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Glucose-Sensitive Insulin (NN1845) Starts A Phase-I Clinical Trial

Discussion in 'Research' started by joshualevy, Dec 12, 2020.

  1. joshualevy

    joshualevy Approved members

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    Glucose sensitive insulin refers to any insulin formulation which becomes more available as blood glucose levels rise, and less available as those levels drop. You can think of these insulins as self regulating or self dosing. A person would inject enough to last for a day or more, but the insulin would only be used by the body when glucose levels were high. A highly sensitive insulin could eliminate the need for measuring blood glucose levels and for determining insulin doses based on food, exercise, or anything else. That would transform T1D management to the same injection each day. In the same way people take high blood pressure medicine each day, a T1D could take glucose sensitive insulin each day, and otherwise ignore their T1D. If successful, this could lead to a "practical cure" even if the person still "had" T1D.

    NN1845 is a glucose sensitive insulin under development by Novo Nordisk.

    The Phase-I Clinical Trial

    Officially, this is one clinical trial, but it is better to think of it as two separate clinical trials under one authorization. Both parts are focused on how NN1845 will act within the body (called pharmacology) and how safe it is. Each part is expected to gather data for 10 days, so this study can be done quickly. A total of 78 people will be enrolled.

    The first part will give healthy people (people who do not have T1D) one dose of NN1845, to measure adverse effects (bad side effects), how their blood glucose changes over time, and what happens to the NN1845. Half the people in this group will get NN1845 and half will get a placebo.

    The second part will give people with established T1D either one dose of NN1845 or one dose of insulin degludec (Tresiba®). Again the researchers will look for adverse effects (bad side effects), how their blood glucose changes over time, and what happens to the NN1845.

    This study is recruiting at the Novo Nordisk Investigational Site in Mainz, Germany, 55116. The only contact information provided is an American phone number:
    (+1) 866-867-7178 clinicaltrials@novonordisk.com

    New article: https://ml-eu.globenewswire.com/Resource/Download/fc66cefd-2090-4c42-95d7-b8c3237a8092 (p18)
    Clinical trial registry: https://www.clinicaltrials.gov/ct2/show/NCT04569994
    Talk: https://www.youtube.com/watch?v=E0wpg4oiDBw

    Discussion

    One thing that I really like about this study is that it should be quick. Each part only requires about 10 days of data collection. This is in stark contrast to most trials I follow, which are often 1 or 2 years. This is because NN1845 is being tested like a new insulin rather than a possible cure. Insulins start out by being tested with one dose, and then for a few weeks, and then for longer. But those first tests are very quick. While people given a potential cure are generally followed for a year or two, and this is true even in the early clinical trials. Therefore, they take a lot longer to move through the development pipeline.

    But there are big issues here. The first is that glucose sensitive insulin is not "fixing" someone's type-1 diabetes. In many ways, it is closer to a pin holding together a bone. The bone is still broken, but the pin allows the person to ignore the fact that the bone is broken. Is that a cure? Is it a practical cure? I'm going to track this as a potential cure, because I think some people will consider it one. However, not everyone will. If you don't consider this a cure, then just ignore my coverage of it.

    The second issue is that this insulin may not be glucose sensitive enough to be a practical cure. If NN1845 is so sensitive that you can take it in the morning, and it will act as a background insulin all day, and react so quickly that you don't need to take extra insulin for meals, for me, that would be a practical cure. But NN1845 may not be that sensitive or that fast acting. Maybe it will act as a background insulin, and make it extra hard to go low, but is not sensitive enough to react to meals. That has some advantages in terms of extra safety as a background insulin, but it is not a practical cure in my mind. For this issue, only clinical trials will answer the question of how sensitive and how fast NN1845 is. Therefore, I'll follow the research and see what we learn.

    Other Glucose Sensitive Insulin Research

    An earlier glucose sensitive insulin was known as "Smart Insulin". That insulin was developed by Smart Cells, Inc. which was bought by Merck. The insulin made it to Phase-I trials, but the results were not good enough to continue in clinical trials.

    About two years ago, Novo Nordisk bought Ziylo, a company developing a glucose sensitive insulin. However, NN1845 is not the Zilyo product. Novo Nordisk development of the Ziylo product was in the news as recently as mid-2020, so the company is positive enough on the general idea of glucose sensitive insulins to develop two different candidates in parallel. That is a strong commitment.

    There are several other glucose sensitive insulins currently in animal testing. Maybe a dozen over all. I'll cover those when they move into human testing.

    Thanks

    I want to specifically thank the JDCA (Juvenile Diabetes Cure Alliance) who tracked down some important background information about NN1845, Novo Nordisk, and Ziylo, and then kindly shared what they learned with me. You can see their other research here: http://thejdca.org/2020-reports
    JDCA does not fund T1D research. They do publish the best public information on how money flows through the T1D research process, and great overviews of the research landscape in general.

    Joshua Levy
    http://cureresearch4type1diabetes.blogspot.com
    publicjoshualevy at gmail dot com

    All the views expressed here are those of Joshua Levy, and nothing here is official JDRF or JDCA news, views, policies or opinions. My daughter has type-1 diabetes and participates in clinical trials, which might be discussed here. My blog contains a more complete non-conflict of interest statement. Thanks to everyone who helps with the blog.
     
  2. rgcainmd

    rgcainmd Approved members

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    Thank you for this information, Joshua!
     
  3. Ernst

    Ernst Approved members

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    Thank you for saying thank you to Joshua Levy.

    Then I don't have to say thank you to Joshua Levy.

    [​IMG]
     
  4. RockReady

    RockReady New Member

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    Dec 19, 2020
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    Hi Mr Levy. Your research and blog are awesome. Major work and dedication it's much appreciated.

    I don't know who runs the forum here. I have 2 threads awaiting moderation. I am also replying here just to test the site.

    Thanks
     
  5. joshualevy

    joshualevy Approved members

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    You guys are welcome, and I'm glad you find the posts helpful. --Joshua
     

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