Clinical trial NCT03703869: 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.
Official title: 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 type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2018-10-12
Enrollment: 4589
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Insulin-naïve patients with type 2 diabetes mellitus and Oral Antidiabetic Drug failure

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.

Detailed description: Patients will be observed for one year

Eligibility criteria: 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.

Primary outcomes:
measure: Change in HbA1c at month 6
timeFrame: Baseline, month 6
Secondary outcomes:
measure: Change in HbA1c
timeFrame: Baseline, months 3, 6, 12
measure: Change in fasting plasma glucose
timeFrame: Baseline, months 3, 6, 12
measure: Change in Self-Monitored Plasma Glucose
timeFrame: Baseline, months 3, 6, 12
measure: Hypoglycemia
timeFrame: Baseline to month 12
measure: Adverse events
timeFrame: Baseline to month 12
measure: Serious adverse events
timeFrame: Baseline to month 12
measure: Body weight
timeFrame: Baseline to month 12
Other outcomes:
Locations:
city: Barranquilla
country: Colombia
facility: Investigational Site Number 1700001
city: Bogota
country: Colombia
facility: Investigational Site Number 1700004
city: Bogota
country: Colombia
facility: Investigational Site Number 1700010
city: Cali
country: Colombia
facility: Investigational Site Number 1700005
city: Cali
country: Colombia
facility: Investigational Site Number 1700009
city: Ibague
country: Colombia
facility: Investigational Site Number 1700003
city: Manizales
country: Colombia
facility: Investigational Site Number 1700007
city: Popayan
country: Colombia
facility: Investigational Site Number 1700006
city: Zipaquira
country: Colombia
facility: Investigational Site Number 1700002
city: Alexandria
country: Egypt
facility: Investigational Site Number 8180015
city: Alexandria
country: Egypt
facility: Investigational Site Number 8180007
city: Alexandria
country: Egypt
facility: Investigational Site Number 8180008
city: Alexandria
country: Egypt
facility: Investigational Site Number 8180012
city: Alexandria
country: Egypt
facility: Investigational Site Number 8180018
city: Cairo
country: Egypt
facility: Investigational Site Number 8180001
city: Cairo
country: Egypt
facility: Investigational Site Number 8180005
city: Cairo
country: Egypt
facility: Investigational Site Number 8180006
city: Cairo
country: Egypt
facility: Investigational Site Number 8180016
city: Cairo
country: Egypt
facility: Investigational Site Number 8180020
city: Giza
country: Egypt
facility: Investigational Site Number 8180003
city: Giza
country: Egypt
facility: Investigational Site Number 8180011
city: Giza
country: Egypt
facility: Investigational Site Number 8180002
city: Giza
country: Egypt
facility: Investigational Site Number 8180009
city: Giza
country: Egypt
facility: Investigational Site Number 8180014
city: Mansoura
country: Egypt
facility: Investigational Site Number 8180017
city: Portsaeid
country: Egypt
facility: Investigational Site Number 8180013
city: Ahmedabad
country: India
facility: Investigational Site Number 3560056
city: Ahmedabad
country: India
facility: Investigational Site Number 3560021
city: Ahmedabad
country: India
facility: Investigational Site Number 3560049
city: Ahmedabad
country: India
facility: Investigational Site Number 3560077
city: Ahmedabad
country: India
facility: Investigational Site Number 3560068
city: Aurangabad
country: India
facility: Investigational Site Number 3560014
city: Bangalore
country: India
facility: Investigational Site Number 3560081
city: Bangalore
country: India
facility: Investigational Site Number 3560088
city: Bangalore
country: India
facility: Investigational Site Number 3560066
city: Bangalore
country: India
facility: Investigational Site Number 3560009
city: Bangalore
country: India
facility: Investigational Site Number 3560059
city: Bangalore
country: India
facility: Investigational Site Number 3560064
city: Bangalore
country: India
