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

Primary Purpose

Type 1 Diabetes Mellitus

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Insulin glargine,300 U/mL

Insulin glargine (100 units /mL)

Background therapy

About this trial

This is an interventional treatment trial for Type 1 Diabetes Mellitus

Eligibility Criteria

6 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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 participant.

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.
Participants using premix insulins in the last 3 months before screening visit or participants 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.
Any contraindication to use of insulin glargine as defined in the national product label.
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 were unwilling or unable to be tested for pregnancy. Abstinence from sexual intercourse was considered as an acceptable form of birth control.
Pregnant or breast-feeding adolescents, or adolescents who intended to become pregnant during the study period, or who were 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 participant's potential participation in a clinical trial.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

HOE901-U300

Lantus

Arm Description

HOE901-U300 (Insulin glargine 300 Units/milliliter [U/mL]) Subcutaneous(SC) injection once daily for 12 months.

Lantus (Insulin glargine 100 U/mL) SC injection once daily for 12 months.

Outcomes

Primary Outcome Measures

Change From Baseline in HbA1c to Month 6

Change in HbA1c was calculated by subtracting baseline value from Month 6 value. Adjusted least-square (LS) means and standard errors (SE) were obtained using analysis of covariance (ANCOVA) after multiple imputations of missing data using post-baseline HbA1c data available on the main 6-month randomized period.

Secondary Outcome Measures

Change From Baseline in Fasting Plasma Glucose (FPG) to Month 6

Change in FPG was calculated by subtracting baseline value from Month 6 value. Adjusted LS means and SE were obtained using ANCOVA after multiple imputation to address missing data in the main 6 month randomized period.

Percentage of Participants With HbA1c Values of <7.5% at Month 6

Participants without any available HbA1c assessment at month 6 and/or with a premature study discontinuation during the main 6-month randomized period were considered as a failure (non-responders) in the analysis. Analysis was performed using Cochran-Mantel-Haenszel (CMH) method with randomization strata of screening HbA1c (<8.5%; >=8.5%) and randomization strata of age at screening (<12 years, >=12 years).

Percentage of Participants With HbA1c Values of <7.5% Without Any Episode of Severe and/or Documented Self-Monitored Plasma Glucose ([SMPG] <54 mg/dL [3.0 mmol/L]) Symptomatic Hypoglycemia During the Last 3 Months of the Main 6-month Randomized Period

Percentage of Participants With FPG of <=130 mg/dL (7.2 mmol/L) at Month 6

Participants without any available FPG assessment at month 6 and/or with a premature study discontinuation during the main 6-month randomized period were considered as a failure (non-responders) in the analysis. Analysis was performed using Cochran-Mantel-Haenszel (CMH) method with randomization strata of screening HbA1c (<8.5%; >=8.5%) and randomization strata of age at screening (<12 years, >=12 years).

Percentage of Participants With FPG of <=130 mg/dL (7.2 mmol/L) Without Any Episode of Severe and/or Documented (SMPG <54 mg/dL [3.0 mmol/L]) Symptomatic Hypoglycemia During the Last 3 Months of the Main 6-month Randomized Period

Change From Baseline in 24-Hour Mean Plasma Glucose Based on 8-point SMPG Profiles to Month 6

8-point SMPG profiles were measured at the following 8 points: between 01:00 and 04:00 (clock time) at night, pre-breakfast, 2 hours after breakfast, pre-lunch, 2 hours after lunch, pre-dinner, 2 hours after dinner, and bedtime. Analysis was performed using a ANCOVA model including the fixed categorical effects of treatment group, randomization strata of screening HbA1c (<8.5%; >=8.5%), randomization strata of age at screening (<12 years, >=12 years) and the baseline 24-hour average 8-point profile SMPG.

Change From Baseline in Variability of 24-Hour Mean Plasma Glucose Based on 8-point SMPG Profiles at Month 6

8-point SMPG profiles were measured at the following 8 points: between 01:00 and 04:00 (clock time) at night, pre-breakfast, 2 hours after breakfast, pre-lunch, 2 hours after lunch, pre-dinner, 2 hours after dinner, and bedtime. Variability was assessed by the coefficient of variation (standard deviation divided by mean) calculated over the 8-point SMPG. Analysis was performed using a ANCOVA model including the fixed categorical effects of treatment group, randomization strata of screening HbA1c (<8.5%; >=8.5%) and randomization strata of age at screening (<12 years, >=12 years).

