DiabetesATOSNCT03703869

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.

An observational study of Diabetes, run by Sanofi at 388 sites in 18 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Diabetes
What is being tested?: Insulin glargine (U300)
Type of treatment: Injection or infusion
How many people: 4,589 participants
Where: 388 sitesin 18 countries
Study dates: 6 Mar 2018to 24 Feb 2020
Phase: Observational
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

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

Who may be able to join

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

Who cannot join

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.

Trial locations and contacts

388 sites in 18 countries.

Country

City, postcode or hospital

388 sites in 18 countries

India127 sites

Investigational Site Number 3560056
Ahmedabad, 380006
Investigational Site Number 3560021
Ahmedabad, 380007
Investigational Site Number 3560049
Ahmedabad, 380009
Investigational Site Number 3560077
Ahmedabad, 380009
Investigational Site Number 3560068
Ahmedabad, 380054
Investigational Site Number 3560014
Aurangabad, 431001
Investigational Site Number 3560081
Bangalore, 560005
Investigational Site Number 3560088
Bangalore, 560019
Investigational Site Number 3560066
Bangalore, 560078
Investigational Site Number 3560009
Bangalore, 560079
Investigational Site Number 3560059
Bangalore
Investigational Site Number 3560064
Bangalore
Investigational Site Number 3560075
Bangalore
Investigational Site Number 3560122
Bangalore
Investigational Site Number 3560044
Belagavi
Investigational Site Number 3560074
Bengaluru, 560003
Investigational Site Number 3560046
Bengaluru, 560040
Investigational Site Number 3560116
Bhabaneswar, 751012
Investigational Site Number 3560062
Bhubaneswar, 751003
Investigational Site Number 3560106
Chandigarh, 160012
Investigational Site Number 3560126
Chandigarh, 160043
Investigational Site Number 3560110
Chennai, 600005
Investigational Site Number 3560029
Chennai, 600008
Investigational Site Number 3560080
Chennai, 600014
Investigational Site Number 3560067
Chennai, 600017
Investigational Site Number 3560030
Chennai, 600032
Investigational Site Number 3560008
Chennai, 600040
Investigational Site Number 3560031
Chennai, 600042
Investigational Site Number 3560011
Chennai, 600083
Investigational Site Number 3560124
Chennai, 600085
Investigational Site Number 3560105
Chennai, 600090
Investigational Site Number 3560098
Chennai, 600100
Investigational Site Number 3560104
Chennai, 600106
Investigational Site Number 3560133
Chennai
Investigational Site Number 3560012
Coimbatore, 641004
Investigational Site Number 3560131
Coimbatore, 641009
Investigational Site Number 3560032
Delhi, 110005
Investigational Site Number 3560041
Delhi, 110017
Investigational Site Number 3560108
Delhi, 110021
Investigational Site Number 3560002
Delhi, 110060
Investigational Site Number 3560019
Delhi, 110063
Investigational Site Number 3560047
Delhi, 110063
Investigational Site Number 3560102
Delhi, 110076
Investigational Site Number 3560020
Delhi, 110085
Investigational Site Number 3560085
Delhi, 110087
Investigational Site Number 3560118
Erode, 638011
Investigational Site Number 3560051
Guwahati, 781001
Investigational Site Number 3560094
Guwahati, 781005
Investigational Site Number 3560087
Guwahati, 781006
Investigational Site Number 3560113
Guwahati, 781006
Investigational Site Number 3560070
Guwahati, 781011
Investigational Site Number 3560097
Guwahati, 781022
Investigational Site Number 3560109
Gwalior, 474001
Investigational Site Number 3560089