facility: Investigational Site Number 3560075
city: Bangalore
country: India
facility: Investigational Site Number 3560122
city: Belgaum
country: India
facility: Investigational Site Number 3560044
city: Bengaluru
country: India
facility: Investigational Site Number 3560074
city: Bengaluru
country: India
facility: Investigational Site Number 3560046
city: Bhabaneswar
country: India
facility: Investigational Site Number 3560116
city: Bhubaneswar
country: India
facility: Investigational Site Number 3560062
city: Chandigarh
country: India
facility: Investigational Site Number 3560106
city: Chandigarh
country: India
facility: Investigational Site Number 3560126
city: Chennai
country: India
facility: Investigational Site Number 3560110
city: Chennai
country: India
facility: Investigational Site Number 3560029
city: Chennai
country: India
facility: Investigational Site Number 3560080
city: Chennai
country: India
facility: Investigational Site Number 3560067
city: Chennai
country: India
facility: Investigational Site Number 3560030
city: Chennai
country: India
facility: Investigational Site Number 3560008
city: Chennai
country: India
facility: Investigational Site Number 3560031
city: Chennai
country: India
facility: Investigational Site Number 3560011
city: Chennai
country: India
facility: Investigational Site Number 3560124
city: Chennai
country: India
facility: Investigational Site Number 3560105
city: Chennai
country: India
facility: Investigational Site Number 3560098
city: Chennai
country: India
facility: Investigational Site Number 3560104
city: Chennai
country: India
facility: Investigational Site Number 3560133
city: Cochin
country: India
facility: Investigational Site Number 3560016
city: Coimbatore
country: India
facility: Investigational Site Number 3560012
city: Coimbatore
country: India
facility: Investigational Site Number 3560131
city: Delhi
country: India
facility: Investigational Site Number 3560032
city: Delhi
country: India
facility: Investigational Site Number 3560041
city: Delhi
country: India
facility: Investigational Site Number 3560108
city: Delhi
country: India
facility: Investigational Site Number 3560002
city: Delhi
country: India
facility: Investigational Site Number 3560019
city: Delhi
country: India
facility: Investigational Site Number 3560047
city: Delhi
country: India
facility: Investigational Site Number 3560102
city: Delhi
country: India
facility: Investigational Site Number 3560020
city: Delhi
country: India
facility: Investigational Site Number 3560085
city: Erode
country: India
facility: Investigational Site Number 3560118
city: Guwahati
country: India
facility: Investigational Site Number 3560051
city: Guwahati
country: India
facility: Investigational Site Number 3560094
city: Guwahati
country: India
facility: Investigational Site Number 3560087
city: Guwahati
country: India
facility: Investigational Site Number 3560113
city: Guwahati
country: India
facility: Investigational Site Number 3560070
city: Guwahati
country: India
facility: Investigational Site Number 3560097
city: Gwalior
country: India
facility: Investigational Site Number 3560109
city: Haryana
country: India
facility: Investigational Site Number 3560089
city: Howrah
country: India
facility: Investigational Site Number 3560135
city: Howrah
country: India
facility: Investigational Site Number 3560096
city: Hyderabad
country: India
facility: Investigational Site Number 3560045
city: Hyderabad
country: India
facility: Investigational Site Number 3560058
city: Hyderabad
country: India
facility: Investigational Site Number 3560036
city: Hyderabad
country: India
facility: Investigational Site Number 3560069
city: Hyderabad
country: India
facility: Investigational Site Number 3560035
city: Hyderabad
country: India
facility: Investigational Site Number 3560024
city: Hyderabad
country: India
facility: Investigational Site Number 3560027
city: Hyderabad
country: India
facility: Investigational Site Number 3560043
city: Hyderabad
country: India
facility: Investigational Site Number 3560100
city: Hyderabad
country: India
facility: Investigational Site Number 3560107
