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Post by harryx1 on Oct 14, 2019 10:46:22 GMT -5
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Post by hellodolly on Oct 14, 2019 10:53:37 GMT -5
NCT number not found? I clicked on the link and that was the response, Harry.
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Post by harryx1 on Oct 14, 2019 10:57:38 GMT -5
I updated it with a different link but the original link was working for me.
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Post by mango on Oct 14, 2019 11:14:29 GMT -5
Nice!
This appears to be a 16 week, Investigational, Phase 4, investigator-initiated clinical trial.
Collaborators:
Mannkind Corporation
DexCom, Inc.
Primary Outcome Measures:
1. Time In Range [ Time Frame: Week 2 to End of Study ] Evaluation of percentage of time spent in goal range, above (hyperglycemic range) and below (hypoglycemic range) via CGM system from visit week 2 baseline to final study visit with inhaled insulin (Afrezza®).
2. Hypoglycemia [ Time Frame: Week 2 to Week 16 ] Incidence of significant hypoglycemic events
Secondary Outcome Measures:
1. Hemoglobin A1c [ Time Frame: Week 2 to Week 16 ] Evaluation of A1c from visit week 2 baseline to final study visit
2. Quality of Life Questionnaires [ Time Frame: Screening to Week 16 ] Evaluation of Diabetes Quality of Life Questionnaires from baseline to final study visit.
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Post by mnholdem on Oct 14, 2019 11:18:48 GMT -5
clinicaltrials.gov/ct2/show/NCT04125082?term=mannkind&recrs=abf&rank=3Study Type : Interventional (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Single-Site, Investigator-Initiated Study to Evaluate Time in Range in Subjects With Type 2 Diabetes Mellitus Using Mealtime Inhaled Insulin (Afrezza®) Plus Basal Insulin Compared to Multiple Daily Injections
Actual Study Start Date : February 27, 2019
Estimated Primary Completion Date : November 1, 2019
Estimated Study Completion Date : March 1, 2020Recruitment Status : Recruiting First Posted : October 14, 2019 Last Update Posted : October 14, 2019 It would appear that the Estimated Primary Completion Date is only a few weeks away. If the Actual Study Start Date was in February, why would MannKind wait until October 14 to make its first post with ClinicalTrials.gov? This management team is strange... 
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Post by mango on Oct 14, 2019 11:25:09 GMT -5
Very nice to see Dexcom and MannKind working closely together on such an important project.
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Post by mango on Oct 14, 2019 11:33:30 GMT -5
clinicaltrials.gov/ct2/show/NCT04125082?term=mannkind&recrs=abf&rank=3Study Type : Interventional (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Single-Site, Investigator-Initiated Study to Evaluate Time in Range in Subjects With Type 2 Diabetes Mellitus Using Mealtime Inhaled Insulin (Afrezza®) Plus Basal Insulin Compared to Multiple Daily Injections
Actual Study Start Date : February 27, 2019
Estimated Primary Completion Date : November 1, 2019
Estimated Study Completion Date : March 1, 2020Recruitment Status : Recruiting First Posted : October 14, 2019 Last Update Posted : October 14, 2019 It would appear that the Estimated Primary Completion Date is only a few weeks away. If the Actual Study Start Date was in February, why would MannKind wait until October 14 to make its first post with ClinicalTrials.gov? This management team is strange... 🥳 SURPISE! 🥳 |
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Post by centralcoastinvestor on Oct 14, 2019 11:44:41 GMT -5
Great find. This is good news. Having DexCom involved is also very good. Time in Range is heading towards being the Standard of Care approach to managing diabetes. Afrezza cannot be beat in that arena. |
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Post by mnholdem on Oct 14, 2019 11:48:03 GMT -5
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Post by mnholdem on Oct 14, 2019 12:44:29 GMT -5
In all fairness to MannKind management:
Information provided by (Responsible Party):
Diabetes and Glandular Disease Clinic
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Post by radgray68 on Oct 14, 2019 12:51:04 GMT -5
I LOVE IT! Love the evolution of medical thinking to finally recognizing the importance of time in range. Hope the insurance payers take note now.
Just wish it were 300 instead of 30. But, larger India trials are coming up hopefully soon.
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Post by mango on Oct 14, 2019 13:15:46 GMT -5
Positive outcomes from this clinical trial will warrant revision to ADA’s SoC, IMO.
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Post by mnholdem on Oct 14, 2019 14:03:04 GMT -5
I used to think that about short-term intensive insulin treatment for early Type 2 diabets. ~ 50% drug free remission, multiple studies involving thousands of trial participants and STII still barely gets a mention in the Standard of Care and remains the last choice for treatment.
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Post by goyocafe on Oct 14, 2019 14:15:45 GMT -5
I used to think that about short-term intensive insulin treatment for early Type 2 diabets. ~ 50% drug free remission, multiple studies involving thousands of trial participants and STII still barely gets a mention in the Standard of Care and remains the last choice for treatment. Imagine what it would mean to the sponsors and major contributors of the ADA to see all the drugs they've developed suddenly lose 50% of the patients using them. I wonder to what extent the establishment would go to squelch the release of a real cure. |
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Post by letitride on Oct 14, 2019 17:30:39 GMT -5
I want to believe MC is doing things on the down low for my good pleasure, and all do malice toward short interest.
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