Table of Contents
- Trial overview
- Who is being studied
- What the trials measure
- Trial phases and study design
- Main trials involving INSULIN DEGLUDEC
- Patient glossary of key terms
Trial overview
The source data includes several interventional studies that investigate INSULIN DEGLUDEC in people with type 2 diabetes.[1][1][1][1] 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.[1][1]
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.[1][1][1][1]
Who is being studied
The main condition studied is type 2 diabetes.[1][1][1][1] 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.[1][1][1]
One study also focuses on people with type 2 diabetes and looks at heart and nerve-related changes, not only blood sugar control.[1]
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.[1][1][1] One trial also measures change in body weight, because the study compares blood sugar and weight effects between treatments.[1]
Another study measures heart rate variability, glucose variability, and signs of cardiovascular autonomic neuropathy, which is nerve damage that can affect heart control.[1] That study uses outcomes such as the LF:HF ratio and CART parameters, which are technical ways to assess heart and nerve function.[1]
Trial phases and study design
All four trials are Phase 3 interventional studies.[1][1][1][1] 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.[1][1][1][1] Enrollment ranges from 80 participants to 680 participants across the listed trials.[1][1][1][1]
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.[1] 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.[1] INSULIN DEGLUDEC was listed among the insulin treatments used in the study background and comparison set.[1]
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.[1] 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.[1] This study listed several daily basal insulin analogues, including Tresiba, which is the brand name used in the source data for INSULIN DEGLUDEC.[1]
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.[1] INSULIN DEGLUDEC was one of the treatments listed in the study interventions, alongside several other diabetes medicines.[1] The trial measured improvement in LF:HF ratio, at least one CART parameter, and glucose variability over 6 months.[1]
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.[1] 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.[1] This trial is especially relevant because INSULIN DEGLUDEC is part of the comparator treatment named in the title and brief summary.[1]
Patient glossary of key terms
Interventional study means the researchers give a treatment and compare outcomes between groups.[1]
Comparator treatment means the treatment used as a comparison in a trial, such as a daily insulin or placebo.[1][1]
Non-inferiority margin means the largest allowed difference where a new treatment can still be judged close enough to the comparison treatment.[1]
Oral antidiabetic drugs are diabetes medicines taken by mouth.[1]
Cardiovascular autonomic neuropathy is nerve damage that can affect how the heart and blood vessels respond.[1]
CART parameters are tests used to assess nerve control of the heart.[1]
LF:HF ratio is a measure used in heart rate variability testing.[1]
Pre-mixed insulin means a fixed mix of insulin types used in one treatment plan.[1]
