Changes in HbA1c and hypoglycemic episodes in type 1 diabetes patients after switching to insulin glargine U300: Pilot study

doi:10.1016/j.diabres.2017.03.036

Diabetes Research and Clinical Practice

Volume 129, July 2017, Pages 144-147

https://doi.org/10.1016/j.diabres.2017.03.036 Get rights and content

Abstract

We included diabetes type 1 (T1 DM) patients with suboptimal glycemic control on morning application glargine (I-Glar) U100, switching them to U300. After six months improvement in HbA1c was observed, while hypoglycemic episodes decreased. Switch from I-Glar U100 to U300 could be a good therapeutic option for that subset of patients.

Introduction

Insulin therapy is essential for the treatment of type 1 diabetes (T1DM). However, due to pharmacological properties of insulin, it is often related to hypoglycemia, a major obstacle in reaching optimal glycemic targets in diabetic patients. Current research has shown that timing of insulin application can have an important effect on overall glucoregulation and in case of morning instead of evening application of basal insulin glargine U100 can reduce the hypoglycemic risk [1]. We reported recently that transition from bedtime to morning basal insulin (I-Glar U100) administration in poorly regulated type 1 diabetic patients could improve glucoregulation and reduce number of hypoglycemic episodes without affecting body weight [2]. However, those patients still remained suboptimally controlled. The new insulin glargine U300 (I-Glar U300) with flatter and more prolonged pharmacokinetic and pharmacodynamic profile than I-Glar U100 could represent a new, more efficient therapeutic option in this particular subset of patients [3]. In present study we included those patients and investigated whether the transition to I-Glar U300 has a beneficiary effect on glucose regulation and hypoglycemic episodes.

Section snippets

Methods

18 patients (9 females and 9 male) with suboptimally controlled T1DM treated by intensified insulin regimen based on I-Glar U100 applied in the morning participated in this prospective longitudinal study. Written informed consent was obtained from each patient. This study complied with the Declaration of Helsinki and was approved by ethics committees of above mentioned institutions.

Patients were eligible for participation if they were diagnosed with T1DM, had suboptimal glycemic control (HbA1c

Results

Table 1 shows a comparison of the data obtained at baseline, at transition and 12 weeks after the transition. The average HbA1c was significantly reduced over time. Bonferroni correction for multiple comparison shows a significant reduction in the second measurement (at transition) compared to the first, and an additional significant reduction 6 months after introduction of I-Glar U300 than at transition.

Regarding glycemic control based on SMBG values (4 point and 8 point), there was no

Discussion

According to our observation use of I-Glar U300 in young patients with T1DM, in whom tight glycemic control is suggested but failed mainly due to risk of hypoglycemia, would be a safe and successful treatment option. I-Glar U300 received a European marketing authorization in April 2015, so there are still very limited patient-oriented outcome data. Our present study adds to the ample of safety and efficacy evidence on I-Glar U300. In a randomized controlled trial (RCT) in 549 people with type 1

Disclosure

Marina Gradiser, Maja Cigrovski Berkovic and Ines Bilic-Curcic declare no conflict of interest.

All procedures followed were in accordance with the ethical standards of the responsible committee on human experimentation (institutional and national) and with the Helsinki Declaration of 1964, as revised in 2013. Informed consent was obtained from all patients for being included in the study.

Authors’ contributions

MG, MBC and IBC conceived and designed this study, collected patients and drafted the manuscript.

References (5)

A. Hamann et al.
A randomized clinical trial comparing breakfast, dinner, or bedtime administration of insulin glargine in patients with type 1 diabetes
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M. Gradiser et al.
The effects of transition from bedtime to morning glargine administration in patients with poorly regulated type 1 diabetes mellitus: croatian pilot study
Diabetes Ther
(2015)

There are more references available in the full text version of this article.

