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)

April 21, 2022 updated by: Sanofi

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

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.

Study Overview

Status

Completed

Conditions

Diabetes

Intervention / Treatment

Drug: Insulin glargine (U300)

Detailed Description

Patients will be observed for one year

Study Type

Observational

Enrollment (Actual)

4589

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Colombia
- - Barranquilla, Colombia
    - Investigational Site Number 1700001
  - Bogota, Colombia
    - Investigational Site Number 1700004
  - Bogota, Colombia
    - Investigational Site Number 1700010
  - Cali, Colombia
    - Investigational Site Number 1700005
  - Cali, Colombia
    - Investigational Site Number 1700009
  - Ibague, Colombia
    - Investigational Site Number 1700003
  - Manizales, Colombia, 170
    - Investigational Site Number 1700007
  - Popayan, Colombia
    - Investigational Site Number 1700006
  - Zipaquira, Colombia
    - Investigational Site Number 1700002
Egypt
- - Alexandria, Egypt, 21575
    - Investigational Site Number 8180015
  - Alexandria, Egypt
    - Investigational Site Number 8180007
  - Alexandria, Egypt
    - Investigational Site Number 8180008
  - Alexandria, Egypt
    - Investigational Site Number 8180012
  - Alexandria, Egypt
    - Investigational Site Number 8180018
  - Cairo, 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
  - Giza, Egypt, 11535
    - Investigational Site Number 8180003
  - Giza, Egypt, 28452
    - Investigational Site Number 8180011
  - Giza, Egypt
    - Investigational Site Number 8180002
  - Giza, Egypt
    - Investigational Site Number 8180009
  - Giza, Egypt
    - Investigational Site Number 8180014
  - Mansoura, Egypt
    - Investigational Site Number 8180017
  - Portsaeid, Egypt
    - Investigational Site Number 8180013
India
- - Ahmedabad, India, 380006
    - Investigational Site Number 3560056
  - Ahmedabad, India, 380007
    - Investigational Site Number 3560021
  - Ahmedabad, India, 380009
    - Investigational Site Number 3560049
  - Ahmedabad, India, 380009
    - Investigational Site Number 3560077
  - Ahmedabad, India, 380054
    - Investigational Site Number 3560068
  - Aurangabad, India, 431001
    - Investigational Site Number 3560014
  - Bangalore, India, 560005
    - Investigational Site Number 3560081
  - Bangalore, India, 560019
    - Investigational Site Number 3560088
  - Bangalore, India, 560078
    - Investigational Site Number 3560066
  - Bangalore, India, 560079
    - Investigational Site Number 3560009
  - Bangalore, India
    - Investigational Site Number 3560059
  - Bangalore, India
    - Investigational Site Number 3560064
  - Bangalore, India
    - Investigational Site Number 3560075
  - Bangalore, India
    - Investigational Site Number 3560122
  - Belgaum, India
    - Investigational Site Number 3560044
  - Bengaluru, India, 560003
    - Investigational Site Number 3560074
  - Bengaluru, India, 560040
    - Investigational Site Number 3560046
  - Bhabaneswar, India, 751012
    - Investigational Site Number 3560116
  - Bhubaneswar, India, 751003
    - Investigational Site Number 3560062
  - Chandigarh, India, 160012
    - Investigational Site Number 3560106
  - Chandigarh, India, 160043
    - Investigational Site Number 3560126
  - Chennai, India, 600005
    - Investigational Site Number 3560110
  - Chennai, India, 600008
    - Investigational Site Number 3560029
  - Chennai, India, 600014
    - Investigational Site Number 3560080
  - Chennai, India, 600017
    - Investigational Site Number 3560067
  - Chennai, India, 600032
    - Investigational Site Number 3560030
  - Chennai, India, 600040
    - Investigational Site Number 3560008
  - Chennai, India, 600042
    - Investigational Site Number 3560031
  - Chennai, India, 600083
    - Investigational Site Number 3560011
  - Chennai, India, 600085
    - Investigational Site Number 3560124
  - Chennai, India, 600090
    - Investigational Site Number 3560105
  - Chennai, India, 600100
    - Investigational Site Number 3560098
  - Chennai, India, 600106
    - Investigational Site Number 3560104
  - Chennai, India
    - Investigational Site Number 3560133
  - Cochin, India
    - Investigational Site Number 3560016
  - Coimbatore, India, 641004
    - Investigational Site Number 3560012
  - Coimbatore, India, 641009
    - Investigational Site Number 3560131
  - Delhi, India, 110005
    - Investigational Site Number 3560032