Change From Baseline to Month 6 in 8-Point SMPG Profile Per Time Point

8-point SMPG profiles were measured for following 8 time points at Baseline and Month 6: between 01:00 and 04:00 (clock time) at night, pre-breakfast, 2 hours after breakfast, pre-lunch, 2 hours after lunch, pre-dinner, 2 hours after dinner, and bedtime.

Percentage of Participants With at Least One Hypoglycemic Events (Any Hypoglycemia, Severe Hypoglycemia, Documented Symptomatic, Probable Symptomatic, Asymptomatic Hypoglycemia, Pseudo-hypoglycemia and Severe and/or Confirmed Hypoglycemia) at Month 12

Severe hypoglycemia: an event in which the child/adolescent having altered mental status and cannot assist in their care, is semiconscious or unconscious, or in coma ± convulsions and may require parenteral therapy (glucagon or glucose). Documented symptomatic hypoglycemia: an event during which typical symptoms of hypoglycemia were accompanied by a measured plasma glucose concentration of <=70 mg/dL (3.9 mmol/L). Asymptomatic hypoglycemia: an event not accompanied by typical symptoms of hypoglycemia but with a measured plasma glucose concentration <=70 mg/dL. Probable symptomatic hypoglycemia: an event during which symptoms of hypoglycemia were not accompanied by plasma glucose determination but was presumably caused by a plasma glucose concentration <=70 mg/dL. Pseudo-hypoglycemia:an event with any of the typical symptoms of hypoglycaemia with plasma glucose concentration >70 mg/dL.

Percentage of Participants With Any Hyperglycemia With Ketosis at Month 12

Hyperglycemia with ketosis was defined as SMPG >=252 mg/dL (14 mmol/L) with accompanying self-measured blood ketones >=1.5 mmol/L.

Full Information

NCT ID

NCT02735044

First Posted

March 30, 2016

Last Updated

March 15, 2022

Sponsor

Sanofi

1. Study Identification

Unique Protocol Identification Number

NCT02735044

Brief Title

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

Acronym

EDITION JUNIOR

Official 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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2022

Overall Recruitment Status

Completed

Study Start Date

April 14, 2016 (Actual)

Primary Completion Date

May 31, 2018 (Actual)

Study Completion Date

December 20, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Sanofi

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

Primary Objective: To compare the efficacy of a new formulation of insulin glargine (HOE901-U300) to Lantus in terms of change of HbA1c from baseline to endpoint (month 6) in children and adolescents with type 1 diabetes mellitus. . Secondary Objectives: To compare HOE901-U300 and Lantus in terms of: Percentage of participants 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.

Detailed Description

The study duration per participant was approximately 58 weeks that consisted of a 2 week screening period, a main 6-month comparative efficacy and safety treatment period, a 6-month comparative safety extension period, and a 4-week post treatment follow up period.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Type 1 Diabetes Mellitus

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

463 (Actual)

8. Arms, Groups, and Interventions

Arm Title

HOE901-U300

Arm Type

Experimental

Arm Description

HOE901-U300 (Insulin glargine 300 Units/milliliter [U/mL]) Subcutaneous(SC) injection once daily for 12 months.

Arm Title

Lantus

Arm Type

Active Comparator

Arm Description

Lantus (Insulin glargine 100 U/mL) SC injection once daily for 12 months.

