Patients with type 1 diabetes mellitus, aged at least 1 year to less than 6 years MedDRA version: 12.0 Level: LLT Classification code 10012609 Term:
Conditions
Interventions
Trade Name: Lantus®
Product Name: Lantus®
Product Code: HOE901
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Insulin glargine
CAS Number: 160337-95-1
Current Sponsor code: HOE901
Co
Sponsors
sanofi-aventis recherche & développement
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Pediatric patients with type 1 diabetes mellitus aged at least one year to less than 6 years, for whom signed written informed consent has been obtained from parent or legal guardian to participate in the study. Pediatric patients with type 1 diabetes mellitus aged at least one year to less than 6 years at screening, for whom a signed written informed consent has been obtained from parent or legal guardian to participate in the study. Consent for a child's participation must be obtained from one or both parents, according to local regulations. Are the trial subjects under 18? yes Number of subjects for this age range: 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: - Diagnosis of type 1 diabetes for less than one year - HbA1c at screening >12% or 2.0mg/dL at screening - Serum ALT or AST greater than 3x upper limit of normal for the patient’s age and gender, at screening - Hemoglobin < 10g/dL, or platelet count less than 100,000/cu mm, at screening - Treatment with any anti-hyperglycemic oral agent at any time since the diagnosis of diabetes - Treatment with any pharmacologic anti-hyperglycemic oral agent, since the diagnosis of diabetesfor more than 3 months at any time - Treatment with any non-insulin antihyperglycemic medication (eg, Symlin®) for the 3 months prior to screening - Treatment with systemic glucocorticoids within the month prior to screening
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary study objective is to compare the rate of "all hypoglycemia" between children treated with insulin glargine and NPH insulin.;Primary end point(s): Event rate of "all hypoglycemia" during treatment with study drugs, which consists of: CGMS glucose <70 mg/dL (3.9mM) , Self-Monitored Blood Glucose values <70 mg/dL (3.9mM), symptomatic hypoglycemia episodes.;Secondary Objective: Secondary objectives are to compare insulin glargine and NPH in terms of: - rates of specific types of hypoglycemia: symptomatic, severe, nocturnal, nocturnal symptomatic, and severe nocturnal symptomatic hypoglycemia - HbA1c change from baseline to end-of-treatment, and HbA1c at end-of-treatment - percentage of patients reaching HbA1 less than 7.5% (target value) at end-of-treatment - average blood glucose over whole trial and at end of trial, as estimated by CGMS. | — |
Countries
Austria, Czech Republic, Hungary, Spain
Outcome results
None listed