  - Delhi, India, 110017
    - Investigational Site Number 3560041
  - Delhi, India, 110021
    - Investigational Site Number 3560108
  - Delhi, India, 110060
    - Investigational Site Number 3560002
  - Delhi, India, 110063
    - Investigational Site Number 3560019
  - Delhi, India, 110063
    - Investigational Site Number 3560047
  - Delhi, India, 110076
    - Investigational Site Number 3560102
  - Delhi, India, 110085
    - Investigational Site Number 3560020
  - Delhi, India, 110087
    - Investigational Site Number 3560085
  - Erode, India, 638011
    - Investigational Site Number 3560118
  - Guwahati, India, 781001
    - Investigational Site Number 3560051
  - Guwahati, India, 781005
    - Investigational Site Number 3560094
  - Guwahati, India, 781006
    - Investigational Site Number 3560087
  - Guwahati, India, 781006
    - Investigational Site Number 3560113
  - Guwahati, India, 781011
    - Investigational Site Number 3560070
  - Guwahati, India, 781022
    - Investigational Site Number 3560097
  - Gwalior, India, 474001
    - Investigational Site Number 3560109
  - Haryana, India
    - Investigational Site Number 3560089
  - Howrah, India, 711201
    - Investigational Site Number 3560135
  - Howrah, India
    - Investigational Site Number 3560096
  - Hyderabad, India, 500002
    - Investigational Site Number 3560045
  - Hyderabad, India, 500016
    - Investigational Site Number 3560058
  - Hyderabad, India, 500029
    - Investigational Site Number 3560036
  - Hyderabad, India, 500033
    - Investigational Site Number 3560069
  - Hyderabad, India, 500073
    - Investigational Site Number 3560035
  - Hyderabad, India, 500081
    - Investigational Site Number 3560024
  - Hyderabad, India
    - Investigational Site Number 3560027
  - Hyderabad, India
    - Investigational Site Number 3560043
  - Hyderabad, India
    - Investigational Site Number 3560100
  - Hyderabad, India
    - Investigational Site Number 3560107
  - Hyderabd, India
    - Investigational Site Number 3560034
  - Jaipur, India, 302015
    - Investigational Site Number 3560111
  - Jaipur, India, 302015
    - Investigational Site Number 3560123
  - Jaipur, India, 302016
    - Investigational Site Number 3560134
  - Jaipur, India, 302018
    - Investigational Site Number 3560017
  - Jaipur, India
    - Investigational Site Number 3560022
  - Jalandhar, India, 144003
    - Investigational Site Number 3560073
  - Kanpur, India, 208002
    - Investigational Site Number 3560005
  - Kanpur, India, 208002
    - Investigational Site Number 3560125
  - Kochi, India, 682019
    - Investigational Site Number 3560026
  - Kochi, India, 682020
    - Investigational Site Number 3560018
  - Kochi, India, 682041
    - Investigational Site Number 3560050
  - Kolkata, India, 700020
    - Investigational Site Number 3560091
  - Kolkata, 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
  - Lucknow, India
    - Investigational Site Number 3560103
  - Madurai, India, 625020
    - Investigational Site Number 3560117
  - Mumbai, India, 400005
    - Investigational Site Number 3560033
  - Mumbai, India, 400007
    - Investigational Site Number 3560121
  - Mumbai, India, 400053
    - Investigational Site Number 3560136
  - Mumbai, India, 400064
    - Investigational Site Number 3560042
  - Mumbai, India, 400068
    - Investigational Site Number 3560065
  - Mumbai, India, 400092
    - Investigational Site Number 3560015
  - Mumbai, India, 400601
    - Investigational Site Number 3560079
  - Mumbai, India
    - Investigational Site Number 3560003
  - Mumbai, India
    - Investigational Site Number 3560023
  - Mumbai, India
    - Investigational Site Number 3560040
  - Mumbai, India
    - Investigational Site Number 3560119
  - Navi Mumbai, India, 400706
    - Investigational Site Number 3560112
  - Nellore, India, 524001
    - Investigational Site Number 3560010
  - Noida, India
    - Investigational Site Number 3560086
  - Noida, India
    - Investigational Site Number 3560132
  - Pondicherry, India, 605005
    - Investigational Site Number 3560053
  - Pune, India, 411001
    - Investigational Site Number 3560004
  - Pune, India, 411004
    - Investigational Site Number 3560038
  - Pune, India, 411021
    - Investigational Site Number 3560055
  - Pune, India, 411037
    - Investigational Site Number 3560060
  - Rajahmundry, India, 533103
    - Investigational Site Number 3560072
  - Rajkot, India, 360001
    - Investigational Site Number 3560025
  - Rajkot, India, 360002
