Treatment of diabetes in children

Gao, Yiqing; Gao, Min; Xue, Yongbiao

doi:10.3892/etm.2016.3039

Cited by 11 publications

(6 citation statements)

References 31 publications

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“…This can reduce the impact of individual lifestyle changes such as increased exercise and improved nutrition for the treatment of T2D 14 . Despite the increase in childhood diabetes and the diverse range of oral and injectable agents available for the treatment of T2D in adults, most have not been studied in children 15 . The ability to perform long‐term interventional clinical studies in children and adolescents is limited due to insufficient pediatric trial infrastructure and inclusion/exclusion criteria that limit an already restricted participant pool 16 .…”

Section: Introductionmentioning

confidence: 99%

A study on pharmacokinetics, pharmacodynamics and safety of lixisenatide in children and adolescents with type 2 diabetes

et al. 2022

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Objective The aim of this study was to investigate the pharmacokinetic, pharmacodynamic and safety profile of the glucagon‐like peptide‐1 receptor agonist, lixisenatide, for the treatment of type 2 diabetes (T2D) in pediatric individuals. Materials and Methods In this Phase 1, multicenter, randomized, double‐blind, placebo‐controlled, parallel‐group, ascending repeated dose study (NCT02803918), participants aged ≥10 and < 18 years were randomized 3:1 to receive once‐daily lixisenatide in 2‐week increments of 5, 10, and 20 μg (n = 18) or placebo (n = 5) for 6 weeks. Results Mean lixisenatide concentrations generally increased with increasing doses irrespective of anti‐drug antibody (ADA) status; however, mean lixisenatide concentrations and inter‐subject variability were higher for participants with positive ADA status. Improvements in fasting plasma glucose, post‐prandial glucose, AUC0–4.5, HbA1c, and body weight were observed with lixisenatide. Overall, the safety profile was consistent with the known profile in adults, with no unexpected side effects and no treatment‐emergent adverse events resulting in death or discontinuation. The most common events in the lixisenatide group were vomiting (11.1%) and nausea (11.1%). No symptomatic hypoglycemia was reported in either group. No clinically significant hematologic, biochemical or vital sign abnormalities were observed. Conclusions Mean lixisenatide concentrations generally increased with increasing dose, irrespective of ADA status. Lixisenatide was associated with improved glycemic control and a trend in body weight reduction compared with placebo. The safety and tolerability profile of repeated lixisenatide doses of up to 20 μg per day in children and adolescents with T2D was reflective of the established safety profile of lixisenatide in adults.

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Section: Introductionmentioning

confidence: 99%

A study on pharmacokinetics, pharmacodynamics and safety of lixisenatide in children and adolescents with type 2 diabetes

et al. 2022

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“…Incidence trends of type 1 diabetes mellitus (T1DM) in the paediatric population show an increase in cases over the last decade in the USA and worldwide with a disproportionately higher incidence in certain ethnic minorities . Achieving glycaemic control in patients with T1DM is essential but regardless only 17% of adolescent patients with T1DM accomplish glycaemic goals with the currently available management options .…”

Section: Introductionmentioning

confidence: 99%

Comparison of pharmacokinetics and the exposure–response relationship of dapagliflozin between adolescent/young adult and adult patients with type 1 diabetes mellitus

Busse

Tang

Scheerer

et al. 2019

Brit J Clinical Pharma

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Funding information AstraZenecaAims: To quantitatively compare pharmacokinetics (PK) and the exposure-response (ER) relationship of the sodium-glucose cotransporter-2 inhibitor, dapagliflozin, between adolescents/young adults and adults with type 1 diabetes mellitus (T1DM).Methods: Data from 2 clinical studies for dapagliflozin were analysed using a nonlinear mixed-effects approach. The PK and the relationship between dapagliflozin exposure and response (24-hour urinary glucose excretion) were characterized. PK was evaluated using a 2-compartment model with first-order absorption while the exposure response-relationship was analysed using a sigmoidal maximal-effect model.The 24-hour median blood glucose, estimated glomerular filtration rate (eGFR), sex, age and body weight were evaluated as covariates. Results:A 2-compartment model with first order absorption provided a reasonable fit to the dapagliflozin PK data. Body weight was found to be a significant covariate on dapagliflozin exposure. The ER relationship was best described by a sigmoidal maximal effect model with 24-hour median blood glucose and eGFR as significant covariates on maximal effect. In accordance with the observed data, model-predicted urinary glucose excretion response following 10 mg dapagliflozin dose was higher in the study in adolescents/young adults (138.0 g/24 h) compared to adults (70.5 g/24 h) with T1DM. This is linked to higher eGFR and 24-hour median blood glucose in this trial.Conclusions: Dapagliflozin PK and ER relationship were similar in the 2 analysed studies after accounting for covariate effects. These results suggest that no dose adjustment is required for adolescent patients with T1DM.

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“…This finding suggests benefits in monitoring pediatric serum vitamin B12 level, especially when using a high dose for longer duration. This suggestion is reinforced by the increasingly common use of metformin among obese children with metabolic problems such as T2DM [ 3 , 4 , 8 , 9 , 24 ].…”

Section: Discussionmentioning

confidence: 99%

“…This suggestion is reinforced by the increasingly common use of metformin among obese children with metabolic problems such as T2DM. 3,4,8,9,24)…”

Section: Discussionmentioning

confidence: 99%

The effect of metformin on vitamin B12 level in pediatric patients

Khallouq

2022

Ann Pediatr Endocrinol Metab

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Purpose: Metformin is a common medication for patients with hyperglycemia. In adults, one well-documented side effect of metformin is vitamin B12 deficiency. However, this side effect has rarely been studied in pediatric patients. This study examined the changes of vitamin B12 level in pediatric patients being treated with metformin.Methods: Data were collected from pediatric patients (n=151) with at least 3 months of consecutive metformin intake. The effects of dose of metformin on the mean vitamin B12 level were investigated at 6, 12, 24, and 36 months. The effect of compliance of metformin intake on vitamin B12 level also was studied.Results: There was no significant decrease in mean vitamin B12 level at 6, 12, 24, or 36 months in patients treated with metformin. Mean vitamin B12 decrease was only noticeable (<i>p</i><0.05) in patients taking a high dose of metformin with good compliance. Despite this change, the mean vitamin B12 remained well within the normal reference range. Furthermore, of the 151 patients studied, only 1 demonstrated vitamin B12 deficiency after 12 months of treatment. However, his B12 level was normal at 24 and 36 months without any vitamin B12 supplements. Conclusion: Our findings suggest that metformin treatment in children does not cause vitamin B12 deficiency; however, the effect of long-term consistent high-dose treatment on vitamin B12 level remains unknown.

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Treatment of diabetes in children

Cited by 11 publications

References 31 publications

A study on pharmacokinetics, pharmacodynamics and safety of lixisenatide in children and adolescents with type 2 diabetes

A study on pharmacokinetics, pharmacodynamics and safety of lixisenatide in children and adolescents with type 2 diabetes

Comparison of pharmacokinetics and the exposure–response relationship of dapagliflozin between adolescent/young adult and adult patients with type 1 diabetes mellitus

The effect of metformin on vitamin B12 level in pediatric patients

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