Do you have type 1 diabetes?
Have you been diagnosed with type 1 diabetes? If so, you may be interested in a clinical trial that is currently underway to evaluate a new, investigational, faster-acting insulin to see if it can provide improved blood glucose control in adults with type 1 diabetes.
What are the "onset trials"?
The onset trials are a set of eight international diabetes studies that will investigate a new faster-acting mealtime insulin, known as faster-acting insulin aspart, and its effect on blood glucose in children and adults with type 1 and type 2 diabetes. The trials will involve about 3,000 adult patients and 800 children and adolescents from more than 20 countries worldwide. Recruitment is continuing for the last four of the eight trials.
What is faster-acting insulin aspart?
Faster-acting insulin aspart is a fast-acting insulin used in the treatment of diabetes. It contains the same main ingredient (insulin aspart) as another widely available insulin treatment but has added ingredients that increase the speed of insulin uptake in the blood. It is hoped that the fast action of faster-acting insulin aspart will improve blood glucose control with low risk of low blood glucose events and provide more flexible dosing around meals.
Can I be involved?
There are some key criteria that you will need to meet to join the onset 8 trial. The trial doctor is responsible for deciding whether or not you qualify for the trial. He/she will be able to explain in more detail whether you are a good candidate.
You may qualify for the onset 8 trial if you:
Are 18 years of age or older
Have been diagnosed with type 1 diabetes for at least one year
Are currently treated with both mealtime and long-acting insulin
Have an HbA1c between 7.0-9.5 percent
Before any trial procedures are performed, you will be asked to read and sign an Informed Consent Form (IC). This is an important document. Before you sign it, you should make sure that you understand your responsibilities as a participant and that any questions you have about participation in the trial are answered to your liking. The information on this page is explained more fully in the IC.
What’s involved in participating?
The trial has three parts:
1. Screening period: In the beginning of the trial (for approximately two weeks), you will continue your current diabetes treatment until the trial site staff have evaluated whether you fulfill the criteria for further participation.
2. Run-in period: During the first eight weeks of the trial, you will receive a marketed insulin analogue called Novolog (insulin aspart) and insulin degludec.
3. Treatment period: A computer program will assign you randomly (like flipping a coin) into one of three trial groups. The group you are in will not be known by you, your doctor, or your trial team unless you are assigned to the group that will receive faster-acting insulin aspart after the meal.
1/3 of participants will receive faster-acting insulin aspart at mealtime and insulin degludec
1/3 of participants will receive Novolog at mealtime and insulin degludec
1/3 of participants will receive faster-acting insulin aspart after meals and insulin degludec
All treatments will be provided with disposable pre-filled insulin pens.
Your participation in the trial will last 36 weeks plus a 30 day follow-up period. If you choose to participate in the trial, you are free to stop participation in the trial at any time without giving a reason.
Involvement in the trial will include:
Taking your assigned insulin treatment as prescribed by your doctor
Measuring your blood glucose
Recording changes in your medication diary
Weekly contact with trial nurse or doctor (by phone or in person)
Attending frequent doctor visits for necessary health checks
What is a clinical trial?
Clinical trials are performed to determine whether a new investigational drug or medical device is safe and effective. Sometimes clinical trials are used to study different ways of using investigational drugs so they will be more effective, easier to use, and/or associated with fewer side effects.
Clinical trials may also be performed to discover how to best use an investigational drug in a specific group of people. Very strict procedures are followed to protect the safety or trial participants. These procedures are reviewed by an ethics committee, and by the government’s health authority.
Why participate in a clinical trial?
Participating in a clinical trial is an important decision. By participating, you will be contributing to the understanding of type 1 and type 2 diabetes and different ways to treat these conditions. You will also take an active role in your own healthcare, which may make you feel more in control of your diabetes.
The potential benefits include possible improvement of your condition. However, the benefits are by no means assured as the safety and effectiveness of the investigational drug is still being studied. The trial team can help explain this to you so that you may be fully informed about whether you would like to participate.
What do I do next?
The onset 8 trial is currently looking for trial participants. If you are interested in learning more, or if you or someone you know might want to be considered as a participant for this trial, please contact the trial team.
Lisa Mamo, RN
Baylor Endocrine Center
3600 Gaston Ave., Wadley Tower, Suite 656
Dallas, Texas 75246