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Post by mnholdem on Oct 6, 2015 12:00:51 GMT -5
Good news...
The trial "Single Dose Clamp Study to Evaluate Concentration-time Profile and Metabolic Activity of 3 Dose Levels of Afrezza and 3 Dose Levels of Insulin Lispro in Patients With Type 1 Diabetes Mellitus" is now complete.
clinicaltrials.gov/ct2/results?term=SAR439065&Search=Search
Sanofi has not posted the results, though.
Hopefully, they are over chatting with the FDA. We sure could use an announcement of an upgraded label, mais oui?
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Post by factspls88 on Oct 6, 2015 12:19:32 GMT -5
Good news...
The trial "Single Dose Clamp Study to Evaluate Concentration-time Profile and Metabolic Activity of 3 Dose Levels of Afrezza and 3 Dose Levels of Insulin Lispro in Patients With Type 1 Diabetes Mellitus" is now complete.
clinicaltrials.gov/ct2/results?term=SAR439065&Search=Search
Sanofi has not posted the results, though.
Hopefully, they are over chatting with the FDA. We sure could use an announcement of an upgraded label, mais oui?
This is great news mn - thanks for posting. I have to believe that this study was done to substantiate and "ultra-rapid" claim/designation. We shall see - but as you said, let's hope they are talking to the FDA as we speak. We could use some good news. |
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Post by vissertrades on Oct 6, 2015 12:19:47 GMT -5
PK/PD graph now flat like scripts and stock price? Sick of this $hit!
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Post by stevil on Oct 6, 2015 12:28:56 GMT -5
Looks like only 30 participants in the study. Hopefully that will be enough for a label change. Small sample size, though...
Briefly glanced at it... does anyone know where to find the results of the study?
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Post by vissertrades on Oct 6, 2015 12:32:31 GMT -5
RESULTS: [...] [...] [...]
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Post by roseylv on Oct 6, 2015 12:38:41 GMT -5
RESULTS: [...] [...] [...] Perhaps a key topic of discussion tomorrow from Matt. I however would counter any result w/ "why such a small sample set of patients? Could you at least get 100+?" The results are there, I know it! |
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Post by avogadro on Oct 6, 2015 12:43:55 GMT -5
Good news...
The trial "Single Dose Clamp Study to Evaluate Concentration-time Profile and Metabolic Activity of 3 Dose Levels of Afrezza and 3 Dose Levels of Insulin Lispro in Patients With Type 1 Diabetes Mellitus" is now complete.
clinicaltrials.gov/ct2/results?term=SAR439065&Search=Search
Sanofi has not posted the results, though.
Hopefully, they are over chatting with the FDA. We sure could use an announcement of an upgraded label, mais oui?
I have a feeling that like all things regarding MNKD, the results will be ambiguous and years away. |
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Post by kimi on Oct 6, 2015 12:57:02 GMT -5
Mnholdem - appreciate your posts - but status complete for this study was end of septemeber - old stuff.
Please remeber Afrezza trial to compare insulin from two different suppliers - completed in Oct 2014 - we've never seen or heard results.
Of course - every disclosing is up to sanofi - not to mannkind - and if I would have to manage afrezza - I would never disclose any information if not necessary.
Our time will come - with european approval and better label ( but the second trial has to be finshed first).
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Post by newmnkdinvestor on Oct 6, 2015 13:17:45 GMT -5
I thought this clamp study was a requirement by the FDA post Afrezza approval. I thought the results from this clamp study will not give SNY the ability to improve the label. Can anyone confirm or deny?
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Post by factspls88 on Oct 6, 2015 13:18:47 GMT -5
RESULTS: [...] [...] [...] Yes the sample size is in the small side, but I have to believe Sanofi knows what they are doing regarding this type of testing and would have coordinated with the fda regarding study design. As I've said before, I suspect this has been done to support an "ultra rapid" label change. We will learn in due time whether or not they were successful. I would put my money on a positive result. |
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Post by docfrezza on Oct 6, 2015 13:33:43 GMT -5
This is primarily a PK profile study in type 1. Not sure if it will be used to change the label. For sure it will not alter the label for type 2 DM use.
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Post by bradleysbest on Oct 6, 2015 13:36:25 GMT -5
Due to competitive reasons Matt won't release the results of the clamp study.....
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Post by dreamboatcruise on Oct 6, 2015 13:38:58 GMT -5
The PD profile graph from prior clamp study is already shown in the prescribing material and insert... clearly indicating more rapid peak and clearance. This new study will produce a similar set of graphs for different doses. Whether that is what the FDA would require to attach a new adjective is something I wouldn't speculate on, though I would speculate that the adjective "ultra" isn't going to be some marketing miracle worker. The data on PD has been out there for some time. Simply saying "ultra" isn't going to effect the rate of formulary improvement, and likely wouldn't sway many doctors. It is data on A1c and hypos that will likely be the important game changer.
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Post by 4Balance on Oct 6, 2015 13:40:07 GMT -5
Due to competitive reasons Matt won't release the results of the clamp study..... How do you know? |
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Post by vissertrades on Oct 6, 2015 13:53:05 GMT -5
ALL of MNKD "details" are [...] :-)
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