Intervention Type

Drug

Intervention Name(s)

Insulin glargine,300 U/mL

Other Intervention Name(s)

Toujeo ®

Intervention Description

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])

Intervention Type

Drug

Intervention Name(s)

Insulin glargine (100 units /mL)

Intervention Description

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)

Intervention Type

Drug

Intervention Name(s)

Background therapy

Intervention Description

Fast-acting mealtime insulin analogs

Primary Outcome Measure Information:

Title

Change From Baseline in HbA1c to Month 6

Description

Time Frame

Baseline to Month 6

Secondary Outcome Measure Information:

Title

Change From Baseline in Fasting Plasma Glucose (FPG) to Month 6

Description

Time Frame

Baseline to Month 6

Title

Percentage of Participants With HbA1c Values of <7.5% at Month 6

Description

Time Frame

Month 6

Title

Description

Time Frame

upto Month 6

Title

Percentage of Participants With FPG of <=130 mg/dL (7.2 mmol/L) at Month 6

Description

Time Frame

Month 6

Title

Description

Time Frame

upto Month 6

Title

Change From Baseline in 24-Hour Mean Plasma Glucose Based on 8-point SMPG Profiles to Month 6

Description

Time Frame

Baseline to Month 6

Title

Change From Baseline in Variability of 24-Hour Mean Plasma Glucose Based on 8-point SMPG Profiles at Month 6

Description

8-point SMPG profiles were measured at the following 8 points: between 01:00 and 04:00 (clock time) at night, pre-breakfast, 2 hours after breakfast, pre-lunch, 2 hours after lunch, pre-dinner, 2 hours after dinner, and bedtime. Variability was assessed by the coefficient of variation (standard deviation divided by mean) calculated over the 8-point SMPG. Analysis was performed using a ANCOVA model including the fixed categorical effects of treatment group, randomization strata of screening HbA1c (<8.5%; >=8.5%) and randomization strata of age at screening (<12 years, >=12 years).

Time Frame

Baseline, Month 6

Title

Change From Baseline to Month 6 in 8-Point SMPG Profile Per Time Point

Description

Time Frame

Baseline to Month 6

Title

Description

Time Frame

Month 12

Title

Percentage of Participants With Any Hyperglycemia With Ketosis at Month 12

Description

Hyperglycemia with ketosis was defined as SMPG >=252 mg/dL (14 mmol/L) with accompanying self-measured blood ketones >=1.5 mmol/L.

Time Frame

Month 12

10. Eligibility

Sex

All

Minimum Age & Unit of Time

6 Years

Maximum Age & Unit of Time

17 Years

Accepts Healthy Volunteers

Eligibility Criteria

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 participant. 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. Participants using premix insulins in the last 3 months before screening visit or participants 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. Any contraindication to use of insulin glargine as defined in the national product label. 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 were unwilling or unable to be tested for pregnancy. Abstinence from sexual intercourse was considered as an acceptable form of birth control. Pregnant or breast-feeding adolescents, or adolescents who intended to become pregnant during the study period, or who were 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 participant's potential participation in a clinical trial.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Clinical Sciences & Operations

Organizational Affiliation

Sanofi

Official's Role

Study Director

Facility Information:

