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  • 1
    In: Diabetes, American Diabetes Association, Vol. 68, No. Supplement_1 ( 2019-06-01)
    Abstract: LixiLan-G (NCT02787551) was a randomized, open-label, 26-week trial in T2D participants (pts) with HbA1c 7‒9%, receiving maximum tolerated doses of a once- or twice-daily (QD/BID) GLP-1 RA or a once-weekly (QW) GLP-1 RA with metformin ± pioglitazone ± SGLT2i. Pts were randomized to continue their GLP-1 RA regimen with supported adherence or switch to a fixed-ratio combination of insulin glargine and lixisenatide (iGlarLixi). This exploratory analysis assessed efficacy and safety by daily or weekly GLP-1 RA use at screening. Among 514 randomized pts, 60% and 40% were on daily and weekly GLP-1 RA, respectively, at screening (liraglutide QD 54%, dulaglutide QW 20%, exenatide extended-release QW 18%, exenatide BID 5%, albiglutide QW 2% [all % rounded]); GLP-1 RA treatment and T2D duration were slightly longer in the QD/BID vs. QW subgroup (Table). Change in HbA1c was larger with iGlarLixi vs. GLP-1 RA regardless of GLP-1 RA subtype (LS mean difference: −0.7 [95% confidence interval (CI): −0.8, −0.5] with QD/BID formulations, −0.6 [95% CI: −0.8, −0.4] with QW formulations). Similar results were observed for FPG and 2-hour PPG (Table). Safety profiles of iGlarLixi and GLP-1 RA were consistent with previous publications. In conclusion, benefits of switching to iGlarLixi vs. continued GLP-1 RA in inadequately controlled T2D are observed irrespective of daily or weekly GLP-1 RA use. Disclosure J. Rosenstock: Research Support; Self; AstraZeneca, Bristol-Myers Squibb Company, Genentech, Inc., GlaxoSmithKline plc., Lexicon Pharmaceuticals, Inc., Melior Pharmaceuticals, Inc., Bukwang Pharm. Co., Ltd., Merck & Co., Inc., Oramed Pharmaceuticals, PegBio Co., Ltd., Pfizer Inc. Other Relationship; Self; Boehringer Ingelheim International GmbH, Eli Lilly and Company, Intarcia Therapeutics, Inc., Janssen Pharmaceuticals, Inc., Novo Nordisk Inc., Sanofi. L. Blonde: Consultant; Self; Gilead Sciences, Inc., Janssen Pharmaceuticals, Inc., Merck & Co., Inc., Novo Nordisk Inc., Sanofi US. Research Support; Self; Janssen Pharmaceuticals, Inc., Lexicon Pharmaceuticals, Inc., Merck & Co., Inc., Novo Nordisk Inc., Sanofi US. Speaker's Bureau; Self; Janssen Pharmaceuticals, Inc., Novo Nordisk Inc., Sanofi US. S. Del Prato: Advisory Panel; Self; AstraZeneca, Boehringer Ingelheim Pharmaceuticals, Inc., Eli Lilly and Company, GlaxoSmithKline plc., Merck Sharp & Dohme Corp., Novartis Pharmaceuticals Corporation, Novo Nordisk A/S, Sanofi, Servier, Takeda Pharmaceutical Company Limited. Board Member; Self; AstraZeneca. Research Support; Self; AstraZeneca, Boehringer Ingelheim Pharmaceuticals, Inc. Speaker's Bureau; Self; Boehringer Ingelheim Pharmaceuticals, Inc., Takeda Pharmaceutical Company Limited. R.R. Henry: Advisory Panel; Self; Elcelyx Therapeutics, Inc. Consultant; Self; Diasome Pharmaceuticals, Inc., Ionis Pharmaceuticals, Inc. Employee; Self; Eli Lilly and Company. Research Support; Self; AstaReal, Hitachi, Ltd., Viacyte, Inc. Speaker's Bureau; Self; Servier. Other Relationship; Self; Abbott, AstraZeneca, Boehringer Ingelheim Pharmaceuticals, Inc., Intarcia Therapeutics, Inc., Johnson & Johnson, Lexicon Pharmaceuticals, Inc., Merck & Co., Inc., Sanofi-Aventis. N. Shehadeh: Advisory Panel; Self; AstraZeneca, Boehringer Ingelheim Pharmaceuticals, Inc., Novo Nordisk Inc., Sanofi-Aventis. Speaker's Bureau; Self; Eli Lilly and Company, Merck Sharp & Dohme Corp. E. Niemoeller: Employee; Self; Sanofi. Stock/Shareholder; Self; Sanofi. E. Souhami: Employee; Self; Sanofi Research & Development. J. Wu: Employee; Self; Sanofi. X. Wang: Employee; Self; Sanofi Research & Development. C. Ji: Employee; Self; Sanofi Research & Development. V.R. Aroda: Consultant; Self; ADOCIA, AstraZeneca, Becton, Dickinson and Company, Novo Nordisk Inc., Sanofi, Zafgen, Inc. Employee; Spouse/Partner; Merck & Co., Inc. Research Support; Self; AstraZeneca, Calibra Medical, Eisai Inc., Janssen Research & Development, Novo Nordisk Inc., Sanofi, Theracos, Inc. Funding Sanofi
    Type of Medium: Online Resource
    ISSN: 0012-1797 , 1939-327X
    Language: English
    Publisher: American Diabetes Association
    Publication Date: 2019
