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

Overview

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

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