6-month Comparison of Morning Lantus Versus Neutral Protamine Hagedorn Insulin in Young Children With Type 1 Diabetes (PRESCHOOL)

Sanofi

Status and phase: Completed; Phase 3

Conditions: Type 1 Diabetes Mellitus

Treatments: Drug: Insulin glargine (HOE901); Drug: Neutral Protamine Hagedorn (NPH) insulin; Drug: Insulin lispro

Study type: Interventional

Funder types: Industry

Identifiers

NCT00993473

2009-011231-12 (EudraCT Number)

EFC11202

Details and patient eligibility

About

The primary study objective was to compare the rate of "all hypoglycemia" (composite outcome of the following hypoglycemia events: symptomatic hypoglycemia episodes, low continuous glucose monitoring system (CGMS) excursions confirmed by fingerstick blood glucose (FSBG), low FSBG readings performed at other times) between children treated with Lantus (insulin glargine) and Neutral Protamine Hagedorn (NPH) insulin.

Secondary objectives were to compare insulin glargine and NPH in terms of:

• rates of specific types of hypoglycemia: symptomatic, severe, nocturnal, nocturnal symptomatic, and severe nocturnal symptomatic hypoglycemia
• HbA1c change from baseline to end-of-treatment, and HbA1c at end-of-treatment
• percentage of patients reaching HbA1c less than 7.5% (target value) at end of treatment
• average blood glucose over whole trial and at end of trial, as estimated by continuous glucose monitoring (CGM), and blood glucose variability

Full description

Screening phase: 2 to 4 weeks

Treatment phase: 24 weeks

At randomization, patients were stratified with respect to their baseline HbA1c level (<8.5% or ≥8.5%) and hypoglycemic event rate (number of CGMS hypoglycemic excursions <0.5 or ≥0.5 events per 24 hours). Following randomization, trial basal insulin was initiated and up-titrated within the first 12 weeks to reach a stable dose.

Follow-up phase: 2 weeks

All Phases: 28 to 30 weeks

Enrollment: 125 patients

Sex: All

Ages: 1 to 6 years old

Volunteers: No Healthy Volunteers

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

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

Above information not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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125 participants in 2 patient groups

Lantus (insulin glargine)

Experimental group

Description:

Lantus given as basal insulin once a day in the morning by subcutaneous injection

Treatment:

Drug: Insulin glargine (HOE901)

Drug: Insulin lispro

NPH insulin

Active Comparator group

Description:

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

Treatment:

Drug: Insulin lispro

Drug: Neutral Protamine Hagedorn (NPH) insulin