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Completed

NCT Number: NCT01223131

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

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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Key information

Conditions

Type 1 Diabetes Mellitus Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

6 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Investigational Site Number 156001, Beijing, China

Loading trial locations.

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Insulin glargine (HOE901)

Drug

Pharmaceutical form:aqueous solution for injection

Route of administration: Subcutaneous

NPH insulin

Drug

Pharmaceutical form:aqueous solution for injection

Route of administration: Subcutaneous

Primary outcomes

  1. Absolute change of glycosylated hemoglobin (HbA1c)

    Time frame: from baseline to week 24

Secondary outcomes

  1. Percentage of patients reaching HbA1c < 7.5%

    Time frame: at week 24

  2. Change in Fasting Blood Glucose (FBG)

    Time frame: from baseline to week 24

  3. Change in nocturnal Blood Glucose (BG)

    Time frame: from baseline to week 24

  4. Change in 24-hour blood glucose profile based on 8-point self-monitoring blood glucose (SMBG)

    Time frame: from baseline to week 24

  5. Change in total insulin dose and basal insulin dose

    Time frame: from baseline to week 24

  6. Rate of asymptomatic and/or symptomatic, severe, nocturnal, nocturnal symptomatic hypoglycemia.

    Time frame: during 24-week treatment period

  7. Anti-glargine and anti-human insulin antibody assessment

    Time frame: at screening, week 4, week 24

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Registry information

Official study 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

Acronym: Lantus-P-CN

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Oct 18, 2010
Registry last updated
Apr 1, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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