diaTribe

[sportsrancho]

diatribe.org/drugdevice-name/afrezza

[minnlearner]

GOOD JOB, as usual!

[peppy]

Sept 1, 2016 13:37:27 GMT -5 sportsrancho said:

diatribe.org/drugdevice-name/afrezza

This article is exciting to me because the way afrezza is being described has changed coinciding with the 2016 abstracts.

www.mannkindcorp.com/Collateral/Documents/English-US/Baughman%20poster%20100-LB%20FINAL%20X2.pdf

For example:

Afrezza in now being referred to as ultra rapid

"MannKind has relaunched its ultra-rapid-acting inhaled (needle free) mealtime insulin, "

See the fast in fast out:

 "Afrezza is an ultra-rapid-acting insulin for people with type 1 and 2 diabetes, peaking in only 16-21 minutes versus about 60-90 minutes for current injected rapid-acting insulins such as Humalog and Novolog – that’s a big difference! Recent studies of Afrezza also showed that it lasts two-to-three hours less than other rapid-acting insulins. This is an important advantage for a mealtime insulin – fast-in, fast-out ensures the insulin covers food quickly, without lingering and causing delayed low blood sugar. "

The pediatric trial information:

Twitter Summary: Trial assesses the safety of inhaled rapid-acting insulin Afrezza for pediatric patients – enrolling now in CO + FL.

Clinical Trial Identifier: NCT02527265

Trial name: Afrezza Safety and Pharmacokinetics Study in Pediatric Patients

Diabetes type: Type 1 diabetes

What it’s testing: This trial will assess the safety, pharmacokinetics (how a drug is metabolized by the body), and ability to titrate Afrezza (rapid-acting inhaled insulin) in children ages 4 to 17 years with type 1 diabetes.

Trial participants will initially receive a single dose at breakfast and have several blood draws for four hours to assess pharmacokinetics. They will subsequently receive an individualized dose of Afrezza at each meal (breakfast, lunch and dinner) for 30 days, with an optional extension of up to a year. All participants will receive injections of basal long acting insulin at bedtime each day.

What the trial is measuring: This safety study is focused on adverse events, hypoglycemia, and other critical safety outcomes in kids. More details here.

Why is this new/important: Afrezza was approved in 2014 in adults, and this study could help bring it to younger patients. We believe Afrezza would be particularly useful for children who are averse to needles and injections.

Trial Length: Six to eight weeks (from initial screening to the last follow-up visit), with optional extension up to a year for those who respond well to the Afrezza + basal insulin therapy.

Trial Location: The trial is currently recruiting in Aurora, Colorado and Gainesville, Florida.

Estimated Study Completion Date: August 2017
Estimated Primary Completion Date: August 2017 (Final data collection date for primary outcome measure) 

Quote: "The company also plans to update its product label to reflect how quickly Afrezza works and how to change doses effectively. "

 
Quote from the article:" Afrezza peaks in just 12-15 minutes, making it much faster than current rapid-acting insulins (Humalog, Novolog, and Apidra) that generally take about 45-90 minutes to peak. "

Things have changed.

[sportsrancho]

Thanks peppy for laying it all out! Yes very exciting!

[Deleted]

Oh Peppy on the pediatric trial the rules will be re written as Mnkd is developing a new protocol with JDRF . The new trial may include some aspects of the old trial but I doubt any.

Notice the date of publication 10/05/2015 pay attention

[sportsrancho]

Sept 5, 2016 13:22:39 GMT -5 @iam2sekc4u2002 said:

Oh Peppy on the pediatric trial the rules will be re written as Mnkd is developing a new protocol with JDRF . The new trial may include some aspects of the old trial but I doubt any.

Notice the date of publication 10/05/2015 pay attention

Trial participants will initially receive a single dose at breakfast and have several blood draws for four hours to assess pharmacokinetics. They will subsequently receive an individualized dose of Afrezza at each meal (breakfast, lunch and dinner) for 30 days, with an optional extension of up to a year. All participants will receive injections of basal long acting insulin at bedtime each day.

Why would it be different?

[mannmade]

I hope the trials will be formatted to correct the mistakes made in the adult trials. We all know AFREZZA needs to be administered differently than RAA's otherwise other than safety it may be the same set of issues all over again.

[peppy]

Sept 5, 2016 13:22:39 GMT -5 @iam2sekc4u2002 said:

Oh Peppy on the pediatric trial the rules will be re written as Mnkd is developing a new protocol with JDRF . The new trial may include some aspects of the old trial but I doubt any.

Notice the date of publication 10/05/2015 pay attention

I do see the date published now.

The trial numbers identical.

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

Clinical Trial Identifier: NCT02527265

Damn I really dislike when you talk down to me and turn out to be correct. I can tolerate it this once, since this is the first time you are correct.

[Deleted]

I am sorry if I sounded down talking. I didn't have that intention. Just was trying to level set expectations

[mnholdem]

Now, THAT was funny, peppy.

[nylefty]

Sept 5, 2016 18:46:28 GMT -5 @iam2sekc4u2002 said:

I am sorry if I sounded down talking. I didn't have that intention. Just was trying to level set expectations

As a neutral observer, I gotta say that pay attention is talking down. 

[Deleted]

Sept 5, 2016 19:48:29 GMT -5 nylefty said:

Sept 5, 2016 18:46:28 GMT -5 @iam2sekc4u2002 said:

I am sorry if I sounded down talking. I didn't have that intention. Just was trying to level set expectations

As a neutral observer, I gotta say that pay attention is talking down. 

well.. whats the point in reading something and ignore/not looking at the important details?