Facility Name

Investigational Site Number 8400008

City

Tucson

State/Province

Arizona

ZIP/Postal Code

85724

Country

United States

Facility Name

Investigational Site Number 8400037

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30318

Country

United States

Facility Name

Investigational Site Number 8400032

City

Indianapolis

State/Province

Indiana

ZIP/Postal Code

46202

Country

United States

Facility Name

Investigational Site Number 8400015

City

Buffalo

State/Province

New York

ZIP/Postal Code

14222

Country

United States

Facility Name

Investigational Site Number 8400016

City

Chapel Hill

State/Province

North Carolina

ZIP/Postal Code

27599-7295

Country

United States

Facility Name

Investigational Site Number 8400035

City

Morehead City

State/Province

North Carolina

ZIP/Postal Code

28557

Country

United States

Facility Name

Investigational Site Number 8400038

City

Oklahoma City

State/Province

Oklahoma

ZIP/Postal Code

73112

Country

United States

Facility Name

Investigational Site Number 8400030

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19104

Country

United States

Facility Name

Investigational Site Number 8400010

City

Rapid City

State/Province

South Dakota

ZIP/Postal Code

57701

Country

United States

Facility Name

Investigational Site Number 8400005

City

Dallas

State/Province

Texas

ZIP/Postal Code

75231

Country

United States

Facility Name

Investigational Site Number 8400021

City

Dallas

State/Province

Texas

ZIP/Postal Code

75235

Country

United States

Facility Name

Investigational Site Number 8400029

City

Lufkin

State/Province

Texas

ZIP/Postal Code

75904

Country

United States

Facility Name

Investigational Site Number 8400034

City

Seattle

State/Province

Washington

ZIP/Postal Code

98105

Country

United States

Facility Name

Investigational Site Number 0320003

City

Caba

ZIP/Postal Code

C1180AAX

Country

Argentina

Facility Name

Investigational Site Number 0320001

City

Caba

ZIP/Postal Code

C1270AAN

Country

Argentina

Facility Name

Investigational Site Number 0320004

City

Capital Federal

ZIP/Postal Code

C1179AAB

Country

Argentina

Facility Name

Investigational Site Number 0320002

City

Capital Federal

ZIP/Postal Code

C1425DUC

Country

Argentina

Facility Name

Investigational Site Number 0320006

City

Mendoza

ZIP/Postal Code

5500

Country

Argentina

Facility Name

Investigational Site Number 0320005

City

Salta

ZIP/Postal Code

4400

Country

Argentina

Facility Name

Investigational Site Number 0320007

City

San Miguel De Tucuman

ZIP/Postal Code

4107

Country

Argentina

Facility Name

Investigational Site Number 0760005

City

Curitiba

ZIP/Postal Code

80810-040

Country

Brazil

Facility Name

Investigational Site Number 0760006

City

Fortaleza

ZIP/Postal Code

60115-282

Country

Brazil

Facility Name

Investigational Site Number 0760004

City

Fortaleza

ZIP/Postal Code

60430-350

Country

Brazil

Facility Name

Investigational Site Number 0760003

City

Porto Alegre

ZIP/Postal Code

91350-250

Country

Brazil

Facility Name

Investigational Site Number 0760001

City

Sao Paulo

ZIP/Postal Code

04022-001

Country

Brazil

Facility Name

Investigational Site Number 0760002

City

Sao Paulo

Country

Brazil

Facility Name

Investigational Site Number 1000001

City

Plovdiv

ZIP/Postal Code

4000

Country

Bulgaria

Facility Name

Investigational Site Number 1000005

City

Sofia

ZIP/Postal Code

1784

Country

Bulgaria

Facility Name

Investigational Site Number 1000004

City

Varna

ZIP/Postal Code

9000

Country

Bulgaria

Facility Name

Investigational Site Number 1240003

City

Halifax

ZIP/Postal Code

B3K6R8

Country

Canada

Facility Name

Investigational Site Number 1240002

City

Montreal

ZIP/Postal Code

H1T 2M4

Country

Canada

Facility Name

Investigational Site Number 1240005

City

Montreal

ZIP/Postal Code

H3T 1C5

Country

Canada

Facility Name

Investigational Site Number 1240006

City

Sherbrooke

ZIP/Postal Code

J1H 5N4

Country

Canada

Facility Name

Investigational Site Number 1520002

City

Santiago

ZIP/Postal Code

8207257

Country

Chile

Facility Name

Investigational Site Number 1520004

City

Santiago

ZIP/Postal Code

8330074

Country

Chile