    - Investigational Site Number 3560076
  - Surat, India
    - Investigational Site Number 3560063
  - Tinsukia, India, 786125
    - Investigational Site Number 3560084
  - Trichy, India, 620017
    - Investigational Site Number 3560006
  - Trichy, India, 620018
    - Investigational Site Number 3560001
  - Trichy, India, 620018
    - Investigational Site Number 3560101
  - Tripura, India, 799001
    - Investigational Site Number 3560114
  - Trivandrum, India, 695033
    - Investigational Site Number 3560039
  - Trivandrum, India
    - Investigational Site Number 3560013
  - Vijayawada, India, 520002
    - Investigational Site Number 3560127
  - Visakhapatnam, India, 530002
    - Investigational Site Number 3560061
  - Visakhapatnam, India, 530016
    - Investigational Site Number 3560054
  - Yamunanagar, India
    - Investigational Site Number 3560128
Indonesia
- - Denpasar, Indonesia, 80234
    - Investigational Site Number 3600003
  - Jakarta, Indonesia, 10220
    - Investigational Site Number 3600001
  - Jakarta, Indonesia, 10630
    - Investigational Site Number 3600002
Israel
- - Haifa, Israel
    - Investigational Site Number 3760001
  - Petach Tikva, Israel
    - Investigational Site Number 3760002
  - Rishon Le-Zion, Israel
    - Investigational Site Number 3760005
  - Tel Aviv, Israel
    - Investigational Site Number 3760004
  - Tel-Aviv, Israel
    - Investigational Site Number 3760003
Jordan
- - Amman, Jordan, 11183
    - Investigational Site Number 4000002
  - Amman, Jordan, 11183
    - Investigational Site Number 4000005
  - Amman, Jordan, 11183
    - Investigational Site Number 4000006
  - Amman, Jordan, 11183
    - Investigational Site Number 4000008
  - Amman, Jordan
    - Investigational Site Number 0004
  - Amman, Jordan
    - Investigational Site Number 4000009
  - Irbid, Jordan, 211-81
    - Investigational Site Number 0007
Kuwait
- - Al Jabriya, Kuwait
    - Investigational Site Number 4140001
  - Al Jabriya, Kuwait
    - Investigational Site Number 4140010
  - Kuwait, Kuwait
    - Investigational Site Number 4140003
  - Kuwait, Kuwait
    - Investigational Site Number 4140004
  - Kuwait, Kuwait
    - Investigational Site Number 4140006
  - Kuwait, Kuwait
    - Investigational Site Number 4140009
  - Kuwait, Kuwait
    - Investigational Site Number 4140011
  - Kuwait, Kuwait
    - Investigational Site Number 4140012
Lebanon
- - Achrafieh, Lebanon
    - Investigational Site Number 4220006
  - Achrafieh, Lebanon
    - Investigational Site Number 4220016
  - Airport Road, Lebanon
    - Investigational Site Number 4220017
  - Aley, Lebanon
    - Investigational Site Number 4220008
  - Beirut, Lebanon
    - Investigational site number 4220001
  - Beirut, Lebanon
    - Investigational Site Number 4220015
  - Bir Al Abed, Lebanon
    - Investigational Site Number 4220012
  - Chtoura, Lebanon
    - Investigational Site Number 4220007
  - Corniche El Mazraa, Lebanon
    - Investigational Site Number 4220011
  - Hadath, Lebanon
    - Investigational Site Number 4220018
  - Hamra, Lebanon
    - Investigational Site Number 4220013
  - Jal El Baher, Lebanon
    - Investigational Site Number 4220019
  - Jounieh, Lebanon
    - Investigational Site Number 4220014
  - Metn, Lebanon
    - Investigational Site Number 4220010
  - Mount Lebanon, Lebanon
    - Investigational Site Number 4220004
  - Saida, Lebanon
    - Investigational Site Number 4220005
  - Sarba, Lebanon
    - Investigational Site Number 4220003
  - Tyr, Lebanon
    - Investigational Site Number 4220009
Mexico
- - Aguascalientes, Mexico, 20230
    - Investigational Site Number 4840001
  - Celaya, Mexico, 38000
    - Investigational Site Number 4840009
  - Chihuahua, Mexico, 31200
    - Investigational Site Number 4840008
  - Cuernavaca, Mexico, 62250
    - Investigational Site Number 4840004
  - Durango, Mexico
    - Investigational Site Number 4840007
  - Guadalajara, Mexico, 44130
    - Investigational Site Number 4840006
  - Guadalajara, Mexico, 44500
    - Investigational Site Number 4840003
  - Mexico, Mexico, 07760
    - Investigational Site Number 4840010
  - Mexico, Mexico, 40100
    - Investigational Site Number 4840002
  - México City, Mexico, 06470
    - Investigational Site Number 4840005
Peru
- - Arequipa, Peru
    - Investigational Site Number 6040003
  - Lima, Peru
    - Investigational Site Number 6040001
  - Lima, Peru
    - Investigational Site Number 6040002
Philippines
- - Dasmarinas Cavite, Philippines, 4114
    - Investigational Site Number 6080001
