Dataset Information

Glycaemic Control in People with Type 2 Diabetes Treated with Insulin Degludec: A Real-World, Prospective Non-interventional Study-UPDATES Saudi Arabia.

ABSTRACT:

Introduction

Insulin degludec (degludec) has proven benefits in type 2 diabetes (T2D), in terms of improved glycaemic control, low risk of hypoglycaemia, and flexibility in dosing time. This prospective non-interventional UPDATES study aimed to investigate whether results obtained from randomised clinical trials and other real-world studies with degludec are generalisable to patients with T2D in routine clinical practice in Saudi Arabia.

Methods

Eligible adults (n = 561) with T2D received degludec for 26-34 weeks, at physicians' discretion and in accordance with local routine clinical practice. The primary endpoint was mean change in HbA_1c from baseline to end of study (EOS). Secondary endpoints included mean change from baseline to EOS in fasting plasma glucose (FPG), daily insulin dose and rate of hypoglycaemia.

Results

At baseline, mean age, HbA_1c and FPG were 55.7 years, 9.4% and 185.6 mg/dL, respectively. Mean (standard error [SE]) changes from baseline to EOS (crude analysis) were statistically significant for HbA_1c (- 1.1 [0.08] %-points, 95% CI - 1.29, - 0.98; P < 0.0001), FPG (- 39.1 [3.42] mg/dL, 95% CI - 45.9, - 32.4; P < 0.0001) and total daily insulin dose (+ 4.7 [1.6] units, 95% CI 1.63, 7.86; P = 0.003, insulin-experienced population). In exploratory analysis of patients switching from insulin glargine U100 or U300 to degludec, similar reductions were seen in HbA_1c and FPG. The rate of hypoglycaemia was significantly reduced with degludec versus previous treatment, with no apparent or unexpected safety and tolerability issues. The number of insulin-experienced patients utilising resources associated with severe hypoglycaemia was also reduced. Most patients (95.5%) were willing to continue treatment at EOS, and expressed a preference for degludec over their previous regimen (93.0%).

Conclusion

Patients with T2D treated with degludec in routine clinical practice in Saudi Arabia experienced clinically significant improvements in glycaemic control and a lower rate of hypoglycaemia compared with baseline, with no new safety concerns reported.

Clinical trial registration

NCT03785522.

SUBMITTER: AlMalki MH

PROVIDER: S-EPMC9685061 | biostudies-literature | 2023 Feb

REPOSITORIES: biostudies-literature

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Publications

Glycaemic Control in People with Type 2 Diabetes Treated with Insulin Degludec: A Real-World, Prospective Non-interventional Study-UPDATES Saudi Arabia.

AlMalki Mussa H MH Aldesokey Hossam H Alkhafaji Dania D Alsheikh Abdulrahman A Braae Uffe Christian UC Lehrskov Lars Lang LL Magawry Waleed W Yahia Moataz M Haroun Ahmed A

Advances in therapy 20221122 2

<h4>Introduction</h4>Insulin degludec (degludec) has proven benefits in type 2 diabetes (T2D), in terms of improved glycaemic control, low risk of hypoglycaemia, and flexibility in dosing time. This prospective non-interventional UPDATES study aimed to investigate whether results obtained from randomised clinical trials and other real-world studies with degludec are generalisable to patients with T2D in routine clinical practice in Saudi Arabia.<h4>Methods</h4>Eligible adults (n = 561) with T2D ...[more]

PMID: 36417058

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Project description:IntroductionIn this literature review we evaluated the real-world clinical effectiveness of switching Japanese diabetic patients from their current insulin regimen to insulin degludec (IDeg).MethodsStudies were identified from Japanese Diabetes Society (JDS) abstracts (2014-2015) and PubMed (2012 onwards). Inclusion criteria were: Japanese population, >15 participants, and studies switching patients from basal or basal-bolus insulin regimens to IDeg. Randomized controlled trials and case reports were excluded. Weighted mean changes in safety and effectiveness endpoints were calculated using the number of patients in each study.ResultsIn total, 81 JDS abstracts and seven manuscripts met the search criteria, representing 4238 patients [1028 with type 1 diabetes (T1D), 602 with type 2 diabetes (T2D), 2608 with unspecified or mixed diabetes]. Glycated hemoglobin (HbA1c) was reported in 93% of studies, with an improvement in 84% of these (51% significant, 33% numerical), no change in 12%, and worsening in 4% (3% numerical, 1% significant). Across all studies, the weighted mean absolute change in HbA1c was -0.3% (-2.7 mmol/mol). Basal insulin dose was reported in 58% of studies and was lower in 60% of these (30% significant, 30% numerical), numerically unchanged in 26%, and higher in 14% (2% significant, 12% numerical). The weighted mean change in basal insulin dose was -4.8% and -3.0% for all studies and for studies with only significant results, respectively. The weighted mean change in basal dose based on all studies was -8.9, -5.5, and -2.9% for the T1D, T2D, and unspecified patient populations, respectively. Hypoglycemia was recorded in 31% of the studies. After switching treatment to IDeg, 55% of studies reported decreased hypoglycemia, 29% no change, and 16% an increase. Quality of life (QoL) was measured in 11% of studies, of which 82% reported improved QoL after switching, and 18% reported no change in QoL.ConclusionSwitching from a conventional basal insulin to IDeg has the potential to improve HbA1c with a lower insulin dose. Switching to IDeg may also provide a reduced risk of hypoglycemia and improvement in QoL.FundingNovo Nordisk.

Dataset Information

Glycaemic Control in People with Type 2 Diabetes Treated with Insulin Degludec: A Real-World, Prospective Non-interventional Study-UPDATES Saudi Arabia.

Introduction

Methods

Results

Conclusion

Clinical trial registration

Publications

Glycaemic Control in People with Type 2 Diabetes Treated with Insulin Degludec: A Real-World, Prospective Non-interventional Study-UPDATES Saudi Arabia.

Similar Datasets

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