Author, year of publication (study name)	Study design	Participant inclusion criteria	Interventions	Key baseline characteristics	Duration	Primary endpoint/s
Randomized Controlled Trials
Philis-Tsimikas et al. [48] (CONCLUDE)	Multicentre, multinational, open-label, parallel-group RCT (superiority testing of the primary endpoint); target FPG 4.0–5.0 mmol/L	≥18 years with T2DM; previous basal insulin use +/− OADs (stable dose for ≥90 days); HbA1c ≤9.5%; BMI ≤45 kg/m2	IDeg 200 U/mL (n = 805) vs Gla-300 (n = 804)	IDeg vs Gla-300 (mean): Age 63 vs 63 years BMI 31.7 vs 31.5 kg/m2 HbA1c 7.6 vs 7.6 % Duration of diabetes 15.1 vs 15.0 years Basal insulin dose 42.7 vs 42.2 U/day	Up to 94 weeks*	Rate of overall symptomatic hypoglycemic events (defined as severe or confirmed blood glucose < 3.1 mmol/L [with symptoms]) during the maintenance period of 36 weeks: No significant difference was found with IDeg (216.8 events per 100 PY) compared with Gla-300 (243.9 events per 100 PY) during the maintenance period (RR 0.88 [95% CI 0.73, 1.06]). Because there was no significant difference between treatments for the primary endpoint, the confirmatory testing procedure for superiority was stopped
Kawaguchi et al. [47]	Single-centre, open-label, parallel-group, two-period, randomized cross-over study; target FPG 5.6–7.2 mmol/L	≥20 years; T2DM ≥1 year; OADs +/− insulin ≥6 months; HbA1c 6.5-11.0%	Gla-300 vs IDeg 100 U/mL (total population n = 30)	Total study population (mean): Age 70 years BMI 24.6 kg/m2 HbA1c 8.2% Duration of diabetes 18.3 years	2 x 5 day CGM periods (excluding titration periods)	Mean percentage of time within the target glucose range of 3.9–10 mmol/L (70–180 mg/dL) and hypoglycemia of < 3.9 mmol/L (< 70 mg/dL) measured by CGM: Similar time within target range between Gla-300 (77.8%) vs IDeg (76.9%) (P= 0.85). Gla-300 had lees time in hypoglycaemia vs IDeg (1.3% vs 5.5%, respectively P=0.002)
Yamabe et al. [50]	Single-centre, open-label, parallel-group, two-period, randomized cross-over study; Target FPG 5.6–8.3 mmol/L	T2DM; previously treated on IDeg (morning dosing) with OADs ≥3 months	Gla-300 vs IDeg 100 U/mL (total population n = 24)	Total study population (mean): Age 71 years BMI 23.1 kg/m2 HbA1c 6.8 % Duration of diabetes 14 years Insulin dose 6 U/day	8 weeks with 2 x 14 day FGM periods	Mean percentage of time within a glucose range of 3.9–9.9 mmol/L (70–179 mg/dL) for the seven consecutive days of each treatment period: Time in range for Gla-300 was 73.4% (SD 14.9) and 77.3% (SD 11.8) for IDeg P=0.31
Rosenstock et al. [49] (BRIGHT)	Multicentre, multinational, open-label, parallel-group, non-inferiority RCT; target FPG 4.4–5.6 mmol/L	≥18 years; T2DM duration ≥1 year; OADs +/− GLP-1 RA (stable dose ≥3 months; insulin naïve; HbA1c 7.5–10.5%; BMI 25–40 kg/m2	Gla-300 (n = 462) vs IDeg 100 U/mL (n = 462)	Gla-300 vs IDeg (mean): Age 61 vs 61 years BMI 31.7 vs 31.3 kg/m2 HbA1c 8.7 vs 8.6 % Duration of diabetes 10.5 vs 10.7 years	24 weeks	HbA1c change from baseline to week 26s: LS mean change was −1.64% (SE 0.04) for Gla-300 and −1.59% (SE 0.04) with a LS mean difference of -0.05% (95% CI −0.15 to 0.05) P<0.0001 demonstrating non-inferiority of Gla-300 vs IDeg
Real World Evidence
Sullivan et al. [45] (DELIVER Naïve D)	Retrospective, observational, propensity score-matched cohort study using EMR data from the US	≥18 years; confirmed T2DM on OADs +/− GLP-1 RA commenced on Gla-300 or IDeg commenced on 1 March 2015 and 30 September 2017	Gla-300 (n = 638) vs IDeg (n = 638)	Gla-300 vs IDeg (mean): Age 59 vs 59 years BMI 33.5 vs 33.3 kg/m2 HbA1c 9.7 vs 9.6 % Hypoglycemia incidence in 12 months prior 8.6 vs 8.9 %	HbA1c during follow-up period (3–6 months from index date)	Change in HbA1c from 6 month baseline period to the latest value in 3–6 months follow-up period: HbA1c decreased significantly from baseline to follow-up in both groups; and these reductions were comparable in the Gla-300 and IDeg cohorts −1.67% (SD 2.22) vs. −1.58% (SD 2.20) respectively; P= 0.51
Sullivan et al. [51] (DELIVER D+)	Retrospective, observational, propensity score-matched cohort study using EMR data from the US in patients switching to Gla-300 or IDeg	≥18 years; confirmed T2DM who switched from Gla-100 or IDet to either Gla-300 or IDeg during 1 March 2015 to 31 January 2017; ≥12 month baseline period in EMR	Gla-300 (n = 1592) vs IDeg (n =1592)	Gla-300 vs IDeg (mean): Age 59 vs 59 years BMI 34.8 vs 34.7 kg/m2 HbA1c 9.1 vs 9.1 % Hypoglycaemia incidence in previous 6 months 15.6 vs 14.3 %	HbA1c during follow-up period (3-6 months from index date)	Change in HbA1c from 6 month baseline period to the latest value in 3–6 months follow-up period: HbA1c decreased significantly from baseline in both groups without any difference the groups (Gla-300 −0.63% [SD 1.7] vs IDeg −0.58% [SD 1.6], P=0.49)
Tibaldi et al. [52] (CONFIRM)	Retrospective, observational, propensity score-matched cohort study using EMR data from the US	≥18 years; confirmed T2DM on OADs +/− GLP-1 RA commenced on Gla-300 or IDeg commenced on March 2015 and January 2018 with 360 days of data prior to insulin initiation and ≥1 HbA1c measure at baseline	PSM cohort: IDeg (n = 2028) vs Gla-300 (n = 2028) Primary endpoint analysis: IDeg (n = 671) vs Gla-300 749)	IDeg vs Gla-300 (mean PSM cohort): Age 58 years BMI 34.0 vs 34.7 kg/m2 HbA1c 9.6 vs 9.5 % Duration of diabetes 4.8 vs 4.8 years Hypoglycemia incidence in 180 days prior 6.7 vs 5.6 %	Up to 180 days follow-up	Change in baseline HbA1c from initiation of basal insulin (−90 days to +7 days) until 180 days of follow-up: Change of −1.48% for IDeg and −1.22% for Gla-300 with estimated treatment difference of −0.27% (95% CI −0.51 to −0.03) P=0.03