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

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

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

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

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

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.

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.