Facility Name

Investigational Site Number 1520006

City

Santiago

Country

Chile

Facility Name

Investigational Site Number 1520007

City

Temuco

ZIP/Postal Code

4813299

Country

Chile

Facility Name

Investigational Site Number 1520003

City

Viña Del Mar

Country

Chile

Facility Name

Investigational Site Number 2030003

City

Hradec Kralove

ZIP/Postal Code

500 05

Country

Czechia

Facility Name

Investigational Site Number 2030005

City

Ostrava - Poruba

ZIP/Postal Code

70852

Country

Czechia

Facility Name

Investigational Site Number 2030001

City

Praha 5 - Motol

ZIP/Postal Code

15006

Country

Czechia

Facility Name

Investigational Site Number 2080001

City

Herlev

ZIP/Postal Code

2730

Country

Denmark

Facility Name

Investigational Site Number 2500003

City

Montpellier

ZIP/Postal Code

34295

Country

France

Facility Name

Investigational Site Number 2500002

City

Toulouse

ZIP/Postal Code

31059

Country

France

Facility Name

Investigational Site Number 2760002

City

Hannover

ZIP/Postal Code

30173

Country

Germany

Facility Name

Investigational Site Number 2760001

City

Heidelberg

ZIP/Postal Code

69120

Country

Germany

Facility Name

Investigational Site Number 2760004

City

Leipzig

ZIP/Postal Code

04103

Country

Germany

Facility Name

Investigational Site Number 2760003

City

Münster

ZIP/Postal Code

48155

Country

Germany

Facility Name

Investigational Site Number 3480001

City

Budapest

ZIP/Postal Code

1036

Country

Hungary

Facility Name

Investigational Site Number 3480004

City

Budapest

ZIP/Postal Code

1083

Country

Hungary

Facility Name

Investigational Site Number 3480003

City

Budapest

ZIP/Postal Code

1089

Country

Hungary

Facility Name

Investigational Site Number 3480005

City

Gyula

ZIP/Postal Code

5700

Country

Hungary

Facility Name

Investigational Site Number 3480002

City

Miskolc

ZIP/Postal Code

3529

Country

Hungary

Facility Name

Investigational Site Number 3480006

City

Pécs

ZIP/Postal Code

7623

Country

Hungary

Facility Name

Investigational Site Number 3480007

City

Székesfehérvár

ZIP/Postal Code

8000

Country

Hungary

Facility Name

Investigational Site Number 3760003

City

Beer Sheva

ZIP/Postal Code

84101

Country

Israel

Facility Name

Investigational Site Number 3760001

City

Haifa

ZIP/Postal Code

31096

Country

Israel

Facility Name

Investigational Site Number 3760006

City

Holon

ZIP/Postal Code

58100

Country

Israel

Facility Name

Investigational Site Number 3760002

City

Petach Tikva

Country

Israel

Facility Name

Investigational Site Number 3800001

City

Firenze

ZIP/Postal Code

50139

Country

Italy

Facility Name

Investigational Site Number 3800005

City

Roma

ZIP/Postal Code

00165

Country

Italy

Facility Name

Investigational Site Number 3800004

City

Torino

ZIP/Postal Code

10126

Country

Italy

Facility Name

Investigational Site Number 3800006

City

Varese

ZIP/Postal Code

21100

Country

Italy

Facility Name

Investigational Site Number 3800003

City

Verona

ZIP/Postal Code

37134

Country

Italy

Facility Name

Investigational Site Number 3920006

City

Chiyoda-Ku

Country

Japan

Facility Name

Investigational Site Number 3920002

City

Fukuoka-Shi

Country

Japan

Facility Name

Investigational Site Number 3920003

City

Hiroshima-Shi

Country

Japan

Facility Name

Investigational Site Number 3920007

City

Kobe-Shi

Country

Japan

Facility Name

Investigational Site Number 3920005

City

Osaka-Shi

Country

Japan

Facility Name

Investigational Site Number 3920004

City

Shinjuku-Ku

Country

Japan

Facility Name

Investigational Site Number 4280002

City

Daugavpils

ZIP/Postal Code

LV-5417

Country

Latvia

Facility Name

Investigational Site Number 4280001

City

Rīga

ZIP/Postal Code

LV-1004

Country

Latvia

Facility Name

Investigational Site Number 4840003

City

Durango

ZIP/Postal Code

34000

Country

Mexico

Facility Name

Investigational Site Number 4840001

City

Monterrey

ZIP/Postal Code

64460

Country

Mexico

Facility Name

Investigational Site Number 4840004

City

México

ZIP/Postal Code

06700

Country

Mexico

Facility Name

Investigational Site Number 4840002

City

Puebla

ZIP/Postal Code

72190

Country

Mexico

Facility Name

Investigational Site Number 4840005

