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

NCT01223131 | Completed Phase 3

• 2 other identifiers: EFC11681U1111-1116-3661
• Study Type: interventional
• Target: 162
• Locations: 1 country
• Sites: 10

Brief 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

Conditions

Type 1 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• Absolute change of glycosylated hemoglobin (HbA1c)

  from baseline to week 24

Secondary Outcomes (7)

• 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

Study Arms (2)

Insulin glargine

EXPERIMENTAL

injection once daily at bedtime

Drug: Insulin glargine (HOE901)

NPH insulin

ACTIVE COMPARATOR

injection once daily at bedtime or twice daily in the morning and at bedtime

Drug: NPH insulin

Interventions

Insulin glargine (HOE901) DRUG

Pharmaceutical form:aqueous solution for injection Route of administration: Subcutaneous

Insulin glargine

NPH insulin DRUG

Pharmaceutical form:aqueous solution for injection Route of administration: Subcutaneous

NPH insulin

Eligibility Criteria

• Age: 6 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• \- Paediatric patients diagnosed with T1DM aged at least 6 years to less than 18 years at screening.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sanofi: lead

Study Sites (10)

Investigational Site Number 156006

Beijing, 100020, China

Location

Investigational Site Number 156001

Beijing, 100045, China

Location

Investigational Site Number 156007

Beijing, 100730, China

Location

Investigational Site Number 156009

Changsha, 410011, China

Location

Investigational Site Number 156008

Guangzhou, 510630, China

Location

Investigational Site Number 156004

Hangzhou, 310003, China

Location

Investigational Site Number 156016

Shanghai, 200040, China

Location

Investigational Site Number 156005

Shanghai, 201102, China

Location

Investigational Site Number 156019

Taiyuan, 030013, China

Location

Investigational Site Number 156002

Wuhan, 430030, China

Location

Related Publications (1)

• 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.

  PMID: 27887605 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Insulin Glargine; Insulin, Isophane

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Insulin, Long-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Clinical Sciences & Operations

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 15, 2010
• First Posted: October 18, 2010
• Study Start: February 1, 2011
• Primary Completion: March 1, 2014
• Study Completion: March 1, 2014
• Last Updated: April 1, 2014

Record last verified: 2014-03

Locations

CN (10)