Phase
Condition
Diabetes Prevention
Diabetes And Hypertension
Diabetes Mellitus Types I And Ii
Treatment
IcoSema
Insulin glargine
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Male or female and age above or equal to 18 years at the time of signing theinformed consent.
Diagnosed with T2D greater than or equal to (≥) 180 days before screening.
HbA1c ≥ 8.0% (≥ 64.0 millimoles per mole [mmol/mol]) as assessed by centrallaboratory on the day of screening.
Insulin naïve. Short term insulin treatment for a maximum of 14 consecutive daysbefore screening is allowed, as is prior insulin treatment for gestational diabetes.
Currently treated with 1-3 oral anti diabetic drug (OADs) with stable daily doses ≥ 90 days before screening comprising any of the following anti diabetic drug(s) ateffective or maximum tolerated dose.
Metformin
Sulfonylureas
Meglitinides (glinides)
Dipeptidyl peptidase (DPP) 4 inhibitors
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 kilogram per square meter (kg/m^2).
Exclusion
Exclusion Criteria:
Female who is pregnant, breast-feeding or intends to become pregnant or is ofchildbaring potential and not using highly effective contraceptive method.
Anticipated initiation or change in concomitant medication (for more than 14consecutive days) known to affect weight or glucose metabolism (e.g. treatment withorlistat, thyroid hormones, or systemic corticosteroids).
Any episodes of diabetic ketoacidosis or treatment with any medication for theindication of diabetes or obesity other than stated in the inclusion criteria within 90 days before screening.
Presence or history of pancreatitis (acute or chronic) within 180 days beforescreening.
Any of the following: Myocardial infarction, stroke, hospitalization for unstableangina pectoris or transient ischaemic attack within 180 days before screening.
Chronic heart failure classified as being in New York Heart Association Class IV atscreening.
Recurrent severe hypoglycaemic episodes within the last year (12 months) as judgedby the investigator.
Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verifiedby a fundus examination performed within the past 90 days before screening or in theperiod between screening and randomisation. Pharmacological pupil dilation is arequirement unless using a digital fundus photography camera specified for nondilated examination.
Study Design
Connect with a study center
Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing 100050
ChinaSite Not Available
Beijing Friendship Hospital, Capital Medical University-Endocrinology
Beijing, Beijing 100050
ChinaSite Not Available
Peking University People's Hospital
Beijing, Beijing 100044
ChinaSite Not Available
Peking University People's Hospital-Endocrinology
Beijing, Beijing 100044
ChinaSite Not Available
Chongqing University Three Gorges Hospital
Chongqing, Chongqing 404000
ChinaSite Not Available
Huizhou Central People's Hospital
Huizhou, Guangdong 516001
ChinaSite Not Available
Huizhou Central People's Hospital-Endocrinology
Huizhou, Guangdong 516001
ChinaSite Not Available
The Second Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu 210011
ChinaSite Not Available
The Affiliated Hospital of Jiangsu University
Zhenjiang, Jiangsu 212001
ChinaSite Not Available
Jinan Central Hospital
Jinan, Shandong 250013
ChinaSite Not Available
Shanghai Pudong New Area People's Hospital
Shanghai, Shanghai 201200
ChinaSite Not Available
Shanghai Pudong New Area People's Hospital-Endocrinology
Shanghai, Shanghai 201200
ChinaSite Not Available
Harrison International Peace Hospital
Hengshui, 053000
ChinaSite Not Available
"Laiko" General Hospital of Athens
Athens, 11527
