Clinical Outcome Assessment of the Effectiveness of Insulin Degludec (Degludec) in Real-life Medical Practice (CONFIRM)—A Comparative Effectiveness Study of Degludec and Insulin Glargine 300U/mL (Glargine U300) in Insulin-Naïve Patients with Type 2 Diabetes (T2D)

Tibaldi, Joseph M.; Haldrup, Steffen; Sandberg, Viktor; Wolden, Michael Lyng; Rodbard, Helena W.

doi:10.2337/db18-98-lb

Cited by 7 publications

(13 citation statements)

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“…Finally, it is worth noting that the CONFIRM population appears to have a pattern of baseline medication that is inconsistent with what might be expected for an insulin‐naïve cohort. Initial insulin doses, among those patients with data available, appear to be much higher than would be expected (given their body weight), at around 40 units/d . This contrasts with the ~20 units/d in the present study, and the doses in the BRIGHT trial, which followed the products' licenses (Gla‐300: 0.2 units/kg 2 IDeg: 10 units 3 ).…”

Section: Discussioncontrasting

confidence: 82%

Comparable glycaemic control and hypoglycaemia in adults with type 2 diabetes after initiating insulin glargine 300 units/mL or insulin degludec: The DELIVER Naïve D real‐world study

Sullivan

Nicholls

Gupta

et al. 2019

Diabetes Obesity Metabolism

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Aim To compare glycaemic control, hypoglycaemia and treatment discontinuation of insulin glargine 300 units/mL (Gla‐300) and insulin degludec (IDeg) in a real‐world study of insulin‐naïve adults with type 2 diabetes (T2D). Materials and methods DELIVER Naive D was a retrospective observational study that used electronic medical record data from the IBM Watson Health Explorys database. Insulin‐naïve adults with T2D who started Gla‐300 or IDeg between March 2015 and September 2017 were identified. Patients were active in the system for ≥12 months before and ≥6 months after starting Gla‐300 or IDeg and had HbA1c measurements during 6‐month baseline and 3‐ to 6‐month follow‐up. Outcomes were compared among 1:1 propensity score‐matched cohorts. Results In the matched cohorts (n = 638 each), the mean age was 59 years, approximately 53% were male, and mean HbA1c was 9.67% (82 mmol/mol). Mean (SD) HbA1c decreases were comparable in the Gla‐300 and IDeg cohorts (−1.67% [2.22] and −1.58% [2.20]; P = 0.51), as were HbA1c target attainment [<7% (53 mmol/mol): 23.8% and 27.4%; P = 0.20; <8% (64 mmol/mol): 55.0% and 57.1%; P = 0.63] and treatment discontinuation (29.2% and 32.6%; P = 0.14). Overall and inpatient/emergency department‐associated hypoglycaemia incidences and event rates were similar in both cohorts using fixed 6‐month or variable on‐treatment follow‐up. Conclusions Among real‐world insulin‐naïve adults with T2D, initiation of Gla‐300 or IDeg resulted in comparable improvements in glycaemic control and similar rates of hypoglycaemia. These real‐world data complement and confirm a randomized trial and other real‐world studies.

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Section: Discussioncontrasting

confidence: 82%

Comparable glycaemic control and hypoglycaemia in adults with type 2 diabetes after initiating insulin glargine 300 units/mL or insulin degludec: The DELIVER Naïve D real‐world study

Sullivan

Nicholls

Gupta

et al. 2019

Diabetes Obesity Metabolism

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“…database. 36 The analysis found significantly greater HbA 1c reductions, Hence, the populations used for analysis were not necessarily well matched. In addition, the greater reduction of hypoglycaemia risk with IDeg compared with Gla-300 seen in CONFIRM could be explained by the higher rates of hypoglycaemia observed at baseline in the IDeg group, while rates of hypoglycaemia at follow-up were similar.…”

Section: Confirmmentioning

confidence: 93%

Insulin glargine 300 U/mL and insulin degludec: A review of the current evidence comparing these two second‐generation basal insulin analogues

