Diabetes, Type 2
Conditions
Brief summary
This study compares insulin icodec, a new insulin taken once a week, to insulin glargine, an insulin taken once a day. The study medicine will be investigated in participants with type 2 diabetes. Participants will either get insulin icodec or insulin glargine. Which treatment participants get is decided by chance. Insulin icodec is the new medicine being tested, while insulin glargine is already approved and can be prescribed by doctors. Participants will get one injection of insulin icodec once a week, or one injection of insulin glargine once a day, depending on the treatment group participants are assigned into. Participants will use a pen with a small needle to inject the medicine under participants skin into participants thigh, upper arm or stomach.The study will last for about 9 months, but participants will only be taking the study medicine for 6 months.
Interventions
DRUGInsulin icodec
Insulin Icodec will be administered subcutaneously.
DRUGInsulin glargine
Insulin glargine will be administered subcutaneously.
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 equal to (≥) 180 days prior to the day of screening. * HbA1c from 7.0-10.0% (53.0-85.8 mmol/mol), both inclusive, at screening confirmed by central laboratory analysis. * Treated with once-daily or twice-daily basal insulin (Neutral Protamine Hagedorn insulin, insulin degludec, insulin detemir, insulin glargine 100 U/mL, or insulin glargine 300 U/mL) ≥ 90 days prior to the day of screening with or without any of the following anti-diabetic drugs/regimens with stable doses greater than equal to (≥) 90 days prior to screening: metformin, sulfonylureas, meglitinides (glinides), Dipeptidyl peptidase 4 (DPP-4) inhibitors, Sodium-Glucose Transport Protein 2 (SGLT2) inhibitors, thiazolidinediones, alphaglucosidase inhibitors, oral combination products (for the allowed individual oral anti- diabetic drugs), oral or injectable glucagon-like peptide 1 receptor agonists (GLP-1 RAs), injectable glucagon-like peptide 1(GLP-1)/ glucose-dependent insulinotropic polypeptide receptor agonist (GIP RA) combination products. * Body mass index (BMI) ≤ 40.0 kilogram per square meter (kg/m\^2).
Exclusion criteria
* Any episodes of diabetic ketoacidosis within 90 days prior to the day of screening. * Myocardial infarction, stroke, hospitalisation for unstable angina pectoris or transient ischaemic attack within 180 days prior to the day of screening. * Chronic heart failure classified as being in New York Heart Association Class IV at screening. * Anticipated initiation or change in concomitant medications (for more than 14 consecutive days) known to affect weight or glucose metabolism (e.g., treatment with orlistat, thyroid hormones, or corticosteroids). * 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 randomisation. 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) | Week 0, Week 26 | Change in HbA1c from week 0 to week 26 in percentage point is presented. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Time in Range 3.9-10.0 Millimoles Per Litre (mmol/L) (70-180 Milligrams Per Decilitre (mg/dL)) | week -4-0, week 22-26 | Change in time in range 3.9-10.0 mmol/L (70-180 mg/dL) from week -4-0 to week 22-26 is presented. Time in range is defined as 100 times the number of recorded measurements in glycaemic range 3.9-10.0 mmol/L (70-180 mg/dL), both inclusive, divided by the total number of recorded measurements. |
| Change in DTSQs (Diabetes Treatment Satisfaction Questionnaire Status Version) Total Treatment Satisfaction | week 0 to week 26 | Change in DTSQs total treatment satisfaction from week 0 to week 26 is presented. DTSQs measures the satisfaction with diabetes treatment regimens in people with diabetes. The measure consists of 8 items, of which 6 items contribute to 1 global score. Total Treatment Satisfaction score range is 0-36. 6 items scored on a scale of 0 to 6. The higher the score the greater the satisfaction with treatment. |
| Number of Severe Hypoglycaemic Episodes (Level 3) | From baseline (week 0) to week 31 | Number of severe hypoglycaemic episodes (level 3) from baseline (week 0) to week 31 is presented. |
| Number of Clinically Significant Hypoglycaemic Episodes (Level 2) (<3.0 mmol/L (54 mg/dL), Confirmed by Blood Glucose (BG) Meter) | From baseline (week 0) to week 31 | Number of clinically significant hypoglycaemic episodes (level 2) (\<3.0 mmol/L (54 mg/dL), confirmed by BG meter) from baseline (week 0) to week 31 is presented. |
| 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 0) to week 31 | 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 0) to week 31 is presented. |
| Time Spent < 3.0 mmol/L (54 mg/dL) | Week 22-26 | Time spent \< 3.0 mmol/L (54 mg/dL) during week 22 - 26 is presented. Time spent below threshold is defined as 100 times the number of recorded measurements below 3.0 mmol/L (54 mg/dL), divided by the total number of recorded measurements. |
| Change in Time Spent > 10.0 mmol/L (180 mg/dL) | Week -4-0, Week 22-26 | Change in time spent \> 10.0 mmol/L 180 mg/dL from week -4 - 0 to week 22-26 is presented. Time spent above threshold is defined as 100 times the number of recorded measurements above 10.0 mmol/L (180 mg/dL) divided by the total number of recorded measurements. |
| Mean Weekly Insulin Dose | From week 24 to week 26 | Mean weekly insulin dose from week 24 to week 26 is presented. |
| Change in Body Weight | Week 0, Week 26 | Change in body weight from baseline (week 0) to (week 26) is presented. |
Countries
Bulgaria, Germany, India, Japan, Poland, Puerto Rico, South Africa, Spain, United States
Contacts
STUDY_DIRECTORClinical Transparency (dept. 2834)
Novo Nordisk A/S
Participant flow
Recruitment details
The trial was conducted at 66 sites in 8 countries.
Pre-assignment details
After screening, all participants entered the blinded run-in period. Participants remained on their pre-study basal insulin during the run-in period with continuous glucose monitoring (CGM). After the run-in period, participants were randomised (1:1) to receive once-weekly insulin icodec or once-daily insulin glargine.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 62.41 Years STANDARD_DEVIATION 9.91 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 27 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 175 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 6 Participants |
| Race/Ethnicity, Customized American Indian or Alaska Native | 1 Participants |
| Race/Ethnicity, Customized American Indian or Alaska Native, White | 0 Participants |
| Race/Ethnicity, Customized Asian | 74 Participants |
| Race/Ethnicity, Customized Black or African American | 16 Participants |
| Race/Ethnicity, Customized Not reported | 1 Participants |
| Race/Ethnicity, Customized White | 249 Participants |
| Sex: Female, Male Female | 174 Participants |
| Sex: Female, Male Male | 122 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 206 | 0 / 206 |
| other Total, other adverse events | 42 / 206 | 30 / 206 |
| serious Total, serious adverse events | 16 / 206 | 12 / 206 |
Outcome results
None listed