This study is examining the effectiveness of insulin inhaler Afrezza at mealtimes for patients with type 2 diabetes (T2D). The main outcome of the study will be the time patients’ blood glucose readings are in the ideal range. This study is recruiting in San Antonio, TX, US.
T2D is a disease where a patient’s blood glucose levels are too high. Often this is because their body is not producing enough insulin or their cells are not responding to insulin. Treatment for T2D can include giving patients insulin which is usually administered by injections. These injections are often given at mealtimes (bolus) and throughout the day to top up insulin levels (basal).
Some patients find insulin injections affect their quality of life, particularly at mealtimes. Alternative ways to give insulin are being investigated. This study will examine the effectiveness of insulin inhaler Afrezza at mealtimes alongside basal insulin injections. The main outcome of the study will be the time patients’ blood glucose readings are in the ideal range.
Who are they looking for?
This study is looking for 30 patients with T2D. Patients must be aged 18 or older. Patients must currently be taking multiple daily injections to treat T2D. Patients’ HbA1c levels (a measure of blood glucose for the previous 3 months) must be between 7.5 to 11.5%. Patients must be willing and able to wear a glucose monitoring device. Patients must be willing to take an insulin inhaler at mealtimes. Female patients of childbearing years must be willing to use birth control for the duration of the study.
Patients with chronic obstructive pulmonary disease or asthma cannot participate. Patients who smoke or have smoked in the last 6 months cannot participate. Female patients who are pregnant or breastfeeding cannot participate. Patients who received steroid treatment within 6 weeks of the study start date cannot participate. Patients participating in another clinical trial cannot participate.
How will it work
All patients will be given insulin inhaler Afrezza for mealtimes and insulin injections for basal insulin doses.
The percentage of time patients’ blood glucose is within the target range will be monitored for 16 weeks. Hypoglycemia (dangerously low blood glucose) will be monitored for 16 weeks. HbA1c and patients’ quality of life will be measured for 16 weeks.