School of Medicine - Uni of Colorado 5/24/16 :Clinical Trial

[fofos2000i]

Study short title 
"Are you interested in trying inhaled insulin for your meal/correction doses?"


The purpose of this study is to evaluate the blood levels of the study medication (Afrezza®), for blood sugar levels and safety after 4 weeks of treatment in children and adolescents between 4-17 years of age with T1DM


Age 4-17 years Type 1 Diabetes for at least 1 year A1C between 7-10% Stable Insulin doses for the past 6 weeks


www.ucdenver.edu/academics/colleges/medicalschool/research/trials/Lists/Responses/Responses/displayifs.aspx?List=f93e7669-19d2-4c82-bd60-449db7b44e58&ID=384&Source=http%3A%2F%2Fwww%2Eucdenver%2Eedu%2Facademics%2Fcolleges%2Fmedicalschool%2Fresearch%2FPages%2FClinicalTrials%2Easpx&Web=9b78250a-c104-418d-bc49-7bd54ff9051e

All clinical trials:

www.ucdenver.edu/academics/colleges/medicalschool/research/Pages/ClinicalTrials.aspx

[peppy]

May 25, 2016 7:51:10 GMT -5 fofos2000i said:

Study short title 
"Are you interested in trying inhaled insulin for your meal/correction doses?"


The purpose of this study is to evaluate the blood levels of the study medication (Afrezza®), for blood sugar levels and safety after 4 weeks of treatment in children and adolescents between 4-17 years of age with T1DM


Age 4-17 years Type 1 Diabetes for at least 1 year A1C between 7-10% Stable Insulin doses for the past 6 weeks


www.ucdenver.edu/academics/colleges/medicalschool/research/trials/Lists/Responses/Responses/displayifs.aspx?List=f93e7669-19d2-4c82-bd60-449db7b44e58&ID=384&Source=http%3A%2F%2Fwww%2Eucdenver%2Eedu%2Facademics%2Fcolleges%2Fmedicalschool%2Fresearch%2FPages%2FClinicalTrials%2Easpx&Web=9b78250a-c104-418d-bc49-7bd54ff9051e

All clinical trials:

www.ucdenver.edu/academics/colleges/medicalschool/research/Pages/ClinicalTrials.aspx

fofos any date on this anywhere

Any sponsor named anywhere?

www.clinicaltrials.gov/ct2/show/NCT02527265?term=diabetes&lup_s=08/04/2015&lup_d=14&show_rss=Y&sel_rss=mod14

Just want to make sure this isn't information from the cancelled sanofi trial.

[fofos2000i]

please do check , would appreciate your feedback

found it in this list says 24/5/16

www.ucdenver.edu/academics/colleges/medicalschool/research/Pages/ClinicalTrials.aspx

[victoria]

Strictly the trial under Sanofi was 'suspended' per the clinicaltrials.gov site due to the Sanofi handover so perhaps this is the same trial but resuming?

Either way good news if so. Odd the clinicaltrials.gov site has no update about it resuming though and no new entry for a new trial, as far as I can find so far. Perhaps an email to the trial contact will ascertain if trial is current but the posting date rather implies that it is? Maybe someone who has a young diabetic in their family could ask (I don't want to waste their time asking myslelf, doesnt seem fair to the clinicians if Im not capable of being involved even indirectly)

 

[peppy]

May 25, 2016 8:12:32 GMT -5 fofos2000i said:

please do check , would appreciate your feedback

found it in this list says 24/5/16

www.ucdenver.edu/academics/colleges/medicalschool/research/Pages/ClinicalTrials.aspx

screencast.com/t/baUl2tOC4

If MNKD is initiating pediatric study, this is huge.

thank you fofos.

[victoria]

And it is quite a quick trial too so results wont be too delayed. Real progress. The juvenile diabetes market is really important for MNKD IMHO.

[mnholdem]

The pediatric trial is two parts. The first goes quickly, the second part adds another year... unless the FDA changed the requirements.

[victoria]

What is odd is that only recently MNKD tweeted:

MannKind Corporation ‏@mannkindcorp May 9

$MNKD evaluating including amendments to #Afrezza Pediatric Study to support approval criteria in certain international markets.


MannKind Corporation ‏@mannkindcorp May 9

$MNKD #Afrezza Pediatric Study Protocol expected to be complete 3Q16.


- perhaps they completed protocol amended sooner. Would be helpful if MNKD could include current clinical trial info on the website and update us on this since its unclear what the position is. (Dr Castagna if you're reading...)