Dataset Information

Real-World Evaluation of Glycemic Outcomes and Extra-Glycemic Parameters in Diabetic Patients Treated with the Combined Formulation Degludec-Liraglutide (Ideglira).

ABSTRACT:

Introduction

Combination therapy with both basal insulin (BI) and glucagon-like peptide-1 receptor agonists (GLP-1RAs) is an effective treatment in patients with uncontrolled type 2 diabetes mellitus (T2DM). The recent development and release of a fixed-ratio combination of slow-release insulin degludec and the GLP-1RA liraglutide (IDegLira) represents an improvement to this therapy. We have conducted a real-world evidence study in Italian patients with T2DM to evaluate whether the encouraging clinical trial results obtained with IDegLira, which became available in Italy in January 2018, can be confirmed in Italian clinical practice.

Methods

This was a multicenter, retrospective, observational study in patients with T2DM treated with IDegLira from January to December 2018. Prior to the initiation of IDegLira therapy, patients were treated with BI with or without one or more concomitant oral antidiabetic drugs (BOT group) or according to the basal bolus protocol (BI and rapid-acting insulin treatment; BB group).

Results

A total of 244 patients were included in the present study, of whom 186 were in the BOT group and 58 in the BB group. Following the switch to IDegLira therapy, glycemic control improved in both groups, with significant reductions in glycated hemoglobin after 6 and 12 months of treatment in the BOT group and after 6 months of treatment in the BB group. No gain in body weight and body mass index and reductions in fasting plasma glucose and number of concomitant diabetic medications (in BOT patients) were observed. All results obtained during the study were achieved at a moderate dose of IDegLira.

Conclusion

The findings from this study show that in a real-world setting, the switch to IDegLira treatment is a valid option for patients who are failing to achieve glycemic control targets and/or struggling with the side effects, such as weight gain and hypoglycemia, of other insulin therapies.

SUBMITTER: Zenari L

PROVIDER: S-EPMC7843811 | biostudies-literature | 2021 Jan

REPOSITORIES: biostudies-literature

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Publications

Real-World Evaluation of Glycemic Outcomes and Extra-Glycemic Parameters in Diabetic Patients Treated with the Combined Formulation Degludec-Liraglutide (Ideglira).

Zenari Luciano L Da Porto Andrea A De Moliner Lorena L Lugli Francesca F Guazzoni Valeria V Groppelli Gloria G Molteni Laura L Bracaccia Massimo M Frison Vera V Simioni Natalino N Bonsembiante Barbara B Miranda Cesare C Lapolla Annunziata A

Diabetes therapy : research, treatment and education of diabetes and related disorders 20201026 1

<h4>Introduction</h4>Combination therapy with both basal insulin (BI) and glucagon-like peptide-1 receptor agonists (GLP-1RAs) is an effective treatment in patients with uncontrolled type 2 diabetes mellitus (T2DM). The recent development and release of a fixed-ratio combination of slow-release insulin degludec and the GLP-1RA liraglutide (IDegLira) represents an improvement to this therapy. We have conducted a real-world evidence study in Italian patients with T2DM to evaluate whether the encou ...[more]

PMID: 33104959

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Project description:AimsTo investigate the efficacy and safety of insulin degludec/liraglutide (IDegLira) compared with its individual components in Japanese people with type 2 diabetes (T2D) uncontrolled on an oral antidiabetic drug (OAD).Materials and methodsThis 52-week, open-label, multicentre, treat-to-target trial randomized participants (n = 819) 1:1:1 to IDegLira, liraglutide 1.8 mg or degludec, as add-on to their pre-trial OAD. The maximum IDegLira dose was 50 dose steps (50 U degludec/1.8 mg liraglutide), there was no maximum dose for degludec, and both were titrated based on individual blood glucose measurements.ResultsAfter 52 weeks, glycated haemoglobin (HbA1c) decreased by 26 mmol/mol with IDegLira vs 20 mmol/mol with degludec and liraglutide: estimated treatment differences were -6.91 mmol/mol (95% confidence interval [CI] -8.18; -5.64) and -5.30 mmol/mol (95% CI -6.58; -4.03), confirming non-inferiority of IDegLira to degludec and superiority of IDegLira to liraglutide (P < .0001 for both [primary endpoint]). Mean body weight changes were 2.9 kg, 4.1 kg and -1.0 kg with IDegLira, degludec and liraglutide, respectively, showing superiority of IDegLira versus degludec (P = .0001), but a significant difference in favour of liraglutide (P < .0001). Rates of severe or blood glucose-confirmed hypoglycaemia for IDegLira were lower versus degludec (rate ratio 0.48 [95% CI 0.35; 0.68]; P < .0001), but higher versus liraglutide (rate ratio 37.58 [95% CI 19.80; 71.31]; P < .0001). Mean daily total insulin dose was lower with IDegLira (27.7 U) versus degludec (34.8 U; P < .0001). Overall adverse event (AE) rates were similar. In total, 34.9%, 22.9% and 41.8% of IDegLira-, degludec- and liraglutide-treated participants experienced gastrointestinal AEs.ConclusionIDegLira was superior to degludec and liraglutide in terms of HbA1c reduction and superior to degludec in terms of body weight change and rates of hypoglycaemia in Japanese people with T2D.

Dataset Information

Real-World Evaluation of Glycemic Outcomes and Extra-Glycemic Parameters in Diabetic Patients Treated with the Combined Formulation Degludec-Liraglutide (Ideglira).

Introduction

Methods

Results

Conclusion

Publications

Real-World Evaluation of Glycemic Outcomes and Extra-Glycemic Parameters in Diabetic Patients Treated with the Combined Formulation Degludec-Liraglutide (Ideglira).

Similar Datasets

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