In a nutshell
This study is examining the safety and effectiveness of a new insulin plan for people with type 2 diabetes (T2D) that are already being treated with basal insulin. The new insulin being evaluated is a once-a-week administration of insulin instead of daily injections of basal insulin, which should be substantially more convenient for people with type 2 diabetes. The main outcome to be measured will be the levels of HbA1c (average blood glucose over 3 months) after 32 weeks.
The details
The main aim of diabetes treatment is to control blood glucose levels. Many patients reach a point when oral medication is no longer effective enough. Many require more intense treatment with injectable medicine, including insulin. There are many different types of insulin such as long-acting, short-acting etc. Treatment is started with basal insulin, also known as background insulin, such as insulin Degludec (Tresiba), which controls blood sugar between meals. However, insulin requires daily injections which significantly lower the quality of life of patients. It also comes with the risk of hypoglycemia (dangerously low blood glucose levels) or weight gain.
This experimental drug is insulin given by subcutaneous (under the skin) injection once a week and aims to control blood glucose levels.
This study will evaluate the safety and effectiveness of this new drug in participants with type 2 diabetes that are already being treated with basal insulin. The main outcomes to be measured are changes in blood glucose control, body weight and hypoglycemia episodes following 32 weeks of treatment.
Who are they looking for?
This study will recruit 375 adults with T2D. Patients must be currently treated with basal insulin with or without (up to 3) oral glucose-lowering drugs. They must have HbA1c levels between 6.5% and 10% at the start of the study and a body mass index (BMI; a measurement of weight in relation to height) between 20 and 45kg/m2. Female patients of childbearing age and male patients with female partners of childbearing age must agree to use contraception during the study and at least 15 weeks after the last dose of the study medication.
Participants must not have had any episodes of severe hypoglycemia (dangerously low blood glucose levels) and/or hypoglycemia unawareness within 6 months before the starting of the study. Patients who have had a heart attack or stroke or have heart failure that significantly limits their physical activity will be excluded. Participants must not have hepatitis or other liver diseases, any active or untreated cancer, blood conditions, kidney failure or treatment for more than 14 days with glucocorticoids. Glucocorticoid drugs are man-made versions of steroids that occur naturally in the body. Patients will not be recruited if they have taken any weight loss drugs in the prior 3 months or if they are currently participating in another clinical trial.
How will it work
All participants will be divided into 3 groups. The first 2 groups will receive 2 different doses of study drug by subcutaneous injection (injection under the skin) once a week. The third group will receive insulin Degludec by subcutaneous injection (injection under the skin) once a day. The outcomes measured will be changes in HbA1c, in fasting glucose levels, in body weight and the number of hypoglycemic episodes after 32 weeks of treatment.
Participants will receive study-related care and investigational medication at no cost, as well as possible compensation. Participants may receive compensation up to $1,325 for the study visits completed even if they do not finish the study.
Clinical trial locations
| Type: | Interventional |
| Participants: | 375 |
| Study ID: | NCT03736785 |
| Sponsor: | Lily |