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  • 2
    In: Diabetes, American Diabetes Association, Vol. 68, No. Supplement_1 ( 2019-06-01)
    Abstract: Effects of switching to a titratable fixed-ratio combination of insulin glargine plus lixisenatide (iGlarLixi) in patients (pts) with T2D on GLP-1 RAs have been unknown. LixiLan-G (NCT02787551), a randomized, open-label, 26-week trial, compared switching to iGlarLixi vs. continued GLP-1 RA use in pts with T2D and HbA1c 7-9% despite receiving a maximum tolerated dose of a GLP-1 RA (liraglutide QD, exenatide BID, exenatide extended-release QW, albiglutide QW, or dulaglutide QW) with metformin ± pioglitazone ± SGLT2i. Treatment effects seen across baseline factors, such as BMI, GLP-1 RA type, and pioglitazone or SGLT2i use, were consistent with the primary analysis. This exploratory analysis examined HbA1c change at week 26 and documented symptomatic hypoglycemia in 26-week completers (modified ITT) by screening subgroup HbA1c levels (≤7.5%, & gt;7.5-≤8%, and & gt;8%). At week 26, mean HbA1c levels for iGlarLixi were 6.6%, 6.6%, and 6.9%, respectively, vs. 7.2%, 7.4%, and 7.5%, respectively, for GLP-1 RAs. Reductions were greater for iGlarLixi than for GLP-1 RAs in all subgroups (p & lt;0.0001; Figure). Symptomatic hypoglycemia rates were low overall but higher with iGlarLixi than with GLP-1 RAs (Figure). In conclusion, in pts with T2D inadequately controlled on GLP-1 RA and OAD(s), iGlarLixi demonstrated additional glycemic benefit across a broad range of HbA1c levels. Disclosure S. Del Prato: Advisory Panel; Self; AstraZeneca, Boehringer Ingelheim Pharmaceuticals, Inc., Eli Lilly and Company, GlaxoSmithKline plc., Merck Sharp & Dohme Corp., Novartis Pharmaceuticals Corporation, Novo Nordisk A/S, Sanofi, Servier, Takeda Pharmaceutical Company Limited. Board Member; Self; AstraZeneca. Research Support; Self; AstraZeneca, Boehringer Ingelheim Pharmaceuticals, Inc. Speaker's Bureau; Self; Boehringer Ingelheim Pharmaceuticals, Inc., Takeda Pharmaceutical Company Limited. L. Blonde: Consultant; Self; Gilead Sciences, Inc., Janssen Pharmaceuticals, Inc., Merck & Co., Inc., Novo Nordisk Inc., Sanofi US. Research Support; Self; Janssen Pharmaceuticals, Inc., Lexicon Pharmaceuticals, Inc., Merck & Co., Inc., Novo Nordisk Inc., Sanofi US. Speaker's Bureau; Self; Janssen Pharmaceuticals, Inc., Novo Nordisk Inc., Sanofi US. R.R. Henry: Advisory Panel; Self; Elcelyx Therapeutics, Inc. Consultant; Self; Diasome Pharmaceuticals, Inc., Ionis Pharmaceuticals, Inc. Employee; Self; Eli Lilly and Company. Research Support; Self; AstaReal, Hitachi, Ltd., Viacyte, Inc. Speaker's Bureau; Self; Servier. Other Relationship; Self; Abbott, AstraZeneca, Boehringer Ingelheim Pharmaceuticals, Inc., Intarcia Therapeutics, Inc., Johnson & Johnson, Lexicon Pharmaceuticals, Inc., Merck & Co., Inc., Sanofi-Aventis. V.R. Aroda: Consultant; Self; ADOCIA, AstraZeneca, Becton, Dickinson and Company, Novo Nordisk Inc., Sanofi, Zafgen, Inc. Employee; Spouse/Partner; Merck & Co., Inc. Research Support; Self; AstraZeneca, Calibra Medical, Eisai Inc., Janssen Research & Development, Novo Nordisk Inc., Sanofi, Theracos, Inc. N. Shehadeh: Advisory Panel; Self; AstraZeneca, Boehringer Ingelheim Pharmaceuticals, Inc., Novo Nordisk Inc., Sanofi-Aventis. Speaker's Bureau; Self; Eli Lilly and Company, Merck Sharp & Dohme Corp. E. Niemoeller: Employee; Self; Sanofi. Stock/Shareholder; Self; Sanofi. E. Souhami: Employee; Self; Sanofi Research & Development. J. Wu: Employee; Self; Sanofi. X. Wang: Employee; Self; Sanofi Research & Development. C. Ji: Employee; Self; Sanofi Research & Development. J. Rosenstock: Research Support; Self; AstraZeneca, Bristol-Myers Squibb Company, Genentech, Inc., GlaxoSmithKline plc., Lexicon Pharmaceuticals, Inc., Melior Pharmaceuticals, Inc., Bukwang Pharm. Co., Ltd., Merck & Co., Inc., Oramed Pharmaceuticals, PegBio Co., Ltd., Pfizer Inc. Other Relationship; Self; Boehringer Ingelheim International GmbH, Eli Lilly and Company, Intarcia Therapeutics, Inc., Janssen Pharmaceuticals, Inc., Novo Nordisk Inc., Sanofi. Funding Sanofi
    Type of Medium: Online Resource
    ISSN: 0012-1797 , 1939-327X
    Language: English
    Publisher: American Diabetes Association
    Publication Date: 2019
