Twelve -Month Study Observing How Insulin-naïve Patients With Type 2 Diabetes Mellitus Manage Diabetes Using Toujeo® After Oral Antidiabetic Drug Failure, the Side Effect of Toujeo®, and The Cost.
ATOS
A 12-month Prospective Observational Study Assessing the Real-world Clinical Effectiveness, Safety and Health-economic Benefits of Toujeo® Initiation After Oral Antidiabetic Drug Failure in Insulin-naïve Patients With Type 2 Diabetes Mellitus
2 other identifiers
observational
4,589
18 countries
388
Brief Summary
Primary Objective: Assess effectiveness of insulin glargine (U300) in achieving glycemic goal measured by hemoglobin A1c (HbA1c). Secondary Objectives:
- Assess effectiveness in achieving glycemic goal measured by HbA1c;
- Assess effectiveness on change in HbA1c, fasting plasma glucose (FPG) and self-monitored plasma glucose (SMPG) ;
- Assess requirement for intensification of therapy by additional antidiabetics.
- Assess incidence of hypoglycemia;
- Assess other safety endpoints: adverse events (AEs), serious adverse events (SAEs);
- Assess change in body weight.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2018
388 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 6, 2018
CompletedFirst Submitted
Initial submission to the registry
October 9, 2018
CompletedFirst Posted
Study publicly available on registry
October 12, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 28, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
February 24, 2020
CompletedApril 25, 2022
April 1, 2022
1.3 years
October 9, 2018
April 21, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Change in HbA1c at month 6
Percentage of patients achieving Hemoglobin A1c \<7.0%.
Baseline, month 6
Secondary Outcomes (7)
Change in HbA1c
Baseline, months 3, 6, 12
Change in fasting plasma glucose
Baseline, months 3, 6, 12
Change in Self-Monitored Plasma Glucose
Baseline, months 3, 6, 12
Hypoglycemia
Baseline to month 12
Adverse events
Baseline to month 12
- +2 more secondary outcomes
Study Arms (1)
Insulin glargine (U300)
Insulin glargine (U300) dosage and dosing time as per local product labeling
Interventions
Pharmaceutical form: Solution for injection Route of administration: Subcutaneous injection
Eligibility Criteria
Insulin-naïve patients with type 2 diabetes mellitus and Oral Antidiabetic Drug failure
You may qualify if:
- Signed patient informed consent;
- Type 2 diabetes mellitus;
- Treated with at least 1 oral antidiabetic drug (OAD) for at least 6 months;
- Hemoglobin A1c (HbA1c) \>7.0 % and ≤11% within 3 months of study baseline;
- Physicians' decision in accordance with the current local guidelines to add basal insulin glargine U300 to an existing OAD regimen
You may not qualify if:
- Diabetes mellitus other than type 2;
- Contraindication to insulin glargine U300 according to local product labelling;
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sanofilead
Study Sites (388)
Investigational Site Number 1700001
Barranquilla, Colombia
Investigational Site Number 1700004
Bogotá, Colombia
Investigational Site Number 1700010
Bogotá, Colombia
Investigational Site Number 1700005
Cali, Colombia
Investigational Site Number 1700009
Cali, Colombia
Investigational Site Number 1700003
Ibagué, Colombia
Investigational Site Number 1700007
Manizales, 170, Colombia
Investigational Site Number 1700006
Popayán, Colombia
Investigational Site Number 1700002
Zipaquirá, Colombia
Investigational Site Number 8180017
Al Mansurah, Egypt
Investigational Site Number 8180015
Alexandria, 21575, Egypt
Investigational Site Number 8180007
Alexandria, Egypt
Investigational Site Number 8180008
Alexandria, Egypt
Investigational Site Number 8180012
Alexandria, Egypt
Investigational Site Number 8180018
Alexandria, Egypt
Investigational Site Number 8180001
Cairo, Egypt
Investigational Site Number 8180005
Cairo, Egypt
Investigational Site Number 8180006
Cairo, Egypt
