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

• Status: Completed
• Trial end date: 2014-03-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sanofi
• Treatments: Insulin; Insulin Glargine; Insulin, Globin Zinc; Insulin, Isophane; Isophane insulin, beef; Isophane Insulin, Human; Protamines

Criteria

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.