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  • 3
    Online Resource
    Online Resource
    American Diabetes Association ; 2019
    In:  Diabetes Vol. 68, No. Supplement_1 ( 2019-06-01)
    In: Diabetes, American Diabetes Association, Vol. 68, No. Supplement_1 ( 2019-06-01)
    Abstract: LixiLan-O, a randomized, 30-week, open-label study compared the fixed-ratio combination of insulin glargine/lixisenatide (iGlarLixi) with insulin glargine (iGlar) or lixisenatide in patients inadequately controlled on metformin alone or combined with a second OAD. This exploratory subgroup analysis examines the efficacy and safety of iGlarLixi vs. iGlar in patients with baseline HbA1c ≥8.0% receiving metformin plus a second OAD at screening; the second OAD was a sulfonylurea in 93.8% of patients. Mean age was 59.2 years, mean BMI was 31.5 kg/m2, mean diabetes duration was 10.0 years, and mean duration of second OAD use was 4.5 years. Compared with iGlar alone, the iGlarLixi-treated group demonstrated greater mean reductions from baseline in HbA1c, 2-h PPG, and weight, greater proportions achieving HbA1c & lt;7.0%, or a composite endpoint of HbA1c & lt;7.0% with no weight gain (Table). There were no differences between the groups in change in FPG, or in insulin dose at Week 30 (40.7 vs. 40.2 U/day, respectively; p=0.8664). Incidences of documented symptomatic hypoglycemia (plasma glucose ≤70 mg/dL) were similar between groups (29.0% and 27.9%, respectively). Patients in this difficult-to-treat subgroup with advanced T2D and higher baseline HbA1c achieved better glycemic control without increased risk of hypoglycemia when intensified with iGlarLixi compared with iGlar. Disclosure N. Skolnik: Advisory Panel; Self; AstraZeneca, Boehringer Ingelheim Pharmaceuticals, Inc., GlaxoSmithKline plc., Intarcia Therapeutics, Inc., Janssen Pharmaceuticals, Inc., Mylan, Sanofi, Teva Pharmaceutical Industries Ltd. Research Support; Self; AstraZeneca, Boehringer Ingelheim Pharmaceuticals, Inc., GlaxoSmithKline plc., Sanofi. Speaker's Bureau; Self; AstraZeneca, Boehringer Ingelheim Pharmaceuticals, Inc. E. Niemoeller: Employee; Self; Sanofi. Stock/Shareholder; Self; Sanofi. E. Souhami: Employee; Self; Sanofi Research & Development. L. Meneghini: Advisory Panel; Self; AstraZeneca, Novo Nordisk Inc., Sanofi-Aventis. Consultant; Self; Sanofi-Aventis. Other Relationship; Self; American Diabetes Association. Funding Sanofi
    Type of Medium: Online Resource
    ISSN: 0012-1797 , 1939-327X
    Language: English
    Publisher: American Diabetes Association
    Publication Date: 2019
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  • 4
    In: Diabetes, American Diabetes Association, Vol. 68, No. Supplement_1 ( 2019-06-01)
    Abstract: Fixed-ratio combinations (FRCs) of basal insulin plus a GLP-1 receptor agonist (RA) offer simple administration of complementary injectable therapies for T2D. Effects of switching to a titratable FRC of insulin glargine plus lixisenatide (iGlarLixi) in T2D patients (pts) receiving GLP-1 RAs have been unknown. LixiLan-G (NCT02787551), a randomized, open-label, 26-week trial, compared switching to iGlarLixi vs. continuing a GLP-1 RA in T2D pts with HbA1c 7‒9%, receiving a maximum tolerated dose of a QD/BID GLP-1 RA (60% of pts: liraglutide QD, exenatide BID), or a QW GLP-1 RA (40% of pts: dulaglutide, exenatide extended-release, or albiglutide) with metformin ± pioglitazone ± SGLT2i. Adherence to randomized treatment was reinforced and monitored throughout the study. iGlarLixi (n=257) provided greater HbA1c reductions than GLP-1 RA (n=257), from 7.8% at baseline to 6.7% and 7.4%, respectively (LS mean difference [primary endpoint] ‒0.6%; p & lt;0.0001 [Table]). More iGlarLixi pts achieved HbA1c targets and the composite of HbA1c & lt;7% without documented symptomatic hypoglycemia ( & lt;54 mg/dL). Documented symptomatic hypoglycemia, nausea, and vomiting rates were low but greater with iGlarLixi vs. GLP-1 RA. In conclusion, switching to iGlarLixi can further improve glucose control for T2D pts receiving the maximum tolerated GLP-1 RA dose with OAD(s). Disclosure L. Blonde: Consultant; Self; Gilead Sciences, Inc., Janssen Pharmaceuticals, Inc., Merck & Co., Inc., Novo Nordisk Inc., Sanofi US. Research Support; Self; Janssen