Type 1 diabetes mellitus MedDRA version: 18.1 Level: PT Classification code 10067584 Term: Type 1 diabetes mellitus System Organ Class: 10027433 - Metabolism and nutrition disorders
Conditions
Interventions
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
Sponsors
sanofi-aventis recherche & développement
Eligibility
Sex/Gender
All
Inclusion 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: 564 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
Exclusion criteria: -Age 10% 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the efficacy of HOE901-U300 to Lantus in terms of glycated hemoglobin (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.;Primary end point(s): Change from baseline in HbA1c;Timepoint(s) of evaluation of this end point: Baseline; Week 26 | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
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
Public ContactCONTACT POINT
SANOFI S.P.A.
Outcome results
None listed