Russian Federation
- - Anapa, Russian Federation, 353440
    - Investigational Site Number 6430108
  - Arkhangelsk, Russian Federation, 163045
    - Investigational Site Number 6430170
  - Arkhangelsk, Russian Federation, 163045
    - Investigational Site Number 6430171
  - Arkhangelsk, Russian Federation, 163045
    - Investigational Site Number 6430172
  - Astrakhan, Russian Federation, 414018
    - Investigational Site Number 6430019
  - Barnaul, Russian Federation, 656050
    - Investigational Site Number 6430010
  - Barnaul, Russian Federation, 656050
    - Investigational Site Number 6430138
  - Barnaul, Russian Federation, 656056
    - Investigational Site Number 6430081
  - Barnaul, Russian Federation, 656056
    - Investigational Site Number 6430182
  - Barnaul, Russian Federation, 656066
    - Investigational Site Number 6430160
  - Barnaul, Russian Federation, 656922
    - Investigational Site Number 6430181
  - Belorechensk, Russian Federation, 352630
    - Investigational Site Number 6430157
  - Bryansk, Russian Federation, 241047
    - Investigational Site Number 6430156
  - Chaltyr, Russian Federation, 346801
    - Investigational Site Number 6430060
  - Cheboksary, Russian Federation, 428009
    - Investigational Site Number 6430087
  - Chelyabinsk, Russian Federation, 454046
    - Investigational Site Number 6430097
  - Chelyabinsk, Russian Federation, 454076
    - Investigational Site Number 6430036
  - Chelyabinsk, Russian Federation, 454084
    - Investigational Site Number 6430092
  - Chelyabinsk, Russian Federation, 454091
    - Investigational Site Number 6430107
  - Gorodets, Russian Federation, 606500
    - Investigational Site Number 6430111
  - Kazan, Russian Federation, 420064
    - Investigational Site Number 6430012
  - Kazan, Russian Federation, 420103
    - Investigational Site Number 6430184
  - Kemerovo, Russian Federation, 650066
    - Investigational Site Number 6430011
  - Kemerovo, Russian Federation, 650066
    - Investigational Site Number 6430109
  - Kemerovo, Russian Federation, 650099
    - Investigational Site Number 6430072
  - Kolomna, Russian Federation, 140405
    - Investigational Site Number 6430125
  - Krasnodar, Russian Federation, 350000
    - Investigational Site Number 6430143
  - Krasnodar, Russian Federation, 350001
    - Investigational Site Number 6430047
  - Krasnodar, Russian Federation, 350002
    - Investigational Site Number 6430136
  - Krasnodar, Russian Federation, 350072
    - Investigational Site Number 6430083
  - Krasnodar, Russian Federation, 350075
    - Investigational Site Number 6430140
  - Krasnodar, Russian Federation, 350915
    - Investigational Site Number 6430021
  - Krasnoyarsk, Russian Federation, 660003
    - Investigational Site Number 6430115
  - Krasnoyarsk, Russian Federation, 660052
    - Investigational Site Number 6430004
  - Lipetsk, Russian Federation, 398043
    - Investigational Site Number 6430068
  - Lipetsk, Russian Federation
    - Investigational Site Number 6430067
  - Livny, Russian Federation, 303858
    - Investigational Site Number 6430024
  - Moscow, Russian Federation, 105005
    - Investigational Site Number 6430128
  - Moscow, Russian Federation, 105005
    - Investigational Site Number 6430168
  - Moscow, Russian Federation, 109145
    - Investigational Site Number 6430064
  - Moscow, Russian Federation, 109457
    - Investigational Site Number 6430065
  - Moscow, Russian Federation, 111555
    - Investigational Site Number 6430148
  - Moscow, Russian Federation, 115211
    - Investigational Site Number 6430079
  - Moscow, Russian Federation, 115409
    - Investigational Site Number 6430101
  - Moscow, Russian Federation, 115516
    - Investigational Site Number 6430100
  - Moscow, Russian Federation, 115516
    - Investigational Site Number 6430120
  - Moscow, Russian Federation, 115516
    - Investigational Site Number 6430130
  - Moscow, Russian Federation, 119311
    - Investigational Site Number 6430026
  - Moscow, Russian Federation, 121601
    - Investigational Site Number 6430005
  - Moscow, Russian Federation, 124482
    - Investigational Site Number 6430017
  - Moscow, Russian Federation, 125222
    - Investigational Site Number 6430027
  - Moscow, Russian Federation, 125373
    - Investigational Site Number 6430057
  - Moscow, Russian Federation, 127018
    - Investigational Site Number 6430035
  - Moscow, Russian Federation, 127273
    - Investigational Site Number 6430118
  - Moscow, Russian Federation, 127549