Pharmaceuticals, Inc., Lexicon Pharmaceuticals, Inc., Merck & Co., Inc., Novo Nordisk Inc., Sanofi US. Speaker's Bureau; Self; Janssen Pharmaceuticals, Inc., Novo Nordisk Inc., Sanofi US. J. Rosenstock: Research Support; Self; AstraZeneca, Bristol-Myers Squibb Company, Genentech, Inc., GlaxoSmithKline plc., Lexicon Pharmaceuticals, Inc., Melior Pharmaceuticals, Inc., Bukwang Pharm. Co., Ltd., Merck & Co., Inc., Oramed Pharmaceuticals, PegBio Co., Ltd., Pfizer Inc. Other Relationship; Self; Boehringer Ingelheim International GmbH, Eli Lilly and Company, Intarcia Therapeutics, Inc., Janssen Pharmaceuticals, Inc., Novo Nordisk Inc., Sanofi. S. Del Prato: Advisory Panel; Self; AstraZeneca, Boehringer Ingelheim Pharmaceuticals, Inc., Eli Lilly and Company, GlaxoSmithKline plc., Merck Sharp & Dohme Corp., Novartis Pharmaceuticals Corporation, Novo Nordisk A/S, Sanofi, Servier, Takeda Pharmaceutical Company Limited. Board Member; Self; AstraZeneca. Research Support; Self; AstraZeneca, Boehringer Ingelheim Pharmaceuticals, Inc. Speaker's Bureau; Self; Boehringer Ingelheim Pharmaceuticals, Inc., Takeda Pharmaceutical Company Limited. R.R. Henry: Advisory Panel; Self; Elcelyx Therapeutics, Inc. Consultant; Self; Diasome Pharmaceuticals, Inc., Ionis Pharmaceuticals, Inc. Employee; Self; Eli Lilly and Company. Research Support; Self; AstaReal, Hitachi, Ltd., Viacyte, Inc. Speaker's Bureau; Self; Servier. Other Relationship; Self; Abbott, AstraZeneca, Boehringer Ingelheim Pharmaceuticals, Inc., Intarcia Therapeutics, Inc., Johnson & Johnson, Lexicon Pharmaceuticals, Inc., Merck & Co., Inc., Sanofi-Aventis. N. Shehadeh: Advisory Panel; Self; AstraZeneca, Boehringer Ingelheim Pharmaceuticals, Inc., Novo Nordisk Inc., Sanofi-Aventis. Speaker's Bureau; Self; Eli Lilly and Company, Merck Sharp & Dohme Corp. E. Niemoeller: Employee; Self; Sanofi. Stock/Shareholder; Self; Sanofi. E. Souhami: Employee; Self; Sanofi Research & Development. J. Wu: Employee; Self; Sanofi. X. Wang: Employee; Self; Sanofi Research & Development. C. Ji: Employee; Self; Sanofi Research & Development. V.R. Aroda: Consultant; Self; ADOCIA, AstraZeneca, Becton, Dickinson and Company, Novo Nordisk Inc., Sanofi, Zafgen, Inc. Employee; Spouse/Partner; Merck & Co., Inc. Research Support; Self; AstraZeneca, Calibra Medical, Eisai Inc., Janssen Research & Development, Novo Nordisk Inc., Sanofi, Theracos, Inc. Funding Sanofi
    Type of Medium: Online Resource
    ISSN: 0012-1797 , 1939-327X
    Language: English
    Publisher: American Diabetes Association
    Publication Date: 2019
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  • 5
    In: Diabetes, American Diabetes Association, Vol. 72, No. Supplement_1 ( 2023-06-20)
    Abstract: This post-hoc, pooled analysis of 4 trials aimed to identify factors associated with achieving target HbA1c & lt;7.0% in people with type 2 diabetes (T2D) treated with iGlarLixi. People with T2D advancing from oral (LixiLan-O), GLP-1 RA (LixiLan-G), or insulin (LixiLan-L; SoliMix) therapies were randomized to iGlarLixi vs active comparators for 26 or 30 weeks. HbA1c was assessed at baseline (BL) and end of treatment, and responses were classified by the achievement or non-achievement of target HbA1c & lt;7.0% ( & lt;53 mmol/mol). Predictive factors for achieving target were analyzed by univariable and multivariable stepwise logistic regression. Pooled analyses (N=1455) showed mean [SD] HbA1c, T2D duration, and insulin total daily dose at BL were lower in those who achieved (8.0 [0.7] %, 10.7 [6.7] y, 0.23 [0.15] U/kg) vs those who did not achieve (8.4 [0.7]%, 12.1 [7.0] y, 0.29 [0.15] U/kg) target HbA1c, respectively. Predictors of achieving target glycemic response (p & lt;0.05) included lower BL HbA1c, lower T2D duration, and lower insulin dose at BL, as well as weight change (decrease) from BL. Age, BMI, and fasting plasma glucose at BL had no predictive value (Table). In conclusion, HbA1c, T2D duration, and insulin dose at BL, in addition to weight change from BL, were predictors of achieving target HbA1c & lt;7.0% in people with T2D treated with iGlarLixi. Disclosure A.Y.Cheng: Advisory Panel; Merck & Co., Inc., Pfizer Inc., GlaxoSmithKline plc., Other Relationship; Diabetes Canada, Research Support; Applied Therapeutics Inc., Speaker's