Investigational Site Number 8180016
Cairo, Egypt
Investigational Site Number 8180020
Cairo, Egypt
Investigational Site Number 8180003
Giza, 11535, Egypt
Investigational Site Number 8180011
Giza, 28452, Egypt
Investigational Site Number 8180002
Giza, Egypt
Investigational Site Number 8180009
Giza, Egypt
Investigational Site Number 8180014
Giza, Egypt
Investigational Site Number 8180013
Portsaeid, Egypt
Investigational Site Number 3560056
Ahmedabad, 380006, India
Investigational Site Number 3560021
Ahmedabad, 380007, India
Investigational Site Number 3560049
Ahmedabad, 380009, India
Investigational Site Number 3560077
Ahmedabad, 380009, India
Investigational Site Number 3560068
Ahmedabad, 380054, India
Investigational Site Number 3560014
Aurangabad, 431001, India
Investigational Site Number 3560081
Bangalore, 560005, India
Investigational Site Number 3560088
Bangalore, 560019, India
Investigational Site Number 3560066
Bangalore, 560078, India
Investigational Site Number 3560009
Bangalore, 560079, India
Investigational Site Number 3560059
Bangalore, India
Investigational Site Number 3560064
Bangalore, India
Investigational Site Number 3560075
Bangalore, India
Investigational Site Number 3560122
Bangalore, India
Investigational Site Number 3560044
Belagavi, India
Investigational Site Number 3560074
Bengaluru, 560003, India
Investigational Site Number 3560046
Bengaluru, 560040, India
Investigational Site Number 3560116
Bhabaneswar, 751012, India
Investigational Site Number 3560062
Bhubaneswar, 751003, India
Investigational Site Number 3560106
Chandigarh, 160012, India
Investigational Site Number 3560126
Chandigarh, 160043, India
Investigational Site Number 3560110
Chennai, 600005, India
Investigational Site Number 3560029
Chennai, 600008, India
Investigational Site Number 3560080
Chennai, 600014, India
Investigational Site Number 3560067
Chennai, 600017, India
Investigational Site Number 3560030
Chennai, 600032, India
Investigational Site Number 3560008
Chennai, 600040, India
Investigational Site Number 3560031
Chennai, 600042, India
Investigational Site Number 3560011
Chennai, 600083, India
Investigational Site Number 3560124
Chennai, 600085, India
Investigational Site Number 3560105
Chennai, 600090, India
Investigational Site Number 3560098
Chennai, 600100, India
Investigational Site Number 3560104
Chennai, 600106, India
Investigational Site Number 3560133
Chennai, India
Investigational Site Number 3560012
Coimbatore, 641004, India
Investigational Site Number 3560131
Coimbatore, 641009, India
Investigational Site Number 3560032
Delhi, 110005, India
Investigational Site Number 3560041
Delhi, 110017, India
Investigational Site Number 3560108
Delhi, 110021, India
Investigational Site Number 3560002
Delhi, 110060, India
Investigational Site Number 3560019
Delhi, 110063, India
Investigational Site Number 3560047
Delhi, 110063, India
Investigational Site Number 3560102
Delhi, 110076, India
Investigational Site Number 3560020
Delhi, 110085, India
Investigational Site Number 3560085
Delhi, 110087, India
Investigational Site Number 3560118
Erode, 638011, India
Investigational Site Number 3560051
Guwahati, 781001, India
Investigational Site Number 3560094
Guwahati, 781005, India
Investigational Site Number 3560087
Guwahati, 781006, India
Investigational Site Number 3560113
Guwahati, 781006, India
Investigational Site Number 3560070
Guwahati, 781011, India
Investigational Site Number 3560097
Guwahati, 781022, India
Investigational Site Number 3560109
Gwalior, 474001, India
Investigational Site Number 3560089
Haryāna, India
Investigational Site Number 3560135
Howrah, 711201, India
Investigational Site Number 3560096
Howrah, India
Investigational Site Number 3560045
Hyderabad, 500002, India
Investigational Site Number 3560058
Hyderabad, 500016, India
Investigational Site Number 3560036
Hyderabad, 500029, India
Investigational Site Number 3560069