Haryāna
Investigational Site Number 3560135
Howrah, 711201
Investigational Site Number 3560096
Howrah
Investigational Site Number 3560045
Hyderabad, 500002
Investigational Site Number 3560058
Hyderabad, 500016
Investigational Site Number 3560036
Hyderabad, 500029
Investigational Site Number 3560069
Hyderabad, 500033
Investigational Site Number 3560035
Hyderabad, 500073
Investigational Site Number 3560024
Hyderabad, 500081
Investigational Site Number 3560027
Hyderabad
Investigational Site Number 3560043
Hyderabad
Investigational Site Number 3560100
Hyderabad
Investigational Site Number 3560107
Hyderabad
Investigational Site Number 3560034
Hyderabd
Investigational Site Number 3560111
Jaipur, 302015
Investigational Site Number 3560123
Jaipur, 302015
Investigational Site Number 3560134
Jaipur, 302016
Investigational Site Number 3560017
Jaipur, 302018
Investigational Site Number 3560022
Jaipur
Investigational Site Number 3560073
Jalandhar, 144003
Investigational Site Number 3560005
Kanpur, 208002
Investigational Site Number 3560125
Kanpur, 208002
Investigational Site Number 3560026
Kochi, 682019
Investigational Site Number 3560018
Kochi, 682020
Investigational Site Number 3560050
Kochi, 682041
Investigational Site Number 3560016
Kochi
Investigational Site Number 3560091
Kolkata, 700020
Investigational Site Number 3560083
Kolkata
Investigational Site Number 3560090
Kolkata
Investigational Site Number 3560092
Kolkata
Investigational Site Number 3560093
Kolkata
Investigational Site Number 3560099
Kolkata
Investigational Site Number 3560115
Kolkata
Investigational Site Number 3560120
Kolkata
Investigational Site Number 3560129
Kolkata
Investigational Site Number 3560130
Kolkata
Investigational Site Number 3650120
Kolkata
Investigational Site Number 3560103
Lucknow
Investigational Site Number 3560117
Madurai, 625020
Investigational Site Number 3560033
Mumbai, 400005
Investigational Site Number 3560121
Mumbai, 400007
Investigational Site Number 3560136
Mumbai, 400053
Investigational Site Number 3560042
Mumbai, 400064
Investigational Site Number 3560065
Mumbai, 400068
Investigational Site Number 3560015
Mumbai, 400092
Investigational Site Number 3560079
Mumbai, 400601
Investigational Site Number 3560003
Mumbai
Investigational Site Number 3560023
Mumbai
Investigational Site Number 3560040
Mumbai
Investigational Site Number 3560119
Mumbai
Investigational Site Number 3560112
Navi Mumbai, 400706
Investigational Site Number 3560010
Nellore, 524001
Investigational Site Number 3560086
Noida
Investigational Site Number 3560132
Noida
Investigational Site Number 3560053
Puducherry, 605005
Investigational Site Number 3560004
Pune, 411001
Investigational Site Number 3560038
Pune, 411004
Investigational Site Number 3560055
Pune, 411021
Investigational Site Number 3560060
Pune, 411037
Investigational Site Number 3560072
Rajahmundry, 533103
Investigational Site Number 3560025
Rajkot, 360001
Investigational Site Number 3560076
Rajkot, 360002
Investigational Site Number 3560063
Surat
Investigational Site Number 3560084
Tinsukia, 786125
Investigational Site Number 3560006
Trichy, 620017
Investigational Site Number 3560001
Trichy, 620018
Investigational Site Number 3560101
Trichy, 620018
Investigational Site Number 3560114
Tripura, 799001
Investigational Site Number 3560039
Trivandrum, 695033
Investigational Site Number 3560013
Trivandrum
Investigational Site Number 3560127
Vijayawada, 520002
Investigational Site Number 3560061
Visakhapatnam, 530002
Investigational Site Number 3560054
Visakhapatnam, 530016
Investigational Site Number 3560128
Yamuna Nagar

