Clinical Trial Details

NCT ID: NCT02735044
Date Last Changed: September 14, 2017

Overview

Research Study Summary

A Phase 3 clinical study for patients with Type 1 Diabetes Mellitus

Research Study Title

6-Month, Multicenter, Randomized, Open-label, 2-Arm, Parallel-group Study Comparing the Efficacy and Safety of a New Formulation of Insulin Glargine and Lantus® Injected Once Daily in Children and Adolescents Age 6 - 17 Years With Type 1 Diabetes Mellitus With a 6-month Safety Extension Period

Purpose

Primary Objective:

To compare the efficacy of HOE901-U300 to Lantus in terms of glycated hemoglobin (HbA1c)

Secondary Objectives:

  • To compare HOE901-U300 and Lantus in terms of:

  • Percentage of patients reaching target HbA1c and fasting plasma glucose (FPG).

  • To assess the safety of HOE901-U300 including analysis of events of hypoglycemia, events of hyperglycemia with ketosis, and development of anti-insulin-antibodies.

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Recruitment Details

Phase
3
Gender
All
Age
6 to 17 Years
Overall Status
Recruiting
Lead Sponsor
Sanofi
Duration
26 Months
Facility Type
N/A
Compensation

Eligibility

All ages 6 Years to 17 Years

Inclusion criteria :

  • Children and adolescents with type 1 diabetes mellitus (T1DM) for at least 1 year confirmed by typical symptoms at diagnosis and/or by antibody testing (presence of anti-GAD (glutamic acid decarboxylase) or anti-IA2 (islet antigen 2/tyrosine phosphatase) or anti-islet cell antibodies) and/or clinical features (eg, history of ketoacidosis).

  • Signed written informed consent obtained from parent(s)/legal guardian and written or oral assent obtained from patient.

Exclusion criteria:

  • Age < 6 years and ≥18 years at randomization.

  • Less than 1 year on insulin treatment prior to screening visit.

  • Less than 6 months on basal plus mealtime insulin and self-monitoring of blood glucose prior to screening visit.

  • Patients using premix insulins in the last 3 months before screening visit or patients using human regular insulin as mealtime insulin in the last 3 months before screening visit.

  • Use of an insulin pump in the last 6 months before screening visit or plans to switch to pump within the next 6 months after screening visit.

  • No willingness to inject insulin glargine (Lantus or HOE901 [U300]) once daily.

  • HbA1c < 7.5% or > 11% at screening.

  • Initiation of any glucose-lowering medications in the last 3 months before screening visit.

  • Hospitalization or care in the emergency ward for diabetic ketoacidosis or history of severe hypoglycemia (as defined by need for glucagon or IV glucose) and accompanied by seizure and/or unconsciousness and/or coma in the last 3 months prior to screening visit.

  • Postmenarchal girls not protected by highly-effective method(s) of birth control and/or who are unwilling or unable to be tested for pregnancy. Abstinence from sexual intercourse will be considered as an acceptable form of birth control.

  • Pregnant or breast-feeding adolescents, or adolescents who intend to become pregnant during the study period, or who are at risk of getting pregnant due to any psychosocial reason during the study period.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Site Locations (108)

