigi 323-0022
JapanSite Not Available
Kumanomae Nishimura Clinic
Arakawa-ku, Tokyo 116-0012
JapanSite Not Available
Fukuwa Clinic
Chuo-ku, Tokyo 104-0031
JapanSite Not Available
Tokyo-Eki Center-building Clinic
Chuo-ku, Tokyo 103-0027
JapanSite Not Available
Hachioji Diabetes Clinic
Hachioji, Tokyo 192-0083
JapanSite Not Available
Hachioji Diabetes Clinic
Hachioji-shi, Tokyo 192-0083
JapanSite Not Available
Medical Corporation Sato Medical clinic
Ootaku, Tokyo 143-0015
JapanSite Not Available
Tomonaga Clinic
Shinjuku, Tokyo 160-0022
JapanSite Not Available
Medical Corporation Sato Medical clinic
Ōtake, Tokyo 143-0015
JapanSite Not Available
Tokuyama Clinic
Chiba, 261-0004
JapanSite Not Available
Jinnouchi Hospital
Kumamoto, 862-0976
JapanSite Not Available
Yoshimura Clinic
Kumamoto, 861-8039
JapanSite Not Available
Abe Clinic
Oita, 870-0039
JapanSite Not Available
Kangwon National University Hospital
Chuncheon, Kang-won-do 24289
Korea, Republic ofSite Not Available
Kangwon National University Hospital
Chuncheon-si, Kang-won-do 24289
Korea, Republic ofSite Not Available
Hanyang University Guri Hospital
Guri-si, Kyǒnggi-do 11923
Korea, Republic ofSite Not Available
Severance Hospital, Yonsei University Health System
Seoul, Seoul-teuk 03722
Korea, Republic ofSite Not Available
Hospital Universitario "Dr. Jose Eleuterio Gonzalez"
Monterrey, Nuevo León 66460
MexicoSite Not Available
Investigacion En Salud Y Metabolismo Sc
Chihuahua, 31217
MexicoSite Not Available
Centro de Endocrinologia y Nutricion
Caguas, 00725
Puerto RicoSite Not Available
Isis Clinical Research Center
Guaynabo, 00970
Puerto RicoSite Not Available
Private Practice - Dr. Paola Mansilla-Letelier
Guaynabo, 00970
Puerto RicoSite Not Available
Neighborhood Healthcare Institute of Health
Escondido, California 92025
United StatesSite Not Available
Valley Research
Fresno, California 93720
United StatesSite Not Available
NorCal Medical Research, Inc
Greenbrae, California 94904
United StatesSite Not Available
Catalina Research Institute, LLC
Montclair, California 91763
United StatesSite Not Available
Southern California Dermatology, Inc.
Santa Ana, California 92701
United StatesSite Not Available
New West Physicians Clinical Research
Golden, Colorado 80401
United StatesSite Not Available
New England Research Associates, LLC
Bridgeport, Connecticut 06606
United StatesSite Not Available
East Coast Institute for Research, LLC
Jacksonville, Florida 32204
United StatesSite Not Available
East Coast Institute for Research - Canton
Canton, Georgia 30114
United StatesSite Not Available
Rophe Adult and Pediatric Medicine/SKYCRNG
Union City, Georgia 30291
United StatesSite Not Available
Central Illinois Diabetes and Clinical Research a Division of Prairie Education and Research Cooperative
Springfield, Illinois 62711
United StatesSite Not Available
Qualmedica Research, LLC
Evansville, Indiana 47715
United StatesSite Not Available
Iowa Diabetes and Endocrinology Research Center
West Des Moines, Iowa 50265
United StatesSite Not Available
Qualmedica Research
Bowling Green, Kentucky 42101
United StatesSite Not Available
Qualmedica Research, LLC
Owensboro, Kentucky 42301
United StatesSite Not Available
MedStar Health Research Institute (MedStar Physician Based Research Network)
Hyattsville, Maryland 20782
United StatesSite Not Available
Endocrine and Metabolic Consultants
Rockville, Maryland 20852
United StatesSite Not Available
SKY Clinical Research Network Group-Quinn
Ridgeland, Mississippi 39157
United StatesSite Not Available
SKY Integrative Medical Center/SKYCRNG
Ridgeland, Mississippi 39157
United StatesSite Not Available
Clinvest Research LLC
Springfield, Missouri 65807
United StatesSite Not Available
Clarity Clinical Research
East Syracuse, New York 13057
United StatesSite Not Available
Velocity Clinical Research, Syracuse
East Syracuse, New York 13057
United StatesSite Not Available
Great Lakes Medical Research, LLC
Westfield, New York 14787
United StatesSite Not Available
Monroe Biomedical Research
Monroe, North Carolina 28112
United StatesSite Not Available
Lucas Research, Inc
Morehead City, North Carolina 28557
United StatesSite Not Available
Alliance for Multispecialty Research, LLC
Norman, Oklahoma 73069
United StatesSite Not Available
Intend Research, LLC
Norman, Oklahoma 73069
United StatesSite Not Available
Jefferson Clinical Research Institute (JCRI)
Philadelphia, Pennsylvania 19114
United StatesSite Not Available
Tribe Clinical Research, LLC
Greenville, South Carolina 29607
United StatesSite Not Available
Dallas Diabetes Research Center
Dallas, Texas 75230
United StatesSite Not Available
Velocity Clinical Research, Dallas
Dallas, Texas 75230
United StatesSite Not Available
Biopharma Informatic, LLC
Houston, Texas 77043
United StatesSite Not Available
Juno Research
Houston, Texas 77040
United StatesSite Not Available
Southern Endocrinology Associates
Mesquite, Texas 75149
United StatesSite Not Available
North Hills Family Medicine/North Hills Medical Research
North Richland Hills, Texas 76180
United StatesSite Not Available
Consano Clinical Research, LLC
Shavano Park, Texas 78231
United StatesSite Not Available
Multicare Institute for Research and Innovation
Spokane, Washington 99202
United StatesSite Not Available
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