Bureau; Abbott, AstraZeneca, Bayer Inc., Boehringer Ingelheim Inc., Eli Lilly and Company, Janssen Pharmaceuticals, Inc., HLS Therapeutics Inc., Medtronic, Novo Nordisk, Sanofi, Insulet Corporation, Dexcom, Inc., Bausch Health, Canada. J.P.Frias: Advisory Panel; Becton, Dickinson and Company, Pfizer Inc., Sanofi, Consultant; Akero Therapeutics, Inc., 89bio, Inc., Aimmune, Boehringer Ingelheim Inc., Eli Lilly and Company, Carmot Therapeutics, Inc., Echosens, Merck & Co., Inc., Metacrine, Inc., Novo Nordisk, Pfizer Inc., Sanofi, Employee; Ionis Pharmaceuticals, Research Support; Akero Therapeutics, Inc., 89bio, Inc., Altimmune, Axcella Health Inc., Boehringer Ingelheim Inc., Eli Lilly and Company, Intercept Pharmaceuticals, Inc., Carmot Therapeutics, Inc., Janssen Pharmaceuticals, Inc., Madrigal Pharmaceuticals, Inc., Merck & Co., Inc., Metacrine, Inc., Novo Nordisk, Oramed Pharmaceuticals, Novartis, Pfizer Inc., Sanofi, Speaker's Bureau; Eli Lilly and Company, Sanofi. C.Guja: Advisory Panel; AstraZeneca, Boehringer-Ingelheim, Eli Lilly and Company, Novo Nordisk A/S, Sanofi, Speaker's Bureau; AstraZeneca, Boehringer-Ingelheim, Eli Lilly and Company, Merck Sharp & Dohme Corp., Novo Nordisk A/S, Sanofi, Servier Laboratories, Viatris Inc. F.Lauand: Employee; Sanofi. L.Melas-melt: None. A.Alvarez: Employee; Sanofi. E.Souhami: Employee; Sanofi, Stock/Shareholder; Sanofi. J.Rosenstock: Advisory Panel; Applied Therapeutics Inc., Boehringer Ingelheim Inc., Eli Lilly and Company, Novo Nordisk, Oramed Pharmaceuticals, Sanofi, Zealand Pharma A/S, Intarcia Therapeutics, Inc., Hanmi Pharm. Co., Ltd., Research Support; Applied Therapeutics Inc., Boehringer Ingelheim Inc., Eli Lilly and Company, Merck & Co., Inc., Novartis, Novo Nordisk, Pfizer Inc., Sanofi, Intarcia Therapeutics, Inc. Funding Sanofi
    Type of Medium: Online Resource
    ISSN: 0012-1797
    Language: English
    Publisher: American Diabetes Association
    Publication Date: 2023
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  • 6
    In: Diabetes, American Diabetes Association, Vol. 71, No. Supplement_1 ( 2022-06-01)
    Abstract: Introduction: LixiLan-O-AP (NCT03798054) showed greater HbA1c improvement with iGlarLixi vs. iGlar or Lixi in Asian Pacific adults with type 2 diabetes (T2D) . This pre-defined analysis assessed iGlarLixi efficacy by HbA1c levels at screening. Methods: Adults (N=878) with suboptimally controlled T2D (HbA1c of 7.5-% or 7-% depending on background oral antihyperglycemic drug [OAD] use) on metformin ± a second OAD were randomized 2:2:1 to iGlarLixi, iGlar or Lixi for 24 weeks. Three screening HbA1c subgroups were defined: & lt;8, 8- & lt;9, ≥9 %. Results: At Week 24, in all HbA1c subgroups, iGlarLixi was associated with greater HbA1c reductions vs. iGlar or Lixi and reached mean HbA1c levels & lt;7 %. iGlarLixi also showed greater 2-h postprandial glucose reductions, and a higher proportion of participants reaching HbA1c & lt;7 % and HbA1c & lt;7 % without weight gain, vs. iGlar or Lixi (Table) . Incidence and rates of documented hypoglycemia ≤70 mg/dL (≤3.9 mmol/L) were similar between iGlarLixi and iGlar in the 8- & lt;9 % and ≥9 % subgroups but were slightly higher with iGlarLixi vs. iGlar in the & lt;8 % subgroup. Conclusions: Regardless of HbA 1c level at screening, iGlarLixi demonstrated better glycemic control vs. iGlar or Lixi, with over 75% of participants achieving the recommended target HbA 1c ( & lt;7 %) with iGlarLixi, even those with HbA1c ≥9 % at screening. Disclosure Y. He: None. W. Yang: Other Relationship; AstraZeneca, Bayer AG, Boehringer Ingelheim International GmbH, Eli Lilly and Company, Mer, Merck Sharp & Dohme Corp., Novo Nordisk, Sanofi-Aventis Deutschland GmbH, Servier Laboratories. M. Liu: None. J. Xiao: None. S. Gu: Employee; Sanofi China. L. Chen: None. E. Souhami: Employee; Sanofi. Stock/Shareholder; Sanofi. Funding Funding: Sanofi
    Type of Medium: Online Resource
    ISSN: 0012-1797
    Language: English
    Publisher: American Diabetes Association
    Publication Date: 2022
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  • 7
    In: Diabetes, American Diabetes Association, Vol. 71, No. Supplement_1 ( 2022-06-01)