Country State City Zip Facility and Contact
United States Arizona Tucson 85724 Investigational Site Number 8400008
United States Georgia Atlanta 30318 Investigational Site Number 8400037
United States Indiana Indianapolis 46202 Investigational Site Number 8400032
United States Michigan Flint 48532 Investigational Site Number 8400036
United States New York Buffalo 14222 Investigational Site Number 8400015
United States North Carolina Chapel Hill 27599-7295 Investigational Site Number 8400016
United States North Carolina Morehead City 28557 Investigational Site Number 8400035
United States Oklahoma Oklahoma City 73112 Investigational Site Number 8400038
United States Pennsylvania Philadelphia 19104 Investigational Site Number 8400030
United States South Dakota Rapid City 57701 Investigational Site Number 8400010
United States Texas Dallas 75231 Investigational Site Number 8400005
United States Texas Dallas 75235 Investigational Site Number 8400021
United States Texas Lufkin 75904 Investigational Site Number 8400029
United States Washington Seattle 98105 Investigational Site Number 8400034
Argentina Caba C1180AAX Investigational Site Number 0320003
Argentina Capital Federal C1179AAB Investigational Site Number 0320004
Argentina Capital Federal C1270AAN Investigational Site Number 0320001
Argentina Capital Federal C1425DUC Investigational Site Number 0320002
Argentina Mendoza 5500 Investigational Site Number 0320006
Argentina Salta 4400 Investigational Site Number 0320005
Argentina San Miguel De Tucuman 4107 Investigational Site Number 0320007
Brazil Curitiba 80810-040 Investigational Site Number 0760005
Brazil Fortaleza 60115-282 Investigational Site Number 0760006
Brazil Fortaleza 60430-350 Investigational Site Number 0760004
Brazil Porto Alegre 91350-250 Investigational Site Number 0760003
Brazil Sao Paulo 04022-001 Investigational Site Number 0760001
Brazil Sao Paulo Investigational Site Number 0760002
Bulgaria Plovdiv 4000 Investigational Site Number 1000001
Bulgaria Sofia 1784 Investigational Site Number 1000005
Bulgaria Varna 9000 Investigational Site Number 1000004
Canada Halifax B3K6R8 Investigational Site Number 1240003
Canada Montreal H1T 2M4 Investigational Site Number 1240002
Canada Montreal H3T 1C5 Investigational Site Number 1240005
Canada Sherbrooke J1H 5N4 Investigational Site Number 1240006
Chile Santiago 8207257 Investigational Site Number 1520002
Chile Santiago 8330074 Investigational Site Number 1520004
Chile Santiago Investigational Site Number 1520006
Chile Temuco 4813299 Investigational Site Number 1520007
Chile Viña Del Mar Investigational Site Number 1520003
Czechia Hradec Kralove 500 05 Investigational Site Number 2030003
Czechia Ostrava - Poruba 70852 Investigational Site Number 2030005
Czechia Praha 5 - Motol 15006 Investigational Site Number 2030001
Denmark Herlev 2730 Investigational Site Number 2080001
France Besancon Cedex 25030 Investigational Site Number 2500001
France Montpellier 34295 Investigational Site Number 2500003
France Toulouse 31059 Investigational Site Number 2500002
Germany Hannover 30173 Investigational Site Number 2760002
Germany Heidelberg 69120 Investigational Site Number 2760001
Germany Leipzig 04103 Investigational Site Number 2760004
Germany Münster 48155 Investigational Site Number 2760003
Hungary Budapest 1036 Investigational Site Number 3480001
Hungary Budapest 1083 Investigational Site Number 3480004
Hungary Budapest 1089 Investigational Site Number 3480003
Hungary Gyula 5700 Investigational Site Number 3480005
Hungary Miskolc 3529 Investigational Site Number 3480002
Hungary Pécs 7623 Investigational Site Number 3480006
Hungary Székesfehérvár 8000 Investigational Site Number 3480007
Israel Beer Sheva 84101 Investigational Site Number 3760003
Israel Haifa 31096 Investigational Site Number 3760001
Israel Holon 58100 Investigational Site Number 3760006
Israel Petach Tikva Investigational Site Number 3760002
Italy Firenze 50139 Investigational Site Number 3800001
Italy Roma 00165 Investigational Site Number 3800005
Italy Torino 10126 Investigational Site Number 3800004
Italy Varese 21100 Investigational Site Number 3800006
Italy Verona 37134 Investigational Site Number 3800003
Japan Chiyoda-Ku Investigational Site Number 3920006
Japan Fukuoka-Shi Investigational Site Number 3920002
Japan Hiroshima-Shi Investigational Site Number 3920003
Japan Iruma-Gun Investigational Site Number 3920008
Japan Isesaki-Shi Investigational Site Number 3920001
Japan Kobe-Shi Investigational Site Number 3920007
Japan Osaka-Shi Investigational Site Number 3920005
Japan Shinjuku-Ku Investigational Site Number 3920004
Latvia Daugavpils LV-5417 Investigational Site Number 4280002
Latvia Rīga LV-1004 Investigational Site Number 4280001
Mexico Durango 34000 Investigational Site Number 4840003
Mexico Monterrey 64460 Investigational Site Number 4840001
Mexico México 06700 Investigational Site Number 4840004
Mexico Puebla 72190 Investigational Site Number 4840002
Mexico Veracruz 91910 Investigational Site Number 4840005
Poland Bielsko-Biala 43-316 Investigational Site Number 6160005
Poland Gdansk 80-952 Investigational Site Number 6160001
Poland Szczecin 71-252 Investigational Site Number 6160006
Poland Warszawa 02-091 Investigational Site Number 6160007
Poland Warszawa 04-730 Investigational Site Number 6160004
Poland Warszawa 04-736 Investigational Site Number 6160003
Romania Bucharest 041451 Investigational Site Number 6420005
Romania Constanta 900591 Investigational Site Number 6420007
Romania Craiova 200542 Investigational Site Number 6420004
Romania Sibiu 550166 Investigational Site Number 6420006
Romania Timisoara 300011 Investigational Site Number 6420003
Russian Federation Moscow 117036 Investigational Site Number 6430001
Russian Federation Smolensk 214018 Investigational Site Number 6430004
Russian Federation St-Petersburg 193144 Investigational Site Number 6430002
Russian Federation Ufa 450000 Investigational Site Number 6430003
Spain Barcelona 08035 Investigational Site Number 7240005
Spain Barcelona 08041 Investigational Site Number 7240002
Spain Esplugues De Llobregat 08950 Investigational Site Number 7240003
Spain Sabadell 08208 Investigational Site Number 7240004
Spain Santa Cruz De Tenerife 38320 Investigational Site Number 7240006
Spain Vitoria 01009 Investigational Site Number 7240001
Sweden Linköping 581 85 Investigational Site Number 7520001
Sweden Stockholm 118 83 Investigational Site Number 7520002
United Kingdom Doncaster DN2 5LT Investigational Site Number 8260005
United Kingdom Ipswich IP4 5PD Investigational Site Number 8260001
United Kingdom Kettering NN16 8UZ Investigational Site Number 8260004
United Kingdom Salisbury SP2 8BJ Investigational Site Number 8260002

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