city: Hyderabd
country: India
facility: Investigational Site Number 3560034
city: Jaipur
country: India
facility: Investigational Site Number 3560111
city: Jaipur
country: India
facility: Investigational Site Number 3560123
city: Jaipur
country: India
facility: Investigational Site Number 3560134
city: Jaipur
country: India
facility: Investigational Site Number 3560017
city: Jaipur
country: India
facility: Investigational Site Number 3560022
city: Jalandhar
country: India
facility: Investigational Site Number 3560073
city: Kanpur
country: India
facility: Investigational Site Number 3560005
city: Kanpur
country: India
facility: Investigational Site Number 3560125
city: Kochi
country: India
facility: Investigational Site Number 3560026
city: Kochi
country: India
facility: Investigational Site Number 3560018
city: Kochi
country: India
facility: Investigational Site Number 3560050
city: Kolkata
country: India
facility: Investigational Site Number 3560091
city: Kolkata
country: India
facility: Investigational Site Number 3560083
city: Kolkata
country: India
facility: Investigational Site Number 3560090
city: Kolkata
country: India
facility: Investigational Site Number 3560092
city: Kolkata
country: India
facility: Investigational Site Number 3560093
city: Kolkata
country: India
facility: Investigational Site Number 3560099
city: Kolkata
country: India
facility: Investigational Site Number 3560115
city: Kolkata
country: India
facility: Investigational Site Number 3560120
city: Kolkata
country: India
facility: Investigational Site Number 3560129
city: Kolkata
country: India
facility: Investigational Site Number 3560130
city: Kolkata
country: India
facility: Investigational Site Number 3650120
city: Lucknow
country: India
facility: Investigational Site Number 3560103
city: Madurai
country: India
facility: Investigational Site Number 3560117
city: Mumbai
country: India
facility: Investigational Site Number 3560033
city: Mumbai
country: India
facility: Investigational Site Number 3560121
city: Mumbai
country: India
facility: Investigational Site Number 3560136
city: Mumbai
country: India
facility: Investigational Site Number 3560042
city: Mumbai
country: India
facility: Investigational Site Number 3560065
city: Mumbai
country: India
facility: Investigational Site Number 3560015
city: Mumbai
country: India
facility: Investigational Site Number 3560079
city: Mumbai
country: India
facility: Investigational Site Number 3560003
city: Mumbai
country: India
facility: Investigational Site Number 3560023
city: Mumbai
country: India
facility: Investigational Site Number 3560040
city: Mumbai
country: India
facility: Investigational Site Number 3560119
city: Navi Mumbai
country: India
facility: Investigational Site Number 3560112
city: Nellore
country: India
facility: Investigational Site Number 3560010
city: Noida
country: India
facility: Investigational Site Number 3560086
city: Noida
country: India
facility: Investigational Site Number 3560132
city: Pondicherry
country: India
facility: Investigational Site Number 3560053
city: Pune
country: India
facility: Investigational Site Number 3560004
city: Pune
country: India
facility: Investigational Site Number 3560038
city: Pune
country: India
facility: Investigational Site Number 3560055
city: Pune
country: India
facility: Investigational Site Number 3560060
city: Rajahmundry
country: India
facility: Investigational Site Number 3560072
city: Rajkot
country: India
facility: Investigational Site Number 3560025
city: Rajkot
country: India
facility: Investigational Site Number 3560076
city: Surat
country: India
facility: Investigational Site Number 3560063
city: Tinsukia
country: India
facility: Investigational Site Number 3560084
city: Trichy
country: India
facility: Investigational Site Number 3560006
city: Trichy
country: India
facility: Investigational Site Number 3560001
city: Trichy
country: India
facility: Investigational Site Number 3560101
city: Tripura
country: India
facility: Investigational Site Number 3560114
city: Trivandrum
country: India
facility: Investigational Site Number 3560039