Hyderabad, 500033, India
Investigational Site Number 3560035
Hyderabad, 500073, India
Investigational Site Number 3560024
Hyderabad, 500081, India
Investigational Site Number 3560027
Hyderabad, India
Investigational Site Number 3560043
Hyderabad, India
Investigational Site Number 3560100
Hyderabad, India
Investigational Site Number 3560107
Hyderabad, India
Investigational Site Number 3560034
Hyderabd, India
Investigational Site Number 3560111
Jaipur, 302015, India
Investigational Site Number 3560123
Jaipur, 302015, India
Investigational Site Number 3560134
Jaipur, 302016, India
Investigational Site Number 3560017
Jaipur, 302018, India
Investigational Site Number 3560022
Jaipur, India
Investigational Site Number 3560073
Jalandhar, 144003, India
Investigational Site Number 3560005
Kanpur, 208002, India
Investigational Site Number 3560125
Kanpur, 208002, India
Investigational Site Number 3560026
Kochi, 682019, India
Investigational Site Number 3560018
Kochi, 682020, India
Investigational Site Number 3560050
Kochi, 682041, India
Investigational Site Number 3560016
Kochi, India
Investigational Site Number 3560091
Kolkata, 700020, India
Investigational Site Number 3560083
Kolkata, India
Investigational Site Number 3560090
Kolkata, India
Investigational Site Number 3560092
Kolkata, India
Investigational Site Number 3560093
Kolkata, India
Investigational Site Number 3560099
Kolkata, India
Investigational Site Number 3560115
Kolkata, India
Investigational Site Number 3560120
Kolkata, India
Investigational Site Number 3560129
Kolkata, India
Investigational Site Number 3560130
Kolkata, India
Investigational Site Number 3650120
Kolkata, India
Investigational Site Number 3560103
Lucknow, India
Investigational Site Number 3560117
Madurai, 625020, India
Investigational Site Number 3560033
Mumbai, 400005, India
Investigational Site Number 3560121
Mumbai, 400007, India
Investigational Site Number 3560136
Mumbai, 400053, India
Investigational Site Number 3560042
Mumbai, 400064, India
Investigational Site Number 3560065
Mumbai, 400068, India
Investigational Site Number 3560015
Mumbai, 400092, India
Investigational Site Number 3560079
Mumbai, 400601, India
Investigational Site Number 3560003
Mumbai, India
Investigational Site Number 3560023
Mumbai, India
Investigational Site Number 3560040
Mumbai, India
Investigational Site Number 3560119
Mumbai, India
Investigational Site Number 3560112
Navi Mumbai, 400706, India
Investigational Site Number 3560010
Nellore, 524001, India
Investigational Site Number 3560086
Noida, India
Investigational Site Number 3560132
Noida, India
Investigational Site Number 3560053
Puducherry, 605005, India
Investigational Site Number 3560004
Pune, 411001, India
Investigational Site Number 3560038
Pune, 411004, India
Investigational Site Number 3560055
Pune, 411021, India
Investigational Site Number 3560060
Pune, 411037, India
Investigational Site Number 3560072
Rajahmundry, 533103, India
Investigational Site Number 3560025
Rajkot, 360001, India
Investigational Site Number 3560076
Rajkot, 360002, India
Investigational Site Number 3560063
Surat, India
Investigational Site Number 3560084
Tinsukia, 786125, India
Investigational Site Number 3560006
Trichy, 620017, India
Investigational Site Number 3560001
Trichy, 620018, India
Investigational Site Number 3560101
Trichy, 620018, India
Investigational Site Number 3560114
Tripura, 799001, India
Investigational Site Number 3560039
Trivandrum, 695033, India
Investigational Site Number 3560013
Trivandrum, India
Investigational Site Number 3560127
Vijayawada, 520002, India
Investigational Site Number 3560061
Visakhapatnam, 530002, India
Investigational Site Number 3560054
Visakhapatnam, 530016, India
Investigational Site Number 3560128
Yamuna Nagar, India
Investigational Site Number 3600003
Denpasar, 80234, Indonesia
Investigational Site Number 3600001
Jakarta, 10220, Indonesia
