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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

162 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-02-28

Study Completion Date

2014-03-31

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

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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

Conditions

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Type 1 Diabetes Mellitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Insulin glargine

injection once daily at bedtime

Group Type EXPERIMENTAL

Insulin glargine (HOE901)

Intervention Type DRUG

Pharmaceutical form:aqueous solution for injection

Route of administration: Subcutaneous

NPH insulin

injection once daily at bedtime or twice daily in the morning and at bedtime

Group Type ACTIVE_COMPARATOR

NPH insulin

Intervention Type DRUG

Pharmaceutical form:aqueous solution for injection

Route of administration: Subcutaneous

Interventions

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Insulin glargine (HOE901)

Pharmaceutical form:aqueous solution for injection

Route of administration: Subcutaneous

Intervention Type DRUG

NPH insulin

Pharmaceutical form:aqueous solution for injection

Route of administration: Subcutaneous

Intervention Type DRUG

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.

Minimum Eligible Age

6 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No