PMID- 29232162
OWN - NLM
STAT- MEDLINE
DCOM- 20181018
LR  - 20181113
IS  - 1557-8593 (Electronic)
IS  - 1520-9156 (Print)
IS  - 1520-9156 (Linking)
VI  - 20
IP  - 1
DP  - 2018 Jan
TI  - Efficacy and Safety of Biosimilar SAR342434 Insulin Lispro in Adults with Type 2 
      Diabetes, Also Using Insulin Glargine: SORELLA 2 Study.
PG  - 49-58
LID - 10.1089/dia.2017.0281 [doi]
AB  - BACKGROUND: SAR342434 (SAR-Lis) is a biosimilar (follow-on) of insulin lispro 
      (U100; Humalog((R)); Ly-Lis). This study aimed to show similar efficacy, safety, 
      and immunogenicity of SAR-Lis versus Ly-Lis in adult patients with type 2 
      diabetes mellitus (T2DM) treated with multiple daily injections, while using 
      insulin glargine (GLA-100; Lantus((R))) as basal insulin. METHODS: SORELLA 2 was a 
      6-month, randomized, open-label, Phase 3 study (NCT02294474). Insulin doses were 
      adjusted to achieve fasting and 2-h postprandial glucose targets according to 
      American Diabetes Association guidelines. Primary endpoint was the HbA(1c) change 
      from baseline to week 26 (tested for noninferiority of SAR-Lis vs. Ly-Lis with a 
      margin of 0.3%). Secondary endpoints included fasting plasma glucose (FPG), 
      seven-point self-monitored plasma glucose (SMPG) profiles, hypoglycemic events, 
      treatment-emergent adverse events (TEAEs), and anti-insulin antibodies (AIA). 
      RESULTS: A total of 505 patients were randomized (1:1) to multiple daily 
      injections of SAR-Lis (n = 253) or Ly-Lis (n = 252) plus once-daily GLA-100. 
      Least square (LS) mean (standard error) change in HbA(1c) from baseline to week 
      26 was similar in both treatment groups (SAR-Lis, -0.92% [0.051] and Ly-Lis, 
      -0.85% [0.051]). Noninferiority at prespecified 0.3% noninferiority margin was 
      demonstrated (LS mean difference of SAR-Lis vs. Ly-Lis: -0.07% [95% CI: -0.215 to 
      0.067]) as was inverse noninferiority. Similar changes in FPG, seven-point SMPG 
      profiles, including postprandial glucose excursions and mean glucose over 24 h, 
      and insulin dosages were observed in the two groups. Hypoglycemia, TEAEs, and AIA 
      (incidence and prevalence) did not differ between groups. CONCLUSIONS: Results 
      from this controlled study in patients with T2DM also using GLA-100 support 
      similar efficacy and safety (including immunogenicity) of SAR-Lis and Ly-Lis.
FAU - Derwahl, Karl-Michael
AU  - Derwahl KM
AD  - 1 Institut fur Klinische Forschung und Entwicklung (IKFE) Berlin GmbH , Berlin, 
      Germany .
FAU - Bailey, Timothy S
AU  - Bailey TS
AD  - 2 AMCR Institute , Escondido, California.
FAU - Wernicke-Panten, Karin
AU  - Wernicke-Panten K
AD  - 3 Sanofi-Aventis Deutschland GmbH , Frankfurt, Germany .
FAU - Ping, Lin
AU  - Ping L
AD  - 4 Sanofi , Bridgewater, New Jersey.
FAU - Pierre, Suzanne
AU  - Pierre S
AD  - 5 Sanofi , Paris, France .
LA  - eng
PT  - Clinical Trial, Phase III
PT  - Comparative Study
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20171212
PL  - United States
TA  - Diabetes Technol Ther
JT  - Diabetes technology & therapeutics
JID - 100889084
RN  - 0 (Hypoglycemic Agents)
RN  - 0 (Insulin Lispro)
RN  - 0 (SAR342434)
RN  - 2ZM8CX04RZ (Insulin Glargine)
SB  - IM
MH  - Aged
MH  - Diabetes Mellitus, Type 2/*drug therapy/immunology
MH  - Female
MH  - Humans
MH  - Hypoglycemic Agents/*therapeutic use
MH  - Insulin Glargine/immunology/therapeutic use
MH  - Insulin Lispro/immunology/*therapeutic use
MH  - Male
MH  - Middle Aged
PMC - PMC5770084
OTO - NOTNLM
OT  - Biosimilar
OT  - Immunogenicity
OT  - Insulin antibodies
OT  - Insulin lispro
OT  - SORELLA 2.
COIS- K.-M.D., Consultant to Astra Zeneca, Lilly, Novo Nordisk, Sanofi; honorarium 
      (lectures) from AstraZeneca, Sanofi, Menarini, Novo Nordisk. T.S.B., Consultant 
      to Astra Zeneca, Ascensia, BD, Calibra, Lilly, Medtronic, Novo Nordisk, Sanofi. 
      Research support from Abbott, Ambra, Ascensia, BD, Boehringer Ingelheim, Calibra, 
      Companion Medical, Dexcom, Elcelyx, Glysens, Janssen, Lexicon, Lilly, Medtronic, 
      Novo Nordisk, Sanofi, Senseonics, Versartis, and Xeris; Speaker's Bureau for 
      Abbott, Insulet, Medtronic, Lilly, Novo Nordisk, Sanofi. K.W.-P., Employee, 
      Sanofi-Aventis Deutschland GmbH; Stock/Shareholder, Sanofi. L.P., Employee, 
      Sanofi, Bridgewater, NJ; Stock/Shareholder, Sanofi. S.P., Employee, Sanofi, 
      Paris, France; Stock/Shareholder, Sanofi.
EDAT- 2017/12/13 06:00
MHDA- 2018/10/20 06:00
PMCR- 2018/01/01
CRDT- 2017/12/13 06:00
PHST- 2017/12/13 06:00 [pubmed]
PHST- 2018/10/20 06:00 [medline]
PHST- 2017/12/13 06:00 [entrez]
PHST- 2018/01/01 00:00 [pmc-release]
AID - 10.1089/dia.2017.0281 [pii]
AID - 10.1089/dia.2017.0281 [doi]
PST - ppublish
SO  - Diabetes Technol Ther. 2018 Jan;20(1):49-58. doi: 10.1089/dia.2017.0281. Epub 
      2017 Dec 12.