Investigational Site Number 3600002
Jakarta, 10630, Indonesia
Investigational Site Number 3760001
Haifa, Israel
Investigational Site Number 3760002
Petah Tikva, Israel
Investigational Site Number 3760005
Rishon LeZiyyon, Israel
Investigational Site Number 3760003
Tel Aviv, Israel
Investigational Site Number 3760004
Tel Aviv, Israel
Investigational Site Number 4000002
Amman, 11183, Jordan
Investigational Site Number 4000005
Amman, 11183, Jordan
Investigational Site Number 4000006
Amman, 11183, Jordan
Investigational Site Number 4000008
Amman, 11183, Jordan
Investigational Site Number 0004
Amman, Jordan
Investigational Site Number 4000009
Amman, Jordan
Investigational Site Number 0007
Irbid, 211-81, Jordan
Investigational Site Number 4140001
Al Jabriya, Kuwait
Investigational Site Number 4140010
Al Jabriya, Kuwait
Investigational Site Number 4140003
Kuwait City, Kuwait
Investigational Site Number 4140004
Kuwait City, Kuwait
Investigational Site Number 4140006
Kuwait City, Kuwait
Investigational Site Number 4140009
Kuwait City, Kuwait
Investigational Site Number 4140011
Kuwait City, Kuwait
Investigational Site Number 4140012
Kuwait City, Kuwait
Investigational Site Number 4220017
Airport Road, Lebanon
Investigational Site Number 4220008
Aley, Lebanon
Investigational Site Number 4220001
Beirut, Lebanon
Investigational Site Number 4220015
Beirut, Lebanon
Investigational Site Number 4220012
Bir Al Abed, Lebanon
Investigational Site Number 4220007
Chtoura, Lebanon
Investigational Site Number 4220011
Corniche El Mazraa, Lebanon
Investigational Site Number 4220006
El Achrafiyé, Lebanon
Investigational Site Number 4220016
El Achrafiyé, Lebanon
Investigational Site Number 4220018
Hadath, Lebanon
Investigational Site Number 4220013
Hamra, Lebanon
Investigational Site Number 4220019
Jal El Baher, Lebanon
Investigational Site Number 4220014
Jounieh, Lebanon
Investigational Site Number 4220010
Metn, Lebanon
Investigational Site Number 4220004
Mount Lebanon, Lebanon
Investigational Site Number 4220005
Saida, Lebanon
Investigational Site Number 4220003
Sarba, Lebanon
Investigational Site Number 4220009
Tyre, Lebanon
Investigational Site Number 4840001
Aguascalientes, 20230, Mexico
Investigational Site Number 4840009
Celaya, 38000, Mexico
Investigational Site Number 4840008
Chihuahua City, 31200, Mexico
Investigational Site Number 4840004
Cuernavaca, 62250, Mexico
Investigational Site Number 4840007
Durango, Mexico
Investigational Site Number 4840006
Guadalajara, 44130, Mexico
Investigational Site Number 4840003
Guadalajara, 44500, Mexico
Investigational Site Number 4840005
México, 06470, Mexico
Investigational Site Number 4840010
México, 07760, Mexico
Investigational Site Number 4840002
México, 40100, Mexico
Investigational Site Number 6040003
Arequipa, Peru
Investigational Site Number 6040001
Lima, Peru
Investigational Site Number 6040002
Lima, Peru
Investigational Site Number 6080001
Dasmarinas Cavite, 4114, Philippines
Investigational Site Number 6430108
Anapa, 353440, Russia
Investigational Site Number 6430170
Arkhangelsk, 163045, Russia
Investigational Site Number 6430171
Arkhangelsk, 163045, Russia
Investigational Site Number 6430172
Arkhangelsk, 163045, Russia
Investigational Site Number 6430019
Astrakhan, 414018, Russia
Investigational Site Number 6430010
Barnaul, 656050, Russia
Investigational Site Number 6430138
Barnaul, 656050, Russia
Investigational Site Number 6430081
Barnaul, 656056, Russia
Investigational Site Number 6430182
Barnaul, 656056, Russia
Investigational Site Number 6430160
Barnaul, 656066, Russia
Investigational Site Number 6430181
Barnaul, 656922, Russia
Investigational Site Number 6430157
Belorechensk, 352630, Russia
Investigational Site Number 6430156
Bryansk, 241047, Russia
Investigational Site Number 6430060
Chaltyr, 346801, Russia
Investigational Site Number 6430087
Cheboksary, 428009, Russia
Investigational Site Number 6430097
