Dataset Information

Comparison of insulin glargine 300 U/mL and insulin degludec using flash glucose monitoring: A randomized cross-over study.

ABSTRACT:

Aims/introduction

We compared the efficacy and safety of insulin glargine 300 U/mL (Gla300) and insulin degludec U100 (Deg) using a flash glucose monitoring system.

Materials and methods

A total of 24 Japanese patients with type 2 diabetes were randomized to receive once-daily Gla300 (n = 12) or Deg (n = 12) in the morning. The primary end-points were the mean percentage of time in the target glucose range (70-179 mg/dL) and hypoglycemia (<70 mg/dL), as measured using flash glucose monitoring during the last 7 days of each 14-day period.

Results

The percentages of time with glucose levels <70 mg/dL were not significantly different between the two insulin treatments. No significant differences were observed in the percentages of time with glucose levels of 70-179 mg/dL or ?180 mg/dL. The percentage of time with nocturnal hypoglycemia with Gla300 was significantly lower than that with Deg treatment (P = 0.021). This difference might be attributable to the difference in the duration of action between the two formulations, and the incidence of nocturnal hypoglycemia with Deg treatment was associated with the concomitant use of metformin (P = 0.035).

Conclusions

The two formulations were comparable in efficacy, whereas the incidence of nocturnal hypoglycemia was significantly lower with Gla300. Thus, the present study suggests that, although Gla300 and Deg are comparable long-acting insulin analogs, Gla300 is safer with respect to the incidence of hypoglycemia.

SUBMITTER: Yamabe M

PROVIDER: S-EPMC6400163 | biostudies-literature | 2019 Mar

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Comparison of insulin glargine 300 U/mL and insulin degludec using flash glucose monitoring: A randomized cross-over study.

Yamabe Mizuho M Kuroda Mami M Hirosawa Yasuyo Y Kamino Hiromi H Ohno Haruya H Yoneda Masayasu M

Journal of diabetes investigation 20180806 2

<h4>Aims/introduction</h4>We compared the efficacy and safety of insulin glargine 300 U/mL (Gla300) and insulin degludec U100 (Deg) using a flash glucose monitoring system.<h4>Materials and methods</h4>A total of 24 Japanese patients with type 2 diabetes were randomized to receive once-daily Gla300 (n = 12) or Deg (n = 12) in the morning. The primary end-points were the mean percentage of time in the target glucose range (70-179 mg/dL) and hypoglycemia (<70 mg/dL), as measured using flash glucos ...[more]

PMID: 29989335

Similar Datasets

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

Comparison of insulin glargine 300 U/mL and insulin degludec using flash glucose monitoring: A randomized cross-over study.

Aims/introduction

Materials and methods

Results

Conclusions

Publications

Comparison of insulin glargine 300 U/mL and insulin degludec using flash glucose monitoring: A randomized cross-over study.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets