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    Home > Active Ingredient News > Endocrine System > Treatment of Type 1 Diabetes: New compound preparation-XP-3924, pharmacodynamic research results released! | ENDO2021

    Treatment of Type 1 Diabetes: New compound preparation-XP-3924, pharmacodynamic research results released! | ENDO2021

    • Last Update: 2021-04-28
    • Source: Internet
    • Author: User
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    Author: Medical team doctors report NMT NMT ENDO finishing compiler, please do not reprint without authorization.

    Introduction: The 2021 annual meeting of the American Society of Endocrinology (ENDO) will continue.
    This ENDO conference has released a number of important research abstracts.
    Yimaitong will extract the essence and compile and organize.

    This article shares with you the study of "Phase 2 evaluation study of compound XP-3924 (pramlintide + insulin) for improving postprandial blood glucose in adults with type 1 diabetes" published by researchers from the University of California San Diego Medical Center.
    As a result, let's look at it together.

     What is XP-3924? Simply put, XP-3924 is a new fixed-ratio pramlintide + conventional insulin compound preparation.

     Amylin is a peptide hormone that can inhibit the secretion of glucagon and delay gastric emptying.

    During meals, pancreatic β-cells secrete amylin and insulin at the same time to control postprandial blood sugar, but due to the destruction of pancreatic cells in diabetic patients, the secretion of amylin is often insufficient.

    Pramlintide is an amylin analog, which is often used in combination with insulin during meals.
    However, due to the cumbersome work of combined injections, patient compliance is often poor.
    As a result, XP-3924 came into being.

     Study description The study is a second-phase randomized, open-label, active drug-controlled three-phase crossover study, and a total of 18 patients with T1DM were enrolled.

    Patients were randomly assigned to 3 treatment sequences (with a washout period of 7-11 days between each treatment sequence), as follows: 1.
    XP-3924 (based on the ratio of insulin to carbohydrate, reducing the insulin dose by 50%); 2.
    Reduction 50% of conventional insulin is combined with pramlintide at the same dose and injected separately and administered together; 3.
    Conventional insulin, full dose.

     For the three treatments, subcutaneous injections were performed 30 minutes before 75g of oral glucose, followed by monitoring of glucose levels for 6 hours.

     The main purpose of the research is to compare the pharmacodynamic characteristics of XP-3924, conventional insulin, and conventional insulin combined with pramlintide (injection alone, co-administered); the secondary research purpose is to compare XP-3924, conventional insulin, and conventional insulin combined The kinetics (PK) characteristics, safety and tolerability of pramlintide drugs (injected separately and administered together) were compared.

     Research results 1.
    The main endpoint of the study is from the comparison of the area under the curve (AUC0-180) of the drug-time curve (AUC0-180) from administration to 180 minutes when the blood glucose is >180mg/dL.
    Compared with conventional insulin, the hyperglycemia after XP-3924 treatment is reduced by 62.
    3% (P=0.
    000), there is no significant difference between XP-3924 and conventional insulin combined with pramlintide (P=0.
    694) (see Table 1).

     Table 1 Comparison of the area under the AUC0-180 drug-time curve of the three treatment options 1LS Mean is expressed as an absolute value.
    In addition, the researchers compared the blood glucose variability within 6 hours under the three treatment options, and it can be seen that it is compared with conventional insulin (71.
    0 %), compared with conventional insulin combined with pramlintide (62.
    1%), the blood glucose variability of the XP-3924 group was lower (53.
    3%) (see Table 2).

     Table 2 Blood glucose variability of the three treatment regimens 2.
    Secondary study endpoints 1) Pharmacokinetic (PK) characteristics Compared with co-administration, the PK of pramlintide in XP-3924 showed longer Position peak time (Tmax, 40.
    5 min VS.
    10min) (see Table 3).

    Table 3 The average pramlintide concentration pharmacokinetic endpoint SD of combined administration and XP-3924, standard deviation; CV%, coefficient of variation.

    1 The value is expressed as the arithmetic mean ± standard deviation (CV%); + Tmax is expressed as the median (range) 2) Safety and tolerability treatment-related adverse events (such as hypoglycemia, injection site discomfort) The incidence and severity of nausea) were similar, and there were no serious adverse events related to the drug (see Table 4).

     Table 4 The safety and tolerability of the three treatment options *AE, adverse events; TEAE, treatment-related emergency adverse events; SAE, serious adverse events.

     Research conclusions Compared with conventional insulin, XP-3924 is well tolerated and can significantly improve postprandial glucose metabolism and blood glucose variability.

    Based on good PK/PD performance, XP-3924 may be a viable alternative to the combination of insulin and pramlintide to improve treatment compliance and overall blood glucose (especially postprandial blood glucose) control, so as to solve the problems in clinical care of T1DM patients.
    Meet the needs.
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