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Post by mnholdem on May 25, 2016 11:08:55 GMT -5
[NOTE: There are some translation errors, ie Mannkind "Cooperation", Danbury, USA]
Abstracts from ATTD 2016
9th International Conference on
Advanced Technologies & Treatments for Diabetes
Milan, Italy—February 3–6, 2016
324
INCORPORATION OF AFREZZA INTO THE TYPE 2 DIABETES SIMULATOR
R. Visentin 1, T. Klabunde 2, M. Grant3, C. Dalla Man 1, C. Cobelli 1 1 University of Padova, Department of Information Engineering, Padova, Italy
2 Sanofi-Aventis Deutschland GmbH, R&D LGCR/Structure-Design & Informatics, Frankfurt, Germany
3 Mannkind Cooperation, Danbury, USA
Background and Aims: Ten percent of the type 2 diabetic (T2DM) population are treated with multiple daily insulin injections. Insulin delivered subcutaneously (SC) is accepted, but important limitations, such as delay in insulin absorption represent major challenges. Afrezza, an inhaled insulin with a fast onset of action, is an alternative treatment option and provides novel opportunities for the control of prandial glucose. Due to the much faster onset, delayed or split dosing, instead of pre-meal dosing as used for regular SC administered insulins, might lead to an improved glucose control. In order to explore in silico different dosing regimens in a meal test, we incorporated a pharmacokinetic (PK) model of Afrezza into our T2DM simulator (Visentin et al. ATTD2014).
Method: We utilized clinical data of 12 T2DM subjects receiving Afrezza at different doses and undergoing a mixed meal test (MKC-TI-118). The T2DM simulator model was identified on glucose and insulin time courses of individual patients. In particular, individual Afrezza PK were randomly extracted from joint parameter distributions that have been created using the parameter estimates obtained from the model identification. The simulator was then validated by replicating the clinical data.
Results: The results were satisfactory: the glucose and insulin dynamics obtained in silico well described the variability observed in the experimental dataset.
Conclusion: In conclusion, we successfully incorporated Afrezza PK into our T2DM simulator. This will allow running several in silico trials to evaluate the post-prandial glucose control in response to different dosing regimens of Afrezza with the potential to inform clinical study design.
Source: online.liebertpub.com/doi/pdfplus/10.1089/dia.2016.2525?src=recsys& (Pages 130-131)
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Post by Deleted on May 25, 2016 11:11:11 GMT -5
I have no idea how to read these. Satisfactory results? I would rather see Molto Bene!!!!!
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Post by kc on May 25, 2016 11:22:46 GMT -5
Interesting to read and this might go to what either Matt or Michael said regarding future or additional trials for EMA or UK approval. That trials would be simplified and an easier protocol. Hopefully I stated that correctly.
Conclusion: In conclusion, we successfully incorporated
Afrezza PK into our T2DM simulator. This will allow running
several in silico trials to evaluate the post-prandial glucose
control in response to different dosing regimens of Afrezza with
the potential to inform clinical study design
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Post by centralcoastinvestor on May 25, 2016 11:30:51 GMT -5
If I'm reading this study correctly, it allows a company to run a simulated trial. Very cool. This simulation can show you where you have gaps or problems with the trial protocol. Then you tweek the protocol parameters and run the simulation again. Once you feel that the protocol is good, you use real people. I've never heard of this. Wow. This takes the use of algorithms to the next level.
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Post by capnbob on May 25, 2016 11:51:20 GMT -5
If I'm reading this study correctly, it allows a company to run a simulated trial. Very cool. This simulation can show you where you have gaps or problems with the trial protocol. Then you tweek the protocol parameters and run the simulation again. Once you feel that the protocol is good, you use real people. I've never heard of this. Wow. This takes the use of algorithms to the next level. I believe they used data collected from past patient trials to produce a simulation of the type 2's response to injected insulin. They then collected data from 12 type 2s using afrezza and modified their simulator using that data. It looks like it's more of an effort to confirm the validity of the simulator than it is to assess afrezza. If the simulator works, then it might be possible to establish better dosing regimens before beginning a future trial. What I find curious is that they have a Type 1 simulator that they've done quite a bit with -- for example: www.ncbi.nlm.nih.gov/pmc/articles/PMC4074748/I wonder why they didn't use that simulator as opposed to a type 2 one. I can't find anything about their type 2 simulator. |
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Post by matt on May 25, 2016 12:15:25 GMT -5
If I'm reading this study correctly, it allows a company to run a simulated trial. Very cool. This simulation can show you where you have gaps or problems with the trial protocol. Then you tweek the protocol parameters and run the simulation again. Once you feel that the protocol is good, you use real people. I've never heard of this. Wow. This takes the use of algorithms to the next level. Yes, you are reading that correctly. Experiments used to be done in vitro (test tubes) or in vivo (living animals or humans) but since about the 1990's the term in silico (in silicon) has been adopted for computer simulations. Simulations will never replace in vivo testing, but as simulation techniques improve they can be used to avoid conducting studies that are doomed to failure before they even start. That saves a lot of time and money (and the rats appreciate it too). |
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