This trial is examining the safety and effectiveness of the new drug MYL-1601D in comparison to Novolog (fast-acting insulin) in the treatment of type 1 diabetes (T1D). The main outcomes to be measured are the antibody response (response of the immune system to the drug) and improvements in blood glucose control. This study is being carried out in Texas, the United States.

In T1D, the body is unable to produce insulin (the hormone that controls blood glucose). Therefore, insulin is used as the main treatment for T1D. There are many different forms of insulin including long-acting (to control blood glucose while fasting) and fast-acting (to control blood glucose at meal times). Novolog is a fast-acting insulin. MYL-1601D is a biosimilar drug. It is a very similar copy of fast-acting insulin.

However, when new substances are introduced to our body, it is possible that our immune system will recognize them as foreign and make antibodies against them. Antibodies are proteins produced by the immune system designed to attack foreign substances.

The aim of this study is to test the safety and effectiveness of MYL-1601D in comparison to the original drug, Novolog. The main outcome to be measured is the antibody response rate during treatment.

This study is recruiting 500 patients. Patients must be able to give written and signed consent and be able and willing to comply with the requirements of the protocol.

Patients must not have a medical condition in which study participation may put them at risk. Patients must not have an allergy/sensitivity to any of the ingredients used in the insulin preparations and must not have a history of serious allergic drug reactions. Patients must not have an abnormal electrocardiogram (test of the electrical activity of the heart) or have any surgery planned for the duration of the study. They must not have had any heart attacks/strokes/angina in the past 6 months or have had major depression in the last 3 years.

Patients will be randomly assigned to one of two groups. One group will be treated with Novolog for 24-weeks and the other group will be treated with MYL-1601D for 24 weeks.

The main outcome to be measured will be antibody response rate during the treatment period. This is normally done by a blood test. Other outcomes to be measured include fasting blood glucose, blood glucose after meals, total units of insulin required and change in HbA1c (blood test measuring average blood glucose level over the past 3 months).

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