Other trials in India

Russia125 sites

Investigational Site Number 6430108
Anapa, 353440
Investigational Site Number 6430170
Arkhangelsk, 163045
Investigational Site Number 6430171
Arkhangelsk, 163045
Investigational Site Number 6430172
Arkhangelsk, 163045
Investigational Site Number 6430019
Astrakhan, 414018
Investigational Site Number 6430010
Barnaul, 656050
Investigational Site Number 6430138
Barnaul, 656050
Investigational Site Number 6430081
Barnaul, 656056
Investigational Site Number 6430182
Barnaul, 656056
Investigational Site Number 6430160
Barnaul, 656066
Investigational Site Number 6430181
Barnaul, 656922
Investigational Site Number 6430157
Belorechensk, 352630
Investigational Site Number 6430156
Bryansk, 241047
Investigational Site Number 6430060
Chaltyr, 346801
Investigational Site Number 6430087
Cheboksary, 428009
Investigational Site Number 6430097
Chelyabinsk, 454046
Investigational Site Number 6430036
Chelyabinsk, 454076
Investigational Site Number 6430092
Chelyabinsk, 454084
Investigational Site Number 6430107
Chelyabinsk, 454091
Investigational Site Number 6430111
Gorodets, 606500
Investigational Site Number 6430012
Kazan', 420064
Investigational Site Number 6430184
Kazan', 420103
Investigational Site Number 6430011
Kemerovo, 650066
Investigational Site Number 6430109
Kemerovo, 650066
Investigational Site Number 6430072
Kemerovo, 650099
Investigational Site Number 6430125
Kolomna, 140405
Investigational Site Number 6430143
Krasnodar, 350000
Investigational Site Number 6430047
Krasnodar, 350001
Investigational Site Number 6430136
Krasnodar, 350002
Investigational Site Number 6430083
Krasnodar, 350072
Investigational Site Number 6430140
Krasnodar, 350075
Investigational Site Number 6430021
Krasnodar, 350915
Investigational Site Number 6430115
Krasnoyarsk, 660003
Investigational Site Number 6430004
Krasnoyarsk, 660052
Investigational Site Number 6430068
Lipetsk, 398043
Investigational Site Number 6430067
Lipetsk
Investigational Site Number 6430024
Livny, 303858
Investigational Site Number 6430128
Moscow, 105005
Investigational Site Number 6430168
Moscow, 105005
Investigational Site Number 6430064
Moscow, 109145
Investigational Site Number 6430065
Moscow, 109457
Investigational Site Number 6430148
Moscow, 111555
Investigational Site Number 6430079
Moscow, 115211
Investigational Site Number 6430101
Moscow, 115409
Investigational Site Number 6430100
Moscow, 115516
Investigational Site Number 6430120
Moscow, 115516
Investigational Site Number 6430130
Moscow, 115516
Investigational Site Number 6430026
Moscow, 119311
Investigational Site Number 6430005
Moscow, 121601
Investigational Site Number 6430017
Moscow, 124482
Investigational Site Number 6430027
Moscow, 125222
Investigational Site Number 6430057
Moscow, 125373
Investigational Site Number 6430035
Moscow, 127018
Investigational Site Number 6430118
Moscow, 127273
Investigational Site Number 6430146
Moscow, 127549
Investigational Site Number 6430147
Moscow, 141411
Investigational Site Number 6430051
Moscow
Investigational Site Number 6430149
Moscow
Investigational Site Number 6430132
Nizhny Novgorod, 603004
Investigational Site Number 6430066
Nizhny Novgorod, 603035
Investigational Site Number 6430129
Nizhny Novgorod, 603163
Investigational Site Number 6430110
Novomoskovsk, 301650
Investigational Site Number 6430007
Novosibirsk, 630047
Investigational Site Number 6430061
Novosibirsk, 630060
Investigational Site Number 6430023
Novosibirsk, 630106
Investigational Site Number 6430117
Omsk, 644010
Investigational Site Number 6430014
Orenburg, 460018
Investigational Site Number 6430112
Oryol, 302030
Investigational Site Number 6430137
Oryol
Investigational Site Number 6430039
Penza, 440052
Investigational Site Number 6430164
Penza, 440052
Investigational Site Number 6430126
Perm
Investigational Site Number 6430040
Petrozavodsk, 185014
Investigational Site Number 6430054
Petrozavodsk, 185014
Investigational Site Number 6430084
Petrozavodsk, 185014
Investigational Site Number 6430038
Pushkin, 196607
Investigational Site Number 6430151
Rostov-on-Don, 344029
Investigational Site Number 6430090
Rostov-on-Don, 344092
Investigational Site Number 6430037
Rybinsk, 152912
Investigational Site Number 6430086
Saint Petersburg, 19323
Investigational Site Number 6430139
Saint Petersburg, 19323
Investigational Site Number 6430022
Saint Petersburg, 193312
Investigational Site Number 6430070
Saint Petersburg, 194156
Investigational Site Number 643085
Saint Petersburg, 195220
Investigational Site Number 6430028
Saint Petersburg, 195256
Investigational Site Number 6430074
Saint Petersburg, 195256
Investigational Site Number 6430135
Saint Petersburg, 195256
Investigational Site Number 6430150
Saint Petersburg, 195256
Investigational Site Number 6430095
Saint Petersburg, 195426
Investigational Site Number 6430032
Saint Petersburg, 197082
Investigational Site Number 6430144
Saint Petersburg, 197101
Investigational Site Number 6430031
Saint Petersburg, 197341
Investigational Site Number 6430099
Saint Petersburg, 197349
Investigational Site Number 6430131
Saint Petersburg, 197349
Investigational Site Number 6430163
Saint Petersburg, 197371
Investigational Site Number 6430152
Saint Petersburg, 199155
Investigational Site Number 6430073
Sal'sk, 347630
Investigational Site Number 6430177
Samara, 443031
Investigational Site Number 6430046
Samara, 443111
Investigational Site Number 6430029
Shatura, 140700
Investigational Site Number 6430155
Smolensk, 214006
Investigational Site Number 6430121
Smolensk, 214019
Investigational Site Number 6430089
Sochi, 354382
Investigational Site Number 6430044
Stavropol, 355035
Investigational Site Number 6430134
Stavropol, 355035
Investigational Site Number 6430153
Stavropol, 355035
Investigational Site Number 6430076
Tambov, 392023
Investigational Site Number 6430142
Tambov, 392023
Investigational Site Number 6430013
Tolyatti, 445000
Investigational Site Number 6430058
Tomsk, 634034
Investigational Site Number 6430030
Tver', 170019
Investigational Site Number 6430169
Tver', 170028
Investigational Site Number 6430166
Tver', 170036
Investigational Site Number 6430123
Tyumen, 625003
Investigational Site Number 6430098
Tyumen, 625031
Investigational Site Number 6430078
Tyumen, 660077
Investigational Site Number 6430189
Ufa, 450099
Investigational Site Number 6430041
Ulyanovsk, 432063
Investigational Site Number 6430114
Vladimir
Investigational Site Number 6430018
Volgograd, 400001
Investigational Site Number 6430052
Vsevolozhsk
Investigational Site Number 6430008
Vyksa, 607060
Investigational Site Number 6430055
Yaroslavl, 150042
Investigational Site Number 6430033
Yartsevo
Investigational Site Number 6430006
Yoshkar-Ola

