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Post by Deleted on Sept 14, 2015 12:39:36 GMT -5
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Post by mssciguy on Sept 14, 2015 12:43:05 GMT -5
Mentally prepare yourself for $22 share price @kastanes Kids HATE needles, did you, @kastanes?
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Post by peppy on Sept 14, 2015 13:02:58 GMT -5
To assess the safety and tolerability of Afrezza in children ages 4 to 17 years with type 1 diabetes mellitus (T1DM). yay
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Post by dreamboatcruise on Sept 14, 2015 13:25:48 GMT -5
Does anyone know the process for getting an already approved drug approved for pediatric use? Are there 3 phases of trials just like for initial approval?
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Post by nemzter on Sept 14, 2015 13:52:52 GMT -5
Estimated Enrollment: 46 Study Start Date: August 2015 Estimated Study Completion Date: July 2017 Estimated Primary Completion Date: July 2017 (Final data collection date for primary outcome measure)
Hmm, is there a pediatric T2DM study as well?
Edit - doh! this is only a Phase 1 study
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Post by saradm16 on Sept 14, 2015 14:01:12 GMT -5
I think most children have type 1.
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Post by peppy on Sept 14, 2015 14:14:26 GMT -5
According to the American Diabetes Association, about 3,600 people under the age of 20 are diagnosed with type 2 diabetes every year. ===================================================================================================================================
In the United States, the peak age at diagnosis is around 14. Type 1 diabetes is associated with deficiency (or lack) of insulin.May 27, 2014 •1.25M Americans are living with T1D including about 200,000 youth (less than 20 years old) and over a million adults (20 years old and older) 1,2,5 •40,000 people are diagnosed each year in the U.S. 1, 2 •5 million people in the U.S. are expected to have T1D by 2050, including nearly 600,000 youth. 2,3 •Between 2001 and 2009 there was a 21% increase in the prevalence of T1D in people under age 20.
jdrf.org/about-jdrf/fact-sheets/type-1-diabetes-facts/
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Post by saradm16 on Sept 14, 2015 14:20:18 GMT -5
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Post by brentie on Sept 14, 2015 14:35:13 GMT -5
Does anyone know the process for getting an already approved drug approved for pediatric use? Are there 3 phases of trials just like for initial approval? It looks that way, otherwise this would be a phase 4 trial. Question: What are clinical trial phases? Answer: Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question. Phase I: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects. Phase II: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety. Phase III: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely. Phase IV: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use. www.nlm.nih.gov/services/ctphases.html
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Post by mssciguy on Sept 14, 2015 16:44:49 GMT -5
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Post by Deleted on Sept 14, 2015 16:53:32 GMT -5
I am surprised at the last primary measurement required in the trial and hence the reason for it lasting more than a year.
"Measurement of anti-insulin antibodies [ Time Frame: Up to 13 months ] Designated as safety issue: Yes"
Do some people create insulin antibodies?
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Post by mssciguy on Sept 14, 2015 16:55:05 GMT -5
I am surprised at the last primary measurement required in the trial and hence the reason for it lasting more than a year. "Measurement of anti-insulin antibodies [ Time Frame: Up to 13 months ] Designated as safety issue: Yes" Do some people create insulin antibodies? That is a great question. Maybe that is part of the puzzle of why the pancreas gets attacked by the immune system. Maybe the doctors will chime in?
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Post by Deleted on Sept 14, 2015 17:07:53 GMT -5
There are two immune responses involved here: white blood cells attaching insulin producing cells and B-cells producing insulin antibodies. If a person is injecting insulin and the immune system can produce antibodies against insulin, these antibodies would have been created early. Is this legitimate or another impediment thrown in front of Afrezza?
Are there documented cases of insulin antibodies?
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Post by peppy on Sept 14, 2015 17:28:45 GMT -5
There are two immune responses involved here: white blood cells attaching insulin producing cells and B-cells producing insulin antibodies. If a person is injecting insulin and the immune system can produce antibodies against insulin, these antibodies would have been created early. Is this legitimate or another impediment thrown in front of Afrezza? Are there documented cases of insulin antibodies? yes, the board has mentioned this. Insulin antiboidies were included in trial 171 and 175 data that I can recall.
I'll dig it up.
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Post by mssciguy on Sept 14, 2015 17:37:53 GMT -5
There are two immune responses involved here: white blood cells attaching insulin producing cells and B-cells producing insulin antibodies. If a person is injecting insulin and the immune system can produce antibodies against insulin, these antibodies would have been created early. Is this legitimate or another impediment thrown in front of Afrezza? Are there documented cases of insulin antibodies? Do you have a whole day to parse these absracts? www.google.com/webhp?sourceid=chrome-instant&rlz=1C1CHFX_enUS607US607&ion=1&espv=2&ie=UTF-8#q=pubmed%20antibodies%20to%20insulinIt's a great topic and a great question, will revisit tomorrow, enjoy
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