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)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT01223131
First received: October 15, 2010
Last updated: March 31, 2014
Last verified: March 2014
  Purpose

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

Condition Intervention Phase
Type 1 Diabetes Mellitus
Drug: Insulin glargine (HOE901)
Drug: NPH insulin
Phase 3

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

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Absolute change of glycosylated hemoglobin (HbA1c) [ Time Frame: from baseline to week 24 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Percentage of patients reaching HbA1c < 7.5% [ Time Frame: at week 24 ] [ Designated as safety issue: No ]
  • Change in Fasting Blood Glucose (FBG) [ Time Frame: from baseline to week 24 ] [ Designated as safety issue: No ]
  • Change in nocturnal Blood Glucose (BG) [ Time Frame: from baseline to week 24 ] [ Designated as safety issue: No ]
  • Change in 24-hour blood glucose profile based on 8-point self-monitoring blood glucose (SMBG) [ Time Frame: from baseline to week 24 ] [ Designated as safety issue: No ]
  • Change in total insulin dose and basal insulin dose [ Time Frame: from baseline to week 24 ] [ Designated as safety issue: No ]
  • Rate of asymptomatic and/or symptomatic, severe, nocturnal, nocturnal symptomatic hypoglycemia. [ Time Frame: during 24-week treatment period ] [ Designated as safety issue: Yes ]
  • Anti-glargine and anti-human insulin antibody assessment [ Time Frame: at screening, week 4, week 24 ] [ Designated as safety issue: No ]

Enrollment: 162
Study Start Date: February 2011
Study Completion Date: March 2014
Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Insulin glargine
injection once daily at bedtime
Drug: Insulin glargine (HOE901)

Pharmaceutical form:aqueous solution for injection

Route of administration: Subcutaneous

Active Comparator: NPH insulin
injection once daily at bedtime or twice daily in the morning and at bedtime
Drug: NPH insulin

Pharmaceutical form:aqueous solution for injection

Route of administration: Subcutaneous


Detailed 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
  Eligibility

Ages Eligible for Study:   6 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01223131

Locations
China
Investigational Site Number 156001
Beijing, China, 100045
Investigational Site Number 156006
Beijing, China, 100020
Investigational Site Number 156007
Beijing, China, 100730
Investigational Site Number 156009
Changsha, China, 410011
Investigational Site Number 156008
Guangzhou, China, 510630
Investigational Site Number 156004
Hangzhou, China, 310003
Investigational Site Number 156016
Shanghai, China, 200040
Investigational Site Number 156005
Shanghai, China, 201102
Investigational Site Number 156019
Taiyuan, China, 030013
Investigational Site Number 156002
Wuhan, China, 430030
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Clinical Sciences & Operations Sanofi
  More Information

No publications provided

Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT01223131     History of Changes
Other Study ID Numbers: EFC11681, U1111-1116-3661
Study First Received: October 15, 2010
Last Updated: March 31, 2014
Health Authority: China: Ethics Committee

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin, Globin Zinc
Isophane insulin, beef
Glargine
Insulin
Insulin, Isophane
Insulin, Long-Acting
Protamines
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Heparin Antagonists
Molecular Mechanisms of Pharmacological Action
Coagulants
Hematologic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 18, 2014