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Post by #NoMoreNeedles on Aug 22, 2017 8:50:35 GMT -5
clinicaltrials.gov/ct2/show/NCT03143816?term=MannKind&recrs=abdf&rank=1Sponsor: University of Colorado Denver School of Medicine Barbara Davis Center Collaborators: Atlanta Diabetes Associates University of Southern California Rainier Clinical Research Center Mannkind Corporation Estimated Enrollment: 60 Anticipated Study Start Date: June 15, 2017 Estimated Study Completion Date: October 15, 2017 Estimated Primary Completion Date: October 15, 2017 (Final data collection date for primary outcome measure) Contacts Contact: Dawn White 3037246770 dawn.white@ucdenver.edu
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Post by sellhighdrinklow on Aug 22, 2017 9:02:21 GMT -5
Recruitment has not started yet. Yet, is was supposed to start in June. I really don't understand why not and as far as I know there has been no communication from Mannkind as to what's happening w regard to the study.
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Post by peppy on Aug 22, 2017 9:13:29 GMT -5
ok which is it?
this reminds me of Sanofi Days, trials that were supposedly started, recruitment, never started.
is it? This study is not yet open for participant recruitment. clinicaltrials.gov/ct2/show/NCT03143816?term=MannKind&recrs=abdf&rank=1
or is it?:
A Time-in-Range study has already begun. MannKind is one of the collaborators with the University of Colorado Denver School of Medicine for the STAT study. This is an excerpt from the ClinicalTrials.gov website for this study:
Purpose
This is an investigator-initiated, prospective, randomized, multicenter, parallel, open-label, pilot clinical trial evaluating the efficacy of TI for PPBG, PPGE, and time-in-range on CGM download in patients with T1D. TI is an inhaled ultra-rapid-acting insulin, approved by the FDA for use in patients with diabetes. This is a pilot, real-life study where patients will continue their routine diabetes care and use post-meal correction dosages as deemed necessary for normalizing PPBG as per the protocol.
This multi-center study will enroll 60 patients with T1D, A1c values between 6.5 to 10%. The patients will be randomized in 1:1 fashion to either TI or NL. Patients who are randomized into the NL arm will continue using their usual prandial insulin dose before meals. Patients who are randomized into the TI arm will be instructed to dose before the meals and take necessary corrections at 1- and 2-hours after meals to optimize PPBG (Table 1B). There will be a total of 7 study visits (screening visit, randomization visit, 2 clinic, and 3 phone visits). There will be a 4-week treatment comparison between TI and NL and 1-week of post-study follow up. (Phone visit; Figure-1). Standard lab tests (A1c, complete metabolic panel {CMP}, complete blood count {CBC}) will be performed at the screening visit.
All patients will use real-time CGM (Dexcom G5®, San Diego, CA), which will be provided at the randomization visit for their day-to-day diabetes care. CGM data will be downloaded at every clinic visit on a secured computer. The data will be analyzed after the study for different primary and secondary end points. All patients will be allowed to keep the CGM after the study is over for their day-to-day diabetes care.
Estimated Enrollment: 60
Anticipated Study Start Date: June 15, 2017
Estimated Study Completion Date: October 15, 2017
Estimated Primary Completion Date: October 15, 2017 (Final data collection date for primary outcome measure)
Source: clinicaltrials.gov/ct2/show/NCT03143816?term=Mannkind&recrs=ab&rank=1
Read more: mnkd.proboards.com/thread/8322/mannkind-partner-launch-clinical-trial?page=9#ixzz4qUeIMCAL
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Post by mango on Aug 22, 2017 9:23:20 GMT -5
I believe in the cc Ray or Mike said the trial had already begun recruiting. They just haven't updated status.
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Post by thall on Aug 22, 2017 9:31:02 GMT -5
So Mannkind is giving away 60 Dexcom G5s plus supplies to do a four week study that won't mean anything to insurance companies since they don't seem to care about time in range, etc? Is that sound business logic?
Why are they even bothering to measure "Change in HbA1c in one-month treatment"? HbA1c is a 3 month average so they'll be adding 2 months of "bad" numbers to one with maybe good numbers. That doesn't seem like the best way to get a positive result.
If they're going to spend the money, why not go ahead, lengthen it out to six months, and make it a real study that might produce numbers that an insurance company might be interested in? |
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Post by mnholdem on Aug 22, 2017 10:02:15 GMT -5
Recruitment has not started yet. Yet, is was supposed to start in June. I really don't understand why not and as far as I know there has been no communication from Mannkind as to what's happening w regard to the study. Updates of the information at ClinicalTrials.gov are the responsibly of the company/researcher and they typically do not update very frequently. In other words, the enrollment could be completed by now but the trial information wouldn't reflect it. I often see the status for various biotech clinical trials go from "Not recruiting" to "Complete" with no updates in between - in spite of press releases by the same companies that publish preliminary endpoint data. The only actual requirement by the government is that the trial be registered within 21 days of the first enrollment. Other than that, it's pretty much up to the company and many choose to keep things under wraps for competitive reasons.
