A few more quick notes:
The Peds trial also has superiority endpoints in the Secondary Outcomes. Chance to show superiority. This could be HUGE.
No Tyvaso DPI supply constraints. Next 4 weeks they will be ready to start meeting UT’s desire for 2 years worth of inventory.
Extremely low drop out rate due to side effects for Afrezza. We’ve known this it’s the safest insulin on the market.
MannKind and UT continue to explore a SECOND molecule.
UT has been a PHENOMENAL partner so far. Great partnership.
Secondary Outcome Measures :
Change in HbA1c [ Time Frame: 26 weeks ]
Change in HbA1c from baseline to Week 26, for superiority assessment
Change in Fasting Plasma Glucose (FPG) [ Time Frame: 26 weeks ]
Change in FPG from baseline to Week 26, for superiority assessment
Event rate of pooled level 2 and level 3 hypoglycemia [ Time Frame: 26 weeks ]
Event rate of pooled level 2 and level 3 hypoglycemia (self-monitored blood glucose [SMBG] <54 mg/dL and/or severe hypoglycemic events) during the 26-week randomized treatment period, for superiority assessment
This is why it took MNKD 2+ years to design the protocols.
Other Outcome Measures:
Event rate of level 1 hypoglycemia (SMBG <70 mg/dL) [ Time Frame: 26 weeks ]
Event rate of level 1 hypoglycemia during the 26-week randomized treatment period
Change in percent Time In Range (glucose 70 - 180 mg/dL) [ Time Frame: 26 weeks ]
Change in percent Time In Range from baseline to Week 26, using Continuous Glucose Monitoring (CGM)-derived data collected over the preceding 30 days for the 24-hour, daytime and nocturnal time periods
Change in percent time with glucose <54 mg/dL [ Time Frame: 26 weeks ]
Change in percent time with glucose <54 mg/dL from baseline to Week 26, using CGM-derived data collected over the preceding 30 days for the 24-hour, daytime and nocturnal time periods
Change in percent Time Below Range (glucose <70 mg/dL) [ Time Frame: 26 weeks ]
Change in percent Time Below Range from baseline to Week 26, using CGM-derived data collected over the preceding 30 days for the 24-hour, daytime and nocturnal time periods
Change in percent Time Above Range (glucose >180 mg/dL) [ Time Frame: 26 weeks ]
Change in percent Time Above Range from baseline to Week 26, using CGM-derived data collected over the preceding 30 days for the 24-hour, daytime and nocturnal time periods
Percentage of subjects with HbA1c <7.0% [ Time Frame: At Week 26 ]
Percentage of subjects with HbA1c <7.0% at Week 26
Score of Diabetes Treatment Satisfaction Questionnaire (DTSQ) Change (c)-Teen [ Time Frame: At Week 26 ]
Score of DTSQ(c)-Teen at Week 26 in the Afrezza group (score ranges from -24 to 24, with higher score means greater satisfaction)
Score of Diabetes Treatment Satisfaction Questionnaire (DTSQ) Change (c)-Parent [ Time Frame: At Week 26 ]
Score of DTSQ(c)-Parent at Week 26 in the Afrezza group (score ranges from -30 to 30, with higher score means greater satisfaction)
Change in scores of DTSQ Status (s)-Teen [ Time Frame: 26 weeks ]
Change in scores of DTSQ(s)-Teen from baseline to Week 26 (change in score ranges from -48 to 48, with higher score means greater satisfaction)
Change in scores of DTSQ Status (s)-Parent [ Time Frame: 26 weeks ]
Change in scores of DTSQ(s)-Parent from baseline to Week 26 (change in scores ranges from -60 to 60, with higher score means greater satisfaction)
Change in HbA1c [ Time Frame: 52 weeks (and 26 weeks if required) ]
Change in HbA1c from baseline to Week 52 (and change from Week 26 to Week 52 if required) in subjects who switch from treatment with RAA injections to Afrezza at Week 26
Change in FPG [ Time Frame: 52 weeks (and 26 weeks if required) ]
Change in FPG from baseline to Week 52 (and change from Week 26 to Week 52 if required) in subjects who switch from treatment with RAA injections to Afrezza at Week 26
Change in percent Time In Range, Time Below Range and Time Above Range [ Time Frame: 52 weeks (and 26 weeks if required) ]
Change in percent Time In Range, Time Below Range and Time Above Range from baseline to Week 52 (and change from Week 26 to Week 52 if required) in subjects who switch from treatment with RAA injections to Afrezza at Week 26; using CGM-derived data collected over the preceding 30 days for the 24-hour, daytime, and nocturnal periods
Change in HbA1c [ Time Frame: 52 weeks ]
Change in HbA1c from baseline to Week 52 in subjects who receive Afrezza in both the randomized treatment period and the treatment extension
Change in FPG [ Time Frame: 52 weeks ]
Change in FPG from baseline to Week 52 in subjects who receive Afrezza in both the randomized treatment period and the treatment extension
Change in percent Time In Range, Time Below Range and Time Above Range [ Time Frame: 52 weeks ]
Change in percent Time In Range, Time Below Range and Time Above Range from baseline to Week 52 in subjects who receive Afrezza in both the randomized treatment period and the treatment extension; using CGM-derived data collected over the preceding 30 days for the 24-hour, daytime, and nocturnal periods
Score of DTSQ(c)-Teen at Week 52 [ Time Frame: At Week 52 ]
Score of DTSQ(c)-Teen at Week 52 (after 6 months of Afrezza treatment) in subjects who switch from RAA injections to Afrezza (score ranges from -24 to 24, with higher score means greater satisfaction)
Score of DTSQ(c)-Parent at Week 52 [ Time Frame: At Week 52 ]
Score of DTSQ(c)-Parent at Week 52 (after 6 months of Afrezza treatment) in subjects who switch from RAA injections to Afrezza (score ranges from -30 to 30, with higher score means greater satisfaction)
Change in scores of DTSQ(s)-Teen [ Time Frame: 52 weeks ]
Change in scores of DTSQ(s)-Teen from baseline to Week 52 (changes in score ranges from -48 to 48, with higher score means greater satisfaction)
Change in scores of DTSQ(s)-Parent [ Time Frame: 52 weeks ]
Change in scores of DTSQ(s)-Parent from baseline to Week 52 (change in scores ranges from -60 to 60, with higher score means greater satisfaction)
Event rates of hypoglycemic events [ Time Frame: 52 weeks ]
Event rates and incidence of total, nocturnal, and severe hypoglycemic events from baseline to Week 52
Incidence of hypoglycemic events [ Time Frame: 52 weeks ]
Incidence of total, nocturnal, and severe hypoglycemic events from baseline to Week 52
Incidence and severity of Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) [ Time Frame: 52 weeks ]
Incidence and severity of TEAEs and SAEs from baseline to Week 52
Incidence and severity of Adverse Events of Special Interest (AESIs) [ Time Frame: 52 weeks ]
Incidence and severity of AESIs (i.e., acute bronchospasm, clinically relevant decline in pulmonary function, hypersensitivity reactions [including anaphylaxis], asthma symptoms or exacerbations [including use of reliever or controller medications and hospitalization], and diabetic ketoacidosis [DKA]) as well as the number of subjects with AESIs and number of individual events from baseline to Week 52
Change in percent predicted Forced Expiratory Volume in 1 Second (FEV1) [ Time Frame: 56 weeks ]
Change from baseline to Weeks 13, 26, 39, 52, and 56 in percent predicted FEV1