City

Veracruz

ZIP/Postal Code

91910

Country

Mexico

Facility Name

Investigational Site Number 8070001

City

Skopje

ZIP/Postal Code

1000

Country

North Macedonia

Facility Name

Investigational Site Number 6160005

City

Bielsko-Biala

ZIP/Postal Code

43-316

Country

Poland

Facility Name

Investigational Site Number 6160001

City

Gdansk

ZIP/Postal Code

80-952

Country

Poland

Facility Name

Investigational Site Number 6160006

City

Szczecin

ZIP/Postal Code

71-252

Country

Poland

Facility Name

Investigational Site Number 6160007

City

Warszawa

ZIP/Postal Code

02-091

Country

Poland

Facility Name

Investigational Site Number 6160004

City

Warszawa

ZIP/Postal Code

04-730

Country

Poland

Facility Name

Investigational Site Number 6160003

City

Warszawa

ZIP/Postal Code

04-736

Country

Poland

Facility Name

Investigational Site Number 6420005

City

Bucharest

ZIP/Postal Code

041451

Country

Romania

Facility Name

Investigational Site Number 6420007

City

Constanta

ZIP/Postal Code

900591

Country

Romania

Facility Name

Investigational Site Number 6420004

City

Craiova

ZIP/Postal Code

200542

Country

Romania

Facility Name

Investigational Site Number 6420006

City

Sibiu

ZIP/Postal Code

550166

Country

Romania

Facility Name

Investigational Site Number 6420003

City

Timisoara

ZIP/Postal Code

300011

Country

Romania

Facility Name

Investigational Site Number 6430001

City

Moscow

ZIP/Postal Code

117036

Country

Russian Federation

Facility Name

Investigational Site Number 6430004

City

Smolensk

ZIP/Postal Code

214018

Country

Russian Federation

Facility Name

Investigational Site Number 6430002

City

St-Petersburg

ZIP/Postal Code

193144

Country

Russian Federation

Facility Name

Investigational Site Number 6430003

City

Ufa

ZIP/Postal Code

450000

Country

Russian Federation

Facility Name

Investigational Site Number 6880002

City

Belgrade

ZIP/Postal Code

11000

Country

Serbia

Facility Name

Investigational Site Number 6880003

City

Belgrade

ZIP/Postal Code

11000

Country

Serbia

Facility Name

Investigational Site Number 6880004

City

Nis

ZIP/Postal Code

18000

Country

Serbia

Facility Name

Investigational Site Number 7240005

City

Barcelona

ZIP/Postal Code

08035

Country

Spain

Facility Name

Investigational Site Number 7240002

City

Barcelona

ZIP/Postal Code

08041

Country

Spain

Facility Name

Investigational Site Number 7240003

City

Esplugues De Llobregat

ZIP/Postal Code

08950

Country

Spain

Facility Name

Investigational Site Number 7240004

City

Sabadell

ZIP/Postal Code

08208

Country

Spain

Facility Name

Investigational Site Number 7240006

City

Santa Cruz De Tenerife

ZIP/Postal Code

38320

Country

Spain

Facility Name

Investigational Site Number 7240001

City

Vitoria

ZIP/Postal Code

01009

Country

Spain

Facility Name

Investigational Site Number 7520002

City

Stockholm

ZIP/Postal Code

118 83

Country

Sweden

Facility Name

Investigational Site Number 8260005

City

Doncaster

ZIP/Postal Code

DN2 5LT

Country

United Kingdom

Facility Name

Investigational Site Number 8260001

City

Ipswich

ZIP/Postal Code

IP4 5PD

Country

United Kingdom

Facility Name

Investigational Site Number 8260004

City

Kettering

ZIP/Postal Code

NN16 8UZ

Country

United Kingdom

Facility Name

Investigational Site Number 8260002

City

Salisbury

ZIP/Postal Code

SP2 8BJ

Country

United Kingdom

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

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

Citations:

PubMed Identifier

32430458

Citation

Danne T, Tamborlane WV, Malievsky OA, Franco DR, Kawamura T, Demissie M, Niemoeller E, Goyeau H, Wardecki M, Battelino T. Efficacy and Safety of Insulin Glargine 300 Units/mL (Gla-300) Versus Insulin Glargine 100 Units/mL (Gla-100) in Children and Adolescents (6-17 years) With Type 1 Diabetes: Results of the EDITION JUNIOR Randomized Controlled Trial. Diabetes Care. 2020 Jul;43(7):1512-1519. doi: 10.2337/dc19-1926. Epub 2020 May 19.

Results Reference

derived

Learn more about this trial

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

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

Type 1 Diabetes Mellitus

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial