Efficacy and Safety of Insulin Glargine 300 Units/mL (Gla-300) Versus Insulin Glargine 100 Units/mL (Gla-100) in Children and Adolescents (6–17 years) With Type 1 Diabetes: Results of the EDITION JUNIOR Randomized Controlled Trial

Danne, Thomas; Tamborlane, William V.; Malievsky, Oleg; Franco, Denise Reis; Kawamura, Tomoyuki; Demissie, Marek; Niemoeller, Elisabeth; Goyeau, Harmonie; Wardęcki, Marek; Battelino, Tadej

doi:10.2337/dc19-1926

Cited by 15 publications

(30 citation statements)

References 32 publications

(26 reference statements)

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“…These results are consistent with the enhanced inhibitory effect of Gla-300 on lipolysis and ketogenesis observed in adult T1DM populations 18-24 h after the administration of the insulin [48]. The findings of the EDITION JUNIOR study are also consistent with those of the BEGIN Young 1 study, underlining a potential role of the higher stability over 24 h of second-generation basal insulins versus first-generation basal insulins in reducing hyperglycaemia [26,41].…”

Section: Gla-300 and The Management Of T1dm In Paediatric Patientssupporting

confidence: 83%

Insulin Glargine 300 U/mL Therapy in Children and Adolescents with Type 1 Diabetes

Maffeis

Rabbone

2022

Pediatr Drugs

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The pharmacokinetic and pharmacodynamic properties of the second-generation basal insulin glargine 300 Units/mL (Gla-300) may be of benefit in the treatment of type 1 diabetes mellitus (T1DM). Gla-300 provides a stable and sustained timeaction profile, which is associated with glycaemic control and flexible dosing schedule. This review summarises the available evidence on the safety and efficacy of Gla-300 in children and adolescents with T1DM. Gla-300 is as effective as the firstgeneration basal insulin glargine 100 Units/mL (Gla-100), a standard of care for patients with diabetes in reducing HbA1c, and shows a lower risk of severe hypoglycaemia and hyperglycaemia in children and adolescents with T1DM. However, Gla-300 and Gla-100 are not bioequivalent and are not directly interchangeable. Real-world studies on patients aged 6-17 years are limited. To date, only one small study assessed the effectiveness and safety of Gla-300 versus Gla-100 in newly diagnosed T1DM paediatric patients, confirming the treatment safety and effectiveness of Gla-300 in clinical practice. Gla-300 is a longer-acting basal insulin alternative in the management of children (aged ≥ 6 years) and adolescents with T1DM.

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Section: Gla-300 and The Management Of T1dm In Paediatric Patientssupporting

confidence: 83%

Insulin Glargine 300 U/mL Therapy in Children and Adolescents with Type 1 Diabetes

Maffeis

Rabbone

2022

Pediatr Drugs

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“…greater doses of Gla-300 SC to match the glucose-lowering efficacy versus Gla-100 2,4,5,[7][8][9][10][11] and versus other basal insulins such as degludec, which do not precipitate. 35…”

Section: Discussionmentioning

confidence: 99%

“…These results indicate that the reduced BG-lowering effects with SC doses of Gla-300 versus Gla-100 reported in humans 1,2 are explained not by the different potency of the two glargine formulations, but by greater MRT and lower bioavailability with of Gla-300 versus Gla-100 SC dosing. In turn, this explains the clinical need in people with type 1 diabetes of 10%-30% greater doses of Gla-300 SC to match the glucose-lowering efficacy versus Gla-100 2,4,5,[7][8][9][10][11] and versus other basal insulins such as degludec, which do not precipitate. 35…”

Section: Discussionmentioning

confidence: 99%

“…[7][8][9] In clinical trials, Gla-300 requires higher doses as compared with Gla-100 in type 1 and type 2 diabetes. 2,4,5,[7][8][9][10][11] In experimental euglycaemic clamp studies in type 1 diabetes, the same subcutaneous (SC) dose of Gla-300 at steady state showed reduced blood glucose (BG)-lowering effects versus Gla-100 by 27%, 1 and by 14%-30% versus degludec, 12,13 over the 24 h post-dosing. Consequently, Gla-300 is referred to as a basal insulin with lower potency versus comparators.…”

mentioning

confidence: 99%

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Equipotency of insulin glargine 300 and 100 U/mL with intravenous dosing but differential bioavailability with subcutaneous dosing in dogs

