Diabetes Mellitus, Type 2
Conditions
Brief summary
This study looks at how a new medicine insulin icodec helps in reducing blood sugar levels when given along with semaglutide in patients with type 2 diabetes. Participants will get the medicine insulin icodec once a week in the first part of the study (run-in period-26 weeks). Participants will only enter the second part of the study if the blood sugar levels have not reduced to normal. If blood sugar levels are normal after the first 26 weeks, participants will continue in a 5-week follow up period. In the second part of the study (intensification period-26 weeks), participants will get both insulin icodec and semaglutide once weekly after which they will continue in a 5-week follow up period. Participants will have to inject the study medicines once a week on the same day of the week in a skin fold in the thigh, upper arm or stomach. The study will last for about 13 months. Participants will get a blood glucose meter to check blood sugar levels. In addition, participants will be asked to enter blood sugar levels in the study phone. In addition, Participants will be asked to enter selected few blood sugar values (three times during the study) in a paper diary that will be provided to participants. Women cannot take part if pregnant, breast-feeding or plan to get pregnant during the study period.
Interventions
DRUGInsulin Icodec
Participants will receive subcutaneously insulin icodec once weekly for 52 weeks.
DRUGSemaglutide
Participants will receive once weekly semaglutide subcutaneously starting from 0.25 mg and dose increased up to 1 mg for 26 weeks.
Sponsors
Novo Nordisk A/S
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosed with type 2 diabetes (T2D) greater than or equal to (\>=) 180 days prior to the day of screening * HbA1c from 7.5%-10.5% (58-91 millimoles per mole \[mmol/mol\]) (both inclusive) * Treated with once daily or twice daily basal insulin (minimum of 0.25 international units per kilograms per day (IU/kg/day) or 20 IU/day) without concomitant glucagon-like peptide-1 receptor agonists (GLP-1 RA) \>= 90 days prior to the day of screening with or without any of the following antidiabetic drugs/regimens with stable doses \>= 90 days prior to 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 anti-diabetic drugs)
Exclusion criteria
* Presence or history of pancreatitis (acute or chronic) within 180 days before screening * Myocardial infarction, stroke, hospitalisation for unstable angina pectoris or transient ischaemic attack within 180 days prior to the day of screening and between screening and initiation * Chronic heart failure classified as being in New York Heart Association (NYHA) Class IV at screening * Planned coronary, carotid or peripheral artery revascularization * Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a fundus examination performed within the past 90 days prior to screening or in the period between screening and initiation. Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Glycated Haemoglobin (HbA1c) | Baseline (Week 26), Week 52 | Change in HbA1c (percentage) from baseline (week 26) to week 52 is presented. The outcome data was evaluated based on the on-intensification phase. On-intensification phase was observed data at planned visits from time of the intensification week 26 until the end of treatment week 52, i.e., for participants who permanently discontinued either insulin icodec or semaglutide treatment, post-discontinuation observations were not included. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Mean 7-point Self-measured Plasma Glucose (SMPG) Profiles | Baseline (Week 26), Week 52 | Change in mean 7-point SMPG profiles from baseline (week 26) to week 52 is presented. The outcome data was evaluated based on the on-intensification phase. On-intensification phase was observed data at planned visits from time of the intensification week 26 until the end of treatment week 52, i.e., for participants who permanently discontinued either insulin icodec or semaglutide treatment, post-discontinuation observations were not included. |
| Change in Mean Post-prandial Glucose Increment (Over All Meals) | Baseline (Week 26), Week 52 | Change in mean post-prandial glucose increment from baseline (week 26) to week 52 is presented. The outcome data was evaluated based on the on-intensification phase. On-intensification phase was observed data at planned visits from time of the intensification week 26 until the end of treatment week 52, i.e., for participants who permanently discontinued either insulin icodec or semaglutide treatment, post-discontinuation observations were not included. |
