Data presented at the American Diabetes Association's 80th Scientific Sessions – June 12-16

Company Product Description Indication Status
Cirius Therapeutics Inc., of San Diego MSDC-0602K Insulin sensitizer; mitochondrial pyruvate carrier 2 inhibitor Nonalcoholic steatohepatitis Biomarker analysis from phase IIb Emminence trial showed statistically significant improvements in fasting plasma insulin in 2 treatment groups (125 mg and 250 mg) after 12 months of treatment, or average reduction of 30% vs. 9% increase for placebo; treated participants showed statistically significant improvements in insulin clearance
Diasome Pharmaceuticals Inc., of Cleveland Insulin therapy (Lispro/Degludec) +  hepatocyte directed vesicle (HDV) Insulin ligand; insulin receptor agonist Type 1 diabetes In phase IIb Opti-1 trial, adding HDV to Lispro prompted additional 17.1% reduction in 24-hour events, 6.7% reduction in daytime events and 25.2% reduction in nighttime events over lispro alone; level 2 hypoglycemic event reductions with HDV + Lispro were achieved despite modest increase in mealtime insulin and total insulin dosing and without negative impact on overall glucose control
Dompé Farmaceutici SpA, of Milan, and subsidiary Dompé US Inc., of San Mateo, Calif. Ladarixin Dual CXCR1/2 chemokine antagonist; IL-8 receptor antagonist Type 1 diabetes Phase II trial in individuals with new-onset disease missed statistical significance in primary endpoint of AUC of C-peptide response to mixed meal tolerance testing at 13 weeks; prespecified subpopulation analysis of those with severe T1D onset showed statistically significant effect on AUC of C-peptide at month 6 vs. placebo (p=0.041)
Eli Lilly and Co., of Indianapolis Trulicity (dulaglutide)  GLP-1 receptor agonist  Type 2 diabetes Real-world study showed adherence of 59.7% for Trulicity vs. 42.7% for injectable semaglutide (Ozempic, Novo Nordisk A/S), with persistence of 143.6 days vs. 129.9 days and treatment discontinuation of 30.8% vs. 40.8%, respectively; adherence was 58.1% for Trulicity vs. 40.3% for exenatide, with persistence of 142 days vs. 121.4 days and discontinuation of 32.1% vs. 49.4%, respectively
Hua Medicine Ltd., of Shanghai Dorzagliatin Glucokinase stimulator Type 2 diabetes In phase III Seed monotherapy study, beta-cell function improved, with increase of 2.56% in HOMA2-beta for study drug vs. decline of 0.72% for placebo; dorzagliatin also achieved statistically significant reduction of 1.07% from baseline in HbA1c
Mannkind Corp., of Westlake Village, Calif. Afrezza (insulin human) Insulin (inhaled, Technosphere) Type 2 diabetes Investigator-initiated observational switch study in people previously treated with injected mealtime insulin showed 0.8% reduction in A1C levels at end of 14-week treatment period; participants maintained 66%-69% time in range and reduced time spent with glucose <90 mg/dL; treatment with study drug also resulted in improved diabetes quality of life scores
Novo Nordisk A/S, of Bagsværd, Denmark Insulin icodec Insulin ligand; insulin receptor agonist Type 2 diabetes In phase II trial, primary endpoint showed similar HbA1c change from baseline to week 26 in once-weekly study drug vs. once-daily insulin glargine U100 (-1.33% vs -1.15% points, respectively, p=0.08); secondary endpoint of change in fasting plasma glucose from baseline to week 26 was -58 mg/dL and -54 mg/dL, respectively
Oramed Pharmaceuticals Inc., of New York ORMD-0801 Insulin ligand; insulin receptor agonist Type 2 diabetes Phase II pilot study in first 8 of planned 40 participants with diabetes and nonalcoholic steatohepatitis showed 12-week, once-daily treatment induced observed mean 6.9±6.8% reduction in liver fat content (sign test p value: 0.035), with relative reduction of 30% measured by MRI-PDFF; concentrations of gamma-glutamyltransferase were lower after 12 weeks vs. baseline (-14.6±13.1 U/L; sign test p value: 0.008), as were fasting insulin levels (-96.5±206 pmol/L; sign test p value: 0.035)
Vtv Therapeutics Inc., of High Point, N.C. TTP-399  Glucokinase stimulator Type 1 diabetes Part 2 of phase II Simplici-T1 Study confirmed results from part 1 in larger group (n=85), with study drug reducing HbA1c by 0.3% (p<0.01; trial product estimand); 0.2% (p<0.05; FAS) vs. placebo; analysis of relationship between glycemic control and insulin dose showed study drug reduced HbA1c vs. placebo (0.41%, p=0.01) in participants who decreased or maintained stable insulin dose throughout study (0.35%, p=0.04)
Xeris Pharmaceuticals Inc., of Chicago Gvoke Ready-to-Use (RTU) Micro Glucagon Glucagon ligand Type 1 diabetes Outpatient stage of phase II study showed exercise-induced hypoglycemia (EIH) events were lower with study drug + standard of care (8.5±1.17 episodes vs. 2.5±1.26 episodes, p=0.0016) and with open-label RTU glucagon vs. SOC alone (8.5±1.17 episodes vs. 3.9±1.37 episodes, p=0.0165); study drug + SOC resulted in about 70% lower rate of EIH vs. SOC alone (12±14.1% VS. 41±21.5% respectively, p<0.0001) and open-label study drug resulted in about 54% lower rate of EIH vs. SOC alone (19±20.2% vs. 41±21.5%, respectively, p=0.0032)
Zealand Pharma A/S, of Copenhagen Hypopal (dasiglucagon) Glucagon ligand; glucagon receptor agonist Type 1 diabetes Phase III trial in 42 children, ages 6 to 17, met primary and secondary endpoints, showing median time to plasma glucose recovery of 10 minutes with dasiglucagon vs. 30 minutes for placebo (p<0.001) and 10 minutes for Glucagen (Novo Nordisk A/S); phase III study in 45 adults met primary and secondary endpoints, with median time to plasma glucose recovery of 10 minutes with dasiglucagon vs. 35 minutes for placebo (p<0.0001)


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