city: Trivandrum
country: India
facility: Investigational Site Number 3560013
city: Vijayawada
country: India
facility: Investigational Site Number 3560127
city: Visakhapatnam
country: India
facility: Investigational Site Number 3560061
city: Visakhapatnam
country: India
facility: Investigational Site Number 3560054
city: Yamunanagar
country: India
facility: Investigational Site Number 3560128
city: Denpasar
country: Indonesia
facility: Investigational Site Number 3600003
city: Jakarta
country: Indonesia
facility: Investigational Site Number 3600001
city: Jakarta
country: Indonesia
facility: Investigational Site Number 3600002
city: Haifa
country: Israel
facility: Investigational Site Number 3760001
city: Petach Tikva
country: Israel
facility: Investigational Site Number 3760002
city: Rishon Le-Zion
country: Israel
facility: Investigational Site Number 3760005
city: Tel Aviv
country: Israel
facility: Investigational Site Number 3760004
city: Tel-Aviv
country: Israel
facility: Investigational Site Number 3760003
city: Amman
country: Jordan
facility: Investigational Site Number 4000002
city: Amman
country: Jordan
facility: Investigational Site Number 4000005
city: Amman
country: Jordan
facility: Investigational Site Number 4000006
city: Amman
country: Jordan
facility: Investigational Site Number 4000008
city: Amman
country: Jordan
facility: Investigational Site Number 0004
city: Amman
country: Jordan
facility: Investigational Site Number 4000009
city: Irbid
country: Jordan
facility: Investigational Site Number 0007
city: Al Jabriya
country: Kuwait
facility: Investigational Site Number 4140001
city: Al Jabriya
country: Kuwait
facility: Investigational Site Number 4140010
city: Kuwait
country: Kuwait
facility: Investigational Site Number 4140003
city: Kuwait
country: Kuwait
facility: Investigational Site Number 4140004
city: Kuwait
country: Kuwait
facility: Investigational Site Number 4140006
city: Kuwait
country: Kuwait
facility: Investigational Site Number 4140009
city: Kuwait
country: Kuwait
facility: Investigational Site Number 4140011
city: Kuwait
country: Kuwait
facility: Investigational Site Number 4140012
city: Achrafieh
country: Lebanon
facility: Investigational Site Number 4220006
city: Achrafieh
country: Lebanon
facility: Investigational Site Number 4220016
city: Airport Road
country: Lebanon
facility: Investigational Site Number 4220017
city: Aley
country: Lebanon
facility: Investigational Site Number 4220008
city: Beirut
country: Lebanon
facility: Investigational Site Number 4220001
city: Beirut
country: Lebanon
facility: Investigational Site Number 4220015
city: Bir Al Abed
country: Lebanon
facility: Investigational Site Number 4220012
city: Chtoura
country: Lebanon
facility: Investigational Site Number 4220007
city: Corniche El Mazraa
country: Lebanon
facility: Investigational Site Number 4220011
city: Hadath
country: Lebanon
facility: Investigational Site Number 4220018
city: Hamra
country: Lebanon
facility: Investigational Site Number 4220013
city: Jal El Baher
country: Lebanon
facility: Investigational Site Number 4220019
city: Jounieh
country: Lebanon
facility: Investigational Site Number 4220014
city: Metn
country: Lebanon
facility: Investigational Site Number 4220010
city: Mount Lebanon
country: Lebanon
facility: Investigational Site Number 4220004
city: Saida
country: Lebanon
facility: Investigational Site Number 4220005
city: Sarba
country: Lebanon
facility: Investigational Site Number 4220003
city: Tyr
country: Lebanon
facility: Investigational Site Number 4220009
city: Aguascalientes
country: Mexico
facility: Investigational Site Number 4840001
city: Celaya
country: Mexico
facility: Investigational Site Number 4840009
city: Chihuahua
country: Mexico
facility: Investigational Site Number 4840008
city: Cuernavaca
country: Mexico
facility: Investigational Site Number 4840004
city: Durango
country: Mexico
facility: Investigational Site Number 4840007
city: Guadalajara
country: Mexico
facility: Investigational Site Number 4840006
city: Guadalajara
country: Mexico
facility: Investigational Site Number 4840003