    - Investigational Site Number 6430146
  - Moscow, Russian Federation, 141411
    - Investigational Site Number 6430147
  - Moscow, Russian Federation
    - Investigational Site Number 6430051
  - Moscow, Russian Federation
    - Investigational Site Number 6430149
  - Nizhny Novgorod, Russian Federation, 603004
    - Investigational Site Number 6430132
  - Nizhny Novgorod, Russian Federation, 603035
    - Investigational Site Number 6430066
  - Nizhny Novgorod, Russian Federation, 603163
    - Investigational Site Number 6430129
  - Novomoskovsk, Russian Federation, 301650
    - Investigational Site Number 6430110
  - Novosibirsk, Russian Federation, 630047
    - Investigational Site Number 6430007
  - Novosibirsk, Russian Federation, 630060
    - Investigational Site Number 6430061
  - Novosibirsk, Russian Federation, 630106
    - Investigational Site Number 6430023
  - Omsk, Russian Federation, 644010
    - Investigational Site Number 6430117
  - Orel, Russian Federation, 302030
    - Investigational Site Number 6430112
  - Orel, Russian Federation
    - Investigational Site Number 6430137
  - Orenburg, Russian Federation, 460018
    - Investigational Site Number 6430014
  - Penza, Russian Federation, 440052
    - Investigational Site Number 6430039
  - Penza, Russian Federation, 440052
    - Investigational Site Number 6430164
  - Perm, Russian Federation
    - Investigational Site Number 6430126
  - Petrozavodsk, Russian Federation, 185014
    - Investigational Site Number 6430040
  - Petrozavodsk, Russian Federation, 185014
    - Investigational Site Number 6430054
  - Petrozavodsk, Russian Federation, 185014
    - Investigational Site Number 6430084
  - Pushkin, Russian Federation, 196607
    - Investigational Site Number 6430038
  - Rostov-on-Don, Russian Federation, 344029
    - Investigational Site Number 6430151
  - Rostov-on-Don, Russian Federation, 344092
    - Investigational Site Number 6430090
  - Rybinsk, Russian Federation, 152912
    - Investigational Site Number 6430037
  - Saint Petersburg, Russian Federation, 19323
    - Investigational Site Number 6430086
  - Saint Petersburg, Russian Federation, 19323
    - Investigational Site Number 6430139
  - Saint Petersburg, Russian Federation, 193312
    - Investigational Site Number 6430022
  - Saint Petersburg, Russian Federation, 194156
    - Investigational Site Number 6430070
  - Saint Petersburg, Russian Federation, 195220
    - Investigational Site Number 643085
  - Saint Petersburg, Russian Federation, 195256
    - Investigational Site Number 6430028
  - Saint Petersburg, Russian Federation, 195256
    - Investigational Site Number 6430074
  - Saint Petersburg, Russian Federation, 195256
    - Investigational Site Number 6430135
  - Saint Petersburg, Russian Federation, 195256
    - Investigational Site Number 6430150
  - Saint Petersburg, Russian Federation, 195426
    - Investigational Site Number 6430095
  - Saint Petersburg, Russian Federation, 197082
    - Investigational Site Number 6430032
  - Saint Petersburg, Russian Federation, 197341
    - Investigational Site Number 6430031
  - Saint Petersburg, Russian Federation, 197349
    - Investigational Site Number 6430099
  - Saint Petersburg, Russian Federation, 197349
    - Investigational Site Number 6430131
  - Saint Petersburg, Russian Federation, 197371
    - Investigational Site Number 6430163
  - Saint Petersburg, Russian Federation, 199155
    - Investigational Site Number 6430152
  - Saint-Petersburg, Russian Federation, 197101
    - Investigational Site Number 6430144
  - Salsk, Russian Federation, 347630
    - Investigational Site Number 6430073
  - Samara, Russian Federation, 443031
    - Investigational Site Number 6430177
  - Samara, Russian Federation, 443111
    - Investigational Site Number 6430046
  - Shatura, Russian Federation, 140700
    - Investigational Site Number 6430029
  - Smolensk, Russian Federation, 214006
    - Investigational Site Number 6430155
  - Smolensk, Russian Federation, 214019
    - Investigational Site Number 6430121
  - Sochi, Russian Federation, 354382
    - Investigational Site Number 6430089
  - Stavropol, Russian Federation, 355035
    - Investigational Site Number 6430044
  - Stavropol, Russian Federation, 355035
    - Investigational Site Number 6430134
  - Stavropol, Russian Federation, 355035
    - Investigational Site Number 6430153
  - Tambov, Russian Federation, 392023
    - Investigational Site Number 6430076
  - Tambov, Russian Federation, 392023