    Abstract: Introduction: The SoliMix trial (EudraCT: 2017-003370-13) found better HbA1c with weight benefit and lower hypoglycemia risk for iGlarLixi vs. premix BIAsp 30 in people with type 2 diabetes advancing from basal insulin plus oral antihyperglycemic drugs. This exploratory analysis investigated whether hypoglycemia influenced insulin titration and achievement of fasting plasma glucose (FPG) targets with each therapeutic option. Methods: Total insulin dose changes from baseline to Week 12 were stratified by hypoglycemia (yes/no) in each treatment arm and ADA Level 2 hypoglycemia ( & lt;54 mg/dL [ & lt;3.0 mmol/L]) event rates during Weeks 0-12 were modeled according to FPG at Week 12 (when most insulin titration occurred) . Results: Lesser insulin dose increases occurred in both treatment groups for those who experienced hypoglycemia (mean ± SD iGlarLixi: 3.9 ± 12.5 U; BIAsp 30: 11.0 ± 18.8 U) vs. those who did not (mean ± SD iGlarLixi: 11.2 ± 9.9 U; BIAsp 30: 19.4 ± 19.3 U) . While higher FPG at Week 12 correlated with greater event rates of hypoglycemia in both treatment arms, event rates were higher for BIAsp 30 than for iGlarLixi irrespective of FPG (Figure) . Conclusions: More frequent hypoglycemia with premix BIAsp 30 than with iGlarLixi may result in lower insulin doses, thus hampering insulin titration and resulting in higher FPG. Disclosure F.Giorgino: Advisory Panel; AstraZeneca, Boehringer Ingelheim International GmbH, Novo Nordisk, Consultant; Lilly Diabetes, Sanofi, Research Support; Lilly Diabetes, Roche Diabetes Care, Takeda Pharmaceutical Company Limited. J.Rosenstock: Consultant; AstraZeneca, Other Relationship; Applied Therapeutics, Boehringer Ingelheim International GmbH, Eli Lilly and Company, Hanmi Pharm. Co., Ltd., Intarcia Therapeutics, Inc., Novo Nordisk, Oramed Pharmaceuticals, Sanofi, Zealand Pharma A/S, Research Support; Genentech, Inc., Merck & Co., Inc., Metacrine, Inc., Novartis Pharmaceuticals Corporation, Pfizer Inc., vTv Therapeutics. R.Ritzel: Consultant; Novo Nordisk, Sanofi, Speaker's Bureau; AstraZeneca, Lilly, Novartis Pharmaceuticals Corporation, Novo Nordisk, Pfizer Inc., Sanofi. O.Deyneli: Advisory Panel; Abbott Diabetes, AstraZeneca, Bayer AG, Boehringer Ingelheim International GmbH, Novo Nordisk, Roche Diagnostics, Sanofi, Speaker's Bureau; Abbott, AstraZeneca, Berlin-Chemie AG, Bilim Ilaç, Boehringer Ingelheim International GmbH, Medtronic, Merck Sharp & Dohme Corp., Novartis Pharmaceuticals Corporation, Novo Nordisk, Roche Diabetes Care, Sanofi. A.Alvarez: Employee; Sanofi. E.Souhami: Employee; Sanofi, Stock/Shareholder; Sanofi. L.Melas-melt: None. R.J.Mccrimmon: Advisory Panel; Novo Nordisk, Sanofi, Research Support; Diabetes UK, European Union, MedImmune. Funding Sanofi
    Type of Medium: Online Resource
    ISSN: 0012-1797
    Language: English
    Publisher: American Diabetes Association
    Publication Date: 2022
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  • 8
    In: Diabetes, American Diabetes Association, Vol. 72, No. Supplement_1 ( 2023-06-20)
    Abstract: This post-hoc, pooled analysis of 3 randomized controlled trials aimed to identify factors associated with achieving a derived Time in Range (dTIR) ≥70% at the end of treatment (EOT) with iGlarLixi in people with type 2 diabetes (T2D). dTIR was calculated from 7-point self-monitored plasma glucose (SMPG) profiles and assessed at baseline (BL) and EOT for people with T2D advancing from oral (LixiLan-O), insulin (LixiLan-L), or GLP-1 RA (LixiLan-G) therapy to once-daily iGlarLixi. Participants at EOT were classified as either achieving or not achieving dTIR ≥70%, and corresponding predictive BL characteristics were analyzed with univariable and multivariable stepwise logistic regression. Analyses (N=880) showed that 86% of participants achieved dTIR ≥70% with iGlarLixi; T2D duration and HbA1c at BL were greater in those with dTIR & lt;70% (mean [SD] 11.35 [7.31] years and 8.26 [0.68] %) than those with dTIR ≥70% (10.40 [6.51] years and 7.96 [0.68] %), respectively. Post-meal SMPG at BL was higher in those not achieving dTIR ≥70%. Lower BL HbA1c (p=0.0205), BL insulin dose (p & lt;0.0001), and hypoglycemia level 2 frequency (p=0.0139 for 1-3 vs 0 events; p=0.0172 for ≥4 vs 0) were predictors of attaining dTIR ≥70% (Table). HbA1c, insulin dose, and hypoglycemia frequency at BL were predictors