It sucks, but that's the current system. 
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Post by dreamboatcruise on Aug 22, 2017 11:01:21 GMT -5
mnholdem... thanks for clarification here. You've answered the question I just posted on the other thread. That would be encouraging if data is really expected in Oct. When I refer to it I shall upgrade my reference from "planned" to "presumably underway". thall... Univ of CO is listed as the sponsor, so perhaps MNKD isn't paying for these. Matt might have speculation about what funding source... do Univ often have sources of money other than the pharma itself? Maybe Dexcom is kicking in some support such as donation of meters.
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Post by itellthefuture777 on Aug 24, 2017 18:44:26 GMT -5
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Post by sayhey24 on Aug 24, 2017 19:50:18 GMT -5
So Mannkind is giving away 60 Dexcom G5s plus supplies to do a four week study that won't mean anything to insurance companies since they don't seem to care about time in range, etc? Is that sound business logic?
Why are they even bothering to measure "Change in HbA1c in one-month treatment"? HbA1c is a 3 month average so they'll be adding 2 months of "bad" numbers to one with maybe good numbers. That doesn't seem like the best way to get a positive result.
If they're going to spend the money, why not go ahead, lengthen it out to six months, and make it a real study that might produce numbers that an insurance company might be interested in? University of Colorado Denver School of Medicine Barbara Davis Center is the sponsor, they are probably giving away the CGMs. As far as insurance companies that means many things. Who pays for Google's health insurance? How about Apple's. Would you like me to name more large companies or even University Systems? Are you seeing the bigger picture? Did you see the deal Aetna did with Apple last week with the IWatch? Whats Aetna trying to do? Who pays for Aetna's 50,000 employee's health insurance, Blue Cross? 24/7 profiling for a month is long enough. The first two weeks are a learning period by the third week they should have afrezza dialed in and the 4th week should provide good data to project what a true A1c would be. But the time in range projects what true medical costs will be; hypos; heart disease, stroke; neuropathy; etc. |
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Post by mango on Sept 13, 2017 12:57:53 GMT -5
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Post by zuegirdor on Sept 13, 2017 13:43:09 GMT -5
This author, Satish Garg, is the same as the one in the trial? Or is he just the contact or a steward of the Clinical Trials franchise? www.nejm.org/doi/full/10.1056/NEJMoa1708337#t=articleThe article on Sotagliflozin in combination with insulin leads with: " In the United States, the number of patients with type 1 diabetes who are younger than 20 years of age may triple within 30 years.2 Less than one third of adults with type 1 diabetes achieve a glycated hemoglobin level lower than 7.0%, and most are overweight or obese.3-5 Patients with type 1 diabetes also face risks of complications or death from severe hypoglycemia and diabetic ketoacidosis.6-10 The ideal treatment for type 1 diabetes should enable patients to maintain a glycated hemoglobin level lower than 7.0% without weight gain or an increased risk of hypoglycemia and diabetic ketoacidosis." .... and concludes that glycemic control was improved but Hypoglycemia and DKA rates were higher with the combo. The Afrezza superiority trial is just a skip and a jump from this study. |
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Post by mango on Sept 13, 2017 14:02:06 GMT -5
This author, Satish Garg, is the same as the one in the trial? Or is he just the contact or a steward of the Clinical Trials franchise? www.nejm.org/doi/full/10.1056/NEJMoa1708337#t=articleThe article on Sotagliflozin in combination with insulin leads with: " In the United States, the number of patients with type 1 diabetes who are younger than 20 years of age may triple within 30 years.2 Less than one third of adults with type 1 diabetes achieve a glycated hemoglobin level lower than 7.0%, and most are overweight or obese.3-5 Patients with type 1 diabetes also face risks of complications or death from severe hypoglycemia and diabetic ketoacidosis.6-10 The ideal treatment for type 1 diabetes should enable patients to maintain a glycated hemoglobin level lower than 7.0% without weight gain or an increased risk of hypoglycemia and diabetic ketoacidosis." .... and concludes that glycemic control was improved but Hypoglycemia and DKA rates were higher with the combo. The Afrezza superiority trial is just a skip and a jump from this study. This was the inTandem3 clinical trial, and I think an inTandem1 and inTandem2 had already been completed. Looking at the financial disclosure reveals: Supported by Lexicon Pharmaceuticals. (Lexicon Pharmaceuticals and Sanofi entered a license agreement, effective November 2015, and are collaborating on the development and commercialization of sotagliflozin.)   |
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Post by mango on Sept 13, 2017 14:04:21 GMT -5
Consensus: Sotagliflozin is unsafe.
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