    - Investigational Site Number 6430142
  - Tolyatti, Russian Federation, 445000
    - Investigational Site Number 6430013
  - Tomsk, Russian Federation, 634034
    - Investigational Site Number 6430058
  - Tver, Russian Federation, 170019
    - Investigational Site Number 6430030
  - Tver, Russian Federation, 170028
    - Investigational Site Number 6430169
  - Tver, Russian Federation, 170036
    - Investigational Site Number 6430166
  - Tyumen, Russian Federation, 625003
    - Investigational Site Number 6430123
  - Tyumen, Russian Federation, 625031
    - Investigational Site Number 6430098
  - Tyumen, Russian Federation, 660077
    - Investigational Site Number 6430078
  - Ufa, Russian Federation, 450099
    - Investigational Site Number 6430189
  - Ulyanovsk, Russian Federation, 432063
    - Investigational Site Number 6430041
  - Vladimir, Russian Federation
    - Investigational Site Number 6430114
  - Volgograd, Russian Federation, 400001
    - Investigational Site Number 6430018
  - Vsevolozhsk, Russian Federation
    - Investigational Site Number 6430052
  - Vyksa, Russian Federation, 607060
    - Investigational Site Number 6430008
  - Yaroslavl, Russian Federation, 150042
    - Investigational Site Number 6430055
  - Yartsevo, Russian Federation
    - Investigational Site Number 6430033
  - Yoshkar-Ola, Russian Federation
    - Investigational Site Number 6430006
Saudi Arabia
- - Al Ehsa, Saudi Arabia
    - Investigational Site Number 6820009
  - Jeddah, Saudi Arabia, 21412
    - Investigational Site Number 6820006
  - Jeddah, Saudi Arabia, 21589
    - Investigational Site Number 6820001
  - Jeddah, Saudi Arabia
    - Investigational Site Number 6820008
  - Jeddah, Saudi Arabia
    - Investigational Site Number 6820010
  - Jubail, Saudi Arabia
    - Investigational Site Number 6820007
  - Najran, Saudi Arabia
    - Investigational Site Number 6820004
  - Riyadh, Saudi Arabia
    - Investigational Site Number 6820003
Singapore
- - Singapore, Singapore, 308433
    - Investigational Site Number 7020001
Taiwan
- - Changhua, Taiwan, 500
    - Investigational Site Number 1580007
  - Kaohsiung Hsien,, Taiwan
    - Investigational Site Number 1580005
  - New Taipei city, Taiwan
    - Investigational Site Number 1580003
  - Taichung, Taiwan, 402
    - Investigational Site Number 1580004
  - Tainan, Taiwan
    - Investigational Site Number 1580002
  - Taipei, Taiwan, 100
    - Investigational Site Number 1580006
Thailand
- - Bangkok, Thailand, 10400
    - Investigational site number 7640002
  - Bangkok, Thailand
    - Investigational site number 7640001
Ukraine
- - Cherkasy, Ukraine, 18009
    - Investigational Site Number 8040020
  - Chernivtsi, Ukraine, 58022
    - Investigational Site Number 8040002
  - Dnipro, Ukraine, 49005
    - Investigational Site Number 8040006
  - Dnipro, Ukraine, 49038
    - Investigational Site Number 8040014
  - Ivano-Frankivsk, Ukraine, 76008
    - Investigational Site Number 8040010
  - Kharkiv, Ukraine, 61037
    - Investigational Site Number 8040013
  - Kharkiv, Ukraine, 61037
    - Investigational Site Number 8040016
  - Kharkiv, Ukraine, 61157
    - Investigational Site Number 8040001
  - Khmelnytskyi, Ukraine, 29000
    - Investigational Site Number 8040012
  - Kyiv, Ukraine, 02091
    - Investigational Site Number 8040019
  - Kyiv, Ukraine, 04053
    - Investigational Site Number 8040005
  - Kyiv, Ukraine, 04073
    - Investigational Site Number 8040008
  - Kyiv, Ukraine, 04114
    - Investigational Site Number 8040011
  - Kyiv, Ukraine, 04114
    - Investigational Site Number 8040017
  - Poltava, Ukraine, 36003
    - Investigational Site Number 8040007
  - Sumy, Ukraine, 40022
    - Investigational Site Number 8040004
  - Ternopil, Ukraine, 46002
    - Investigational Site Number 8040009
  - Ternopil, Ukraine, 46002
    - Investigational Site Number 8040018
  - Vinnytsya, Ukraine, 21010
    - Investigational Site Number 8040003
  - Zaporizhzhia, Ukraine, 69001
    - Investigational Site Number 8040015
United Arab Emirates
- - Abu Dhabi, United Arab Emirates
    - Investigational Site Number 7840017
  - Abu Dhabi, United Arab Emirates
    - Investigational Site Number 7840018
  - Ajman, United Arab Emirates
    - Investigational Site Number 7840007
  - Dubai, 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
  - Umm al Quwain, United Arab Emirates
    - Investigational Site Number 7840019
  - Umm al Quwain, United Arab Emirates
    - Investigational Site Number 7840020