Other trials in Russia

Ukraine20 sites

Investigational Site Number 8040020
Cherkasy, 18009
Investigational Site Number 8040002
Chernivtsi, 58022
Investigational Site Number 8040006
Dnipro, 49005
Investigational Site Number 8040014
Dnipro, 49038
Investigational Site Number 8040010
Ivano-Frankivsk, 76008
Investigational Site Number 8040013
Kharkiv, 61037
Investigational Site Number 8040016
Kharkiv, 61037
Investigational Site Number 8040001
Kharkiv, 61157
Investigational Site Number 8040012
Khmelnytskyi, 29000
Investigational Site Number 8040019
Kyiv, 02091
Investigational Site Number 8040005
Kyiv, 04053
Investigational Site Number 8040008
Kyiv, 04073
Investigational Site Number 8040011
Kyiv, 04114
Investigational Site Number 8040017
Kyiv, 04114
Investigational Site Number 8040007
Poltava, 36003
Investigational Site Number 8040004
Sumy, 40022
Investigational Site Number 8040009
Ternopil, 46002
Investigational Site Number 8040018
Ternopil, 46002
Investigational Site Number 8040003
Vinnytsia, 21010
Investigational Site Number 8040015
Zaporizhzhya, 69001

Other trials in Ukraine

Lebanon18 sites

Investigational Site Number 4220017
Airport Road
Investigational Site Number 4220008
Aley
Investigational Site Number 4220001
Beirut
Investigational Site Number 4220015
Beirut
Investigational Site Number 4220012
Bir Al Abed
Investigational Site Number 4220007
Chtoura
Investigational Site Number 4220011
Corniche El Mazraa
Investigational Site Number 4220006
El Achrafiyé
Investigational Site Number 4220016
El Achrafiyé
Investigational Site Number 4220018
Hadath
Investigational Site Number 4220013
Hamra
Investigational Site Number 4220019
Jal El Baher
Investigational Site Number 4220014
Jounieh
Investigational Site Number 4220010
Metn
Investigational Site Number 4220004
Mount Lebanon
Investigational Site Number 4220005
Saida
Investigational Site Number 4220003
Sarba
Investigational Site Number 4220009
Tyre

Other trials in Lebanon

United Arab Emirates18 sites

Investigational Site Number 7840017
Abu Dhabi
Investigational Site Number 7840018
Abu Dhabi
Investigational Site Number 7840007
Ajman
Investigational Site Number 7840001
Dubai
Investigational Site Number 7840002
Dubai
Investigational Site Number 7840003
Dubai
Investigational Site Number 7840004
Dubai
Investigational Site Number 7840005
Dubai
Investigational Site Number 7840008
Dubai
Investigational Site Number 7840009
Dubai
Investigational Site Number 7840010
Dubai
Investigational Site Number 7840012
Dubai
Investigational Site Number 7840013
Dubai
Investigational Site Number 7840014
Dubai
Investigational Site Number 7840015
Dubai
Investigational Site Number 7840016
Dubai
Investigational Site Number 7840019
Umm Al Quwain City
Investigational Site Number 7840020
Umm Al Quwain City

