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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1116-3661 | Other Identifier | UTN |
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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:
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
The study duration for each patient is 28 weeks +/- 7 day broken down as follows:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Insulin glargine | Experimental | injection once daily at bedtime |
|
| NPH insulin | Active Comparator | injection once daily at bedtime or twice daily in the morning and at bedtime |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Insulin glargine (HOE901) | Drug | Pharmaceutical form:aqueous solution for injection Route of administration: Subcutaneous |
|
| Measure | Description | Time Frame |
|---|---|---|
| Absolute change of glycosylated hemoglobin (HbA1c) | from baseline to week 24 |
| Measure | Description | 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) |
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Inclusion criteria:
- Paediatric patients diagnosed with T1DM aged at least 6 years to less than 18 years at screening.
Exclusion criteria:
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Sciences & Operations | Sanofi | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigational Site Number 156006 | Beijing | 100020 | China | |||
| Investigational Site Number 156001 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27887605 | Derived | 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. |
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| NPH insulin | Drug | Pharmaceutical form:aqueous solution for injection Route of administration: Subcutaneous |
|
| 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 |
| Beijing |
| 100045 |
| China |
| Investigational Site Number 156007 | Beijing | 100730 | China |
| Investigational Site Number 156009 | Changsha | 410011 | China |
| Investigational Site Number 156008 | Guangzhou | 510630 | China |
| Investigational Site Number 156004 | Hangzhou | 310003 | China |
| Investigational Site Number 156016 | Shanghai | 200040 | China |
| Investigational Site Number 156005 | Shanghai | 201102 | China |
| Investigational Site Number 156019 | Taiyuan | 030013 | China |
| Investigational Site Number 156002 | Wuhan | 430030 | China |
| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D000069036 | Insulin Glargine |
| D007336 | Insulin, Isophane |
| ID | Term |
|---|---|
| D049528 | Insulin, Long-Acting |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
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