This trial is examining the effectiveness of a fixed combination of insulin degludec and liraglutide (IDegLira) for type 2 diabetes (T2D).
The main outcome to be measured will be a change in HbA1c (test measuring blood glucose control over the past 3 months). This study is being conducted in Georgia, United States.
The details
Uncontrolled T2D can eventually be treated with insulin therapy. Basal-bolus insulin therapy (involves taking a longer acting form of insulin to keep blood glucose levels stable through periods of fasting and separate injections of shorter acting insulin to prevent rises in blood glucose levels resulting from meals) mimics how the pancreas works in regular condition. However, this treatment option is associated with an increased risk of hypoglycemia (low blood glucose), swings in blood glucose levels, weight gain and poor compliance (patient not taking the injections correctly).
An alternative therapy is IDegLira. It is a combination of insulin degludec (Tresiba) and liraglutide (Victoza).
This trial is examining the effectiveness of IDegLira for type 2 diabetes mellitus. The main outcome to be measured will be a change in HbA1c.
Who are they looking for?
This trial is looking for 140 participants. Patients should have more than 6 months from diagnosis and a HbA1c level of 9-12%. They should have a body mass index between 25 and 40 kg/m2.
Patients must not have had previous treatment with glucagon-like peptide-1 (GLP-1) agonists, mixed insulins or basal-bolus insulin. They must not have acute or chronic pancreatitis (inflammation of the pancreas), pancreatic cancer or end-stage heart failure. They must not have a mental condition, medullary thyroid cancer, repeating hypoglycemia or be participating in another diabetes trial. Female patients should not be pregnant or breastfeeding.
How will it work
There will be two groups. One group will receive IDegLira with metformin (Glucophage) for 26 weeks. The other group will receive the basal-bolus insulin (insulin degludec and insulin aspart) with metformin for 26 weeks. The HbA1c level will be measured after 26 weeks follow up.
