Toujeo® improved blood sugar control vs insulin degludec in adults with type 2 diabetes and moderate-to-severe kidney impairment • Secondary analyses expand results from BRIGHT head-to-head clinical trial
September 18, 2019 Barcelona, Spain - Toujeo® improved blood sugar control vs insulin degludec in adults with type 2 diabetes and moderate-to-severe kidney impairment • Secondary analyses expand results from BRIGHT head-to-head clinical trial
An expanded picture of the similarities and differences between second generation longacting insulins was presented by further sub-analyses of BRIGHT,1 the first head-to-head randomized controlled trial comparing Toujeo (insulin glargine 300 Units/mL, Gla-300) vs insulin degludec 100 Units/mL (iDeg) in adults starting insulin for the first time to treat type 2 diabetes.
Data presented this week at the European Association for the Study of Diabetes 55th Annual Meeting2 showed in a pre-specified secondary analysis that patients with moderate-severe renal impairment (eGFR <60 mL/min/1.73m2) saw a 0.43% greater reduction in average blood sugar through the full study period with Toujeo vs iDeg (95% Cl: -0.74 to -0.12), with similar rates of low blood sugar risk. This analysis also showed that patients with normal kidney function (eGFR ≥90 mL/min/1.73m2) saw a similar level of blood sugar control with both treatments with a lower rates of low blood sugar. These results were seen over the full 24 weeks duration of the study (data presented below).
“In patients with moderate-severe renal impairment, whose diabetes is often complex to manage, Gla-300 appears to confer glycemic advantages versus IDeg, without compromising on hypoglycemia, warranting further investigation,” commented Martin Haluzik M.D., Deputy Director, Centre for Experimental Medicine, Institute for Clinical and Experimental Medicine, Prague, Czech Republic, and an investigator of the study. “These results are consistent with another exploratory analysis from BRIGHT, in which Gla-300 greater reduction in blood sugar and similar rates of hypoglycemia were seen when compared to iDeg in people aged 70 years or older.”
Primary results from the BRIGHT study,1 published in 2018, showed that the two long-acting insulins provided comparable blood sugar control and risk of low blood sugar (hypoglycemia) in the full 24-week study period, with reduced low blood sugar events with Toujeo in the first 12 weeks, the titration period when most of the dose adjustment typically occurs.
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Further analyses, presented American Diabetes Association (ADA) 79th Scientific Sessions on June 7-11, 2019 in San Francisco, CA, U.S. evaluated Toujeo versus insulin degludec in a non-prespecified (post-hoc) analysis of patients aged 70 years or older,3 as well as examining whether patients met treatment targets during the titration period,4 and whether experiencing hypoglycemia in the first 12 weeks can predict increased risk of hypoglycemia later in the study.5
Patients aged ≥ 70 years3 Older people with diabetes typically have increased risk of hypoglycemia and increased severity of episodes. The BRIGHT study population included 160 people aged 70 years or older, and in a post-hoc analysis these people showed a greater reduction of average blood sugar with Toujeo vs iDeg, with similar rates of low blood sugar events (data presented below).3
Achieving treatment target during the titration period4 A new exploratory analysis examined BRIGHT participants reaching treatment target (HbA1c < 7%) without confirmed (≤3.9 mmol/L [≤70 mg/dL]) low blood sugar events during the titration period (weeks 0-12). This analysis showed that 16.9% patients achieved this goal with Toujeo compared to 13.6% with insulin degludec (data presented below).4
Early hypoglycemia predicting increased later risk5 A further presentation showed that low blood sugar in the titration period is associated with increased risk of further events in the maintenance period.5 Pooling patients across both treatment arms, this analysis found that 75% of the 470 patients who experienced one or more confirmed low blood sugar event in the “titration period” (weeks 0-12) went on to experience further events in the “maintenance period” (weeks 13-24). In contrast, only 38% of the 454 patients who did not experience low blood sugar in weeks 0-12 experienced an event in weeks 13-24 (data presented below).
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Summary of analyses Analysis by renal function2 Normal kidney function (eGFR ≥90 mL/min/1.73m2)
Mild-moderate kidney impairment (eGFR 60-90 mL/min/1.73m2)
Moderate-severe kidney impairment (eGFR <60 mL/min/1.73m2)
Blood sugar control (Mean change from baseline and mean difference in HbA1c reduction)
n=428 Gla-300: −1.57% iDeg: −1.67% Mean difference: 0.09% 95% Cl: -0.05 to 0.24
n=337 Gla-300: -1.72% iDeg: -1.58% Mean difference: -0.14% 95% Cl: -0.30 to 0.02
n=89 Gla-300: -1.72% iDeg: -1.30% Mean difference: -0.43% 95% Cl: -0.74 to -0.12
Low blood sugar risk (Anytime (24h) confirmed (≤3.9mmol/L [≤70 mg/dL]) low blood sugar event rate ratio (RR))
n=462 Gla-300 6.5 events/patientyear iDeg 10.4 events/patient-year RR: 0.60 95% Cl: 0.45 to 0.81
n=365 Gla-300 12.3 events/patientyear iDeg: 10.5 events/patientyear RR: 1.23 95% Cl: 0.93 to 1.64
n=96 Gla-300 13.5 events/patient-year iDeg 13.9 events/patientyear RR: 0.93 95% Cl: 0.56 to 1.54
Analysis of patients aged ≥ 70 year3 Toujeo (n=74) Insulin degludec (n=87) Change in HbA1c (baseline to week 24) -1.69% -1.34% Difference (95% CI) -0.34% (-0.56% to -0.10%) Patients experiencing ≥1 confirmed (≤3.9mmol/L [≤70 mg/dL]) hypoglycemic event, n (%) 55 (75.3%) 69 (79.3%) OR (95% CI) 0.80 (0.37 to 1.73)
Analysis of achieving treatment target in titration period4
Analysis of early hypoglycemia (in first 12 weeks) as a predictor of later hypoglycemia5 With early hypoglycemia (n=470) Without early hypoglycemia (n=454) Patients experiencing ≥1 anytime hypoglycemic event of any type in weeks 13-24 n (%) 347 (75.4%) 167 (38.2%)
References: 1. Rosenstock J, et al. Diabetes Care. 2018;41:2147-2154. 2. Muller-Wieland D, et al. Poster presentation #901, European Association for the Study of Diabetes 55th Annual Meeting, September 16-20 2019, Barcelona, Spain. 3. Charbonnel B, et al. Poster presentation #131-LB, American Diabetes Association 79th Scientific Sessions, June 7-11 2019, San Francisco, CA, U.S.
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4. Roussel R, et al. Presented at ADA. Poster presentation #1090-P, American Diabetes Association 79th Scientific Sessions, San Francisco, CA, U.S. 5. Harris S, et al. Poster presentation #1095-P, American Diabetes Association 79th Scientific Sessions, San Francisco, CA, U.S.
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Global Diabetes Communications Serge Spierckel Tel.: +33 (0) 6.75.71.61.24 Serge.Spierckel@sanofi.com