Chelyabinsk, 454046, Russia
Investigational Site Number 6430036
Chelyabinsk, 454076, Russia
Investigational Site Number 6430092
Chelyabinsk, 454084, Russia
Investigational Site Number 6430107
Chelyabinsk, 454091, Russia
Investigational Site Number 6430111
Gorodets, 606500, Russia
Investigational Site Number 6430012
Kazan', 420064, Russia
Investigational Site Number 6430184
Kazan', 420103, Russia
Investigational Site Number 6430011
Kemerovo, 650066, Russia
Investigational Site Number 6430109
Kemerovo, 650066, Russia
Investigational Site Number 6430072
Kemerovo, 650099, Russia
Investigational Site Number 6430125
Kolomna, 140405, Russia
Investigational Site Number 6430143
Krasnodar, 350000, Russia
Investigational Site Number 6430047
Krasnodar, 350001, Russia
Investigational Site Number 6430136
Krasnodar, 350002, Russia
Investigational Site Number 6430083
Krasnodar, 350072, Russia
Investigational Site Number 6430140
Krasnodar, 350075, Russia
Investigational Site Number 6430021
Krasnodar, 350915, Russia
Investigational Site Number 6430115
Krasnoyarsk, 660003, Russia
Investigational Site Number 6430004
Krasnoyarsk, 660052, Russia
Investigational Site Number 6430068
Lipetsk, 398043, Russia
Investigational Site Number 6430067
Lipetsk, Russia
Investigational Site Number 6430024
Livny, 303858, Russia
Investigational Site Number 6430128
Moscow, 105005, Russia
Investigational Site Number 6430168
Moscow, 105005, Russia
Investigational Site Number 6430064
Moscow, 109145, Russia
Investigational Site Number 6430065
Moscow, 109457, Russia
Investigational Site Number 6430148
Moscow, 111555, Russia
Investigational Site Number 6430079
Moscow, 115211, Russia
Investigational Site Number 6430101
Moscow, 115409, Russia
Investigational Site Number 6430100
Moscow, 115516, Russia
Investigational Site Number 6430120
Moscow, 115516, Russia
Investigational Site Number 6430130
Moscow, 115516, Russia
Investigational Site Number 6430026
Moscow, 119311, Russia
Investigational Site Number 6430005
Moscow, 121601, Russia
Investigational Site Number 6430017
Moscow, 124482, Russia
Investigational Site Number 6430027
Moscow, 125222, Russia
Investigational Site Number 6430057
Moscow, 125373, Russia
Investigational Site Number 6430035
Moscow, 127018, Russia
Investigational Site Number 6430118
Moscow, 127273, Russia
Investigational Site Number 6430146
Moscow, 127549, Russia
Investigational Site Number 6430147
Moscow, 141411, Russia
Investigational Site Number 6430051
Moscow, Russia
Investigational Site Number 6430149
Moscow, Russia
Investigational Site Number 6430132
Nizhny Novgorod, 603004, Russia
Investigational Site Number 6430066
Nizhny Novgorod, 603035, Russia
Investigational Site Number 6430129
Nizhny Novgorod, 603163, Russia
Investigational Site Number 6430110
Novomoskovsk, 301650, Russia
Investigational Site Number 6430007
Novosibirsk, 630047, Russia
Investigational Site Number 6430061
Novosibirsk, 630060, Russia
Investigational Site Number 6430023
Novosibirsk, 630106, Russia
Investigational Site Number 6430117
Omsk, 644010, Russia
Investigational Site Number 6430014
Orenburg, 460018, Russia
Investigational Site Number 6430112
Oryol, 302030, Russia
Investigational Site Number 6430137
Oryol, Russia
Investigational Site Number 6430039
Penza, 440052, Russia
Investigational Site Number 6430164
Penza, 440052, Russia
Investigational Site Number 6430126
Perm, Russia
Investigational Site Number 6430040
Petrozavodsk, 185014, Russia
Investigational Site Number 6430054
Petrozavodsk, 185014, Russia
Investigational Site Number 6430084
Petrozavodsk, 185014, Russia
Investigational Site Number 6430038
Pushkin, 196607, Russia
Investigational Site Number 6430151
Rostov-on-Don, 344029, Russia
Investigational Site Number 6430090
Rostov-on-Don, 344092, Russia
Investigational Site Number 6430037
Rybinsk, 152912, Russia
Investigational Site Number 6430086
Saint Petersburg, 19323, Russia
