T1D: PROVEN CONTROL
Proven A1C control comparable to SC RAI1
- Afrezza met the non-inferiority margin: Specifically, the between-group difference in A1C levels from baseline to study end was 0.19% (95% CI, 0.02-0.36), satisfying the non-inferiority margin of 0.4%1
MEAN A1C LEVELS OVER 24-WEEK TREATMENT PERIOD1

In an open-label, non-inferiority trial, Afrezza lowered A1C comparable to SC RAI1
- Trial compared the change in A1C from baseline to week 24 of prandial Afrezza (n=174) with that of SC RAI (n=170), both with basal insulin, in adult patients (≥18 years) with T1D and A1C of 7.5% to 10%1
- Afrezza provided less A1C reduction than RAI, and the difference was statistically significant. More subjects in the SC rapid-acting group achieved the A1C target of ≤7%1
Proven mealtime control2
POSTPRANDIAL GLUCOSE (PPG) LEVELS ASSOCIATED WITH AFREZZA2

Data from the STAT study of patients with T1D with A1C levels 6.5% to 10%. Individuals were randomized to treatment with titrated Afrezza (n=22) or titrated SC RAI aspart (n=34) and included in the final analysis. All were required to wear a real-time continuous glucose monitor (CGM) throughout the trial.2
- The STAT trial assessed both postprandial glucose excursions (PPGE) in 1-4 hours and time-in-range (TIR: 70-180 mg/dL) using a real-time CGM with Afrezza versus insulin aspart in patients with T1D on multiple daily injections2
- Afrezza demonstrated lower PPG values at 60 and 90 minutes post-meal as compared with SC RAI2
- Significantly lower PPGE post-breakfast and -lunch versus SC RAI2
Improvement of TIR2
TIR WITH AFREZZA VERSUS SC RAI2

Data from the STAT study of patients with T1D with A1C levels 6.5% to 10%. Individuals were randomized to treatment with titrated Afrezza (n=22) or titrated SC RAI aspart (n=34) and included in the final analysis. Patients were defined as compliant if ≥90% of postmeal Afrezza dosages were taken per protocol, with at least one of the postmeal inhalations taken if indicated per meal. All were required to wear a real-time continuous glucose monitor (CGM) throughout the trial.2
- Compared with the SC RAI group, TIR was significantly greater in the Afrezza-compliant group (62.5% ± 2.6% versus 53.8% ± 1.7%, P=0.009), and time in hyperglycemia (>180 mg/dL) was lower (34.2% ± 2.7% versus 41.0% ± 1.7%, P=0.045)2
- Additionally, those treated with Afrezza versus aspart spent less time in hypoglycemia (<60 and <50 mg/dL, both P<0.05)2
Lower rates of postprandial hypoglycemia3
HYPOGLYCEMIA EVENT RATE WITH AFREZZA3

Data from a post-hoc regression analysis on a subset of the AFFINITY-1 study of adults (n=279) with T1D ≥12 months and an A1C level of 7.5% to 10%. Patients were randomized to receive basal insulin plus either Afrezza or SC RAI aspart.3 These results should be interpreted along with the efficacy results for this study.
- A primary outcome measure was event rates for levels 1, 2, and 3 hypoglycemia, respectively, defined as blood glucose levels of ≤70.3 mg/dL, <54.1 mg/dL, or requiring assistance of another person to take corrective actions3
- Patients treated with Afrezza experienced significantly fewer level 1 and 2 hypoglycemic event rates than participants treated with insulin aspart3
- Hypoglycemia is the most common adverse reaction of insulin therapy, including Afrezza, and may be serious and life-threatening.4 Educate patients and caregivers on recognizing symptoms and mitigating the risks associated with hypoglycemia
Lower rates of late postprandial hypoglycemia1
POST-MEAL HYPOGLYCEMIA EVENT RATES WTH AFREZZA VERSUS SC RAI1

Data from an open-label, non-inferiority trial compared the change in A1C from baseline to week 24 of prandial Afrezza (n=174) with that of SC RAI (n=170), both with basal insulin, in adult patients (≥18 years) with T1D and A1C of 7.5% to 10%. Afrezza provided a mean reduction in A1C that met the pre-specified non-inferiority margin of 0.4%. Afrezza provided less A1C reduction than RAI, and the difference was statistically significant. More subjects in the SC rapid-acting group achieved the A1C target of ≤7%.1
- Patients who received Afrezza had an overall lower hypoglycemia event rate than those who received aspart (9.8 events/patient-month versus 14.0 events/patient-month, P<0.0001)1
- Specifically, event rates were higher in the >2-5 hours after meals in the insulin aspart group as compared with the Afrezza group1
- These results should be interpreted along with the efficacy results for this study
References: 1. Bode BW, McGill JB, Lorber DL, Gross JL, Chang PC, Bregman DB. Inhaled Technosphere insulin compared with injected prandial insulin in type 1 diabetes: a randomized 24-week trial. Diabetes Care. 2015;38(12):2266-2273. 2. Akturk HK, Snell-Bergeon JK, Rewers A, et al. Improved postprandial glucose with inhaled Technosphere insulin compared with insulin aspart in patients with type 1 diabetes on multiple daily injections: the STAT study. Diabetes Technol Ther. 2018;20(10):639-647. 3. Seaquist ER, Blonde L, McGill JB, et al. Hypoglycaemia is reduced with use of inhaled Technosphere® Insulin relative to insulin aspart in type 1 diabetes mellitus. Diabet Med. 2020;37(5):752-759. 4. Afrezza (insulin human) Inhalation Powder Prescribing Information. MannKind Corporation.
US-AFR-2131