Comparison of the Safety and Efficacy of HOE901-U300 With Lantus in Children and Adolescents With Type 1 Diabetes Mellitus

PHASE3CompletedINTERVENTIONAL
Enrollment

463

Participants

Timeline

Start Date

April 14, 2016

Primary Completion Date

May 31, 2018

Study Completion Date

December 20, 2018

Conditions
Type 1 Diabetes Mellitus
Interventions
DRUG

Insulin glargine,300 U/mL

Subcutaneous injection in the morning or evening using a prefilled pen. Dose titration to achieve fasting self-monitored plasma glucose (SMPG) from 90 to 130 milligram/deciliter (mg/dL) (5.0 to 7.2 millimol per liter \[mmol/L\])

DRUG

Insulin glargine (100 units /mL)

Subcutaneous injection in the morning or evening using a prefilled pen. Dose titration to achieve fasting SMPG from 90 to 130 mg/dL (5.0 to 7.2 mmol/L)

DRUG

Background therapy

Fast-acting mealtime insulin analogs

Trial Locations (107)

1000

Investigational Site Number 8070001, Skopje

1036

Investigational Site Number 3480001, Budapest

1083

Investigational Site Number 3480004, Budapest

1089

Investigational Site Number 3480003, Budapest

1784

Investigational Site Number 1000005, Sofia

2730

Investigational Site Number 2080001, Herlev

3529

Investigational Site Number 3480002, Miskolc

4000

Investigational Site Number 1000001, Plovdiv

4107

Investigational Site Number 0320007, San Miguel de Tucumán

4400

Investigational Site Number 0320005, Salta

5500

Investigational Site Number 0320006, Mendoza

5700

Investigational Site Number 3480005, Gyula

7623

Investigational Site Number 3480006, Pécs

8000

Investigational Site Number 3480007, Székesfehérvár

9000

Investigational Site Number 1000004, Varna

10126

Investigational Site Number 3800004, Torino

11000

Investigational Site Number 6880002, Belgrade

Investigational Site Number 6880003, Belgrade

14222

Investigational Site Number 8400015, Buffalo

15006

Investigational Site Number 2030001, Praha 5 - Motol

18000

Investigational Site Number 6880004, Niš

19104

Investigational Site Number 8400030, Philadelphia

21100

Investigational Site Number 3800006, Varese

28557

Investigational Site Number 8400035, Morehead City

30173

Investigational Site Number 2760002, Hanover

30318

Investigational Site Number 8400037, Atlanta

31059

Investigational Site Number 2500002, Toulouse

31096

Investigational Site Number 3760001, Haifa

34000

Investigational Site Number 4840003, Durango

34295

Investigational Site Number 2500003, Montpellier

37134

Investigational Site Number 3800003, Verona

38320

Investigational Site Number 7240006, Santa Cruz de Tenerife

46202

Investigational Site Number 8400032, Indianapolis

48155

Investigational Site Number 2760003, Münster

50139

Investigational Site Number 3800001, Florence

57701

Investigational Site Number 8400010, Rapid City

58100

Investigational Site Number 3760006, Holon

64460

Investigational Site Number 4840001, Monterrey

69120

Investigational Site Number 2760001, Heidelberg

70852

Investigational Site Number 2030005, Ostrava - Poruba

72190

Investigational Site Number 4840002, Puebla City

73112

Investigational Site Number 8400038, Oklahoma City

75231

Investigational Site Number 8400005, Dallas

75235

Investigational Site Number 8400021, Dallas

75904

Investigational Site Number 8400029, Lufkin

84101

Investigational Site Number 3760003, Beersheba

85724

Investigational Site Number 8400008, Tucson

91910

Investigational Site Number 4840005, Veracruz

98105

Investigational Site Number 8400034, Seattle

117036

Investigational Site Number 6430001, Moscow

193144

Investigational Site Number 6430002, Saint Petersburg

200542

Investigational Site Number 6420004, Craiova

214018

Investigational Site Number 6430004, Smolensk

300011

Investigational Site Number 6420003, Timișoara

450000

Investigational Site Number 6430003, Ufa

550166

Investigational Site Number 6420006, Sibiu

900591

Investigational Site Number 6420007, Constanța

4813299

Investigational Site Number 1520007, Temuco

8207257

Investigational Site Number 1520002, Santiago

8330074

Investigational Site Number 1520004, Santiago

27599-7295

Investigational Site Number 8400016, Chapel Hill

C1180AAX

Investigational Site Number 0320003, Caba

C1270AAN

Investigational Site Number 0320001, Caba

C1179AAB

Investigational Site Number 0320004, Capital Federal

C1425DUC

Investigational Site Number 0320002, Capital Federal

80810-040

Investigational Site Number 0760005, Curitiba

60115-282

Investigational Site Number 0760006, Fortaleza

60430-350

Investigational Site Number 0760004, Fortaleza

91350-250

Investigational Site Number 0760003, Porto Alegre

04022-001

Investigational Site Number 0760001, São Paulo

Unknown

Investigational Site Number 0760002, São Paulo

Investigational Site Number 1520006, Santiago

Investigational Site Number 1520003, Viña del Mar

Investigational Site Number 3760002, Petah Tikva

Investigational Site Number 3920006, Chiyoda-Ku

Investigational Site Number 3920002, Fukuoka

Investigational Site Number 3920003, Hiroshima

Investigational Site Number 3920007, Kobe

Investigational Site Number 3920005, Osaka

Investigational Site Number 3920004, Shinjuku-Ku

B3K6R8

Investigational Site Number 1240003, Halifax

H1T 2M4

Investigational Site Number 1240002, Montreal

H3T 1C5

Investigational Site Number 1240005, Montreal

J1H 5N4

Investigational Site Number 1240006, Sherbrooke

500 05

Investigational Site Number 2030003, Hradec Králové

04103

Investigational Site Number 2760004, Leipzig

00165

Investigational Site Number 3800005, Roma

LV-5417

Investigational Site Number 4280002, Daugavpils

LV-1004

Investigational Site Number 4280001, Riga

06700

Investigational Site Number 4840004, México

43-316

Investigational Site Number 6160005, Bielsko-Biala

80-952

Investigational Site Number 6160001, Gdansk

71-252

Investigational Site Number 6160006, Szczecin

02-091

Investigational Site Number 6160007, Warsaw

04-730

Investigational Site Number 6160004, Warsaw

04-736

Investigational Site Number 6160003, Warsaw

041451

Investigational Site Number 6420005, Bucharest

08035

Investigational Site Number 7240005, Barcelona

08041

Investigational Site Number 7240002, Barcelona

08950

Investigational Site Number 7240003, Esplugues de Llobregat

08208

Investigational Site Number 7240004, Sabadell

01009

Investigational Site Number 7240001, Vitoria-Gasteiz

118 83

Investigational Site Number 7520002, Stockholm

DN2 5LT

Investigational Site Number 8260005, Doncaster

IP4 5PD

Investigational Site Number 8260001, Ipswich

NN16 8UZ

Investigational Site Number 8260004, Kettering

SP2 8BJ

Investigational Site Number 8260002, Salisbury

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Sanofi

INDUSTRY