Robert Ritzel1, Stewart B Harris2, Helen Baron3, Hermes Florez4, Ronan Roussel5, Melanie Espinasse6, Isabel Muehlen-Bartmer7, Nianxian Zhang8, Monica Bertolini6, Claire Brulle-Wohlhueter6, Medha Munshi9, Geremia B Bolli10. 1. Klinikum Schwabing and Klinikum Bogenhausen, Städtisches Klinikum München GmbH, Munich, Germany robert.ritzel@klinikum-muenchen.de. 2. The University of Western Ontario, London, Ontario, Canada. 3. University of Southern California, Los Angeles, CA. 4. Miller School of Medicine, University of Miami, Coral Gables, FL. 5. Bichat Hospital, Paris, France. 6. Sanofi, Paris, France. 7. Sanofi Deutschland GmbH, Frankfurt am Main, Germany. 8. Sanofi R&D China, Beijing, China. 9. Joslin Diabetes Center, Harvard University, Boston, MA. 10. Department of Medicine, Perugia University Medical School, Perugia, Italy.
Abstract
OBJECTIVE: SENIOR compared the efficacy and safety of insulin glargine 300 units/mL (Gla-300) with glargine 100 units/mL (Gla-100) in older people (≥65 years old) with type 2 diabetes. RESEARCH DESIGN AND METHODS: SENIOR was an open-label, two-arm, parallel-group, multicenter phase 3b trial designed to enroll ∼20% of participants aged ≥75 years. Participants were randomized 1:1 to Gla-300 or Gla-100, titrated to a fasting self-monitored plasma glucose of 5.0-7.2 mmol/L (90-130 mg/dL). RESULTS: In total, 1,014 participants were randomized (mean age: 71 years). Comparable reductions in HbA1c were observed from baseline to week 26 for Gla-300 (-0.89%) and Gla-100 (-0.91%) in the overall population (least squares mean difference: 0.02% [95% CI -0.092 to 0.129]) and for participants aged ≥75 years (-0.11% [-0.330 to 0.106]). Incidence and rates of confirmed (≤3.9 mmol/L [≤70 mg/dL]) or severe hypoglycemia events were low and similar between both treatment groups, with lower rates of documented symptomatic hypoglycemia with Gla-300. The lower risk of hypoglycemia with Gla-300 versus Gla-100 was more apparent in the subgroup aged ≥75 years versus the overall population. Significantly lower annualized rates of documented symptomatic (≤3.9 mmol/L [≤70 mg/dL]) hypoglycemia were observed (Gla-300: 1.12; Gla-100: 2.71; rate ratio: 0.45 [95% CI 0.25-0.83]). CONCLUSIONS:Efficacy and safety of Gla-300 was demonstrated in older people (≥65 years of age) with type 2 diabetes, with comparable reductions in HbA1c and similarly low or lower risk of documented symptomatic hypoglycemia versus Gla-100. A significant benefit in hypoglycemia reduction was seen in participants aged ≥75 years.
RCT Entities:
OBJECTIVE: SENIOR compared the efficacy and safety of insulin glargine 300 units/mL (Gla-300) with glargine 100 units/mL (Gla-100) in older people (≥65 years old) with type 2 diabetes. RESEARCH DESIGN AND METHODS: SENIOR was an open-label, two-arm, parallel-group, multicenter phase 3b trial designed to enroll ∼20% of participants aged ≥75 years. Participants were randomized 1:1 to Gla-300 or Gla-100, titrated to a fasting self-monitored plasma glucose of 5.0-7.2 mmol/L (90-130 mg/dL). RESULTS: In total, 1,014 participants were randomized (mean age: 71 years). Comparable reductions in HbA1c were observed from baseline to week 26 for Gla-300 (-0.89%) and Gla-100 (-0.91%) in the overall population (least squares mean difference: 0.02% [95% CI -0.092 to 0.129]) and for participants aged ≥75 years (-0.11% [-0.330 to 0.106]). Incidence and rates of confirmed (≤3.9 mmol/L [≤70 mg/dL]) or severe hypoglycemia events were low and similar between both treatment groups, with lower rates of documented symptomatic hypoglycemia with Gla-300. The lower risk of hypoglycemia with Gla-300 versus Gla-100 was more apparent in the subgroup aged ≥75 years versus the overall population. Significantly lower annualized rates of documented symptomatic (≤3.9 mmol/L [≤70 mg/dL]) hypoglycemia were observed (Gla-300: 1.12; Gla-100: 2.71; rate ratio: 0.45 [95% CI 0.25-0.83]). CONCLUSIONS: Efficacy and safety of Gla-300 was demonstrated in older people (≥65 years of age) with type 2 diabetes, with comparable reductions in HbA1c and similarly low or lower risk of documented symptomatic hypoglycemia versus Gla-100. A significant benefit in hypoglycemia reduction was seen in participants aged ≥75 years.
Authors: Andreas Fritsche; Helmut Anderten; Martin Pfohl; Stefan Pscherer; Anja Borck; Katrin Pegelow; Peter Bramlage; J Seufert Journal: BMJ Open Diabetes Res Care Date: 2019-08-01
Authors: Richard E Pratley; Scott S Emerson; Edward Franek; Matthew P Gilbert; Steven P Marso; Darren K McGuire; Thomas R Pieber; Bernard Zinman; Charlotte T Hansen; Melissa V Hansen; Thomas Mark; Alan C Moses; John B Buse Journal: Diabetes Obes Metab Date: 2019-04-15 Impact factor: 6.577
Authors: Timothy S Bailey; Jasmanda Wu; Fang L Zhou; Rishab A Gupta; Arjun A Menon; Paulos Berhanu; Jukka Westerbacka; John Van Vleet; Lawrence Blonde Journal: Diabetes Obes Metab Date: 2019-07-18 Impact factor: 6.577
Authors: Geremia B Bolli; Carol Wysham; Miles Fisher; Soazig Chevalier; Anna M G Cali; Bruno Leroy; Matthew C Riddle Journal: Diabetes Obes Metab Date: 2018-10-02 Impact factor: 6.577