Efficacy and Safety of Insulin Glargine Versus. Neutral Protamine Hagedorn (NPH) Insulin in Children With Type 1 Diabetes Above 6 Years Old.

Study Overview
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Brief Summary
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Primary Objective: 6 To assess the efficacy of insulin glargine given once daily (QD) on glycosylated hemoglobin (HbA1c) levels over a period of 24 weeks in children with type 1 diabetes mellitus (T1DM) aged at least 6 years to less than 18 years. Secondary Objectives: To assess the effects of insulin glargine compared to NPH insulin over 24 weeks on: Percentage of patients reaching International Society of Pediatric and Adolescent Diabetes (ISPAD) recommended target of HbA1c < 7.5%, Fasting blood glucose (FBG), Nocturnal blood glucose (BG), 24-hour blood glucose profile based on 8-point self-monitoring of blood glucose (SMBG) values, Daily total insulin dose and basal insulin dose, Rates of asymptomatic and/or symptomatic, severe, nocturnal and nocturnal symptomatic hypoglycemia. To assess the safety and tolerability of insulin glargine versus NPH insulin based on the occurrence of treatment-emergent adverse events (TEAEs). To assess anti-insulin and anti-glargine antibody development in both groups. To assess insulin glargine pharmacokinetic(PK) for all patients treated with insulin glargine in selected sites with approximately 45% of insulin glargine population to rule out accumulation tendency of insulin glargine after repeated dosing

Detailed Description
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The study duration for each patient is 28 weeks +/- 7 day broken down as follows: Screening phase: up to 2 weeks Run-in phase: 1 week Treatment phase: 24 weeks Follow-up: 1 week

Official Title
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A 24-week, Randomized, Open-label, Parallel Group, Multicenter Comparison of Lantus® (Insulin Glargine) Given Once Daily Versus Neutral Protamine Hagedorn (NPH) Insulin in Children With Type 1 Diabetes Mellitus Aged at Least 6 Years to Less Than 18 Years

Conditions
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Type 1 Diabetes Mellitus

Intervention / Treatment
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* Drug: Insulin glargine (HOE901)
* Drug: NPH insulin


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: - Paediatric patients diagnosed with T1DM aged at least 6 years to less than 18 years at screening. Exclusion criteria: Treatment with oral or parenteral glucose-lowering medications other than insulin. HbA1c < 7% or > 12 % at screening. The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Insulin glargine<br>injection once daily at bedtime | Drug: Insulin glargine (HOE901)<br>* Pharmaceutical form:aqueous solution for injection Route of administration: Subcutaneous<br>|
| Active Comparator: NPH insulin<br>injection once daily at bedtime or twice daily in the morning and at bedtime | Drug: NPH insulin<br>* Pharmaceutical form:aqueous solution for injection Route of administration: Subcutaneous<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Absolute change of glycosylated hemoglobin (HbA1c) |  | from baseline to week 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients reaching HbA1c < 7.5% |  | at week 24 | 
| Change in Fasting Blood Glucose (FBG) |  | from baseline to week 24 | 
| Change in nocturnal Blood Glucose (BG) |  | from baseline to week 24 | 
| Change in 24-hour blood glucose profile based on 8-point self-monitoring blood glucose (SMBG) |  | from baseline to week 24 | 
| Change in total insulin dose and basal insulin dose |  | from baseline to week 24 | 
| Rate of asymptomatic and/or symptomatic, severe, nocturnal, nocturnal symptomatic hypoglycemia. |  | during 24-week treatment period | 
| Anti-glargine and anti-human insulin antibody assessment |  | at screening, week 4, week 24 |