Pediatric Trial Enrollment Underway

[neil36]

Multi-center study to assess the efficacy and safety of Afrezza in patients aged 4-17 living with type 1 or type 2 diabetes
WESTLAKE VILLAGE, Calif., Oct. 04, 2021 (GLOBE NEWSWIRE) -- MannKind Corporation (Nasdaq: MNKD), a company focused on the development and commercialization of inhaled therapeutic products for patients with endocrine and orphan lung diseases, announced today the enrollment of the first pediatric patient in the INHALE-1 study. The multi-center study will evaluate the efficacy and safety of Afrezza® (Technosphere Insulin) in combination with basal insulin vs. multiple daily injections of insulin in children and adolescents aged 4-17 who are living with type 1 or type 2 diabetes.

“We are pleased to announce enrollment has begun for the INHALE-1 Phase 3 study, which is designed to assess the safety and efficacy of Afrezza in young people living with type 1 or type 2 diabetes,” said Dr. Kevin Kaiserman, Vice President, Medical Affairs and Safety of MannKind Corporation. “MannKind is pleased to sponsor this study with the goal of bringing Afrezza to a younger generation.”

INHALE-1 is a 26-week open-label, randomized clinical trial with a 26-week extension. The primary endpoint is change in HbA1c level after 26 weeks. Secondary endpoints include change in fasting plasma glucose after 26 weeks and rate of hypoglycemic events.

Enrollment is underway at several sites, including AM Diabetes & Endocrinology Center in Bartlett, Tenn., where the first patient was enrolled. In all, approximately 260 patients are planned to be enrolled at more than 30 sites across the United States. Details of the study and sites can be found at: clinicaltrials.gov/ct2/show/NCT04974528.

“We are glad to see the INHALE-1 study start enrolling pediatric patients and look forward to its expansion to more youth across the country,” said Dr. Michael J. Haller, Professor and Chief of Pediatric Endocrinology at the University of Florida and Chair for the INHALE-1 study. “Being involved with studies that can impact a large population of people living with T1D/T2D is so valuable, and I’m looking forward to seeing the data as MannKind continues to explore the potential of Afrezza for youth.”

For more information about INHALE-1, please visit go.afrezza.com/INHALE1 or email [e-mail].

[Clement]

possible FDA approval in late 2025?

Estimated Study Completion Date : April 2024

[esstan2001]

No mention of TIR? Use of continuous monitors? Will have to look at the trial registration statement, Jas to be there as secondary metric I would think..

[esstan2001]

Oct 4, 2021 8:15:40 GMT -5 esstan2001 said:

No mention of TIR? Use of continuous monitors? Will have to look at the trial registration statement, has to be there as secondary metric I would think..

Well maybe not for 4 yr olds…

[Clement]

Oct 4, 2021 8:15:40 GMT -5 esstan2001 said:

No mention of TIR? Use of continuous monitors? Will have to look at the trial registration statement, Jas to be there as secondary metric I would think..

clinicaltrials.gov/ct2/show/NCT04974528

"Outcome Measures
Go to sections

Primary Outcome Measures :

Change in HbA1c After 26 Weeks [ Time Frame: 26 weeks ]
HbA1c change after 26 weeks of Afrezza compared to Rapid-Acting Analog (RAA)


Secondary Outcome Measures :

Change in Fasting Plasma Glucose (FPG) After 26 weeks [ Time Frame: 26 weeks ]
FPG change after 26 weeks of Afrezza compared to Rapid-Acting Analog (RAA)

Rate of Hypoglycemic Events After 26 weeks [ Time Frame: 26 weeks ]
Event rate of hypoglycemia (SMBG <70 mg/dL) after 26 weeks of Afrezza compared to Rapid-Acting Analog (RAA).


Other Outcome Measures:

Time in Range (70 - 180 mg/dL) [ Time Frame: 26 weeks ]
Time in Range after 26 weeks of Afrezza compared to Rapid-Acting Analog (RAA), based on continuous glucose monitoring derived glucose values.

Change in Percent Time with Glucose <54 mg/dL [ Time Frame: 26 weeks ]
Percent Time with Glucose <54 mg/dL after 26 weeks of Afrezza compared to Rapid-Acting Analog (RAA), based on continuous glucose monitoring derived values.

Time Below Range (glucose <70 mg/dL) [ Time Frame: 26 weeks ]
Time Below Range after 26 weeks of Afrezza compared to Rapid-Acting Analog (RAA), based on continuous glucose monitoring derived values."


<There's more.  Just go to the link.>

[Deleted]

Oct 4, 2021 7:57:29 GMT -5 Clement said:

possible FDA approval in late 2025?

Estimated Study Completion Date : April 2024

There's talk this could take up to a year to complete enrollment.  It could be difficult to find kids not on the pump. 

[Clement]

Oct 4, 2021 8:15:40 GMT -5 esstan2001 said:

No mention of TIR? Use of continuous monitors? Will have to look at the trial registration statement, Jas to be there as secondary metric I would think..

clinicaltrials.gov/ct2/show/NCT04974528
Under inclusion criteria, one of the bullets says,
"Utilized continuous glucose monitor (CGM) for ≥70% of the time over a 14-day period preceding randomization."

(That's all I can find about CGMs, but there might be more.)
(For TIR, see my earlier post.)

[cedafuntennis]

Me too, but this is not TIR.  This is just what the patients need to do to be included in the trial, not a target.  They MUST include a test point about TIR, otherwise that would be a major miss.  Maybe they are again giving the FDA Gods their bribe by not including important results not to rock the boat, just like they did in the first trial.  Hope not!

[Clement]

TIR is under "other outcome measures" in the clinicaltrials.gov link above.

[oldfishtowner]

Oct 4, 2021 7:57:29 GMT -5 Clement said:

possible FDA approval in late 2025?

Estimated Study Completion Date : April 2024

The primary completion date is April 2023.  Castagna said at one point that the FDA had agreed to a 6-month study.  So, the way I interpret the trial description is that all of the data for submission will be collected by the projected primary completion date and MNKD can submit an NDA on the basis of these data.  This leads me to believe MNKD could submit an NDA after the primary completion date.   Maybe the extended 52-week data were required in order to get the FDA to agree to the 6-month study, or maybe MNKD thought the data after 52 weeks would show even more improvement with Afrezza over injected RRA.   Based on this I think that approval could be as early as 2024 if MNKD can keep to the projected schedule.

[mango]

I would like to point out one very important detail with this clinical trial that has been overlooked.

Someone correct me here if I am incorrect, but I believe that neither insulin aspart/fiasp, lispro nor glulisine is approved for children with type 2 diabetes.

In this clinical trial, Afrezza is being evaluated in pediatrics and adolescents with type 1 and type 2 diabetes.

If approved by FDA, Afrezza will become the first and only mealtime insulin that I am aware of that will be FDA approved for children with type 2 diabetes (assuming I am correct, would be nice if someone else can confirm).

[myocat]

The data readout should be by Mid March 2022.

[sportsrancho]

Medication. There are three medications that have been approved by the Food and Drug Administration for treating type 2 diabetes in children — metformin (Glumetza, others), liraglutide (Victoza) and insulin. Metformin is a pill and liraglutide and insulin are taken by injection.