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Insulin-naïve patients with type 2 diabetes mellitus and Oral Antidiabetic Drug failure

Description

Inclusion criteria :

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

Exclusion criteria:

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Observational Models: Cohort
Time Perspectives: Prospective

Number of groups / cohorts

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Insulin glargine (U300) Insulin glargine (U300) dosage and dosing time as per local product labeling	Drug: Insulin glargine (U300) Pharmaceutical form: Solution for injection Route of administration: Subcutaneous injection Other Names: HOE901, Toujeo, Toujeo Solostar

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in HbA1c at month 6 Time Frame: Baseline, month 6	Percentage of patients achieving Hemoglobin A1c <7.0%.	Baseline, month 6

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in HbA1c Time Frame: Baseline, months 3, 6, 12	Change from baseline in HbA1c at 3, 6, and 12 months	Baseline, months 3, 6, 12
Change in fasting plasma glucose Time Frame: Baseline, months 3, 6, 12	Change from baseline in Fasting Plasma Glucose at 3, 6, and 12 months	Baseline, months 3, 6, 12
Change in Self-Monitored Plasma Glucose Time Frame: Baseline, months 3, 6, 12	Change from baseline in Self-Monitored Plasma Glucose at 3, 6, and 12 months	Baseline, months 3, 6, 12
Hypoglycemia Time Frame: Baseline to month 12	Number of participants with symptomatic hypoglycemic events	Baseline to month 12
Adverse events Time Frame: Baseline to month 12	Number of participants with Adverse Events	Baseline to month 12
Serious adverse events Time Frame: Baseline to month 12	Number of participants with Serious Adverse Events	Baseline to month 12
Body weight Time Frame: Baseline to month 12	Change in average body weight	Baseline to month 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sanofi

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Galstyan 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.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 6, 2018

Primary Completion (Actual)

June 28, 2019

Study Completion (Actual)

February 24, 2020

Study Registration Dates

First Submitted

October 9, 2018

First Submitted That Met QC Criteria

October 10, 2018

First Posted (Actual)

October 12, 2018

Study Record Updates

Last Update Posted (Actual)

April 25, 2022

Last Update Submitted That Met QC Criteria

April 21, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

OBS14708
U1111-1215-0174 (Other Identifier: UTN)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

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

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

product manufactured in and exported from the U.S.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Diabetes

University of Colorado, Denver
Massachusetts General Hospital; Beta Bionics, Inc.

Completed

Feasibility of Closed-loop Automated Insulin Delivery System by Primary Care & Endocrinology, in Person & Via Telehealth

Diabetes Mellitus, Type 1 | Type 1 Diabetes | Diabetes type1 | Type 1 Diabetes Mellitus | Autoimmune Diabetes | Diabetes Mellitus, Insulin-Dependent | Juvenile-Onset Diabetes | Diabetes, Autoimmune | Insulin-Dependent Diabetes Mellitus 1 | Diabetes Mellitus, Insulin-Dependent, 1 | Diabetes Mellitus, Brittle | Diabetes Mellitus, Juvenile-Onset and other conditions

United States
Guang Ning

Recruiting

China Diabetes Registry by Metabolic Management Center (CDR-MMC)

Type 2 Diabetes Mellitus | Type1 Diabetes Mellitus | Monogenetic Diabetes | Pancreatogenic Diabetes | Drug-Induced Diabetes Mellitus | Other Forms of Diabetes Mellitus

China
University of Trás-os-Montes and Alto Douro

Completed

Diabetes em Movimento® - Community-based Lifestyle Intervention Program for Patients With Type 2 Diabetes

Type 2 Diabetes Mellitus | Diabetes-Related Complications

Portugal
Northern Care Alliance NHS Foundation Trust
Brighter AB

Completed

Actiste® Diabetes Management as a Service (ADMS) Clinical Investigation (ADMSUK01)

Diabetes type1 | Diabetes type2

United Kingdom
VeraLight, Inc.
InLight Solutions

Unknown

Evaluation and Comparison of Noninvasive Blood Glucose Concentrations

Gestational Diabetes | Insulin Dependent Diabetes | Non Insulin Dependent Diabetes

