Diabetes Mellitus, Type 2
Conditions
Brief summary
This study compares insulin icodec, taken once a week, with other basal insulins, taken once a day, in people with type 2 diabetes.The purpose of this study is to see how well the approved injectable weekly insulin icodec maintains blood sugar levels when compared to approved and available daily injectable basal insulins in people with type 2 diabetes. The participants will either be prescribed weekly insulin icodec or a daily basal insulin (insulin glargine, insulin detemir or insulin degludec) based on current standards for the treatment of type 2 diabetes. The study will last for about 13 months.
Interventions
DRUGInsulin icodec
Insulin icodec will be administered as subcutaneous injection.
DRUGBasal insulin analogues
Basal insulin analogues will be administered as subcutaneous injection.
Sponsors
Novo Nordisk A/S
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosed with T2D greater than or equal to (≥) 180 days prior to the day of screening. * Treatment with any of the following non-insulin glucose-lowering medication(s) or combination regimen(s) at the time of screening: Metformin, Sulfonylureas, Meglitinides (glinides), dipeptidyl peptidase-4 (DPP-4) inhibitors, sodium-glucose cotransporter-2 (SGLT2) inhibitors, Thiazolidinediones, Alpha-glucosidase inhibitors, Oral combination products (for the allowed individual oral antidiabetic drugs), Oral or injectable glucagon-like peptide-1 (GLP-1) receptor agonists and Injectable dual glucose-dependent insulinotropic polypeptides (GIP) and GLP-1 receptor agonist. * Need of intensification with basal insulin, as indicated at the discretion of the investigator. * Recorded HbA1c value ≥7% within the last 90 days prior to randomization.
Exclusion criteria
* Known or suspected hypersensitivity to study intervention(s) or related products. * Previous participation in this study. Participation is defined as signed informed consent. * Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using adequate contraceptive method. * Participation (i.e., received any study intervention) in any interventional clinical study within 90 days before screening. * Any disorder which in the investigator's opinion might jeopardize participant's safety.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in glycated haemoglobin (HbA1c) | From baseline week 0 to week 52 | Measured as %-point. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adelphi Adherence Questionnaire (ADAQ©) | At week 52 | Measured as Score. The ADAQ© score is calculated as the mean of 11 individual items, each rated on a scale from 0 to 4. To obtain the mean score, at least 8 of these items must be answered. A lower score indicates greater adherence. |
| Change in Diabetes Treatment Satisfaction Questionnaire- status version(DTSQs) total treatment satisfaction | From baseline week 0 to week 52 | Measured as Score of 0-36. DTSQs score ranges from 0 to 36, based on 6 items that are each rated on a scale of 0 to 6. A higher score reflects greater satisfaction with the treatment received. |
| Treatment Related Impact Measure for Diabetes (TRIM-D) compliance domain | At week 52 | Measured as Score of 4-20.The score ranges from 4 to 20, based on 4 items rated on a scale of 1 to 5. This score is then transformed to a 0-100 scale, where higher scores indicate better compliance. |
| Treatment Related Impact Measure for Diabetes (TRIM-D) treatment burden domain | At week 52 | Measured as Score of 6-30. The score ranges from 6 to 30, derived from 6 items each rated on a scale of 1 to 5. This score is then transformed to a 0-100 scale, where higher scores indicate less treatment burden. |
| Number of severe hypoglycaemic episodes (level 3) | From baseline week 0 to week 52 | Measured as Number of episodes. |
| Mean weekly basal insulin dose | From week 50 to week 52 | Measures in Units. |
| Participant achieved individualised HbA1c target | At week 52 | Reported as Yes or No. |
Countries
Canada, Germany, Italy
Contacts
CONTACTNovo Nordisk
STUDY_DIRECTORClinical Transparency (dept. 2834)
Novo Nordisk A/S
Outcome results
None listed