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

NCT ID: NCT02735044

Last Updated: 2022-03-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 463 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-04-14
• Study Completion Date: 2018-12-20

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.

Conditions

Type 1 Diabetes Mellitus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

HOE901-U300

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

Group Type: EXPERIMENTAL

Insulin glargine,300 U/mL

Intervention Type: DRUG

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 \[mmol/L\])

Background therapy

Intervention Type: DRUG

Fast-acting mealtime insulin analogs

Lantus

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

Group Type: ACTIVE_COMPARATOR

Insulin glargine (100 units /mL)

Intervention Type: DRUG

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)

Background therapy

Intervention Type: DRUG

Fast-acting mealtime insulin analogs

Interventions

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 \[mmol/L\])

Intervention Type: 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)

Intervention Type: DRUG

Background therapy

Fast-acting mealtime insulin analogs

Intervention Type: DRUG

Other Intervention Names

Toujeo ®

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.

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sanofi

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Sciences & Operations

Role: STUDY_DIRECTOR

Sanofi

Locations

Investigational Site Number 8400008

Tucson, Arizona, United States

Investigational Site Number 8400037

Atlanta, Georgia, United States

Investigational Site Number 8400032

Indianapolis, Indiana, United States

Investigational Site Number 8400015

Buffalo, New York, United States

Investigational Site Number 8400016

Chapel Hill, North Carolina, United States

Investigational Site Number 8400035

Morehead City, North Carolina, United States

Investigational Site Number 8400038

Oklahoma City, Oklahoma, United States

Investigational Site Number 8400030

Philadelphia, Pennsylvania, United States

Investigational Site Number 8400010

Rapid City, South Dakota, United States

Investigational Site Number 8400005

Dallas, Texas, United States

Investigational Site Number 8400021

Dallas, Texas, United States

Investigational Site Number 8400029

Lufkin, Texas, United States

Investigational Site Number 8400034

Seattle, Washington, United States

Investigational Site Number 0320003

Caba, , Argentina

Investigational Site Number 0320001

Caba, , Argentina

Investigational Site Number 0320004

Capital Federal, , Argentina

Investigational Site Number 0320002

Capital Federal, , Argentina

Investigational Site Number 0320006

Mendoza, , Argentina

Investigational Site Number 0320005

Salta, , Argentina

Investigational Site Number 0320007

San Miguel de Tucumán, , Argentina

Investigational Site Number 0760005

Curitiba, , Brazil

Investigational Site Number 0760006

Fortaleza, , Brazil

Investigational Site Number 0760004

Fortaleza, , Brazil

Investigational Site Number 0760003

Porto Alegre, , Brazil

Investigational Site Number 0760001

São Paulo, , Brazil

Investigational Site Number 0760002

São Paulo, , Brazil

Investigational Site Number 1000001

Plovdiv, , Bulgaria

Investigational Site Number 1000005

Sofia, , Bulgaria

Investigational Site Number 1000004

Varna, , Bulgaria

Investigational Site Number 1240003

Halifax, , Canada

Investigational Site Number 1240002

Montreal, , Canada

Investigational Site Number 1240005

Montreal, , Canada

Investigational Site Number 1240006

Sherbrooke, , Canada

Investigational Site Number 1520002

Santiago, , Chile

Investigational Site Number 1520004

Santiago, , Chile

Investigational Site Number 1520006

Santiago, , Chile

Investigational Site Number 1520007

Temuco, , Chile

Investigational Site Number 1520003

Viña del Mar, , Chile

Investigational Site Number 2030003

Hradec Králové, , Czechia

Investigational Site Number 2030005

Ostrava - Poruba, , Czechia

Investigational Site Number 2030001

Praha 5 - Motol, , Czechia

Investigational Site Number 2080001

Herlev, , Denmark

Investigational Site Number 2500003

Montpellier, , France

Investigational Site Number 2500002

