Aims To 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 methods This 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. Results After 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. Conclusion IDegLira 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.

AimsTo investigate the efficacy and safety of insulin degludec/liraglutide (IDegLira) compared with 50 U insulin degludec (degludec) or less in Japanese individuals with type 2 diabetes (T2D).Materials and methodsIn this 26‐week, double‐blind, multicentre, treat‐to‐target trial, Japanese individuals with T2D that was uncontrolled with basal or pre‐mix insulin (20–50 units) were randomized (1:1) to receive IDegLira or degludec, both with metformin. The maximum dose was 50 dose steps (IDegLira) or 50 units (degludec). The primary endpoint was change from baseline in HbA1c with IDegLira vs degludec after 26 weeks of treatment.ResultsIn total, 210 Japanese individuals were randomized to IDegLira or degludec and completion rates were 100% and 93%, respectively. IDegLira was superior to degludec with respect to change from baseline in HbA1c: estimated treatment difference (ETD) (95% confidence interval), −13.98 mmol/Mol (−16.41; −11.55); P < 0.0001. The change in mean HbA1c was from 70.6 by −21.3 mmol/Mol with IDegLira and from 70.1 by −7.1 mmol/Mol with degludec. Mean change in body weight was −0.7 kg with IDegLira and 0.7 kg with degludec: ETD (95% CI) −1.41 kg (−2.26; −0.56); P = 0.0012. Mean daily total insulin dose was significantly lower with IDegLira (37.6 U) as compared to that with degludec (41.2 U) at Week 26. Overall rates of severe or blood glucose‐confirmed hypoglycaemia and adverse events were comparable between treatment groups.ConclusionsIDegLira provided superior reductions in HbA1c compared with ≤50 U degludec, with weight loss and similar hypoglycaemia rates and no unexpected safety or tolerability issues. These results suggest that this treatment could be an attractive intensification option for Japanese subjects with T2D that was uncontrolled with basal or pre‐mixed insulin.

Aim To assess the efficacy and safety of insulin degludec/liraglutide (IDegLira) versus insulin degludec (degludec) in Chinese people with type 2 diabetes (T2D) treated with basal insulin. Materials and Methods In DUAL II China, a randomized, double‐blinded, multicentre, treat‐to‐target trial, Chinese adults with T2D and HbA1c of 7.5% or more on basal insulin and metformin, with or without other oral antidiabetic drugs (OADs), were randomized 2:1 to 26 weeks of treatment with either IDegLira (max. dose 50 U degludec/1.8 mg liraglutide) or degludec (max. 50 U/day), respectively, combined with metformin. At 26 weeks, superiority of IDegLira over degludec was assessed for change in HbA1c (primary endpoint), and body weight and number of severe or blood glucose (BG)‐confirmed hypoglycaemic episodes (confirmatory secondary endpoints). Results Overall, 453 participants were randomized to IDegLira (n = 302) or degludec (n = 151). Superiority was confirmed for IDegLira over degludec in HbA1c change (−1.9% vs. −1.0%, respectively, estimated treatment difference [ETD] [95% confidence interval]: −0.92% [−1.09; −0.75], P < .0001), body weight change (−0.7 vs. +0.4 kg, respectively, ETD [95% CI]: −1.08 kg [−1.63; −0.52], P = .0002) and severe or BG‐confirmed hypoglycaemia (estimated rate ratio [95% CI]: 0.53 [0.30; 0.94], P = .0297). The odds of achieving HbA1c less than 7.0% without hypoglycaemia and/or weight gain were greater with IDegLira than degludec (P < .0001 for all). Daily insulin dose at 26 weeks was lower for IDegLira (34.3 U) than degludec (37.4 U) (P = .0014). No unexpected safety signals were observed. Conclusions IDegLira may be an efficacious and well‐tolerated treatment intensification option for Chinese people with T2D uncontrolled on basal insulin and OADs.

Background In patients with paroxysmal atrial fibrillation (PAF) or persistent atrial fibrillation (PeAF) symptom burden and fear of hospital readmission are major causes of reduced quality of life. We attempted to develop a prediction model for future atrial fibrillation hospitalization (AFH) risk in PAF and PeAF patients including all previously experienced AFHs in the analysis, as opposed to time to first event. Methods Recurrent event survival analysis was used to model the impact of past AFHs on the risk of future AFHs. A recurrent event was defined as a hospitalization due to a new episode of AF. Death or progression to permanent AF were included as competing risks. Results We enrolled 174 patients with PAF or PeAF, mean follow up duration was 1279 days, and 325 AFHs were observed. Median patient age was 63.0 (IQR 52.2–68.0), 29% had PAF, and 71% were male. Highly significant predictors of future AFH risk were PeAF (HR 3.20, CI 2.01–5.11) and number of past AFHs observed (HR for 1 event: 2.97, CI 2.04–4.32, HR for ≥2 events: 7.54, CI 5.47–10.40). Conclusion In PAF and PeAF patients, AF type and observed AFH frequency are highly significant predictors of future AFH risk. The developed model enables risk prediction in individual patients based on AFH history and baseline characteristics, utilizing all events experienced by the patient. This is the first time recurrent event survival analysis has been used in AF patients.

Background: Atrial fibrillation (AF) is associated with enlargement of the left atrium (LA). The LA volume can be assessed by cardiac magnetic resonance (CMR). The standard CMR method for measuring the LA volume is the shortaxis (SA) method, which is time consuming, hence little useful in the clinical setting. For this reason more simplified methods have been developed to assess the LA volume. Objective: To compare the standard SA method and the simplified single plane area-length (AL) method for measurements of the LA volume in patients with permanent AF. Methods and Results: CMR was performed in 34 patients with permanent AF. CMR was conducted with the steady-state free precession (SSFP) technique TrueFISP. LA volumes were measured using the single plane AL method and the SA method. A good and statistically significant correlation was found between the two methods. The Pearson's correlation coefficients for LA maximal volume (LAmax) and LA minimal volume (LAmin) were 0.92, p<0.0001 and 0.91, p<0.0001, respectively. The single plane AL method underestimated LA volumes compared to the SA method (LAmax: 143 ± 35 ml vs. 149 ml ± 38, p=0.046, LAmin: 124 ml ± 30 vs. 130 ml ± 34, p=0.014). Intra-and interobserver agreement was inferior for the single plane AL method. Conclusion: Measurements of LA volumes by the SA method and the single plane AL methods correlate closely in patients with permanent AF. However, the single plane AL method underestimates the LA volume and the reproducibility is inferior compared to the SA method.