Other trials in United Arab Emirates

Egypt17 sites

Investigational Site Number 8180017
Al Mansurah
Investigational Site Number 8180015
Alexandria, 21575
Investigational Site Number 8180007
Alexandria
Investigational Site Number 8180008
Alexandria
Investigational Site Number 8180012
Alexandria
Investigational Site Number 8180018
Alexandria
Investigational Site Number 8180001
Cairo
Investigational Site Number 8180005
Cairo
Investigational Site Number 8180006
Cairo
Investigational Site Number 8180016
Cairo
Investigational Site Number 8180020
Cairo
Investigational Site Number 8180003
Giza, 11535
Investigational Site Number 8180011
Giza, 28452
Investigational Site Number 8180002
Giza
Investigational Site Number 8180009
Giza
Investigational Site Number 8180014
Giza
Investigational Site Number 8180013
Portsaeid

Other trials in Egypt

Mexico10 sites

Investigational Site Number 4840001
Aguascalientes, 20230
Investigational Site Number 4840009
Celaya, 38000
Investigational Site Number 4840008
Chihuahua City, 31200
Investigational Site Number 4840004
Cuernavaca, 62250
Investigational Site Number 4840007
Durango
Investigational Site Number 4840006
Guadalajara, 44130
Investigational Site Number 4840003
Guadalajara, 44500
Investigational Site Number 4840005
México, 06470
Investigational Site Number 4840010
México, 07760
Investigational Site Number 4840002
México, 40100

Other trials in Mexico

Colombia9 sites

Investigational Site Number 1700001
Barranquilla
Investigational Site Number 1700004
Bogotá
Investigational Site Number 1700010
Bogotá
Investigational Site Number 1700005
Cali
Investigational Site Number 1700009
Cali
Investigational Site Number 1700003
Ibague
Investigational Site Number 1700007
Manizales, 170
Investigational Site Number 1700006
Popayán
Investigational Site Number 1700002
Zipaquirá

Other trials in Colombia

Kuwait8 sites

Investigational Site Number 4140001
Al Jabriya
Investigational Site Number 4140010
Al Jabriya
Investigational Site Number 4140003
Kuwait City
Investigational Site Number 4140004
Kuwait City
Investigational Site Number 4140006
Kuwait City
Investigational Site Number 4140009
Kuwait City
Investigational Site Number 4140011
Kuwait City
Investigational Site Number 4140012
Kuwait City

Other trials in Kuwait

Saudi Arabia8 sites

Investigational Site Number 6820009
Al Ehsa
Investigational Site Number 6820006
Jeddah, 21412
Investigational Site Number 6820001
Jeddah, 21589
Investigational Site Number 6820008
Jeddah
Investigational Site Number 6820010
Jeddah
Investigational Site Number 6820007
Jubail
Investigational Site Number 6820004
Najran
Investigational Site Number 6820003
Riyadh

Other trials in Saudi Arabia

Jordan7 sites

Investigational Site Number 4000002
Amman, 11183
Investigational Site Number 4000005
Amman, 11183
Investigational Site Number 4000006
Amman, 11183
Investigational Site Number 4000008
Amman, 11183
Investigational Site Number 0004
Amman
Investigational Site Number 4000009
Amman
Investigational Site Number 0007
Irbid, 211-81

Other trials in Jordan

Taiwan6 sites

Investigational Site Number 1580007
Changhua, 500
Investigational Site Number 1580005
Kaohsiung Hsien,
Investigational Site Number 1580003
New Taipei City
Investigational Site Number 1580004
Taichung, 402
Investigational Site Number 1580002
Tainan
Investigational Site Number 1580006
Taipei, 100

Other trials in Taiwan

Israel5 sites

Investigational Site Number 3760001
Haifa
Investigational Site Number 3760002
Petah Tikva
Investigational Site Number 3760005
Rishon LeZiyyon
Investigational Site Number 3760003
Tel Aviv
Investigational Site Number 3760004
Tel Aviv

Other trials in Israel

Indonesia3 sites

Investigational Site Number 3600003
Denpasar, 80234
Investigational Site Number 3600001
Jakarta, 10220
Investigational Site Number 3600002
Jakarta, 10630

Other trials in Indonesia

Peru3 sites

Investigational Site Number 6040003
Arequipa
Investigational Site Number 6040001
Lima
Investigational Site Number 6040002
Lima

Other trials in Peru

Thailand2 sites

Investigational Site Number 7640002
Bangkok, 10400
Investigational Site Number 7640001
Bangkok

Other trials in Thailand

Philippines1 site

Investigational Site Number 6080001
Dasmarinas Cavite, 4114

Other trials in Philippines

Singapore1 site

Investigational Site Number 7020001
Singapore, 308433

Other trials in Singapore

About this study

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

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.

