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Background and rationale
Study design and methods of InRange study
Baseline characteristics
Key Results
Abstract
Abstract Body
Background: 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.
Methods: 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.
Planned outcomes: 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.
Trial registration: NCT04075513<http://clinicaltrials.gov/show/NCT04075513
Reference: https://doi.org/10.1007/s13300-020-00781-6
Safety results
Conclusions and clinical implications
Q&A
Abstract - COMPARISON OF SECOND-GENERATION BASAL INSULIN ANALOGUES GLARGINE 300 U/ML AND DEGLUDEC 100 U/ML USING CONTINUOUS GLUCOSE MONITORING IN PEOPLE WITH T1D: INRANGE RANDOMISED CONTROLLED TRIAL
Abstract
Background and Aims
InRange (NCT04075513) is the first large randomised controlled trial to use continuous blood glucose monitoring (CGM) time-in-range (TIR) as a primary efficacy endpoint to compare second-generation basal insulin (BI) analogues, insulin glargine 300 U/mL (Gla-300) and insulin degludec 100 U/mL (IDeg-100) in adults with T1D.
Methods
Multicentre, randomised, active-controlled, parallel-group, 12-week open-label study comparing efficacy of Gla-300 and IDeg-100 using 20-day CGM profiles (≥10 days evaluable) at Week 12. Inclusion: adults with T1D treated with multiple daily injections, using BI analogues once daily and rapid-acting insulin analogues for ≥1 year; HbA1c ≥7 and ≤10% at screening; not requiring CGM for routine care during study.
Results
In total, 343 participants were randomised (172 Gla-300, 171 IDeg-100): mean (SD) age was 42.8 (13.3) years, BMI 27.3 (4.8) kg/m2, T1D duration 20.5 (12.8) years, 33.8% had ≥1 diabetic complication. Non-inferiority of Gla-300 versus IDeg-100 was demonstrated on percent TIR 70–180 mg/dL (primary endpoint, Table). Non-inferiority was demonstrated on glucose total coefficient of variation (CV, main secondary endpoint) with lower CV for Gla-300. Following demonstration of non-inferiority on TIR and glucose CV, superiority of Gla-300 over IDeg-100 on TIR 70–180 mg/dL was tested and not demonstrated. Rates of hypoglycaemia at <70 to ≥54 mg/dL and <54 mg/dL thresholds did not differ between groups. Safety profiles were consistent with known profiles of Gla-300/IDeg-100 and no unexpected safety findings were identified.
Conclusions
Using clinically relevant CGM metrics, the InRange study shows that Gla-300 is non-inferior to IDeg-100 in people with T1D, with similar hypoglycaemia and safety profiles.