Cited by (8)

Experience after switching from insulin glargine U100 to glargine U300 in patients with type 1 diabetes mellitus. A study after one year of treatment in real life
2019, Endocrinologia, Diabetes y Nutricion
Los tratamientos insulínicos actuales para diabetes tipo 1 (DM1) no siempre consiguen los objetivos de control metabólico debido, entre otros aspectos, a la aparición de episodios de hipoglucemia asociados al uso de insulina.
Estudio descriptivo en la vida real con 247 pacientes DM1, el 55,5% varones, de 46,53 ± 16,23 años, con un tiempo de evolución de 21,89 ± 11,99 años, a los que se sustituyó su insulina basal, glargina U100, por glargina U300. Los objetivos primarios fueron los cambios en la HbA1c y en el número de hipoglucemias y los secundarios fueron los cambios en el peso y en la dosis de insulina trascurridos 6 y 12 meses.
Tras un año, no se observaron cambios en la HbA1c en el total de los pacientes, si bien se comprobó un descenso significativo en los pacientes mal controlados. Sin embargo, aumentó el porcentaje de pacientes con HbA1c < 7,5% a los 6 meses (33,5 vs. 40,5%; p < 0,05), que se mantuvo al año. El número de hipoglucemias leves se redujo tras los 12 meses de tratamiento en aquellos pacientes con antecedentes de hipoglucemias leves. En cuanto al peso, no observamos cambios.
La dosis total de insulina/kg se incrementó significativamente en un 7,24% a los 6 meses y en un 8,69% al año por el aumento de la insulina basal. Las diferencias en las dosis a los 6 meses y al año no fueron significativas. Este aumento fue similar entre los grupos según el control metabólico, la presencia de hipoglucemias y no se relacionó con la insulina basal inicial, la HbA1c inicial, el número de hipoglucemias leves ni con el peso inicial.
En la vida real glargina U300 muestra un mejor control glucémico en pacientes mal controlados, al reducir las hipoglucemias en pacientes con antecedentes de hipoglucemias sin incrementar el peso corporal.
Current treatment of type 1 diabetes mellitus (T1DM) does not always achieve metabolic control because, among other things, the ocurrence of hypoglycemic events associated to insulin use.
A descriptive real life study of 247 T1DM patients, 55.5% male, aged 46.53 ± 16.23 years, and with a mean diabetes duration of 21.89 ± 11.99 years, who were switched from basal insulin glargine U100 to glargine U300. The primary endpoints were changes in Hba1c and number of hypoglycemic events, while secondary endpoints included changes in weight and insulin dose after 6 and 12 months.
After one year, no changes were seen in HbA1c, but the proportion of patients with HbA1c values <7.5% increased at 6 months (33.5 vs. 40.5%; P<0.05) and remained stable during one year of follow-up. Hypoglycemic events significantly decreased after one year of treatment in patients with previous hypoglycemic events. No changes were seen in body weight.
Total insulin dose (U/kg) increased 7.24% at 6 months of treatment and by 8.69% at one year, mainly due to basal insulin. No changes were seen between the doses given at 6 and 12 months. These changes were similar in the different metabolic control groups and in patients with or without hypoglycemia. This increase was not related with prior basal insulin dose, baseline HbA1c level, number of hypoglycemic events or baseline weight.
Glargine U300 is a good basal insulin alternative to treat T1DM, improving metabolic control in patients with HbA1c levels >7,5 and decreasing hypoglycemic events in patients with history of hypoglycemia without increasing body weight.
Comparative clinical outcomes of insulin degludec and insulin glargine 300 U/mL after switching from other basal insulins in real-world patients with type 1 and type 2 diabetes
2021, Journal of Diabetes Investigation
Insulin doses requirements in patients with type 1 diabetes using glargine U300 or degludec in routine clinical practice
2021, Journal of Investigative Medicine
Effects of insulin degludec and insulin glargine U300 on glycaemic stability in individuals with type 1 diabetes: A multicentre, randomized controlled crossover study
2020, Diabetes, Obesity and Metabolism
Understanding the Clinical Profile of Insulin Degludec, the Latest Basal Insulin Approved for Use in Canada: a Narrative Review
2020, Diabetes Therapy
Characteristics of Patients with Type-1 or Type-2 Diabetes Receiving Insulin Glargine U300: An Analysis of 7268 Patients Based on the DPV and DIVE Registries
2019, Advances in Therapy

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Changes in HbA1c and hypoglycemic episodes in type 1 diabetes patients after switching to insulin glargine U300: Pilot study

Abstract

Introduction

Section snippets

Methods

Results

Discussion

Disclosure

Authors’ contributions

A randomized clinical trial comparing breakfast, dinner, or bedtime administration of insulin glargine in patients with type 1 diabetes

Diabetes Care

The effects of transition from bedtime to morning glargine administration in patients with poorly regulated type 1 diabetes mellitus: croatian pilot study

Diabetes Ther