Investigational Site Number 6430139
Saint Petersburg, 19323, Russia
Investigational Site Number 6430022
Saint Petersburg, 193312, Russia
Investigational Site Number 6430070
Saint Petersburg, 194156, Russia
Investigational Site Number 643085
Saint Petersburg, 195220, Russia
Investigational Site Number 6430028
Saint Petersburg, 195256, Russia
Investigational Site Number 6430074
Saint Petersburg, 195256, Russia
Investigational Site Number 6430135
Saint Petersburg, 195256, Russia
Investigational Site Number 6430150
Saint Petersburg, 195256, Russia
Investigational Site Number 6430095
Saint Petersburg, 195426, Russia
Investigational Site Number 6430032
Saint Petersburg, 197082, Russia
Investigational Site Number 6430144
Saint Petersburg, 197101, Russia
Investigational Site Number 6430031
Saint Petersburg, 197341, Russia
Investigational Site Number 6430099
Saint Petersburg, 197349, Russia
Investigational Site Number 6430131
Saint Petersburg, 197349, Russia
Investigational Site Number 6430163
Saint Petersburg, 197371, Russia
Investigational Site Number 6430152
Saint Petersburg, 199155, Russia
Investigational Site Number 6430073
Sal'sk, 347630, Russia
Investigational Site Number 6430177
Samara, 443031, Russia
Investigational Site Number 6430046
Samara, 443111, Russia
Investigational Site Number 6430029
Shatura, 140700, Russia
Investigational Site Number 6430155
Smolensk, 214006, Russia
Investigational Site Number 6430121
Smolensk, 214019, Russia
Investigational Site Number 6430089
Sochi, 354382, Russia
Investigational Site Number 6430044
Stavropol, 355035, Russia
Investigational Site Number 6430134
Stavropol, 355035, Russia
Investigational Site Number 6430153
Stavropol, 355035, Russia
Investigational Site Number 6430076
Tambov, 392023, Russia
Investigational Site Number 6430142
Tambov, 392023, Russia
Investigational Site Number 6430013
Tolyatti, 445000, Russia
Investigational Site Number 6430058
Tomsk, 634034, Russia
Investigational Site Number 6430030
Tver', 170019, Russia
Investigational Site Number 6430169
Tver', 170028, Russia
Investigational Site Number 6430166
Tver', 170036, Russia
Investigational Site Number 6430123
Tyumen, 625003, Russia
Investigational Site Number 6430098
Tyumen, 625031, Russia
Investigational Site Number 6430078
Tyumen, 660077, Russia
Investigational Site Number 6430189
Ufa, 450099, Russia
Investigational Site Number 6430041
Ulyanovsk, 432063, Russia
Investigational Site Number 6430114
Vladimir, Russia
Investigational Site Number 6430018
Volgograd, 400001, Russia
Investigational Site Number 6430052
Vsevolozhsk, Russia
Investigational Site Number 6430008
Vyksa, 607060, Russia
Investigational Site Number 6430055
Yaroslavl, 150042, Russia
Investigational Site Number 6430033
Yartsevo, Russia
Investigational Site Number 6430006
Yoshkar-Ola, Russia
Investigational Site Number 6820009
Al Ehsa, Saudi Arabia
Investigational Site Number 6820006
Jeddah, 21412, Saudi Arabia
Investigational Site Number 6820001
Jeddah, 21589, Saudi Arabia
Investigational Site Number 6820008
Jeddah, Saudi Arabia
Investigational Site Number 6820010
Jeddah, Saudi Arabia
Investigational Site Number 6820007
Jubail, Saudi Arabia
Investigational Site Number 6820004
Najrān, Saudi Arabia
Investigational Site Number 6820003
Riyadh, Saudi Arabia
Investigational Site Number 7020001
Singapore, 308433, Singapore
Investigational Site Number 1580007
Changhua, 500, Taiwan
Investigational Site Number 1580005
Kaohsiung Hsien,, Taiwan
Investigational Site Number 1580003
New Taipei City, Taiwan
Investigational Site Number 1580004
Taichung, 402, Taiwan
Investigational Site Number 1580002
Tainan, Taiwan
Investigational Site Number 1580006
Taipei, 100, Taiwan
Investigational Site Number 7640002
Bangkok, 10400, Thailand
Investigational Site Number 7640001
Bangkok, Thailand
Investigational Site Number 8040020
Cherkasy, 18009, Ukraine
Investigational Site Number 8040002