Toulouse, , France

Investigational Site Number 2760002

Hanover, , Germany

Investigational Site Number 2760001

Heidelberg, , Germany

Investigational Site Number 2760004

Leipzig, , Germany

Investigational Site Number 2760003

Münster, , Germany

Investigational Site Number 3480001

Budapest, , Hungary

Investigational Site Number 3480004

Budapest, , Hungary

Investigational Site Number 3480003

Budapest, , Hungary

Investigational Site Number 3480005

Gyula, , Hungary

Investigational Site Number 3480002

Miskolc, , Hungary

Investigational Site Number 3480006

Pécs, , Hungary

Investigational Site Number 3480007

Székesfehérvár, , Hungary

Investigational Site Number 3760003

Beersheba, , Israel

Investigational Site Number 3760001

Haifa, , Israel

Investigational Site Number 3760006

Holon, , Israel

Investigational Site Number 3760002

Petah Tikva, , Israel

Investigational Site Number 3800001

Florence, , Italy

Investigational Site Number 3800005

Roma, , Italy

Investigational Site Number 3800004

Torino, , Italy

Investigational Site Number 3800006

Varese, , Italy

Investigational Site Number 3800003

Verona, , Italy

Investigational Site Number 3920006

Chiyoda-Ku, , Japan

Investigational Site Number 3920002

Fukuoka, , Japan

Investigational Site Number 3920003

Hiroshima, , Japan

Investigational Site Number 3920007

Kobe, , Japan

Investigational Site Number 3920005

Osaka, , Japan

Investigational Site Number 3920004

Shinjuku-Ku, , Japan

Investigational Site Number 4280002

Daugavpils, , Latvia

Investigational Site Number 4280001

Riga, , Latvia

Investigational Site Number 4840003

Durango, , Mexico

Investigational Site Number 4840004

México, , Mexico

Investigational Site Number 4840001

Monterrey, , Mexico

Investigational Site Number 4840002

Puebla City, , Mexico

Investigational Site Number 4840005

Veracruz, , Mexico

Investigational Site Number 8070001

Skopje, , North Macedonia

Investigational Site Number 6160005

Bielsko-Biala, , Poland

Investigational Site Number 6160001

Gdansk, , Poland

Investigational Site Number 6160006

Szczecin, , Poland

Investigational Site Number 6160007

Warsaw, , Poland

Investigational Site Number 6160004

Warsaw, , Poland

Investigational Site Number 6160003

Warsaw, , Poland

Investigational Site Number 6420005

Bucharest, , Romania

Investigational Site Number 6420007

Constanța, , Romania

Investigational Site Number 6420004

Craiova, , Romania

Investigational Site Number 6420006

Sibiu, , Romania

Investigational Site Number 6420003

Timișoara, , Romania

Investigational Site Number 6430001

Moscow, , Russia

Investigational Site Number 6430002

Saint Petersburg, , Russia

Investigational Site Number 6430004

Smolensk, , Russia

Investigational Site Number 6430003

Ufa, , Russia

Investigational Site Number 6880002

Belgrade, , Serbia

Investigational Site Number 6880003

Belgrade, , Serbia

Investigational Site Number 6880004

Niš, , Serbia

Investigational Site Number 7240005

Barcelona, , Spain

Investigational Site Number 7240002

Barcelona, , Spain

Investigational Site Number 7240003

Esplugues de Llobregat, , Spain

Investigational Site Number 7240004

Sabadell, , Spain

Investigational Site Number 7240006

Santa Cruz de Tenerife, , Spain

Investigational Site Number 7240001

Vitoria-Gasteiz, , Spain

Investigational Site Number 7520002

Stockholm, , Sweden

Investigational Site Number 8260005

Doncaster, , United Kingdom

Investigational Site Number 8260001

Ipswich, , United Kingdom

Investigational Site Number 8260004

Kettering, , United Kingdom

Investigational Site Number 8260002

Salisbury, , United Kingdom

Countries

United States; Argentina; Brazil; Bulgaria; Canada; Chile; Czechia; Denmark; France; Germany; Hungary; Israel; Italy; Japan; Latvia; Mexico; North Macedonia; Poland; Romania; Russia; Serbia; Spain; Sweden; United Kingdom

References

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.

Reference Type: DERIVED

PMID: 32430458 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

2015-002084-42

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

U1111-1168-4546

Identifier Type: OTHER

Identifier Source: secondary_id

EFC13957

Identifier Type: -

Identifier Source: org_study_id