Endocrinology Advisor: When using inhaled insulin for post-prandial hyperglycemia, how should clinicians advise patients to adjust their insulin dose prior to meals?
Dr. Kendall: The starting dose for patients new to mealtime insulin is 4 units per meal. Similar to other insulins, clinicians will should adjust the dose of Afrezza based on specific patient needs in order to achieve optimal glucose control. For example, the patient can use a 4 unit Afrezza cartridge at meal time and check their blood glucose at approximately 2 hours post-meal. If their blood glucose is remains elevated, providers should consider an increase in Afrezza dose of 4 units and consider increasing the dose for any subsequent meals of similar composition.
For patients who are currently using injectable insulin it is generally recommend that providers consider a conversion (to Afrezza) of 1.5 times their current dose of subcutaneous injectable insulin and as always adjust insulin dose with meals as noted above.
Endocrinology Advisor: What type of patient would most benefit from using inhaled insulin to prevent post-prandial hyperglycemia?
Dr. Kendall: Afrezza is a rapid acting mealtime insulin indicated to improve glycemic control in adults with both Type 1 diabetes and Type 2 diabetes. It is not approved for use in patients under 18 years of age and individuals who have lung problems such as asthma or COPD or in people who smoke or have recently stopped smoking (less than 6 months).
Endocrinology Advisor: How often would you advise patients test their glucose levels to adjust the dose of inhaled insulin to effectively reduce blood sugar levels?
Dr. Kendall: Patients should check their glucose levels as recommended by their treating provider. Recent advancements in continuous glucose monitoring via CGM or flash technology may allow patients to monitor glucose levels more frequently and obtain glucose values in real time. These can be useful tools to use while adjusting Afrezza mealtime doses. In patients who utilize SMBG, it is recommended that individual patients consider pre-meal and 1-2 post-prandial glucose level assessment to assist with Afrezza dose adjustment.
Endocrinology Advisor: Can you comment on potential acute changes in lung function (declines from baseline in mean FEV1) associated with T1 administration?
Dr. Kendall: The average adult male total lung capacity is approximately 6L. In clinical studies with Afrezza, patients experienced small declines in FEV1. FEV1 decline is also observed with normal aging and occurs in those with diabetes. Patients on Afrezza has a decline of approximately 40 mL in FEV1 as to those receiving usual care. Upon Afrezza discontinuation after 24 weeks of treatment, FEV1 levels returned to levels similar to the control group. FEV1 should be tested at baseline, and at 6 months of treatment with Afrezza – and annual thereafter. Providers should consider discontinuation of Afrezza in any patient with persistent respiratory symptoms and/or in patients with a decline in FEV1 > 20% from baseline. In the clinical trial program with Afrezza, 2% of subjects had a decline in FEV1 greater than 20% as compared to 1% of individuals receiving usual care.
Endocrinology Advisor: TI is currently not contraindicated for patients with cancer or a prior history of cancer. That being said, how should clinicians assess whether the benefits of T1 outweigh this potential risk?
Dr. Kendall: Cancer risk is known to be higher in those with diabetes and obesity. All patients should be counselled on the risk and benefit associated with any diabetes therapy. Afrezza should not be used in patients with active lung cancer and patients with a history of or at high risk of lung cancer should discuss the risk with their physician. In the clinical trial program for Afrezza there were 2 cases of lung cancer that were reported in Afrezza treated subjects (both of whom also has significant history of tobacco use) with no cases reported in the control group. Two additional cases of pulmonary malignancy have been reported in the post-study period after open-label exposure. When compared to rates of similarly matched populations, rates of lung cancer in the study population were comparable to those rate anticipated in the general population. No new cases of lung cancer have been reported since Afrezza has been approved for clinical use in the U.S.
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The STAT study was supported by MannKind Corporation. Please refer to reference for a complete list of authors’ disclosures.
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