of achieving target dTIR ≥70% in people with T2D advancing therapy with iGlarLixi. Disclosure I.Hramiak: Research Support; Eli Lilly and Company, Novo Nordisk, Sanofi, Speaker's Bureau; Canadian Medical & Surgical Knowledge Translation Research Group (CMS), Insulet Corporation, Medtronic, Merck & Co., Inc., Bayer Inc. J.P.Frias: Advisory Panel; Becton, Dickinson and Company, Pfizer Inc., Sanofi, Consultant; Akero Therapeutics, Inc., 89bio, Inc., Aimmune, Boehringer Ingelheim Inc., Eli Lilly and Company, Carmot Therapeutics, Inc., Echosens, Merck & Co., Inc., Metacrine, Inc., Novo Nordisk, Pfizer Inc., Sanofi, Employee; Ionis Pharmaceuticals, Research Support; Akero Therapeutics, Inc., 89bio, Inc., Altimmune, Axcella Health Inc., Boehringer Ingelheim Inc., Eli Lilly and Company, Intercept Pharmaceuticals, Inc., Carmot Therapeutics, Inc., Janssen Pharmaceuticals, Inc., Madrigal Pharmaceuticals, Inc., Merck & Co., Inc., Metacrine, Inc., Novo Nordisk, Oramed Pharmaceuticals, Novartis, Pfizer Inc., Sanofi, Speaker's Bureau; Eli Lilly and Company, Sanofi. H.Aydin: Advisory Panel; Sanofi, Novo Nordisk, Boehringer Ingelheim Inc., Speaker's Bureau; Novo Nordisk. F.Lauand: Employee; Sanofi. L.Melas-melt: None. E.Souhami: Employee; Sanofi, Stock/Shareholder; Sanofi. M.Haluzik: Advisory Panel; Novo Nordisk, Lilly Diabetes, Boehringer-Ingelheim, Research Support; Sanofi, Speaker's Bureau; Abbott, AstraZeneca. J.Rosenstock: Advisory Panel; Applied Therapeutics Inc., Boehringer Ingelheim Inc., Eli Lilly and Company, Novo Nordisk, Oramed Pharmaceuticals, Sanofi, Zealand Pharma A/S, Intarcia Therapeutics, Inc., Hanmi Pharm. Co., Ltd., Research Support; Applied Therapeutics Inc., Boehringer Ingelheim Inc., Eli Lilly and Company, Merck & Co., Inc., Novartis, Novo Nordisk, Pfizer Inc., Sanofi, Intarcia Therapeutics, Inc. Funding Sanofi
    Type of Medium: Online Resource
    ISSN: 0012-1797
    Language: English
    Publisher: American Diabetes Association
    Publication Date: 2023
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  • 9
    In: Diabetes, American Diabetes Association, Vol. 72, No. Supplement_1 ( 2023-06-20)
    Abstract: We aimed to evaluate derived Time in Range (dTIR) and identify predictors for achieving HbA1c and dTIR targets after commencing iGlarLixi in people with type 2 diabetes (T2D). These exploratory analyses of LixiLan-L, an open-label, randomized trial, included people with T2D advancing from basal insulin ± oral agents. dTIR (70−180 mg/dL), derived Time above Range (dTAR, & gt;180 mg/dL), and derived Time below Range (dTBR, & lt;70 mg/dL) were calculated from the 7-point SMBG profiles. HbA1c and dTIR were assessed at Week 30. Predictive factors for achieving targets were analyzed with univariable and multivariable stepwise logistic regression. Participants receiving iGlarLixi (n=366) showed an increase in dTIR from 64% at baseline (BL) to 82%, with 66% achieving dTIR ≥70% and 50% achieving clinically significant improvements (≥5% dTIR) at Week 30. The dTIR & gt;70%, dTBR & lt;4%, and dTAR & lt;25% triple target was attained by 54% of participants receiving iGlarLixi. Weight change from BL, and lower HbA1c and total daily insulin dose at BL were predictors for attaining HbA1c & lt;7.0%; lower BL HbA1c was a predictor of dTIR ≥70% (Table). In conclusion, iGlarLixi is associated with clinically significant HbA1c and dTIR improvements in T2D advancing from basal insulin. Lower BL HbA1c predicted achieving HbA1c & lt;7.0% and dTIR ≥70% goals, whereas lower BL insulin dose predicted achieving HbA1c & lt;7.0% only. Disclosure M.Haluzik: Advisory Panel; Novo Nordisk, Lilly Diabetes, Boehringer-Ingelheim, Research Support; Sanofi, Speaker's Bureau; Abbott, AstraZeneca. J.P.Frias: Advisory Panel; Becton, Dickinson and Company, Pfizer Inc., Sanofi, Consultant; Akero Therapeutics, Inc., 89bio, Inc., Aimmune, Boehringer Ingelheim Inc., Eli Lilly and Company, Carmot Therapeutics, Inc., Echosens, Merck & Co., Inc., Metacrine, Inc., Novo Nordisk, Pfizer Inc., Sanofi, Employee; Ionis Pharmaceuticals, Research Support; Akero Therapeutics, Inc., 89bio, Inc., Altimmune, Axcella Health Inc., Boehringer Ingelheim Inc., Eli Lilly and Company, Intercept Pharmaceuticals, Inc., Carmot Therapeutics, Inc., Janssen Pharmaceuticals, Inc., Madrigal