The aim of this study is the test the effectiveness of new drug BTI320 on blood glucose control in type 2 diabetes (T2D). The main outcome to be measured will be a change in blood glucose 2 hours after meals. This study is being carried out in the United States.
The details
The number of patients with T2D is constantly on the rise. However, blood glucose control still remains a problem, even with all of the current medications. Many different combinations of drugs are used to try to lower blood glucose levels. Metformin (Glucophage) is usually the first drug used to treat T2D. If blood glucose is still not controlled with metformin, other drugs such as sulfonylureas (gliclazide, glipizide, glimepiride) can be used instead or added to metformin. If still not controlled, more drugs can be added. BTI320 is a new drug being developed for the treatment for T2D.
The aim of this study is to examine how safe and effective BTI320 is for blood glucose control when added on to metformin and/or sulfonylureas treatments. The main outcome to be measured is a change in average blood glucose 2 hours after meals.
Who are they looking for?
This study is recruiting 60 patients. Patients must be in otherwise good health and willing/able to adhere to a suitable diet, keep online food diaries and record their weight weekly.
Patients must not have been involved in a trial with BTI320 previously. Patients must not have had significant heart disease or stroke in the past year. Patients must not be planning to get pregnant within a year of the trial or have a severe food allergy or intolerance. Patients must not have HIV, hepatitis, tuberculosis or any other serious infectious diseases or a history of drug/alcohol abuse. Patients must not have a planned surgical procedure in the next 6 months or have a history of cancer for the 5 years prior to the study. Patients must not have had an organ transplant, have blood diseases or be taking corticosteroids or anti-psychotics. Patients must not have a job or lifestyle that involves night shifts/hours.
How will it work
Patients will be randomly assigned to one of two groups. The first group will receive 4 g BTI320 10 minutes before breakfast, lunch, and dinner. The other group will receive a placebo 10 minutes before breakfast, lunch, and dinner. Patients will take their other prescribed diabetic medications as normal. A dietician will advise on diet and patients will need to keep a detailed online record of their food. Blood glucose 2 hours after meals will be measured by skin-prick testing on the fingers and an electronic glucose meter.
Changes in blood glucose 2 hours after meals will be compared between the two groups. Other outcomes to be measured include changes in HbA1c (blood test measuring average blood sugar level over the past 3 months), change in body mass index and change in blood pressure. Patients will be treated for 12 weeks.
