Health Condition 1: null- In patients with Type 1 diabetes mellitus insufficiently aged between 1 to 6 years Health Condition 2: E109- Type 1 diabetes mellitus without complications
Conditions
Interventions
Intervention1: Insulin glargine: Insulin glargine administration will occur in the morning, after waking up and before breakfast, at roughly the same time each day for a given patient: NPH insulin inj
pen devices
containing 300 U, and in 10 mL vials (each containing 1000 U)
Sponsors
Sanofi Synthelabo India limited
Eligibility
Inclusion criteria
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
Exclusion criteria
Exclusion criteria: Diagnosis of type 1 diabetes for less than one year HbA1c at screening >12% or <6% Diabetes other than type 1 diabetes. Parents and patients not willing to undergo all study assessments and treatments, including home blood glucose monitoring, Continuous Glucose Monitoring System (CGMS) sensor placement and maintenance both at the site and at home, multiple daily insulin injections, and visits, as dictated by the protocol (if a telephone is not available patients may undergo all visits in person) Patients and families for whom 6 days in total (not necessarily continuous) of useable CGMS data cannot be obtained (either by home sensor replacement, or by sensor replacement at the site at additional screening visits if needed) during the screening CGMS evaluations between Visit 2 and the randomization visit Patients treated with insulin pump therapy during the two months prior to screening History of primary seizure disorder History of severe hypoglycemic episode accompanied by seizure and/or coma, or diabetic ketoacidosis leading to hospitalization or to care in the emergency ward, in the 2 months prior to the screening visit Hypoglycemia unawareness, as determined by the Investigator Serum creatinine > 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 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 |
|---|---|
| Event rate of "all hypoglycemia" during treatment with study drugs, which consists of: CGM glucose 70 mg/dL (3.9mM) , Self-Monitored Blood Glucose values 70 mg/dL (3.9mM), symptomatic hypoglycemia episodes Timepoint: 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| vent Rate of Symptomatic Hypoglycemia (Individual Component of Primary Endpoint) Defined as the Total Number of Episodes Divided by the Total Duration of the On-treatment Period in Years (Events Per Patient-year)Timepoint: 6 months | — |
Countries
Australia, Brazil, Chile, Czech Republic, Germany, Hungary, India, Mexico, Peru, Poland, Romania, Russian Federation, South Africa, Spain, Turkey, United States of America
Contacts
Public ContactMs Gayatri Jaiswal
Sanofi Synthelabo India Limited
Outcome results
None listed