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

Type 1 Diabetes Mellitus Clinical Trial

Official title: 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

Status Completed

Clinical Trial Summary

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

Clinical Trial Description

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 ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type 1 Diabetes Mellitus

• NCT number: NCT01223131
• Study type: Interventional
• Source: Sanofi
• Status: Completed
• Phase: Phase 3
• Start date: February 2011
• Completion date: March 2014