city: Mexico
country: Mexico
facility: Investigational Site Number 4840010
city: Mexico
country: Mexico
facility: Investigational Site Number 4840002
city: México City
country: Mexico
facility: Investigational Site Number 4840005
city: Arequipa
country: Peru
facility: Investigational Site Number 6040003
city: Lima
country: Peru
facility: Investigational Site Number 6040001
city: Lima
country: Peru
facility: Investigational Site Number 6040002
city: Dasmarinas Cavite
country: Philippines
facility: Investigational Site Number 6080001
city: Anapa
country: Russian Federation
facility: Investigational Site Number 6430108
city: Arkhangelsk
country: Russian Federation
facility: Investigational Site Number 6430170
city: Arkhangelsk
country: Russian Federation
facility: Investigational Site Number 6430171
city: Arkhangelsk
country: Russian Federation
facility: Investigational Site Number 6430172
city: Astrakhan
country: Russian Federation
facility: Investigational Site Number 6430019
city: Barnaul
country: Russian Federation
facility: Investigational Site Number 6430010
city: Barnaul
country: Russian Federation
facility: Investigational Site Number 6430138
city: Barnaul
country: Russian Federation
facility: Investigational Site Number 6430081
city: Barnaul
country: Russian Federation
facility: Investigational Site Number 6430182
city: Barnaul
country: Russian Federation
facility: Investigational Site Number 6430160
city: Barnaul
country: Russian Federation
facility: Investigational Site Number 6430181
city: Belorechensk
country: Russian Federation
facility: Investigational Site Number 6430157
city: Bryansk
country: Russian Federation
facility: Investigational Site Number 6430156
city: Chaltyr
country: Russian Federation
facility: Investigational Site Number 6430060
city: Cheboksary
country: Russian Federation
facility: Investigational Site Number 6430087
city: Chelyabinsk
country: Russian Federation
facility: Investigational Site Number 6430097
city: Chelyabinsk
country: Russian Federation
facility: Investigational Site Number 6430036
city: Chelyabinsk
country: Russian Federation
facility: Investigational Site Number 6430092
city: Chelyabinsk
country: Russian Federation
facility: Investigational Site Number 6430107
city: Gorodets
country: Russian Federation
facility: Investigational Site Number 6430111
city: Kazan
country: Russian Federation
facility: Investigational Site Number 6430012
city: Kazan
country: Russian Federation
facility: Investigational Site Number 6430184
city: Kemerovo
country: Russian Federation
facility: Investigational Site Number 6430011
city: Kemerovo
country: Russian Federation
facility: Investigational Site Number 6430109
city: Kemerovo
country: Russian Federation
facility: Investigational Site Number 6430072
city: Kolomna
country: Russian Federation
facility: Investigational Site Number 6430125
city: Krasnodar
country: Russian Federation
facility: Investigational Site Number 6430143
city: Krasnodar
country: Russian Federation
facility: Investigational Site Number 6430047
city: Krasnodar
country: Russian Federation
facility: Investigational Site Number 6430136
city: Krasnodar
country: Russian Federation
facility: Investigational Site Number 6430083
city: Krasnodar
country: Russian Federation
facility: Investigational Site Number 6430140
city: Krasnodar
country: Russian Federation
facility: Investigational Site Number 6430021
city: Krasnoyarsk
country: Russian Federation
facility: Investigational Site Number 6430115
city: Krasnoyarsk
country: Russian Federation
facility: Investigational Site Number 6430004
city: Lipetsk
country: Russian Federation
facility: Investigational Site Number 6430068
city: Lipetsk
country: Russian Federation
facility: Investigational Site Number 6430067
city: Livny
country: Russian Federation
facility: Investigational Site Number 6430024
city: Moscow
country: Russian Federation
facility: Investigational Site Number 6430128
city: Moscow
country: Russian Federation
facility: Investigational Site Number 6430168
city: Moscow
country: Russian Federation
facility: Investigational Site Number 6430064
