None listed
Conditions
Interventions
Group 1 Type of group
Lantus given as basal insulin once a day in the morning by subcutaneous injection
Group name:Group 2 Type of group
Neutral Protamine Hagedorn (NPH) human insulin given as basal insulin either once or twice per day generally in the morning and /or at bedtime by subcutaneous injection
Sponsors
sanofi-aventis Recherche & Development,
Eligibility
Age
1 Years to 6 Years
Inclusion criteria
Inclusion criteria: Pediatric patients with type 1 diabetes mellitus with ages of at least one year and less than 6 years for whom written informed consent was obtained signed by the parent or who has legal custody to participate in the study.
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 |
|---|---|
| Outcome name:The rate of all hypoglycemia was calculated from all hypoglycemia episodes which occurred during the 24-week on-treatment period and consisted of: - symptomatic hypoglycemia episodes validated by the study investigator based on entries in patients diaries, - low continuous glucose monitoring system (CGMS) excursions (interstitial glucose <70 mg/dL [3.9 mmol/L]) confirmed by fingerstick blood glucose (FSBG) <70 mg/dL, - low FSBG readings (values <70 mg/dL) performed at other times. Measure:Event Rate of All Hypoglycemia Defined as the Total Number of Episodes Divided by the Total Duration of the On-treatment Period in Years (Events Per Patient-year) Timepoints:6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Symptomatic hypoglycemia: any event with clinical symptoms considered to result from hypoglycemia, validated by the study investigator based on data from patient diaries. Measure:Event 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) Timepoints:6 months ; Outcome name:Severe symptomatic hypoglycemia: any event with clinical symptoms considered to result from a hypoglycemic episode for which the patients required the assistance of a third party (ie, other than the patient, or a parent/usual caregiver; eg, from emergency personnel), because the patients/parents could not treat the event with acute neurological impairment directly resulting from the hypoglycemic event. The occurrence of seizure, coma, unconsciousness, or the use of glucagon, were also to qualify a hypoglycemic episode as severe. Measure:Event Rate of Severe Symptomatic Hypoglycemia Defined as the Total Number of Episodes Divided by the Total Duration of the On-treatment Period in Years Timepoints:6 months ; Outcome name:Nocturnal hypoglycemia: any event from the all hypoglycemia total that occurred between 23:00 and 07:00 hours. Measure:Event Rate of Nocturnal Hypoglycemia Defined as the Total Number of All Hypoglycemia Episodes Divided by the Total Duration of the On-treatment Period in Years Timepoints:6 months ; Outcome name:Nocturnal symptomatic hypoglycemia: any symptomatic hypoglycemic event that occurred between 23:00 and 07:00 hours. Measure:Event Rate of Nocturnal Symptomatic Hypoglycemia Defined as the Total Number of Episodes Divided by the Total Duration of the On-treatment Period in Years Timepoints:6 months ; Outcome name:Severe nocturnal symptomatic hypoglycemia: any severe symptomatic hypoglycemic event that occurred between 23:00 and 07:00 hours. Me | — |
Countries
Austria, Czech Republic, Hungary, Peru, Spain
Contacts
Public ContactPablo Antonio Acevedo
SANOFI AVENTIS DEL PERU S.A.
Outcome results
None listed