Pharmaceuticals, Inc., Merck & Co., Inc., Metacrine, Inc., Novo Nordisk, Oramed Pharmaceuticals, Novartis, Pfizer Inc., Sanofi, Speaker's Bureau; Eli Lilly and Company, Sanofi. A.Y.Cheng: Advisory Panel; Merck & Co., Inc., Pfizer Inc., GlaxoSmithKline plc., Other Relationship; Diabetes Canada, Research Support; Applied Therapeutics Inc., Speaker's Bureau; Abbott, AstraZeneca, Bayer Inc., Boehringer Ingelheim Inc., Eli Lilly and Company, Janssen Pharmaceuticals, Inc., HLS Therapeutics Inc., Medtronic, Novo Nordisk, Sanofi, Insulet Corporation, Dexcom, Inc., Bausch Health, Canada. M.Al-sofiani: Consultant; Eli Lilly and Company, Speaker's Bureau; Sanofi, Medtronic, Vitalair. F.Lauand: Employee; Sanofi. L.Melas-melt: None. E.Souhami: Employee; Sanofi, Stock/Shareholder; Sanofi. J.Rosenstock: Advisory Panel; Applied Therapeutics Inc., Boehringer Ingelheim Inc., Eli Lilly and Company, Novo Nordisk, Oramed Pharmaceuticals, Sanofi, Zealand Pharma A/S, Intarcia Therapeutics, Inc., Hanmi Pharm. Co., Ltd., Research Support; Applied Therapeutics Inc., Boehringer Ingelheim Inc., Eli Lilly and Company, Merck & Co., Inc., Novartis, Novo Nordisk, Pfizer Inc., Sanofi, Intarcia Therapeutics, Inc. Funding Sanofi
    Type of Medium: Online Resource
    ISSN: 0012-1797
    Language: English
    Publisher: American Diabetes Association
    Publication Date: 2023
    detail.hit.zdb_id: 1501252-9
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  • 10
    In: Diabetes, American Diabetes Association, Vol. 72, No. Supplement_1 ( 2023-06-20)
    Abstract: For older adults ( & gt;65 years) with type 2 diabetes (T2D), iGlarLixi can be a simple and effective therapeutic option. We aimed to identify factors associated with achieving target HbA1c & lt;7% and derived Time in Range (dTIR) ≥70% in this population in response to once daily iGlarLixi. This post-hoc, pooled analysis of 4 randomized trials included 465 people advancing from oral (LixiLan-O), GLP-1 RA (LixiLan-G), or insulin (LixiLan-L; SoliMix) therapies to iGlarLixi for 26 or 30 weeks. HbA1c and dTIR responses were assessed at baseline (BL) and end of treatment (EOT) for each participant and classified as attained ( & lt;7.0% or dTIR ≥70%) or unattained (≥7.0% or & lt;70%). dTIR was calculated from 7-point self-monitored plasma glucose profiles from the three LixiLan studies (LixiLan-O. G, and L). Potential predictive factors were analyzed by univariable and multivariable stepwise logistic regression. Overall, 60% of participants achieved HbA1c & lt;7.0% and 87.5% achieved dTIR ≥70%. Predictors of attained HbA1c response (p & lt;0.05) included lower BL HbA1c and lower BL insulin dose. Predictor of attained dTIR response (p & lt;0.05) was higher BL fasting plasma glucose (FPG; Table), while sex, T2D duration, and obesity had no predictive value. To conclude, in older people with T2D treated with iGlarLixi, consideration of BL HbA1c and FPG, as well as BL insulin dose may improve achieving individualized glycemic targets. Disclosure M.Munshi: Consultant; Sanofi. R.Ritzel: Consultant; Novo Nordisk, Sanofi, Speaker's Bureau; Novo Nordisk, Sanofi, Pfizer Inc., Merck Sharp & Dohme Corp., Lilly. R.J.Mccrimmon: Advisory Panel; Sanofi, Speaker's Bureau; Novo Nordisk A/S. I.Hramiak: Research Support; Eli Lilly and Company, Novo Nordisk, Sanofi, Speaker's Bureau; Canadian Medical & Surgical Knowledge Translation Research Group (CMS), Insulet Corporation, Medtronic, Merck & Co., Inc., Bayer Inc. F.Lauand: Employee; Sanofi. L.Melas-melt: None. E.Souhami: Employee; Sanofi, Stock/Shareholder; Sanofi. J.Rosenstock: Advisory Panel; Applied Therapeutics Inc., Boehringer Ingelheim Inc., Eli Lilly and Company, Novo Nordisk, Oramed Pharmaceuticals, Sanofi, Zealand Pharma A/S, Intarcia Therapeutics, Inc., Hanmi Pharm. Co., Ltd., Research Support; Applied Therapeutics Inc., Boehringer Ingelheim Inc., Eli Lilly and Company, Merck & Co., Inc., Novartis, Novo Nordisk, Pfizer Inc., Sanofi, Intarcia Therapeutics, Inc. Funding Sanofi
    Type of Medium: Online Resource
    ISSN: 0012-1797
    Language: English
    Publisher: American Diabetes Association
    Publication Date: 2023
    detail.hit.zdb_id: 1501252-9
    Location Call Number Limitation Availability
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