6-month comparison of morning Lantus versus Neutral Protamine Hagedorn insulin in young children with type 1 diabetes

Conditions: Type 1 diabetes mellitus
MedDRA version: 14.1Level: LLTClassification code 10012609Term: Diabetes mellitus juvenile onsetSystem Organ Class: 10027433 - Metabolism and nutrition disorders
Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

Registration Number: EUCTR2009-011231-12-Outside-EU/EEA

Lead Sponsor: sanofi-aventis recherche & développement

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: A

Sex: All

Target Recruitment: 120

Inclusion Criteria

Pediatric patients with type 1 diabetes mellitus aged at least one year to less than 6 years at screening, for whom 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
- 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 pharmacologic anti-hyperglycemic oral agent for 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.;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<br>;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 ;Timepoint(s) of evaluation of this end point: 6 months

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): - Rates of symptomatic, severe, nocturnal, nocturnal symptomatic, and severe nocturnal symptomatic hypoglycemia <br>- HbA1c change from baseline to end-of-treatment <br>- HbA1c at end of treatment <br>- Percentage of patients reaching HbA1c target of less than 7.5% at the end-of-treatment visit <br>- Average daily blood glucose (BG) based on CGMS (both the end-of-treatment value and the change from baseline to end of treatment ;Timepoint(s) of evaluation of this end point: 6 months