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

• Register: EUCTR
• Last refreshed on: 30 April 2019
• Main ID: EUCTR2015-002084-42-HU
• Date of registration: 01/03/2016
• Prospective Registration: Yes
• Primary sponsor: sanofi-aventis recherche & développement
• Public title: Comparison of the Safety and Efficacy of HOE901-U300 with Lantus in Children and Adolescents with Type 1 Diabetes Mellitus
• 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 - EDITION JUNIOR
• Date of first enrolment: 06/04/2016
• Target sample size: 564
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2015-002084-42
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes; Randomised: yes; Open: yes; Single blind: no; Double blind: no; Parallel group: yes; Cross over: no; Other: no; If controlled, specify comparator, Other Medicinial Product: yes; Placebo: no; Other: no; Number of treatment arms in the trial: 2
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

Argentina, Brazil, Bulgaria, Canada, Chile, Czech Republic, Denmark, France, Germany, Hungary, Israel, Italy, Japan, Latvia, Mexico, Poland, Romania, Russian Federation, Spain, Sweden, United Kingdom, United States

Contacts

• Name: NA.
• Affiliation: sanofi-aventis Zrt.

• Name: NA.
• Affiliation: sanofi-aventis Zrt.

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 patient.
Are the trial subjects under 18? yes
Number of subjects for this age range: 31
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

Type 1 diabetes mellitus
MedDRA version: 19.0 Level: PT Classification code 10067584 Term: Type 1 diabetes mellitus System Organ Class: 10027433 - Metabolism and nutrition disorders

Intervention(s)

Trade Name: Toujeo
Product Name: Insulin glargine
Product Code: HOE901 - U300
Pharmaceutical Form: Solution for injection
INN or Proposed INN: INSULIN GLARGINE
CAS Number: 160337-95-1
Current Sponsor code: HOE901 - U300
Concentration unit: U/ml unit(s)/millilitre
Concentration type: equal
Concentration number: 300-

Trade Name: Lantus SoloStar 100 units/ml solution for injection in a pre-filled pen
Pharmaceutical Form: Solution for injection in pre-filled pen
INN or Proposed INN: INSULIN GLARGINE
CAS Number: 160337-95-1
Current Sponsor code: HOE901
Concentration unit: U/ml unit(s)/millilitre
Concentration type: equal
Concentration number: 100-

Primary Outcome(s)

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

Primary end point(s): Change from baseline in HbA1c

Secondary Objective: -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.

Timepoint(s) of evaluation of this end point: Baseline; Week 26

Secondary Outcome(s)

Secondary end point(s): 1- Percentage of patients with HbA1c values of <7.5% 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 on-treatment period
2- Change from baseline in FPG
3- Percentage of patients 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
4- Change from baseline in 24-hour mean plasma glucose based on 8-point self-monitored plasma glucose (SMPG) profiles
5- Change from baseline in variability of 24-hour mean plasma glucose based on 8-point SMPG profiles
6- Number (%) of patients with hypoglycemia
7- Number (%) of patients with hyperglycemia with ketosis
8- Number (%) of patients with adverse events

Timepoint(s) of evaluation of this end point: 1- Week 26
2- Baseline; Week 26
3- Week 26
4- Baseline; Week 26
5- Baseline; Week 26
6- Up to Month 12
7- Up to Month 12
8- Up to Month 12

Secondary ID(s)

2015-002084-42-GB

EFC13957

Source(s) of Monetary Support

sanofi-aventis recherche & développement

Ethics review

Status: Approved
Approval date:
Contact:

Results

• Results available: Yes
• Date Posted: 04/07/2019
• Date Completed: 20/12/2018
• URL: https://www.clinicaltrialsregister.eu/ctr-search/trial/2015-002084-42/results