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)

Conditions: Patients with type 1 diabetes mellitus, aged at least 1 year to less than 6 years
MedDRA version: 12.0Level: LLTClassification code 10012609Term: <Manually entered code. Term in E.1.1>

Registration Number: EUCTR2009-011231-12-HU

Lead Sponsor: sanofi-aventis recherche & développement

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 120

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

- 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 clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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:<br>- rates of specific types of hypoglycemia: symptomatic, severe, nocturnal, nocturnal symptomatic, and severe nocturnal symptomatic hypoglycemia<br>- HbA1c change from baseline to end-of-treatment, and HbA1c at end-of-treatment<br>- percentage of patients reaching HbA1 less than 7.5% (target value) at end-of-treatment<br>- average blood glucose over whole trial and at end of trial, as estimated by CGMS.

Secondary Outcome Measures