city: Moscow
country: Russian Federation
facility: Investigational Site Number 6430065
city: Moscow
country: Russian Federation
facility: Investigational Site Number 6430148
city: Moscow
country: Russian Federation
facility: Investigational Site Number 6430079
city: Moscow
country: Russian Federation
facility: Investigational Site Number 6430101
city: Moscow
country: Russian Federation
facility: Investigational Site Number 6430100
city: Moscow
country: Russian Federation
facility: Investigational Site Number 6430120
city: Moscow
country: Russian Federation
facility: Investigational Site Number 6430130
city: Moscow
country: Russian Federation
facility: Investigational Site Number 6430026
city: Moscow
country: Russian Federation
facility: Investigational Site Number 6430005
city: Moscow
country: Russian Federation
facility: Investigational Site Number 6430017
city: Moscow
country: Russian Federation
facility: Investigational Site Number 6430027
city: Moscow
country: Russian Federation
facility: Investigational Site Number 6430057
city: Moscow
country: Russian Federation
facility: Investigational Site Number 6430035
city: Moscow
country: Russian Federation
facility: Investigational Site Number 6430118
city: Moscow
country: Russian Federation
facility: Investigational Site Number 6430146
city: Moscow
country: Russian Federation
facility: Investigational Site Number 6430147
city: Moscow
country: Russian Federation
facility: Investigational Site Number 6430051
city: Moscow
country: Russian Federation
facility: Investigational Site Number 6430149
city: Nizhny Novgorod
country: Russian Federation
facility: Investigational Site Number 6430132
city: Nizhny Novgorod
country: Russian Federation
facility: Investigational Site Number 6430066
city: Nizhny Novgorod
country: Russian Federation
facility: Investigational Site Number 6430129
city: Novomoskovsk
country: Russian Federation
facility: Investigational Site Number 6430110
city: Novosibirsk
country: Russian Federation
facility: Investigational Site Number 6430007
city: Novosibirsk
country: Russian Federation
facility: Investigational Site Number 6430061
city: Novosibirsk
country: Russian Federation
facility: Investigational Site Number 6430023
city: Omsk
country: Russian Federation
facility: Investigational Site Number 6430117
city: Orel
country: Russian Federation
facility: Investigational Site Number 6430112
city: Orel
country: Russian Federation
facility: Investigational Site Number 6430137
city: Orenburg
country: Russian Federation
facility: Investigational Site Number 6430014
city: Penza
country: Russian Federation
facility: Investigational Site Number 6430039
city: Penza
country: Russian Federation
facility: Investigational Site Number 6430164
city: Perm
country: Russian Federation
facility: Investigational Site Number 6430126
city: Petrozavodsk
country: Russian Federation
facility: Investigational Site Number 6430040
city: Petrozavodsk
country: Russian Federation
facility: Investigational Site Number 6430054
city: Petrozavodsk
country: Russian Federation
facility: Investigational Site Number 6430084
city: Pushkin
country: Russian Federation
facility: Investigational Site Number 6430038
city: Rostov-on-Don
country: Russian Federation
facility: Investigational Site Number 6430151
city: Rostov-on-Don
country: Russian Federation
facility: Investigational Site Number 6430090
city: Rybinsk
country: Russian Federation
facility: Investigational Site Number 6430037
city: Saint Petersburg
country: Russian Federation
facility: Investigational Site Number 6430086
city: Saint Petersburg
country: Russian Federation
facility: Investigational Site Number 6430139
city: Saint Petersburg
country: Russian Federation
facility: Investigational Site Number 6430022
city: Saint Petersburg
country: Russian Federation
facility: Investigational Site Number 6430070
city: Saint Petersburg
country: Russian Federation
facility: Investigational Site Number 643085
city: Saint Petersburg
country: Russian Federation
facility: Investigational Site Number 6430028
city: Saint Petersburg
country: Russian Federation