GreeceSite Not Available
'G. Gennimatas' General Hospital of Athens
Athens, 115 27
GreeceSite Not Available
Evangelismos Hospital
Athens, 10676
GreeceSite Not Available
General Hospital of Kalamata
Kalamata, 24100
GreeceSite Not Available
Univ Gen Hospital Larisa, Endocrinology & Metabolic Disease
Larissa, 41110
GreeceSite Not Available
"Thermi" Private Hosital
Thessaloniki, 57001
GreeceSite Not Available
Ramaiah Memorial Hospital
Bangalore, Karnataka 560054
IndiaSite Not Available
Mysore Medical College and Research Institute
Mysore, Karnataka 570001
IndiaSite Not Available
BSES MG hospital
Mumbai, Maharashtra 400058
IndiaSite Not Available
BYL Nair Hospital and T N Medical College Department of endo
Mumbai, Maharashtra 400008
IndiaSite Not Available
Seth GS Medical College & KEM Hospital
Mumbai, Maharashtra 400012
IndiaSite Not Available
Chellaram Diabetes Institute
Pune, Maharashtra 411021
IndiaSite Not Available
Diabetes, Thyroid and Endocrine Centre
Jaipur, Rajasthan 302006
IndiaSite Not Available
J K Lon Hospital, SMS Medical College & Attached Hospitals
Jaipur, Rajasthan 302004
IndiaSite Not Available
SMS Medical College & Hospital
Jaipur, Rajasthan 302004
IndiaSite Not Available
Madras Diabetes Research Foundation
Chennai, Tamil Nadu 600086
IndiaSite Not Available
Udyaan Health Care
Lucknow, Uttar Pradesh 226002
IndiaSite Not Available
Post Graduate Institute of Medical Education & Research
Chandigarh, 160012
IndiaSite Not Available
IPGME&R and SSKM Hospital
Kolkata, 700020
IndiaSite Not Available
Ospedale San Salvatore, Dipartimento Medico ASL1 Abruzzo, UOC Diabetologia
L'Aquila, Abbruzzo 67100
ItalySite Not Available
Casa Sollievo della Sofferenza reparto endocrinologia
San Giovanni Rotondo, FG 71013
ItalySite Not Available
I.N.R.C.A. Istituto Nazionale di Riposo E Cura Per Gli Anziani
Ancona, 60127
ItalySite Not Available
Casa della Salute di Ceccano (FR)
Ceccano (Frosinone), 03023
ItalySite Not Available
ASL 4 Chiavarese
Chiavari (genova), 16043
ItalySite Not Available
ASST Grande Ospedale Metropolitano Niguarda
Milano, 20162
ItalySite Not Available
Azienda Ospedaliera di Perugia;Ospedale S. Maria della Miser
Perugia, 06129
ItalyActive - Recruiting
Azienda Ospedaliera di Perugia;Ospedale S. Maria della Misericordia
Perugia, 06129
ItalySite Not Available
A.O.U. Policlinico Umberto I
Rome, 00161
ItalySite Not Available
Heiwadai Hospital
Miyazaki-shi, Miyazaki 880-0034
JapanSite Not Available
Tokuyama clinic
Chiba, 261-0004
JapanSite Not Available
Oodouri Diabetes, Internal medicine Clinic
Hokkaido, 060-0001
JapanSite Not Available
Oyama East Clinic
Tochigi, 323-0022
JapanSite Not Available
Fukuwa Clinic
Tokyo, 104-0031
JapanSite Not Available
Juntendo University Hospital
Tokyo, 113-8431
JapanSite Not Available
Tokyo-Eki Center-building Clinic
Tokyo, 103-0027
JapanSite Not Available
NZOZ Specjalistyczny Osrodek Internistyczno-Diabetologiczny Małgorzata Arciszewska
Bialystok, Podlaskie 15-435
PolandSite Not Available
Velocity Nova Sp. z o.o.
Staszow, Świętokrzyskie 28-200
PolandSite Not Available
SNZOZ Lege Artis
Bialystok, 15-404
PolandSite Not Available
Uniwersyteckie Centrum Kliniczne Regionalne Centrum Diabetologii
Gdansk, 80-214
PolandSite Not Available
Grazyna Pulka Specjalistyczny Osrodek "All-Med"
Krakow, 30-033
PolandSite Not Available
Centrum Terapii Wspolczesnej
Lodz, 90-338
PolandSite Not Available
Centrum Terapii Współczesnej J.M. Jasnorzewska S.K.A.
Lodz, 90-338
PolandSite Not Available
Gabinet Lekarski Malgorzata Saryusz-Wolska
Lodz, 90-132
PolandSite Not Available
Ko-Med Nova Sp.zo.o. Lublin II
Lublin, 20-362
PolandSite Not Available
Velocity Nova Sp. z o.o.
