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

• Register: ClinicalTrials.gov
• Last refreshed on: 28 March 2022
• Main ID: NCT02735044
• Date of registration: 30/03/2016
• Prospective Registration: Yes
• Primary sponsor: Sanofi
• Public title: Comparison of the Safety and Efficacy of HOE901-U300 With Lantus in Children and Adolescents With Type 1 Diabetes Mellitus EDITION JUNIOR
• Scientific 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
• Date of first enrolment: April 14, 2016
• Target sample size: 463
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02735044
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 3

Countries of recruitment

Argentina, Brazil, Bulgaria, Canada, Chile, Czech Republic, Czechia, Denmark, France, Germany, Hungary, Israel, Italy, Japan, Latvia, Macedonia, The Former Yugoslav Republic of, Mexico, North Macedonia, Poland, Romania, Russian Federation, Serbia, Spain, Sweden, United Kingdom, United States

Contacts

• Name: Clinical Sciences & Operations
• Affiliation: Sanofi

Key inclusion & exclusion 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.



Age minimum: 6 Years
Age maximum: 17 Years
Gender: All

Health Condition(s) or Problem(s) studied

Type 1 Diabetes Mellitus

Intervention(s)

Drug: Background therapy

Drug: Insulin glargine (100 units /mL)

Drug: Insulin glargine,300 U/mL

Primary Outcome(s)

Change From Baseline in HbA1c to Month 6 [Time Frame: Baseline to Month 6]

Secondary Outcome(s)

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 [Time Frame: upto Month 6]

Percentage of Participants With HbA1c Values of <7.5% at Month 6 [Time Frame: Month 6]

Change From Baseline to Month 6 in 8-Point SMPG Profile Per Time Point [Time Frame: Baseline to Month 6]

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 [Time Frame: Month 12]

Percentage of Participants With Any Hyperglycemia With Ketosis at Month 12 [Time Frame: Month 12]

Change From Baseline in Fasting Plasma Glucose (FPG) to Month 6 [Time Frame: Baseline to Month 6]

Percentage of Participants With FPG of <=130 mg/dL (7.2 mmol/L) at Month 6 [Time Frame: Month 6]

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 [Time Frame: upto Month 6]

Change From Baseline in 24-Hour Mean Plasma Glucose Based on 8-point SMPG Profiles to Month 6 [Time Frame: Baseline to Month 6]

Change From Baseline in Variability of 24-Hour Mean Plasma Glucose Based on 8-point SMPG Profiles at Month 6 [Time Frame: Baseline, Month 6]

Secondary ID(s)

EFC13957

2015-002084-42

U1111-1168-4546

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 19/06/2019
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02735044