facility: Investigational Site Number 6430074
city: Saint Petersburg
country: Russian Federation
facility: Investigational Site Number 6430135
city: Saint Petersburg
country: Russian Federation
facility: Investigational Site Number 6430150
city: Saint Petersburg
country: Russian Federation
facility: Investigational Site Number 6430095
city: Saint Petersburg
country: Russian Federation
facility: Investigational Site Number 6430032
city: Saint Petersburg
country: Russian Federation
facility: Investigational Site Number 6430031
city: Saint Petersburg
country: Russian Federation
facility: Investigational Site Number 6430099
city: Saint Petersburg
country: Russian Federation
facility: Investigational Site Number 6430131
city: Saint Petersburg
country: Russian Federation
facility: Investigational Site Number 6430163
city: Saint Petersburg
country: Russian Federation
facility: Investigational Site Number 6430152
city: Saint-Petersburg
country: Russian Federation
facility: Investigational Site Number 6430144
city: Salsk
country: Russian Federation
facility: Investigational Site Number 6430073
city: Samara
country: Russian Federation
facility: Investigational Site Number 6430177
city: Samara
country: Russian Federation
facility: Investigational Site Number 6430046
city: Shatura
country: Russian Federation
facility: Investigational Site Number 6430029
city: Smolensk
country: Russian Federation
facility: Investigational Site Number 6430155
city: Smolensk
country: Russian Federation
facility: Investigational Site Number 6430121
city: Sochi
country: Russian Federation
facility: Investigational Site Number 6430089
city: Stavropol
country: Russian Federation
facility: Investigational Site Number 6430044
city: Stavropol
country: Russian Federation
facility: Investigational Site Number 6430134
city: Stavropol
country: Russian Federation
facility: Investigational Site Number 6430153
city: Tambov
country: Russian Federation
facility: Investigational Site Number 6430076
city: Tambov
country: Russian Federation
facility: Investigational Site Number 6430142
city: Tolyatti
country: Russian Federation
facility: Investigational Site Number 6430013
city: Tomsk
country: Russian Federation
facility: Investigational Site Number 6430058
city: Tver
country: Russian Federation
facility: Investigational Site Number 6430030
city: Tver
country: Russian Federation
facility: Investigational Site Number 6430169
city: Tver
country: Russian Federation
facility: Investigational Site Number 6430166
city: Tyumen
country: Russian Federation
facility: Investigational Site Number 6430123
city: Tyumen
country: Russian Federation
facility: Investigational Site Number 6430098
city: Tyumen
country: Russian Federation
facility: Investigational Site Number 6430078
city: Ufa
country: Russian Federation
facility: Investigational Site Number 6430189
city: Ulyanovsk
country: Russian Federation
facility: Investigational Site Number 6430041
city: Vladimir
country: Russian Federation
facility: Investigational Site Number 6430114
city: Volgograd
country: Russian Federation
facility: Investigational Site Number 6430018
city: Vsevolozhsk
country: Russian Federation
facility: Investigational Site Number 6430052
city: Vyksa
country: Russian Federation
facility: Investigational Site Number 6430008
city: Yaroslavl
country: Russian Federation
facility: Investigational Site Number 6430055
city: Yartsevo
country: Russian Federation
facility: Investigational Site Number 6430033
city: Yoshkar-Ola
country: Russian Federation
facility: Investigational Site Number 6430006
city: Al Ehsa
country: Saudi Arabia
facility: Investigational Site Number 6820009
city: Jeddah
country: Saudi Arabia
facility: Investigational Site Number 6820006
city: Jeddah
country: Saudi Arabia
facility: Investigational Site Number 6820001
city: Jeddah
country: Saudi Arabia
facility: Investigational Site Number 6820008
city: Jeddah
country: Saudi Arabia
facility: Investigational Site Number 6820010
city: Jubail
country: Saudi Arabia
facility: Investigational Site Number 6820007
city: Najran
country: Saudi Arabia