Cheng

Bailey

Mauricio

et al. 2020

Diabetes Metabolism Res

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For most people with type 2 diabetes (T2D), treatment intensification with the addition of basal insulin therapy is required to maintain glycaemic control. However, this often does not happen in real-life practice promoting the development of long-term diabetes-related complications. The second-generation basal insulin analogues glargine 300 U/mL (Gla-300) and degludec (IDeg) provide pharmacokinetic and pharmacodynamic improvements that may allow them to be more effective in appropriately managing diabetes compared with first-generation basal insulin analogues. Both Gla-300 and IDeg have been extensively studied vs the first-generation basal insulin glargine 100 U/mL, demonstrating comparable efficacy in terms of glycaemic control, and a lower risk of hypoglycaemia. The BRIGHT randomized controlled trial is the first direct comparison of the efficacy and safety profiles of Gla-300 and IDeg in patients with T2D. Moreover, real-world data have been used to assess the effectiveness of these basal insulins during routine clinical practice. Further research is required to determine if the properties of Gla-300 and IDeg may lead to improvements in healthcare-related costs and the quality of life of patients, which are important factors for informing clinical decisions.

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“…The effectiveness and safety of Gla‐100 or IDeg have been investigated in observational retrospective studies of such databases, such as the DELIVER and ReFLECT studies . Additionally, the LIGHTNING and CONFIRM trials compared rates of hypoglycaemia between Gla‐300 and IDeg reported in real‐world data from electronic healthcare records …”

Section: Hypoglycaemia Assessment In Rwe Studiesmentioning

confidence: 99%

“…86 Additionally, the LIGHTNING and CONFIRM trials compared rates of hypoglycaemia between Gla-300 and IDeg reported in real-world data from electronic healthcare records. 87,88 Given the less stringent protocols that are often associated with RWE studies, the diversity in hypoglycaemia reporting in these studies is likely to be even greater than that in RCTs. Hypoglycaemia docu- Furthermore, given that many observational studies are less resourceintensive, the capacity for long periods of follow-up is much greater than that for many RCTs.…”

Section: Rcts Versus Real-life Clinical Practicementioning

confidence: 99%

Reporting of hypoglycaemia in clinical trials of basal insulins: A need for consensus

Frier

Ratzki‐Leewing

Harris

2019

Diabetes Obesity Metabolism

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Hypoglycaemia is a common side‐effect of diabetes therapies, particularly insulin, and imposes a substantial burden on individuals and healthcare systems. Consequently, regulatory approval of newer basal insulin (BI) therapies has relied on demonstration of a balance between achievement of good glycaemic control and less hypoglycaemia. Randomized controlled trials (RCTs) are the gold standard for assessing efficacy and safety, including hypoglycaemia risk, of BIs and are invaluable for obtaining regulatory approval. However, their highly selected patient populations and their conditions lead to results that may not be representative of real‐life situations. Real‐world evidence (RWE) studies are more representative of clinical practice, but they also have limitations. As such, data both from RCTs and RWE studies provide a fuller picture of the hypoglycaemia risk with BI therapies. However, substantial differences exist in the way hypoglycaemia is reported across these studies, which confounds comparisons of hypoglycaemia frequency among different BIs. This problem is ongoing and persists in recent trials of second‐generation BI analogues. Although they provide a lower risk of hypoglycaemia when compared with earlier BIs, they do not eliminate it. This review describes differences in the way hypoglycaemia is reported across RCTs and RWE studies of second‐generation BI analogues and examines potential reasons for these differences. For studies of BIs, there is a need to standardize aspects of design, analysis and methods of reporting to better enable interpretation of the efficacy and safety of such insulins among studies; such aspects include length of follow‐up, glycaemic targets, hypoglycaemia definitions and time intervals for determining nocturnal events.

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Clinical Outcome Assessment of the Effectiveness of Insulin Degludec (Degludec) in Real-life Medical Practice (CONFIRM)—A Comparative Effectiveness Study of Degludec and Insulin Glargine 300U/mL (Glargine U300) in Insulin-Naïve Patients with Type 2 Diabetes (T2D)

Cited by 7 publications

References 0 publications

Comparable glycaemic control and hypoglycaemia in adults with type 2 diabetes after initiating insulin glargine 300 units/mL or insulin degludec: The DELIVER Naïve D real‐world study

Comparable glycaemic control and hypoglycaemia in adults with type 2 diabetes after initiating insulin glargine 300 units/mL or insulin degludec: The DELIVER Naïve D real‐world study

Insulin glargine 300 U/mL and insulin degludec: A review of the current evidence comparing these two second‐generation basal insulin analogues

Reporting of hypoglycaemia in clinical trials of basal insulins: A need for consensus

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