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

Data from an open-label, non-inferiority trial comparing 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 an A1C of 7.5% to 10%. Afrezza provided less A1C reduction than RAI, satisfied the non-inferiority margin of 0.4%, and the difference was statistically significant. More subjects in the SC rapid-acting group achieved the A1C target of ≤7%.1

In an open-label, non-inferiority trail, Afrezza lowered A1C comparable to SC RAI1

  • Trail 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-1670

Important Safety Information  for AFREZZA® (insulin human) Inhalation Powder

WARNING: RISK OF ACUTE BRONCHOSPASM IN PATIENTS WITH CHRONIC LUNG DISEASE. Acute bronchospasm has been observed in patients with asthma and COPD using AFREZZA. AFREZZA is contraindicated in patients with chronic lung disease such as asthma or COPD. Before initiating AFREZZA, perform a detailed medical history, physical examination, and spirometry (FEV1) to identify potential lung disease in all patients.

Important Safety Information

Indications and Usage:

Afrezza® (insulin human) Inhalation Powder is a rapid-acting inhaled insulin indicated to improve glycemic control in adult patients with diabetes mellitus.

Limitations of Use: Patients with type 1 diabetes must use with a long-acting insulin, not recommended for the treatment of diabetic ketoacidosis, not recommended in patients who smoke.

WARNING: RISK OF ACUTE BRONCHOSPASM IN PATIENTS WITH CHRONIC LUNG DISEASE

  • Acute bronchospasm has been observed in patients with asthma and COPD using AFREZZA.
  • AFREZZA is contraindicated in patients with chronic lung disease such as asthma or COPD.
  • Before initiating AFREZZA, perform a detailed medical history, physical examination, and spirometry (FEV1) to identify potential lung disease in all patients.

 

Contraindications

AFREZZA is contraindicated: during episodes of hypoglycemia, in patients with chronic lung disease (such as asthma or chronic obstructive pulmonary disease [COPD]) because of the risk of acute bronchospasm, and in patients with hypersensitivity to regular human insulin or any of the AFREZZA excipients.

Warnings and Precautions
Acute Bronchospasm: Acute bronchospasm has been observed following AFREZZA dosing in patients with asthma and COPD. Prior to initiating therapy, evaluate patients with a medical history, physical examination, and spirometry (FEV1) to identify potential underlying lung disease. Do not use in patients with COPD.

Change in Insulin Regimen: Monitor blood glucose in all patients treated with insulin. Modify insulin regimen and dose cautiously and only under medical supervision. Changes in insulin strength, manufacturer, type, or method of administration may result in the need for a change in insulin dose or an adjustment in concomitant oral antidiabetic treatment.

Hypoglycemia: Hypoglycemia is the most common adverse reaction of insulin therapy, including AFREZZA, and may be serious and life-threatening. Educate patients and caregivers on recognizing symptoms and mitigating the risks associated with hypoglycemia.

Decline in Pulmonary Function: AFREZZA has been shown to cause a decrease in lung function as measured by FEV1. In clinical trials lasting up to 2 years, AFREZZA-treated patients experienced a small (40 mL) but greater FEV1 decline than comparator-treated patients. Assess pulmonary function with spirometry at baseline, after the initial 6 months of therapy and annually thereafter even in the absence of pulmonary symptoms. In patients who have a decline of ≥20% in FEV1 from baseline, consider discontinuing AFREZZA. Consider more frequent lung function assessment in patients with pulmonary symptoms, e.g., wheezing, bronchospasm, breathing difficulties, or persistent or recurring cough. If symptoms persist, discontinue AFREZZA.

Lung Cancer: In clinical trials, 2 cases of lung cancer were reported in patients exposed to AFREZZA while no cases were reported for the comparators. Two additional cases of lung cancer (squamous cell and lung blastoma) were reported in non-smokers exposed to AFREZZA after the trial completion. These data are insufficient to determine whether AFREZZA has an effect on lung or respiratory tract tumors. In patients with active lung cancer, a prior history of lung cancer, or in patients at risk of lung cancer, consider whether the benefits of AFREZZA outweigh the risks.

Diabetic Ketoacidosis (DKA): In clinical trials enrolling subjects with type 1 diabetes, diabetic ketoacidosis (DKA) was more common in subjects receiving AFREZZA (0.43%; n=13) than in subjects receiving comparators (0.14%; n=3). Increase the frequency of glucose monitoring and consider an alternate route of administration of insulin in patients at risk for DKA.

Hypersensitivity Reactions: Severe, life-threatening, generalized allergy, including anaphylaxis, can occur. Discontinue AFREZZA, monitor, and treat if indicated.

Hypokalemia: All insulin products, including AFREZZA, cause a shift in potassium from the extracellular to intracellular space, possibly leading to hypokalemia. Untreated hypokalemia may cause respiratory paralysis, ventricular arrhythmia, and death. Closely monitor potassium levels in patients at risk of hypokalemia and treat if indicated.

Fluid Retention and Heart Failure with Concomitant Use of Thiazolidinediones (TZDs): Fluid retention, which may lead to or exacerbate heart failure, can occur with concomitant use of TZDs and insulin. Observe these patients for signs and symptoms of heart failure. If heart failure occurs, consider dose reduction or discontinuation of TZD.

Drug Interactions
Certain drugs may affect glucose metabolism, increasing the risk of hypoglycemia or decreasing the blood glucose–lowering effect of AFREZZA. Dose adjustment and increased frequency of blood glucose monitoring may be required. Co-administration of beta-blockers, clonidine, guanethidine, and reserpine with AFREZZA may reduce the signs and symptoms of hypoglycemia. For full list, see Prescribing Information.

Adverse Reactions
The most common adverse reactions associated with AFREZZA include hypoglycemia, cough, and throat pain or irritation.

Please see full Prescribing Information, including BOXED WARNING for AFREZZA.

AFREZZA, MANNKIND, and the Afrezza and MannKind logos are registered trademarks, and AFREZZAASSIST, AfrezzaAssist and logo are mark applications, all owned by MannKind Corporation. © MannKind Corporation 2021. This site is intended for use by US healthcare professionals only.

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