This trial is testing the effectiveness of once-daily vs thrice-daily oral insulin in patients with type 1 diabetes (T1D). The main outcome is the amount of injected insulin used, and the second outcome is the amount of time blood glucose levels are within specific ranges. This study is being conducted in Orange County, California, USA.
Insulin is a hormone that signals cells to absorb glucose. Patients with type 1 diabetes (T1D) are not able to create insulin within their pancreases. To control their blood sugar levels, patients with T1D must take injected insulin. A common treatment is to take slow-acting insulin (basal insulin) to control glucose levels all day and to also take fast-acting insulin (bolus insulin) before eating. This system is known as multiple-dose injection (MDI) therapy.
In this study, an oral insulin pill, ORMD-0801, is being studied as a non-injection method to take insulin. The study will measure how much injected basal insulin is needed to control glucose levels while taking ORMD-0801.
Who are they looking for?
This study is recruiting 26 subjects with T1D who are being treated with MDI therapy. Subjects’ blood glucose must be controlled, as measured by both C peptide levels and hemoglobin A1c (HbA1c) levels. Patients’ body weight must be in the normal or overweight range (body mass index of 19 - 30 kg/m2), and they must not have recently gained or lost weight. Female patients must not be pregnant and must use two types of birth control, or must be past menopause.
People who have type 2 diabetes are not eligible to be in this study. People who heart disease, a history of stroke, or high blood pressure may not participate. People who have thyroid disease, liver disease, or HIV are not eligible. People who have had active cancer within the past five years are not eligible.
How will it work
In this study, there will be 2 groups. Half the subjects will take 24 mg ORMD-0801 once at bedtime. The other half will take 8 mg ORMD-0801 before each meal (3 times a day). Continuous glucose monitors will record patients' blood glucose levels. Also, patients will record how much injected insulin they need to take and the amount of carbohydrates they eat. Halfway through the study, the participants will switch groups.