United States
Garvan Institute of Medical Research
Weizmann Institute of Science

Active, not recruiting

Personalised Medicine in Pre-diabetes and Early Type 2 Diabetes (PREDICT)

Type 2 Diabetes Mellitus | Pre Diabetes

Australia
Oregon State University
Sanofi

Completed

Empowering Patients to Better Manage Diabetes Through Self-Care

Type I or Type II Diabetes (Excludes Gestational Diabetes)
Taichung Veterans General Hospital
National Health Research Institutes, Taiwan

Recruiting

Optimized Diagnosis and Precision Medicine of MODY

Diabetes Complications | Type 2 Diabetes | Maturity-Onset Diabetes of the Young (MODY)

Taiwan
University of Roehampton

Recruiting

Investigating Plasma Biomarker Molecules Associated With the Progression of Prediabetes to Overt Type 2 Diabetes

Type2 Diabetes Mellitus | Pre Diabetes

United Kingdom
University of Reading

Completed

A Lifestyle Intervention for Type 2 Diabetes Patients in Kuwait and Its Impact on Glycaemic Control

Diabetes, Type 2 | Diabetes Mellitus, Noninsulin-Dependent

United Kingdom, Kuwait

Clinical Trials on Insulin glargine (U300)

Sanofi

Completed

Ease of Use and Safety of the New U300 Pen Injector in Insulin-Naïve Patients With T2DM

Diabetes Mellitus Type 2

Germany
Emory University

Completed

Glargine U300 Hospital Trial

Type 2 Diabetes

United States
Sanofi

Completed

Evaluation of Toujeo Insulin in Type 2 Diabetes Patients Inadequately Control With Their Basal Insulin Treatment (Transition II)

Diabetes Mellitus, Type 2

France
Sanofi

Completed

Study of Two Titration Algorithms With Insulin Glargine 300 Units/mL in Type 2 Diabetes Mellitus Patients (TITRATION)

Type 2 Diabetes Mellitus

Canada
Sanofi

Completed

Comparison of a New Formulation of Insulin Glargine With Lantus in Patients With Type 1 Diabetes Mellitus (EDITION IV)

Type 1 Diabetes Mellitus

United States, Canada, Czech Republic, Denmark, Estonia, Finland, Hungary, Japan, Latvia, Netherlands, Puerto Rico, Romania, Sweden
Sanofi

Completed

Comparison of a New Formulation of Insulin Glargine With Lantus in Patients With Type 1 Diabetes Mellitus on Basal Plus Mealtime Insulin

Type 1 Diabetes Mellitus

United States
Sanofi

Completed

Phase 4 Study to Evaluate Treatment Optimization With Once-daily Insulin Glargine 300 U/mL (TOP1)

Type I Diabetes Mellitus

Brazil
Medanta, The Medicity, India

Completed

Degludec Glargine U300 Hospital Study

Type 2 Diabetes

India
University of Split, School of Medicine
Pavle Vrebalov Cindro; Jonatan Vuković; Darko Modun; Božo Smajić; Gordan Kardum; Tina... and other collaborators

Completed

Insulin Glargine U300 vs Insulin Degludec U100 in Impact on the Glycaemic and Cardiovascular Factors

Diabetes Mellitus, Type 2

Croatia
Sanofi

Completed

Comparison of a New Formulation of Insulin Glargine With Lantus in Patients With Type 2 Diabetes Mellitus on Basal Plus Mealtime Insulin (EDITION I)

Type 2 Diabetes Mellitus

United States, South Africa, Canada, Czechia, Estonia, Finland, France, Germany, Hungary, Latvia, Mexico, Netherlands, Romania

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

Study Overview

Status

Conditions

Intervention / Treatment

Detailed Description

Study Type

Enrollment (Actual)

Contacts and Locations

Study Locations

Participation Criteria

Eligibility Criteria

Ages Eligible for Study

Accepts Healthy Volunteers

Genders Eligible for Study

Sampling Method

Study Population

Description

Study Plan

How is the study designed?

Design Details

Number of groups / cohorts

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Secondary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Collaborators and Investigators

Sponsor

Publications and helpful links

General Publications

Study record dates

Study Major Dates

Study Start (Actual)

Primary Completion (Actual)

Study Completion (Actual)

Study Registration Dates

First Submitted

First Submitted That Met QC Criteria

First Posted (Actual)

Study Record Updates

Last Update Posted (Actual)

Last Update Submitted That Met QC Criteria

Last Verified

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

IPD Plan Description

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

product manufactured in and exported from the U.S.

Clinical Trials on Diabetes

Clinical Trials on Insulin glargine (U300)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Rwanda

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations