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Benefits of insulin degludec/liraglutide are maintained even in patients discontinuing sulphonylureas or dipeptidyl peptidase-4 inhibitors upon initiation of degludec/liraglutide therapy: A post hoc analysis of the DUAL II and DUAL IX trials.

ABSTRACT: AIM:To investigate the efficacy and safety of initiating insulin degludec/liraglutide (IDegLira) in patients with type 2 diabetes (T2D) who had discontinued pretrial sulphonylureas (SUs) or dipeptidyl peptidase-4 inhibitors (DPP4is) versus patients not previously treated with these regimens. MATERIALS AND METHODS:In DUAL II, patients with T2D uncontrolled on basal insulin and metformin ± SU/glinides were randomized to insulin degludec or IDegLira (both capped at 50?U). In DUAL IX, patients were randomized to insulin glargine U100 (no maximum dose) or IDegLira, as add-on to sodium-glucose co-transporter-2 inhibitors ± oral antidiabetic drugs. In this post hoc analysis, patients were grouped according to pretrial use of SU (DUAL II) or DPP4i (DUAL IX). RESULTS:Regardless of pretrial SU/DPP4i use, IDegLira was favourable versus insulin comparators with respect to change in HbA1c and body weight. Lower hypoglycaemia rates and comparable end-of-trial daily insulin dose were achieved with IDegLira, regardless of pretrial regimen. There was no clinically relevant increase in mean self-measured blood glucose in the early weeks after IDegLira initiation. There was no statistically significant interaction between the randomized treatments and previous SU/DPP4i use. CONCLUSIONS:IDegLira was more favourable compared with degludec or glargine U100 in terms of change in HbA1c and body weight, regardless of antecedent treatment. Clinicians should be aware of a potential transient rise in self-measured blood glucose when transitioning therapy in patients. This shows that SUs/DPP4is can be safely discontinued, without deterioration in glycaemic control when initiating IDegLira, allowing a simplified treatment regimen.

SUBMITTER: Janez A

PROVIDER: S-EPMC7079143 | biostudies-literature | 2020 Apr

REPOSITORIES: biostudies-literature

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Benefits of insulin degludec/liraglutide are maintained even in patients discontinuing sulphonylureas or dipeptidyl peptidase-4 inhibitors upon initiation of degludec/liraglutide therapy: A post hoc analysis of the DUAL II and DUAL IX trials.

Janez Andrej A Őrsy Petra P Stachlewska Karolina K Salvesen-Sykes Karen K Billings Liana K LK Philis-Tsimikas Athena A

Diabetes, obesity & metabolism 20200127 4

<h4>Aim</h4>To investigate the efficacy and safety of initiating insulin degludec/liraglutide (IDegLira) in patients with type 2 diabetes (T2D) who had discontinued pretrial sulphonylureas (SUs) or dipeptidyl peptidase-4 inhibitors (DPP4is) versus patients not previously treated with these regimens.<h4>Materials and methods</h4>In DUAL II, patients with T2D uncontrolled on basal insulin and metformin ± SU/glinides were randomized to insulin degludec or IDegLira (both capped at 50 U). In DUAL IX, ...[more]

PMID: 31858673

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Project description:ObjectiveTo quantify the risk of hypoglycaemia associated with the concomitant use of dipeptidyl peptidase-4 (DPP-4) inhibitors and sulphonylureas compared with placebo and sulphonylureas.DesignSystematic review and meta-analysis.Data sourcesMedline, ISI Web of Science, SCOPUS, Cochrane Central Register of Controlled Trials, and clinicaltrial.gov were searched without any language restriction.Study selectionPlacebo controlled randomised trials comprising at least 50 participants with type 2 diabetes treated with DPP-4 inhibitors and sulphonylureas.Review methodsRisk of bias in each trial was assessed using the Cochrane Collaboration tool. The risk ratio of hypoglycaemia with 95% confidence intervals was computed for each study and then pooled using fixed effect models (Mantel Haenszel method) or random effect models, when appropriate. Subgroup analyses were also performed (eg, dose of DPP-4 inhibitors). The number needed to harm (NNH) was estimated according to treatment duration.Results10 studies were included, representing a total of 6546 participants (4020 received DPP-4 inhibitors plus sulphonylureas, 2526 placebo plus sulphonylureas). The risk ratio of hypoglycaemia was 1.52 (95% confidence interval 1.29 to 1.80). The NNH was 17 (95% confidence interval 11 to 30) for a treatment duration of six months or less, 15 (9 to 26) for 6.1 to 12 months, and 8 (5 to 15) for more than one year. In subgroup analysis, no difference was found between full and low doses of DPP-4 inhibitors: the risk ratio related to full dose DPP-4 inhibitors was 1.66 (1.34 to 2.06), whereas the increased risk ratio related to low dose DPP-4 inhibitors did not reach statistical significance (1.33, 0.92 to 1.94).ConclusionsAddition of DPP-4 inhibitors to sulphonylurea to treat people with type 2 diabetes is associated with a 50% increased risk of hypoglycaemia and to one excess case of hypoglycaemia for every 17 patients in the first six months of treatment. This highlights the need to respect recommendations for a decrease in sulphonylureas dose when initiating DPP-4 inhibitors and to assess the effectiveness of this risk minimisation strategy.

Dataset Information

Benefits of insulin degludec/liraglutide are maintained even in patients discontinuing sulphonylureas or dipeptidyl peptidase-4 inhibitors upon initiation of degludec/liraglutide therapy: A post hoc analysis of the DUAL II and DUAL IX trials.

Publications

Benefits of insulin degludec/liraglutide are maintained even in patients discontinuing sulphonylureas or dipeptidyl peptidase-4 inhibitors upon initiation of degludec/liraglutide therapy: A post hoc analysis of the DUAL II and DUAL IX trials.

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