Lublin, 20-362
PolandSite Not Available
Ko-Med Nova Sp.zo.o. STASZOW
Staszow, 28-200
PolandActive - Recruiting
NBR Polska Tomasz Klodawski
Warszawa, 00-710
PolandSite Not Available
PANSTWOWY INSTYTUT MEDYCZNY MSWiA
Warszawa, 02-507
PolandSite Not Available
Clinhouse Centrum Medyczne
Zabrze, 41-807
PolandSite Not Available
Advanced Clinical Research LLC
Bayamon, 00959
Puerto RicoSite Not Available
Dr R Dulabh
Johannesburg, Gauteng 1812
South AfricaSite Not Available
Newtown Clinical Research
Johannesburg, Gauteng 2001
South AfricaSite Not Available
Roodepoort Medicross Clinical Research Centre
Roodepoort, Gauteng 1724
South AfricaSite Not Available
Clinical Research Institute of South Africa
KwaDukuza, KwaZulu Natal 4449
South AfricaSite Not Available
Dr Pillay's Rooms
Durban, KwaZulu-Natal 4450
South AfricaSite Not Available
Langeberg Clinical Trials
Cape Town, Western Cape 7572
South AfricaSite Not Available
Akdeniz University Tip Fakultesi Hastanesi
Antalya, 07058
TurkeySite Not Available
Basaksehir Cam ve Sakura Sehir Hastanesi
Istanbul, 34480
TurkeySite Not Available
Istanbul Universitesi Istanbul Tip Fakultesi - Endokrinoloji
Istanbul, 34390
TurkeySite Not Available
Seyrantepe Hamidiye Etfal Egitim ve Arastirma Hastanesi
Istanbul, 34371
TurkeySite Not Available
Sisli Etfal Egitim ve Arastirma Hastanesi-Nefroloji
Istanbul, 34360
TurkeySite Not Available
T.C. Saglik Bakanligi Pendik Egitim ve Arastirma Hastanesi
Istanbul, 34899
TurkeySite Not Available
Tekirdag Namık Kemal UTF
Tekirdag, 59030
TurkeySite Not Available
Scripps Whittier Diabetes Inst
La Jolla, California 92037
United StatesSite Not Available
First Valley Med Grp Lancaster
Lancaster, California 93534
United StatesSite Not Available
Clinical Trials Research_Sacramento
Lincoln, California 95648
United StatesSite Not Available
Desert Oasis Hlthcr Med Group
Palm Springs, California 92262
United StatesSite Not Available
Clinical Trials Research_Sacramento
Sacramento, California 95821
United StatesSite Not Available
Northeast Research Institute
Fleming Island, Florida 32003
United StatesSite Not Available
Clinical Research of Cent FL
Winter Haven, Florida 33880
United StatesSite Not Available
Clinical Research of Central Florida_Winter Haven
Winter Haven, Florida 33880
United StatesSite Not Available
Atlanta Diabetes Associates
Atlanta, Georgia 30318
United StatesSite Not Available
Endo Res Solutions Inc
Roswell, Georgia 30076
United StatesSite Not Available
Elite Clinical Trials
Blackfoot, Idaho 83221
United StatesSite Not Available
Cedar-Crosse Research Center
Chicago, Illinois 60607
United StatesSite Not Available
Endeavor Health
Skokie, Illinois 60077
United StatesSite Not Available
NorthShore Univ Hlth Sys
Skokie, Illinois 60077
United StatesSite Not Available
Cotton-O'Neil Diab & Endo Ctr
Topeka, Kansas 66606
United StatesSite Not Available
Methodist Phys. Clinic
Omaha, Nebraska 68114
United StatesSite Not Available
Methodist Physicians Clinic Diabetes and Endocrinology Specialists
Omaha, Nebraska 68114
United StatesSite Not Available
Albuquerque Clin Trials, Inc.
Albuquerque, New Mexico 87102
United StatesSite Not Available
Albany Medical College - Endo
Albany, New York 12206
United StatesSite Not Available
Southgate Medical Group, LLP
West Seneca, New York 14224
United StatesSite Not Available
Physician's East Endocrinology
Greenville, North Carolina 27834
United StatesSite Not Available
Diab & Endo Assoc of Stark Co
Canton, Ohio 44718
United StatesSite Not Available
Advanced Medical Research
Maumee, Ohio 43537
United StatesSite Not Available
New Venture Medical Research
Wadsworth, Ohio 44281-9236
United StatesSite Not Available
Holston Medical Group
Kingsport, Tennessee 37660
United StatesSite Not Available
Amarillo Med Spec LLP
Amarillo, Texas 79106
United StatesSite Not Available
Velocity Clinical Research- Cedar Park
Austin, Texas 78759
United StatesSite Not Available
Velocity Clinical Research- Cedar Park
Cedar Park, Texas 78613
United StatesSite Not Available
North Texas Endocrine Center
Dallas, Texas 75231
United StatesSite Not Available
Velocity Clinical Res-Dallas
Dallas, Texas 75230
United StatesSite Not Available
Diabetes and Thyroid Ctr of FW
Fort Worth, Texas 76132
United StatesSite Not Available
Fmc Science, Llc
Lampasas, Texas 76550
United StatesSite Not Available
Flourish Research
San Antonio, Texas 78229
United StatesSite Not Available
Quality Research Inc
San Antonio, Texas 78209
United StatesSite Not Available
Consano Clinical Research, LLC
Shavano Park, Texas 78231
United StatesSite Not Available
Wade Family Medicine
Bountiful, Utah 84010
United StatesSite Not Available
TPMG Clinical Research
Newport News, Virginia 23606
United StatesSite Not Available
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