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)

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

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

Study Overview

• Status: Completed
• Conditions: Type 1 Diabetes Mellitus
• Intervention / Treatment: Drug: Insulin glargine (HOE901); Drug: NPH insulin

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

• Study Type: Interventional
• Enrollment (Actual): 162
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Beijing, China, 100020
    • Investigational Site Number 156006
  • Beijing, China, 100045
    • Investigational Site Number 156001
  • Beijing, China, 100730
    • Investigational Site Number 156007
  • Changsha, China, 410011
    • Investigational Site Number 156009
  • Guangzhou, China, 510630
    • Investigational Site Number 156008
  • Hangzhou, China, 310003
    • Investigational Site Number 156004
  • Shanghai, China, 200040
    • Investigational Site Number 156016
  • Shanghai, China, 201102
    • Investigational Site Number 156005
  • Taiyuan, China, 030013
    • Investigational Site Number 156019
  • Wuhan, China, 430030
    • Investigational Site Number 156002

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 17 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Absolute change of glycosylated hemoglobin (HbA1c)	from baseline to week 24

Secondary Outcome Measures

Outcome Measure	Time Frame
Percentage of patients reaching HbA1c < 7.5%	at week 24
Change in Fasting Blood Glucose (FBG)	from baseline to week 24
Change in nocturnal Blood Glucose (BG)	from baseline to week 24
Change in 24-hour blood glucose profile based on 8-point self-monitoring blood glucose (SMBG)	from baseline to week 24
Change in total insulin dose and basal insulin dose	from baseline to week 24
Rate of asymptomatic and/or symptomatic, severe, nocturnal, nocturnal symptomatic hypoglycemia.	during 24-week treatment period
Anti-glargine and anti-human insulin antibody assessment	at screening, week 4, week 24

Collaborators and Investigators

• Sponsor: Sanofi

Publications and helpful links

General Publications

• Liu M, Zhou Z, Yan J, Li P, Song W, Fu J, Chen X, Zhao W, Xi L, Luo X, Sha L, Deng X, Gong C. A randomised, open-labelstudy of insulin glargine or neutral protamine Hagedorn insulin in Chinese paediatric patients with type 1 diabetes mellitus. BMC Endocr Disord. 2016 Nov 26;16(1):67. doi: 10.1186/s12902-016-0146-2.

Study record dates

Study Major Dates

• Study Start: February 1, 2011
• Primary Completion (Actual): March 1, 2014
• Study Completion (Actual): March 1, 2014

Study Registration Dates

• First Submitted: October 15, 2010
• First Submitted That Met QC Criteria: October 15, 2010
• First Posted (Estimate): October 18, 2010

Study Record Updates

• Last Update Posted (Estimate): April 1, 2014
• Last Update Submitted That Met QC Criteria: March 31, 2014
• Last Verified: March 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 1; Hypoglycemic Agents; Physiological Effects of Drugs; Insulin; Insulin, Globin Zinc; Insulin Glargine; Insulin, Isophane; Isophane Insulin, Human; Isophane insulin, beef
• Other Study ID Numbers: EFC11681; U1111-1116-3661 (Other Identifier: UTN)