Read the detailed description

Patients will be observed for one year

Conditions: Diabetes
Being tested: Insulin glargine (U300)
Medical subject headings: Diabetes Mellitus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Insulin glargine (U300)Drug
Also called HOE901, Toujeo, Toujeo Solostar
Pharmaceutical form: Solution for injection
Route of administration: Subcutaneous injection

Study groups in NCT03703869
Study group	Role	What they receive
Insulin glargine (U300)		Insulin glargine (U300) dosage and dosing time as per local product labeling Receives: Drug: Insulin glargine (U300)

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in HbA1c at month 6
Percentage of patients achieving Hemoglobin A1c <7.0%.
Measured: Baseline, month 6

Secondary outcomes (7)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

6 Mar 201824 Feb 2020

First posted12 Oct 2018
Study start6 Mar 2018
Primary completion28 Jun 2019
Study completion24 Feb 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (3)Papers the sponsor has linked to this study.
Other trials for DiabetesStudies of the same condition, open and under way.
More trials run by SanofiThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 4,589 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03703869
Sponsor's protocol ID: OBS14708
Other IDs: U1111-1215-0174
Acronym: ATOS
Status last verified: Apr 2022
First submitted: 9 Oct 2018
Last updated: 25 Apr 2022
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: 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

Publications

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.
PubMed 40920273
Khan 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.
PubMed 38355814
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.
PubMed 35532858

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Diabetes trials

Study at a glance

From the registry record, last updated by the sponsor on 25 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT03703869
Acronym / sponsor ID: ATOS / OBS14708
Conditions: Diabetes
Study type: Observational
Recruitment status: Completed
Enrolment: 4,589 participants (actual)
Lead sponsor: SanofiIndustry (pharma, biotech, devices)
Study start: 6 Mar 2018 (actual)
Primary completion: 28 Jun 2019 (actual)
Study completion: 24 Feb 2020 (actual)
First posted: 12 Oct 2018 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
Insulin glargine (U300)	–	Drug: Insulin glargine (U300)Insulin glargine (U300) dosage and dosing time as per local product labeling

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Insulin-naïve patients with type 2 diabetes mellitus and Oral Antidiabetic Drug failure

Key inclusion criteria (5 listed)

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

Key exclusion criteria (3 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Insulin glargine (U300)Also: HOE901, Toujeo, Toujeo SolostarPharmaceutical form: Solution for injection Route of administration: Subcutaneous injection	Drug	Insulin glargine (U300)

Primary outcome

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

7 secondary outcomes

Change in HbA1c
Time frame: Baseline, months 3, 6, 12
Change in fasting plasma glucose
Time frame: Baseline, months 3, 6, 12
Change in Self-Monitored Plasma Glucose
Time frame: Baseline, months 3, 6, 12
Hypoglycemia
Time frame: Baseline to month 12
Adverse events
Time frame: Baseline to month 12
Serious adverse events
Time frame: Baseline to month 12
Body weight
Time frame: Baseline to month 12

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2022.
Derived from this study: PubMed 40920273Tirosh 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.
Derived from this study: PubMed 38355814Khan 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.
Derived from this study: PubMed 35532858Galstyan 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.
Individual participant dataSharing planned: Yes. 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

Related trials for Diabetes

Not yet recruiting
Different Aerobic-to-Resistance Training Ratios in Adults Aged 50 Years and Older With Prediabetes
Prediabetes
Not yet recruiting
Efficacy, Safety, and Treatment Satisfaction of Once-Weekly Tirzepatide in Obese Type 2 Diabetic Patients
Type 2 Diabetes Mellitus (T2DM), Obesity, Overweight
Active, not recruiting
Helping Adults With Type 2 Diabetes Use Their Health Data for Healthy Diabetes Self-Management
Type 2 Diabetes Mellitus (T2DM)
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Clinical Sciences & Operations study director

Sanofi

388 sites in 18 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Diabetes, run by Sanofi at 388 sites in 18 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 388 sites in India, Russia, Ukraine, Lebanon, United Arab Emirates and 13 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in HbA1c at month 6 (time frame: Baseline, month 6). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03703869, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2022.