Type 1 Diabetes Mellitus
Conditions
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
Interventions
Pharmaceutical form:aqueous solution for injection Route of administration: Subcutaneous
DRUGNPH insulin
Pharmaceutical form:aqueous solution for injection Route of administration: Subcutaneous
Sponsors
Sanofi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Years to 17 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Absolute change of glycosylated hemoglobin (HbA1c) | from baseline to week 24 |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| Percentage of patients reaching HbA1c < 7.5% | at 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 |
| Change in total insulin dose and basal insulin dose | from baseline to week 24 |
Countries
China
Outcome results
None listed