InRange: Comparison of the Second-Generation Basal Insulin Analogues Glargine 300 U/mL and Degludec 100 U/mL in Persons with Type 1 Diabetes Using Continuous Glucose Monitoring—Study Design

Diabetes Therapy - Tập 11 - Trang 1017-1027 - 2020
Tadej Battelino1, Zsolt Bosnyak2, Thomas Danne3, Bhaswati Mukherjee2, Steve Edelman4, Valerie Pilorget2, Pratik Choudhary5,6, Eric Renard7,8,9, Richard Bergenstal10
1UMC–University Children’s Hospital, Faculty of Medicine, University of Ljubljana, Ljubljana, Slovenia
2Sanofi S.A., Paris, France
3Diabetes Centre for Children and Adolescents, Children’s and Youth Hospital “Auf Der Bult”, Hannover, Germany
4University of California, San Diego, USA
5King’s College Hospital NHS Foundation Trust, London, UK
6Department of Diabetes, School of Life Course Sciences, King’s College London, London, UK
7Department of Endocrinology, Diabetes and Nutrition, Montpellier University Hospital, University of Montpellier, Montpellier, France
8Institute of Functional Genomics, University of Montpellier, Montpellier, France
9INSERM Clinical Investigation Centre, Montpellier, France
10International Diabetes Center at Park Nicollet, Minneapolis, USA

Tóm tắt

Suboptimal 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. InRange 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. The 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. NCT04075513.

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