facility: Investigational Site Number 6820004
city: Riyadh
country: Saudi Arabia
facility: Investigational Site Number 6820003
city: Singapore
country: Singapore
facility: Investigational Site Number 7020001
city: Changhua
country: Taiwan
facility: Investigational Site Number 1580007
city: Kaohsiung Hsien,
country: Taiwan
facility: Investigational Site Number 1580005
city: New Taipei city
country: Taiwan
facility: Investigational Site Number 1580003
city: Taichung
country: Taiwan
facility: Investigational Site Number 1580004
city: Tainan
country: Taiwan
facility: Investigational Site Number 1580002
city: Taipei
country: Taiwan
facility: Investigational Site Number 1580006
city: Bangkok
country: Thailand
facility: Investigational Site Number 7640002
city: Bangkok
country: Thailand
facility: Investigational Site Number 7640001
city: Cherkasy
country: Ukraine
facility: Investigational Site Number 8040020
city: Chernivtsi
country: Ukraine
facility: Investigational Site Number 8040002
city: Dnipro
country: Ukraine
facility: Investigational Site Number 8040006
city: Dnipro
country: Ukraine
facility: Investigational Site Number 8040014
city: Ivano-Frankivsk
country: Ukraine
facility: Investigational Site Number 8040010
city: Kharkiv
country: Ukraine
facility: Investigational Site Number 8040013
city: Kharkiv
country: Ukraine
facility: Investigational Site Number 8040016
city: Kharkiv
country: Ukraine
facility: Investigational Site Number 8040001
city: Khmelnytskyi
country: Ukraine
facility: Investigational Site Number 8040012
city: Kyiv
country: Ukraine
facility: Investigational Site Number 8040019
city: Kyiv
country: Ukraine
facility: Investigational Site Number 8040005
city: Kyiv
country: Ukraine
facility: Investigational Site Number 8040008
city: Kyiv
country: Ukraine
facility: Investigational Site Number 8040011
city: Kyiv
country: Ukraine
facility: Investigational Site Number 8040017
city: Poltava
country: Ukraine
facility: Investigational Site Number 8040007
city: Sumy
country: Ukraine
facility: Investigational Site Number 8040004
city: Ternopil
country: Ukraine
facility: Investigational Site Number 8040009
city: Ternopil
country: Ukraine
facility: Investigational Site Number 8040018
city: Vinnytsya
country: Ukraine
facility: Investigational Site Number 8040003
city: Zaporizhzhia
country: Ukraine
facility: Investigational Site Number 8040015
city: Abu Dhabi
country: United Arab Emirates
facility: Investigational Site Number 7840017
city: Abu Dhabi
country: United Arab Emirates
facility: Investigational Site Number 7840018
city: Ajman
country: United Arab Emirates
facility: Investigational Site Number 7840007
city: Dubai
country: United Arab Emirates
facility: Investigational Site Number 7840001
city: Dubai
country: United Arab Emirates
facility: Investigational Site Number 7840002
city: Dubai
country: United Arab Emirates
facility: Investigational Site Number 7840003
city: Dubai
country: United Arab Emirates
facility: Investigational Site Number 7840004
city: Dubai
country: United Arab Emirates
facility: Investigational Site Number 7840005
city: Dubai
country: United Arab Emirates
facility: Investigational Site Number 7840008
city: Dubai
country: United Arab Emirates
facility: Investigational Site Number 7840009
city: Dubai
country: United Arab Emirates
facility: Investigational Site Number 7840010
city: Dubai
country: United Arab Emirates
facility: Investigational Site Number 7840012
city: Dubai
country: United Arab Emirates
facility: Investigational Site Number 7840013
city: Dubai
country: United Arab Emirates
facility: Investigational Site Number 7840014
city: Dubai
country: United Arab Emirates
facility: Investigational Site Number 7840015
city: Dubai
country: United Arab Emirates
facility: Investigational Site Number 7840016
city: Umm al Quwain
country: United Arab Emirates
facility: Investigational Site Number 7840019
city: Umm al Quwain
country: United Arab Emirates
facility: Investigational Site Number 7840020
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References:
citation: 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.