Dataset Information

Efficacy and safety of insulin glargine 300 U/mL vs insulin degludec in patients with type 2 diabetes: A randomized, open-label, cross-over study using continuous glucose monitoring profiles.

ABSTRACT:

Aims/introduction

Compared with glargine 100 U/mL (Gla100), glargine 300 U/mL (Gla300) and degludec (Deg) - the ultralong-acting insulins - reportedly have more stable effects and reduce the risk of hypoglycemia. Currently, they are considered to be the most useful basal insulins. The present study aimed to compare the efficacy and safety of Gla300 and Deg on glycemic control using continuous glucose monitoring.

Materials and methods

In this single-center, open-label, parallel-group, two-period, cross-over study, 30 patients with type 2 diabetes were randomized to once-daily Gla300 followed by Deg with the same units (n = 15) or vice versa (n = 15). The primary end-points of this study were the mean percentage of time within the target glucose range of 70-180 mg/dL as efficacy and hypoglycemia of <70 mg/dL as safety indicators, as measured using continuous glucose monitoring during each treatment period.

Results

The mean percentage of time within the target glucose range was not different between Gla300 and Deg (77.8 ± 19.2 vs 76.9 ± 18.3%, P = 0.848). However, the mean percentage of time of hypoglycemia with Gla300 was significantly lower than that of Deg (1.3 ± 2.7 vs 5.5 ± 6.4%, P = 0.002). In the secondary safety end-points, the mean percentage of time of severe hypoglycemia (<54 mg/dL) or nocturnal hypoglycemia with Gla300 was also significantly lower than that of Deg.

Conclusions

The present study showed the comparable efficacy of Gla300 and Deg on glycemic control; however, the risk of hypoglycemia was markedly lower for Gla300 than for Deg.

SUBMITTER: Kawaguchi Y

PROVIDER: S-EPMC6400202 | biostudies-literature | 2019 Mar

REPOSITORIES: biostudies-literature

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Publications

Efficacy and safety of insulin glargine 300 U/mL vs insulin degludec in patients with type 2 diabetes: A randomized, open-label, cross-over study using continuous glucose monitoring profiles.

Kawaguchi Yuji Y Sawa Jun J Sakuma Noriko N Kumeda Yasuro Y

Journal of diabetes investigation 20180728 2

<h4>Aims/introduction</h4>Compared with glargine 100 U/mL (Gla100), glargine 300 U/mL (Gla300) and degludec (Deg) - the ultralong-acting insulins - reportedly have more stable effects and reduce the risk of hypoglycemia. Currently, they are considered to be the most useful basal insulins. The present study aimed to compare the efficacy and safety of Gla300 and Deg on glycemic control using continuous glucose monitoring.<h4>Materials and methods</h4>In this single-center, open-label, parallel-gro ...[more]

PMID: 29947060

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Project description:IntroductionSuboptimal glycaemic control among people with type 1 diabetes (T1D) is known to lead to long-term micro- and macrovascular complications and, unfortunately, it is still prevalent even in the most affluent societies. Although glycated haemoglobin monitoring is considered to be the gold standard for assessing glycaemic control, such monitoring is unable to reliably measure acute glycaemic excursions. Continuous glucose monitoring (CGM) has been shown to improve glucose control and reduce the incidence of hypoglycaemia, and also allow a more complete assessment of overall glycaemic control and hyper- and hypoglycaemic excursions. The use of CGM has led to time-in-range, which is the time that a patient is within the glycaemic range of 70 to 180 mg/dL, to be adopted as a treatment target. To date, only limited data comparing the second-generation insulins glargine 300 U/mL (Gla-300) and degludec 100 U/mL (IDeg-100) in people with T1D are available, and there is no CGM literature on comparisons of the use of CGM results to assess primary, secondary and tertiary endpoints. The aim of the InRange study was to address this unmet need.MethodsInRange is a multicentre, randomised, active-controlled, parallel-group, 12-week, open-label, phase 4, comparative study. Adults with T1D will be randomised to receive once-daily Gla-300 or IDeg-100 by subcutaneous injection in the morning. Following an 8-week titration period, CGM data will be collected over 20 consecutive days.Planned outcomesThe primary objective is to demonstrate that Gla-300 is noninferior to IDeg-100 in terms of glycaemic control [time-in-range ≥ 70 to ≤ 180 mg/dL (≥ 3.9 to ≤ 10 mmol/L)] and variability, as assessed using CGM, in adults with T1D. The results are expected to help confirm the utility of CGM in clinical practice in this population and provide insight into its application as an outcome measure in clinical practice.Trial registrationNCT04075513.

Dataset Information

Efficacy and safety of insulin glargine 300 U/mL vs insulin degludec in patients with type 2 diabetes: A randomized, open-label, cross-over study using continuous glucose monitoring profiles.

Aims/introduction

Materials and methods

Results

Conclusions

Publications

Efficacy and safety of insulin glargine 300 U/mL vs insulin degludec in patients with type 2 diabetes: A randomized, open-label, cross-over study using continuous glucose monitoring profiles.

Similar Datasets

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