Ulrich

Tennagels

Fanelli

et al. 2020

Diabetes Obesity Metabolism

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Aims Insulin glargine 300 U/mL (Gla‐300) contains the same units versus glargine 100 U/mL (Gla‐100) in three‐fold lower volume, and higher subcutaneous (SC) doses are required in people with diabetes. To investigate blood glucose (BG) lowering potency, Gla‐300 and Gla‐100 were compared after intravenous (IV, for 4 h) and SC (for 24 h) injection in healthy Beagle dogs. Materials and methods The dose of 0.15 U/kg Gla‐300 and Gla‐100 was injected IV in 12 dogs. BG, C‐peptide, glucagon and the active metabolite 21A‐Gly‐human insulin (M1; liquid chromatography‐tandem mass spectrometry method) were measured. Twelve other dogs were studied after SC injection of 0.3 U/kg Gla‐300 and Gla‐100. Results After IV injection, Gla‐300 and Gla‐100 were equally potent [BG_AUC0‐4 h ratio 1.01 (95% confidence interval, 0.94; 1.09)]. After SC injection, BG decreased slower and less with Gla‐300. Similar metabolism of Gla‐300 and Gla‐100 to M1 occurred with IV dosing [M1_AUC0‐1 h ratio 0.99 (95% confidence interval, 0.82; 1.22)], but with SC dosing M1_Cmax and AUC0‐24h were 44% and 17% lower; mean residency time and bioavailability were 32% longer and 50% lower, with Gla‐300. Conclusions IV Gla‐300 and Gla‐100 have the equivalent of BG‐lowering potency and M1 metabolism. SC Gla‐300 has lower M1 bioavailability with a reduced BG‐lowering effect and need for greater doses versus Gla‐100.

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“…Human insulin was the first peptide hormone synthesized using the recombinant DNA technique in the early 1980s [ 9 ]. At present, some amino acids in this recombinant insulin have been modified to reestablish the physiological effect of endogenous insulin using short-, intermediate- or long-acting insulins [ 10 , 11 , 12 ]. The number of drugs to normalize glucose levels in type 2 DM patients is ostensibly increasing.…”

Section: Introductionmentioning

confidence: 99%

Diabetes Mellitus Is a Chronic Disease that Can Benefit from Therapy with Induced Pluripotent Stem Cells

Arroyave

Montaño

Lizcano

2020

IJMS

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Diabetes mellitus (DM) is one of the main causes of morbidity and mortality, with an increasing incidence worldwide. The impact of DM on public health in developing countries has triggered alarm due to the exaggerated costs of the treatment and monitoring of patients with this disease. Considerable efforts have been made to try to prevent the onset and reduce the complications of DM. However, because insulin-producing pancreatic β-cells progressively deteriorate, many people must receive insulin through subcutaneous injection. Additionally, current therapies do not have consistent results regarding the prevention of chronic complications. Leveraging the approval of real-time continuous glucose monitors and sophisticated algorithms that partially automate insulin infusion pumps has improved glycemic control, decreasing the burden of diabetes management. However, these advances are facing physiologic barriers. New findings in molecular and cellular biology have produced an extraordinary advancement in tissue development for the treatment of DM. Obtaining pancreatic β-cells from somatic cells is a great resource that currently exists for patients with DM. Although this therapeutic option has great prospects for patients, some challenges remain for this therapeutic plan to be used clinically. The purpose of this review is to describe the new techniques in cell biology and regenerative medicine as possible treatments for DM. In particular, this review highlights the origin of induced pluripotent cells (iPSCs) and how they have begun to emerge as a regenerative treatment that may mitigate the pathology of this disease.

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Efficacy and Safety of Insulin Glargine 300 Units/mL (Gla-300) Versus Insulin Glargine 100 Units/mL (Gla-100) in Children and Adolescents (6–17 years) With Type 1 Diabetes: Results of the EDITION JUNIOR Randomized Controlled Trial

Cited by 15 publications

References 32 publications

Insulin Glargine 300 U/mL Therapy in Children and Adolescents with Type 1 Diabetes

Insulin Glargine 300 U/mL Therapy in Children and Adolescents with Type 1 Diabetes

Equipotency of insulin glargine 300 and 100 U/mL with intravenous dosing but differential bioavailability with subcutaneous dosing in dogs

Diabetes Mellitus Is a Chronic Disease that Can Benefit from Therapy with Induced Pluripotent Stem Cells

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