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Post by madog365 on May 8, 2017 20:05:44 GMT -5
Saw this posted on ST. New clinical trial: 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. clinicaltrials.gov/ct2/show/NCT03143816?term=afrezza&rcv_s=05%2F01%2F2017&rank=4Estimated 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) |
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Post by fanz8967 on May 8, 2017 20:09:35 GMT -5
Saw this posted on ST. New clinical trial: 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. clinicaltrials.gov/ct2/show/NCT03143816?term=afrezza&rcv_s=05%2F01%2F2017&rank=4Estimated 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) Big news!! |
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Post by sellhighdrinklow on May 8, 2017 20:18:29 GMT -5
Saw this posted on ST. New clinical trial: 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. clinicaltrials.gov/ct2/show/NCT03143816?term=afrezza&rcv_s=05%2F01%2F2017&rank=4Estimated 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) Big news!! This is why the MNKD traded up and at high volume. Imho!!! Type 1 here, 39 years, Afrezza user, 2-years. Dexcom CGM user for...Can't recall exactly..Probably 4, 5 or 6 years. The holy Grail is coming. Stay tuned ! |
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Post by madog365 on May 8, 2017 20:19:31 GMT -5
This is why the MNKD traded up and at high volume. Imho!!! Type 1 here, 39 years, Afrezza user, 2-years. Dexcom CGM user for...Can't recall exactly..Probably 4, 5 or 6 years. The holy Grail is coming. Stay tuned ! I guess mannkind expects to be around in october, who would have thunk it? |
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Post by promann on May 8, 2017 21:16:41 GMT -5
Not sure what this is means.. But if it's just to show how great Afrezza is that's great. But I would be concerned if this was mandated by the FDA for a label change..
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Post by peppy on May 8, 2017 21:29:33 GMT -5
Saw this posted on ST. New clinical trial: 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. clinicaltrials.gov/ct2/show/NCT03143816?term=afrezza&rcv_s=05%2F01%2F2017&rank=4Estimated 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) Study Comparing Prandial Insulin Aspart vs. Technosphere Insulin in Patients With Type 1 Diabetes on Multiple Daily Injections: Investigator-Initiated A Real-life Pilot Study—STAT 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.
so PPBG post prandial blood glucose. THE TIME IN RANGE. PPGE post prandial glucose excursions.
Sponsors and Collaborators
University of Colorado Denver School of Medicine Barbara Davis Center
Atlanta Diabetes Associates
University of Southern California
Rainier Clinical Research Center
Mannkind Corporation
Anticipated Start Date ICMJE
June 15, 2017 Estimated Primary Completion Date
October 15, 2017 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE
(submitted: May 3, 2017)
•Improved time in range (70-180 mg/dl) with TI on CGM [ Time Frame: 4 weeks ]
•Better post-prandial glucose excursion (1-4 hours after meals) with TI [ Time Frame: 4 weeks ] Current Secondary Outcome Measures ICMJE
(submitted: May 3, 2017)
•Less glucose variability (GV) (standard deviation and/or coefficient variation) [ Time Frame: 4 weeks ]
•The area under the curve calculation (AUC) in the PPBG and PPGE, [ Time Frame: 4 weeks ]
•Change in HbA1c in one-month treatment [ Time Frame: 4 weeks ]
•above the target time (>180 mg/dl) on CGM [ Time Frame: 4 weeks ]
•hypoglycemia frequency (below the target <70, <60, <50 mg/dl) on CGM [ Time Frame: 4 weeks ]
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)
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Post by boytroy88 on May 8, 2017 21:44:47 GMT -5
Saw this posted on ST. New clinical trial: 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. clinicaltrials.gov/ct2/show/NCT03143816?term=afrezza&rcv_s=05%2F01%2F2017&rank=4Estimated 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) 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.
so PPBG post prandial blood glucose. THE TIME IN RANGE. PPGE post prandial glucose excursions.
Sponsors and Collaborators
University of Colorado Denver School of Medicine Barbara Davis Center
Atlanta Diabetes Associates
University of Southern California
Rainier Clinical Research Center
Mannkind Corporation
Woohoo!! |
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Post by lakers on May 8, 2017 23:18:08 GMT -5
TI is an inhaled ultra-rapid-acting insulin, approved by the FDA. Mnkd must have anticipated the URA label approved before the above study starts.
Anticipated Study Start Date: June 15, 2017
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Post by slapshot on May 9, 2017 6:20:24 GMT -5
Not to throw a wrench in the study, but i thought a major problem with the nda clinical trial was the timing of the dosing, particularly that it (before the meal) was too soon?
"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)"
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Post by hellodolly on May 9, 2017 6:26:43 GMT -5
Not to throw a wrench in the study, but i thought a major problem with the nda clinical trial was the timing of the dosing, particularly that it (before the meal) was too soon? "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)" Yes, to compare to the 1st arm of the trial, as both arms dose before meals: "Patients who are randomized into the NL arm will continue using their usual prandial insulin dose before meals." I think they had no choice. |
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Post by Deleted on May 9, 2017 7:00:18 GMT -5
slapshot to make a comparative study both medications have to be administered at the same time, hence the possible need for corrections.
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Post by promann on May 9, 2017 7:06:32 GMT -5
I elect Sam to supervise the trials, Or at least someone that knows how it works as well as he does..
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Post by MnkdWASmyRtrmntPlan on May 9, 2017 8:17:01 GMT -5
This is why the MNKD traded up and at high volume. Imho!!! Type 1 here, 39 years, Afrezza user, 2-years. Dexcom CGM user for...Can't recall exactly..Probably 4, 5 or 6 years. The holy Grail is coming. Stay tuned ! I guess mannkind expects to be around in october, who would have thunk it? Yes, mgt continues to keep giving that impression. The big elephant-in-the-room question lurking is whether the current stockholders will still be around in October. Hopefully, we will get some insight to that answer tomorrow. |
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Post by Deleted on May 9, 2017 9:01:30 GMT -5
Does the ultra-rapid description in the trial indicate Mannkind has received the label change approval?
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Post by scanderson1961 on May 9, 2017 9:43:35 GMT -5
Does the ultra-rapid description in the trial indicate Mannkind has received the label change approval? Email Matt and let' us know too if you hear from him? |
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