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Post by mango on Jun 7, 2022 11:49:26 GMT -5
Randomized, Double-blind, Placebo-controlled, Multicenter, Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of Prandial Technosphere® Insulin Inhalation Powder Versus Placebo Inhalation Powder in Patients with Type 2 Diabetes Mellitus Inadequately Controlled with Oral Antidiabetic Drugs Over a 24-week Treatment Period.It appears recruitment began a little over a year ago and there is 28 sites. The trial website was recently modified last month. This is 24 week trial so don’t anticipate it completing anytime soon. ctri.nic.in/Clinicaltrials/showallp.php?mid1=45751&EncHid=&userName=Technosphere
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Post by dh4mizzou on Jun 7, 2022 11:50:21 GMT -5
But being is Phase 3 is a big plus, no?
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Post by mango on Jun 7, 2022 11:55:52 GMT -5
But being is Phase 3 is a big plus, no? Definitely. With positive outcomes from this trial we can market and sell in India. |
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Post by hellodolly on Jun 7, 2022 12:13:38 GMT -5
A) At screening, for entering in the run-in period:
1. Subject/LAR is willing to sign the informed consent form
2. Male or female, aged 18 to 65 years (both inclusive)
3. Subject has been diagnosed with T2DM at least 12 months prior to screening visit
4. Receiving tolerated dose of OADs and on stable doses before enrollment.
5. Subject has HbA1c between 7.5% and 10% and FPG <250 mg/dL.
6. No treatment with inhaled or injectable insulin, except during an acute illness, gestational diabetes
7. Subject agrees to have regular inhalations of insulin and use self-monitoring glucose device (glucometer) for recording blood glucose values as required by protocol.
8. Subject, in the opinion of the investigator, understands and is willing, able, and likely to comply with all study procedures and restrictions.
B) Subject has to satisfy the following glycemic criteria at the end of run-in period, prior to randomization to treatment period:
9. Subject has HbA1c between 7.5% and 10% (both inclusive) and FPG <250 mg/dL.
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Post by hellodolly on Jun 7, 2022 12:19:19 GMT -5
Target Sample Size Total Sample Size="216"
Sample Size from India ="216"
Phase of Trial Phase 3
Date of First Enrollment (India)
Modification(s) 25/02/2021
Date of First Enrollment (Global) No Date Specified
Estimated Duration of Trial Years="1"
Months="2"
Days="0"
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Post by cjm18 on Jun 7, 2022 12:20:38 GMT -5
Technosphere insulin in comparison with placebo when added to the anti-diabetic treatment regimen of insulin-naïve Indian patients with T2DM inadequately controlled on optimal/maximally tolerated doses of metformin two or more oral anti-diabetic drugs (OADs).
The only benefit of this trial would be approval in India.
Phase iii compares a drug to another drug. No reason to do Phase 1 and 2 for an already approved drug.
No one in the US goes from metformin to insulin in the standard of care. Maybe India is different.
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Post by sayhey24 on Jun 7, 2022 12:26:02 GMT -5
It sounds like the Affinity2 trial all over again. What am I missing maybe the addition of the use of the self-monitoring glucose meter (glucometer).
Don't you think in this day and age these PWDs could have been given a CGM??? Don't you think we should have near realtime monitoring and dose correction coaching? What is Mike thinking? We don't want superior results again. We want to blow out the superior results.
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Post by Deleted on Jun 7, 2022 16:44:46 GMT -5
But being is Phase 3 is a big plus, no? Definitely. With positive outcomes from this trial we can market and sell in India. Selling in INDIA is not what it's cracked up to be. The profit margins will be extremely low like low single digits. It's going to be worst than selling products at Walmart. And I remember a few years ago that Indian People do not take their meds like we do in the US. |
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Post by akemp3000 on Jun 7, 2022 18:01:34 GMT -5
In addition to a Master's degree at Wharton, Dr. Castagna was Vice President of global commercial with Amgen and Executive Director of Immunology at Bristol Myers Squibb. When it comes to Mannkind in Brazil, India, etc. I'm betting he knows what he's doing within the scope of a master plan. Just like in the U.S. there are plenty of wealthy elitists in these countries who can afford the best healthcare while the poorest cannot. I'm going with MC on this  |
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Post by prcgorman2 on Jun 16, 2022 8:15:18 GMT -5
Definitely. With positive outcomes from this trial we can market and sell in India. Selling in INDIA is not what it's cracked up to be. The profit margins will be extremely low like low single digits. It's going to be worst than selling products at Walmart. And I remember a few years ago that Indian People do not take their meds like we do in the US. Since China is no va, India is the largest possible national population that can have access to Afrezza if approved by the regulatory authority. Even a small percentage could result in a large volume. I don’t know what the marketing constraints are in India, but if they’re more liberal than the US it could be a good proving ground for trying study and marketing techniques not permitted in the US but which may transmit usable information for presentation in the US, and at a reduced cost, especially with an in-country partner taking on some or all of the burden. The upside could be great so I watch with interest. |
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Post by sportsrancho on Jun 16, 2022 8:26:29 GMT -5
They haven’t had a plan, The only plan is to figure out a plan🤷🏼♀️
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Post by prcgorman2 on Jun 16, 2022 8:51:35 GMT -5
They haven’t had a plan, The only plan is to figure out a plan🤷🏼♀️ They = Mannkind and/or Cipla? Interesting assertion. International business contracts typically require lawyers who need someone to tell them what they should be putting into the contract(s). And working with regulators and doctors to develop and execute trials might require some idea of the goals and value of the efforts.
Regardless, you reminded me of one of my favorite scenes from Mad Max - Beyond Thunderdome:
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Post by sportsrancho on Jun 16, 2022 14:25:29 GMT -5
No I just meant regarding Afrezza in general.
Until one day it plays out like in the movie:-)
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