Efficacy and Safety of Insulin Glargine Versus. Neutral Protamine Hagedorn (NPH) Insulin in Children With Type 1 Diabetes Above 6 Years Old.
- Conditions
- Type 1 Diabetes Mellitus
- Interventions
- Drug: Insulin glargine (HOE901)Drug: NPH insulin
- Registration Number
- NCT01223131
- Lead Sponsor
- Sanofi
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 162
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Insulin glargine Insulin glargine (HOE901) injection once daily at bedtime NPH insulin NPH insulin injection once daily at bedtime or twice daily in the morning and at bedtime
- Primary Outcome Measures
Name Time Method Absolute change of glycosylated hemoglobin (HbA1c) from baseline to week 24
- Secondary Outcome Measures
Name Time Method Percentage of patients reaching HbA1c < 7.5% at 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 Change in nocturnal Blood Glucose (BG) from baseline to week 24 Change in Fasting Blood Glucose (FBG) from baseline to week 24 Anti-glargine and anti-human insulin antibody assessment at screening, week 4, week 24
Trial Locations
- Locations (10)
Investigational Site Number 156006
🇨🇳Beijing, China
Investigational Site Number 156001
🇨🇳Beijing, China
Investigational Site Number 156004
🇨🇳Hangzhou, China
Investigational Site Number 156009
🇨🇳Changsha, China
Investigational Site Number 156007
🇨🇳Beijing, China
Investigational Site Number 156008
🇨🇳Guangzhou, China
Investigational Site Number 156016
🇨🇳Shanghai, China
Investigational Site Number 156005
🇨🇳Shanghai, China
Investigational Site Number 156019
🇨🇳Taiyuan, China
Investigational Site Number 156002
🇨🇳Wuhan, China