| Change in Fasting Plasma Glucose (FPG) | Baseline (Week 26), Week 52 | Change in FPG from baseline (week 26) to week 52 is presented. The outcome data was evaluated based on the on-intensification phase. On-intensification phase was observed data at planned visits from time of the intensification week 26 until the end of treatment week 52, i.e., for participants who permanently discontinued either insulin icodec or semaglutide treatment, post-discontinuation observations were not included. |
| Number of Severe Hypoglycaemic Episodes (Level 3) | From baseline (week 26) to week 57 | Number of severe hypoglycaemic episodes (level 3) is presented. Severe hypoglycaemia (level 3) is defined as hypoglycaemia with severe cognitive impairment requiring external assistance for recovery. The outcome data was evaluated based on the Treatment-phase-on-treatment period. The Treatment-phase-on-treatment period was all observed data from time of the intensification week 26 until 6 weeks after last date of either insulin icodec or semaglutide treatment (whichever comes last). |
| Number of Clinically Significant Hypoglycaemic Episodes (Level 2) (Less Than [<] 3.0 mmol/L [54 Milligrams Per Deciliter {mg/dL}], Confirmed by Blood Glucose [BG] Meter) | From baseline (week 26) to week 57 | Number of clinically significant hypoglycaemic episodes (level 2) (\<3.0 mmol/L (54 mg/dL), confirmed by BG meter) is presented. Clinically significant hypoglycaemia (level 2) is defined as plasma glucose value of (\<) 3.0 mmol/L (54 mg/dL) confirmed by BG meter. The outcome data was evaluated based on the Treatment-phase-on-treatment period. The Treatment-phase-on-treatment period was all observed data from time of the intensification week 26 until 6 weeks after last date of either insulin icodec or semaglutide treatment (whichever comes last). |
| Number of Clinically Significant Hypoglycaemic Episodes (Level 2) (<3.0 mmol/L [54 mg/dL]), Confirmed by BG Meter) or Severe Hypoglycaemic Episodes (Level 3) | From baseline (week 26) to week 57 | Number of clinically significant hypoglycaemic episodes (level 2) (\<3.0 mmol/L (54 mg/dL), confirmed by BG meter) or severe hypoglycaemic episodes (level 3) is presented. Clinically significant hypoglycaemia (level 2) is defined as plasma glucose value of \< 3.0 mmol/L (54 mg/dL) confirmed by BG meter. Severe hypoglycaemia (level 3) is defined as hypoglycaemia with severe cognitive impairment requiring external assistance for recovery. The outcome data was evaluated based on the Treatment-phase-on-treatment period. The Treatment-phase-on-treatment period was all observed data from time of the intensification week 26 until 6 weeks after last date of either insulin icodec or semaglutide treatment (whichever comes last). |
| Change in Body Weight | Baseline (Week 26), Week 52 | Change in body weight from baseline (week 26) to week 52 is presented. The outcome data was evaluated based on the Treatment-phase-on-treatment period. The Treatment-phase-on-treatment period was all observed data from time of the intensification week 26 until 6 weeks after last date of either insulin icodec or semaglutide treatment (whichever comes last). |
| Relative Change in Weekly Insulin Icodec Dose | From week 25 to week 52 | Relative change in weekly insulin icodec dose from week 25 to week 52 is presented. |
Countries
Czechia, Malaysia, Poland, Serbia, Thailand
Contacts
STUDY_DIRECTORClinical Transparency (dept. 2834)
Novo Nordisk A/S
Participant flow
Recruitment details
The trial was conducted in 5 countries as follows: Poland, Serbia, Czechia, Malaysia and Thailand.
Pre-assignment details
The trial included a 26-week run-in period during which all participants were switched from their previous basal insulin regimen to insulin icodec. This was followed by a 26-week treatment phase with insulin icodec combined with semaglutide.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 60.11 Years STANDARD_DEVIATION 9.75 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 148 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 40 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 108 Participants |
| Sex: Female, Male Female | 68 Participants |
| Sex: Female, Male Male | 80 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 148 | 0 / 94 |
| other Total, other adverse events | 14 / 148 | 50 / 94 |
| serious Total, serious adverse events | 7 / 148 | 3 / 94 |
Outcome results
None listed