A 24-week, randomized, open-label, parallel group multinational comparison of Lantus® (insulin glargine) given in the morning as once-a-day basal insulin versus Neutral Protamine Hagedorn (NPH) insulin, in children with type 1 diabetes mellitus aged at least 1 year to less than 6 years - PRESCHOOL (PRESchool CHildren with type 1 diabetes On mOrning Lantus)

Not Applicable

Completed

Conditions: -E10 Insulin-dependent diabetes mellitus
Insulin-dependent diabetes mellitus
E10

Registration Number: PER-114-09

Lead Sponsor: sanofi-aventis Recherche & Development,

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Complete

Sex: Not specified

Target Recruitment: 0

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

• 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.
• Need for chronic treatment with acetaminophen (paracetamol)-containing medications
• 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 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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br>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.<br><br>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)<br>Timepoints:6 months<br>

Secondary Outcome Measures