Clinical Trials Logo
  1. Home
  2. Diabetes Mellitus, Type 2
  3. NCT03703869
  4. Details
NCT03703869 Clinical Trial

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.

Diabetes Clinical Trial

— ATOS  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03703869
Other study ID # OBS14708
Secondary ID U1111-1215-0174
Status Completed
Phase
First received
Last updated
Start date March 6, 2018
Est. completion date February 24, 2020

Study information
Verified date April 2022
Source Sanofi
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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 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.

Description:

Patients will be observed for one year

Recruitment information / eligibility
Status Completed
Enrollment 4589
Est. completion date February 24, 2020
Est. primary completion date June 28, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Drug:
• Insulin glargine (U300)
Pharmaceutical form: Solution for injection Route of administration: Subcutaneous injection

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

Sponsors (1)
Lead Sponsor Collaborator
Sanofi

Countries where clinical trial is conducted

Colombia,  Egypt,  India,  Indonesia,  Israel,  Jordan,  Kuwait,  Lebanon,  Mexico,  Peru,  Philippines,  Russian Federation,  Saudi Arabia,  Singapore,  Taiwan,  Thailand,  Ukraine,  United Arab Emirates, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change in HbA1c at month 6 Percentage of patients achieving Hemoglobin A1c <7.0%. Baseline, month 6
Secondary Change in HbA1c Change from baseline in HbA1c at 3, 6, and 12 months Baseline, months 3, 6, 12
Secondary Change in fasting plasma glucose Change from baseline in Fasting Plasma Glucose at 3, 6, and 12 months Baseline, months 3, 6, 12
Secondary Change in Self-Monitored Plasma Glucose Change from baseline in Self-Monitored Plasma Glucose at 3, 6, and 12 months Baseline, months 3, 6, 12
Secondary Hypoglycemia Number of participants with symptomatic hypoglycemic events Baseline to month 12
Secondary Adverse events Number of participants with Adverse Events Baseline to month 12
Secondary Serious adverse events Number of participants with Serious Adverse Events Baseline to month 12
Secondary Body weight Change in average body weight Baseline to month 12
See also
  Status Clinical Trial Phase
Completed NCT05594446 - Morphometric Study of the Legs and Feet of Diabetic Patients in Order to Collect Data Intended to be Used to Measure by Dynamometry the Pressures Exerted by Several Medical Compression Socks at the Level of the Forefoot
Completed NCT03975309 - DHS MIND Metabolomics
Completed NCT01855399 - Technologically Enhanced Coaching: A Program to Improve Diabetes Outcomes N/A
Completed NCT01819129 - Efficacy and Safety of FIAsp Compared to Insulin Aspart in Combination With Insulin Glargine and Metformin in Adults With Type 2 Diabetes Phase 3
Recruiting NCT04984226 - Sodium Bicarbonate and Mitochondrial Energetics in Persons With CKD Phase 2
Recruiting NCT05007990 - Caregiving Networks Across Disease Context and the Life Course
Active, not recruiting NCT04420936 - Pragmatic Research in Healthcare Settings to Improve Diabetes and Obesity Prevention and Care for Our Program N/A
Recruiting NCT03549559 - Imaging Histone Deacetylase in the Heart N/A
Completed NCT04903496 - Clinical Characteristics and Disease Burden of Diabetic Patients Based on Tianjin Regional Database
Completed NCT01437592 - Investigating the Pharmacokinetic Properties of NN1250 in Healthy Chinese Subjects Phase 1
Completed NCT01696266 - An International Survey on Hypoglycaemia Among Insulin-treated Patients With Diabetes
Completed NCT04082585 - Total Health Improvement Program Research Project
Completed NCT03390179 - Hyperglycemic Response and Steroid Administration After Surgery (DexGlySurgery)
Not yet recruiting NCT05029804 - Effect of Walking Exercise Training on Adherence to Disease Management and Metabolic Control in Diabetes N/A
Recruiting NCT05294822 - Autologous Regenerative Islet Transplantation for Insulin-dependent Diabetes N/A
Completed NCT04427982 - Dance and Diabetes/Prediabetes Self-Management N/A
Completed NCT02356848 - STEP UP to Avert Amputation in Diabetes N/A
Completed NCT03292185 - A Trial to Investigate the Single Dose Pharmacokinetics of Insulin Degludec/Liraglutide Compared With Insulin Degludec and Liraglutide in Healthy Chinese Subjects Phase 1
Active, not recruiting NCT05477368 - Examining the Feasibility of Prolonged Ketone Supplement Drink Consumption in Adults With Type 2 Diabetes N/A
Completed NCT04496401 - PK Study in Diabetic Transplant récipients : From Twice-daily Tacrolimus to Once-daily Extended-release Tacrolimus Phase 4