Chernivtsi, 58022, Ukraine
Investigational Site Number 8040006
Dnipro, 49005, Ukraine
Investigational Site Number 8040014
Dnipro, 49038, Ukraine
Investigational Site Number 8040010
Ivano-Frankivsk, 76008, Ukraine
Investigational Site Number 8040013
Kharkiv, 61037, Ukraine
Investigational Site Number 8040016
Kharkiv, 61037, Ukraine
Investigational Site Number 8040001
Kharkiv, 61157, Ukraine
Investigational Site Number 8040012
Khmelnytskyi, 29000, Ukraine
Investigational Site Number 8040019
Kyiv, 02091, Ukraine
Investigational Site Number 8040005
Kyiv, 04053, Ukraine
Investigational Site Number 8040008
Kyiv, 04073, Ukraine
Investigational Site Number 8040011
Kyiv, 04114, Ukraine
Investigational Site Number 8040017
Kyiv, 04114, Ukraine
Investigational Site Number 8040007
Poltava, 36003, Ukraine
Investigational Site Number 8040004
Sumy, 40022, Ukraine
Investigational Site Number 8040009
Ternopil, 46002, Ukraine
Investigational Site Number 8040018
Ternopil, 46002, Ukraine
Investigational Site Number 8040003
Vinnytsia, 21010, Ukraine
Investigational Site Number 8040015
Zaporizhzhia, 69001, Ukraine
Investigational Site Number 7840017
Abu Dhabi, United Arab Emirates
Investigational Site Number 7840018
Abu Dhabi, United Arab Emirates
Investigational Site Number 7840007
Ajman, United Arab Emirates
Investigational Site Number 7840001
Dubai, United Arab Emirates
Investigational Site Number 7840002
Dubai, United Arab Emirates
Investigational Site Number 7840003
Dubai, United Arab Emirates
Investigational Site Number 7840004
Dubai, United Arab Emirates
Investigational Site Number 7840005
Dubai, United Arab Emirates
Investigational Site Number 7840008
Dubai, United Arab Emirates
Investigational Site Number 7840009
Dubai, United Arab Emirates
Investigational Site Number 7840010
Dubai, United Arab Emirates
Investigational Site Number 7840012
Dubai, United Arab Emirates
Investigational Site Number 7840013
Dubai, United Arab Emirates
Investigational Site Number 7840014
Dubai, United Arab Emirates
Investigational Site Number 7840015
Dubai, United Arab Emirates
Investigational Site Number 7840016
Dubai, United Arab Emirates
Investigational Site Number 7840019
Umm Al Quwain City, United Arab Emirates
Investigational Site Number 7840020
Umm Al Quwain City, United Arab Emirates
Related Publications (3)
Tirosh A, Khan N, Vargas-Uricoechea H, Galstyan G, Al Shaikh AR, Makkar BM, Mabunay MA, Melas-Melt L, Pilorget V, Karalliedde J. Effectiveness and Safety of Insulin Glargine 300 U/ml in High-Risk Subgroups (Renal Impairment and Older Age >/= 70 years) of Insulin-Naive People with Type 2 Diabetes: A Post hoc Analysis of Real-World ATOS Study. Diabetes Ther. 2025 Oct;16(10):2045-2061. doi: 10.1007/s13300-025-01785-w. Epub 2025 Sep 8.
PMID: 40920273DERIVEDKhan NE, Al Shaikh AAM, Hassoun AAK, Hassan AM, Salah MM, Al Abdella NA, Safarini SSM, Al Dahi WA, Akil YA. Real-World Study on Effectiveness of Insulin Glargine U300 After Oral Antidiabetic Drug Failure in Patients with Type 2 Diabetes in the Gulf Region. Diabetes Ther. 2024 Mar;15(3):691-704. doi: 10.1007/s13300-024-01537-2. Epub 2024 Feb 15.
PMID: 38355814DERIVEDGalstyan GR, Tirosh A, Vargas-Uricoechea H, Mabunay MA, Coudert M, Naqvi M, Pilorget V, Khan N. Real-World Effectiveness and Safety of Insulin Glargine 300 U/mL in Insulin-Naive People with Type 2 Diabetes: the ATOS Study. Diabetes Ther. 2022 Jun;13(6):1187-1202. doi: 10.1007/s13300-022-01266-4. Epub 2022 May 9.
PMID: 35532858DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Sciences & Operations
Sanofi
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 9, 2018
First Posted
October 12, 2018
Study Start
March 6, 2018
Primary Completion
June 28, 2019
Study Completion
February 24, 2020
Last Updated
April 25, 2022
Record last verified: 2022-04
Data Sharing
- IPD Sharing
- Will share
Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org