Clinical trial NCT01223131: Efficacy and Safety of Insulin Glargine Versus. Neutral Protamine Hagedorn (NPH) Insulin in Children With Type 1 Diabetes Above 6 Years Old.
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Type 1 Diabetes Mellitus
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2010-10-18
Enrollment: 162
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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 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.

Primary outcomes:
measure: Absolute change of glycosylated hemoglobin (HbA1c)
timeFrame: from baseline to week 24
Secondary outcomes:
measure: Percentage of patients reaching HbA1c < 7.5%
timeFrame: at week 24
measure: Change in Fasting Blood Glucose (FBG)
timeFrame: from baseline to week 24
measure: Change in nocturnal Blood Glucose (BG)
timeFrame: from baseline to week 24
measure: Change in 24-hour blood glucose profile based on 8-point self-monitoring blood glucose (SMBG)
timeFrame: from baseline to week 24
measure: Change in total insulin dose and basal insulin dose
timeFrame: from baseline to week 24
measure: Rate of asymptomatic and/or symptomatic, severe, nocturnal, nocturnal symptomatic hypoglycemia.
timeFrame: during 24-week treatment period
measure: Anti-glargine and anti-human insulin antibody assessment
timeFrame: at screening, week 4, week 24
Other outcomes:
Locations:
city: Beijing
country: China
facility: Investigational Site Number 156006
city: Beijing
country: China
facility: Investigational Site Number 156001
city: Beijing
country: China
facility: Investigational Site Number 156007
city: Changsha
country: China
facility: Investigational Site Number 156009
city: Guangzhou
country: China
facility: Investigational Site Number 156008
city: Hangzhou
country: China
facility: Investigational Site Number 156004
city: Shanghai
country: China
facility: Investigational Site Number 156016
city: Shanghai
country: China
facility: Investigational Site Number 156005
city: Taiyuan
country: China
facility: Investigational Site Number 156019
city: Wuhan
country: China
facility: Investigational Site Number 156002
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References:
citation: 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.