In short
Clinical trials investigating INSULIN DEGLUDEC are studying how it is used in people with type 2 diabetes, often as a comparison treatment. These trials look at blood sugar control, body weight, and related heart or nerve outcomes. Some studies include people already using basal insulin or other diabetes medicines.
Key points
- Clinical trials involving INSULIN DEGLUDEC in the source data are all in type 2 diabetes. Most studies are Phase 3 and focus on blood sugar control, especially change in HbA1c over time. Some trials compare INSULIN DEGLUDEC with other insulin treatments, while others include it as part of a broader diabetes treatment comparison. The target groups include adults with poorly controlled type 2 diabetes, people already using basal insulin, and people on other diabetes medicines. One trial also looks at heart-related nerve function and glucose variability. Overall, the trials are mainly testing how well treatment strategies work in real patient groups.
Trial overview
The source data includes several interventional studies that investigate INSULIN DEGLUDEC in people with type 2 diabetes. In these trials, INSULIN DEGLUDEC is sometimes used as a comparison treatment and sometimes appears as part of a treatment arm with another insulin medicine.
All listed studies are Phase 3 trials, which means they are testing treatments in larger groups and comparing results such as blood sugar control and other health outcomes.
Who is being studied
The main condition studied is type 2 diabetes. The trials include adults with poor blood sugar control, people already treated with once-daily basal insulin, and people using non-insulin glucose-lowering medicines or pre-mixed insulin treatment.
One study also focuses on people with type 2 diabetes and looks at heart and nerve-related changes, not only blood sugar control.
What the trials measure
The main outcome in most studies is change in HbA1c, which is a blood test that shows average blood sugar over time. One trial also measures change in body weight, because the study compares blood sugar and weight effects between treatments.
Another study measures heart rate variability, glucose variability, and signs of cardiovascular autonomic neuropathy, which is nerve damage that can affect heart control. That study uses outcomes such as the LF:HF ratio and CART parameters, which are technical ways to assess heart and nerve function.
Trial phases and study design
All four trials are Phase 3 interventional studies. Phase 3 trials usually compare treatments in larger groups to see how well they work and to measure important outcomes in real-world-like settings.
Two studies are completed and two are authorised, based on the source data. Enrollment ranges from 80 participants to 680 participants across the listed trials.
Main trials involving INSULIN DEGLUDEC
REIMAGINE 3 studied people with type 2 diabetes who were treated with once-daily basal insulin, with or without metformin. The study compared CagriSema with placebo and measured change in HbA1c from week 0 to week 40, and it also included body weight as part of the study goal. INSULIN DEGLUDEC was listed among the insulin treatments used in the study background and comparison set.
A research study to see how weekly Insulin Icodec maintains blood sugar levels compared to daily basal insulins in adults with type 2 diabetes looked at people with type 2 diabetes who were intensifying treatment in routine clinical practice. The main goal was to compare change in HbA1c after 52 weeks, using a non-inferiority margin of 0.3%, which means the weekly treatment needed to be not meaningfully worse than the daily comparators. This study listed several daily basal insulin analogues, including Tresiba, which is the brand name used in the source data for INSULIN DEGLUDEC.
SGLT-2i, Heart, Improvement of Cardiovascular Autonomic Neuropathy studied people with type 2 diabetes and explored whether SGLT-2 inhibitors affect heart and nerve function. INSULIN DEGLUDEC was one of the treatments listed in the study interventions, alongside several other diabetes medicines. The trial measured improvement in LF:HF ratio, at least one CART parameter, and glucose variability over 6 months.
A research study to see how weekly IcoSema controls blood sugar levels when compared with daily insulin degludec/insulin aspart (IDegAsp) enrolled people with poorly controlled type 2 diabetes. The study compared once-weekly IcoSema with once or twice daily insulin degludec/insulin aspart, with or without oral antidiabetic drugs, and measured change in HbA1c after 40 weeks. This trial is especially relevant because INSULIN DEGLUDEC is part of the comparator treatment named in the title and brief summary.
Patient glossary of key terms
Interventional study means the researchers give a treatment and compare outcomes between groups.
Comparator treatment means the treatment used as a comparison in a trial, such as a daily insulin or placebo.
Non-inferiority margin means the largest allowed difference where a new treatment can still be judged close enough to the comparison treatment.
Oral antidiabetic drugs are diabetes medicines taken by mouth.
Cardiovascular autonomic neuropathy is nerve damage that can affect how the heart and blood vessels respond.
CART parameters are tests used to assess nerve control of the heart.
LF:HF ratio is a measure used in heart rate variability testing.
Pre-mixed insulin means a fixed mix of insulin types used in one treatment plan.