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Related Concept Videos

End Point Prediction: Gran Plot01:07

End Point Prediction: Gran Plot

A Gran plot is used to predict the equivalence volume or endpoint of a potentiometric or acid-base titration without reaching the endpoint. Typically, titration data is collected as a function of the titrant's volume up to a point less than the equivalence volume and then transformed into a linear format. The straight line is extended to the x-axis, indicating the necessary titrant volume to achieve the equivalence point.
For potentiometric titration, the Gran plot is created by plotting the...
Glycolysis: Pay-off Phase01:25

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So far, glycolysis has cost the cell two ATP molecules and produced two small, three-carbon sugar molecules. These molecules will proceed through the second half of the pathway, and sufficient energy will be extracted to pay back the two ATP molecules used as an initial investment and produce a profit for the cell of two additional ATP molecules and two even higher-energy NADH molecules.
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The Endoplasmic Reticulum01:43

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The endoplasmic reticulum or ER makes up for more than half of the membranes in a cell and accounts for 10% of total cell volume. It is also the primary protein and lipid synthesis factory for most cell organelles, such as the Golgi apparatus, lysosomes, secretory vesicles, and the plasma membrane. Despite being the most extensive and functionally complex subcellular organelle, ER was the last to be discovered. After years of deliberation, Keith Porter and George Palade in the year 1954,...
The Endoplasmic Reticulum01:43

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What is the Endocrine System?00:46

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The endocrine system sends hormones—chemical signals—through the bloodstream to target cells—the cells the hormones selectively affect. These signals are produced in endocrine cells, secreted into the extracellular fluid, and then diffuse into the blood. Eventually, they diffuse out of the blood and bind to target cells which have specialized receptors to recognize the hormones.
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Essential proteins such as insulin or low-density lipoprotein (LDL) and micronutrients such as iron enter a eukaryotic cell through receptor-mediated endocytosis. Subsequently, the early endosomes fuse with the vesicles containing such receptor-ligand complexes and play a vital role in sorting the incoming ligands and receptors. While the ligands are either degraded inside the vesicle or released into the cytosol, their receptors are returned to the plasma membrane for further rounds of...

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Microbial Communities in Nature and Laboratory - Interview
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The end point is just the beginning.

Douglas Muchmore1

  • 1Halozyme Therapeutics, Inc., San Diego, California 92121, USA. dmuchmore@halozyme.com

Journal of Diabetes Science and Technology
|October 27, 2011
PubMed
Summary

Developing new diabetes drugs is costly. A proposed composite endpoint combines glycosylated hemoglobin (A1C) and hypoglycemia risk for more meaningful clinical trial results.

Area of Science:

  • Endocrinology
  • Clinical Pharmacology
  • Biostatistics

Background:

  • Drug registration trials are resource-intensive.
  • Glycosylated hemoglobin (A1C) is an accepted surrogate endpoint for glycemic control in diabetes trials.
  • Current guidelines assess A1C efficacy and hypoglycemia safety separately, limiting interpretability.

Purpose of the Study:

  • To propose a composite endpoint for diabetes clinical trials.
  • To integrate glycemic control (A1C) and hypoglycemia risk into a single measure.
  • To discuss the advantages and disadvantages of this novel approach.

Main Methods:

  • Literature review of current regulatory guidance for diabetes trials.
  • Conceptualization of a composite endpoint integrating A1C and hypoglycemia.

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  • Discussion of the potential benefits and limitations of the proposed endpoint.

    • Main Results:

    • A composite endpoint, such as "percentage of patients achieving A1C <7% without unacceptable hypoglycemia," is proposed.
    • This approach offers a more holistic view of treatment efficacy and safety.
    • Separate assessment of A1C and hypoglycemia may not fully reflect clinical utility.

    Conclusions:

    • A composite endpoint can provide a more comprehensive evaluation of diabetes treatments.
    • Integrating efficacy and safety endpoints may improve the efficiency and relevance of clinical trials.
    • Further validation and discussion are needed to implement such composite endpoints in regulatory practice.