A Phase 3 interventional study of Insulin icodec and Placebo insulin icodec in Diabetes Mellitus, Type 2, sponsored by Novo Nordisk A/S. Completed at 190 sites in 12 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-12.
Sponsored by Novo Nordisk A/S · Phase 3, Interventional, and Treatment
This study compares insulin icodec (a new insulin taken once a week) to insulin degludec (an insulin taken once daily which is already available on the market) in people with type 2 diabetes.
The study will look at how well insulin icodec taken weekly controls blood sugar compared to insulin degludec taken daily.
Participants will get their study medicine in an injection pen. Participants will get a pen for weekly injection and one for daily injection. One will be icodec or degludec and the other will be dummy medicine. The treatment participants get is decided by chance. Participants and the study staff will not know which active medicine they get.
The insulin is injected with a needle in a skin fold in the thigh. The study could last for about 8 months. Participants will have 13 clinic visits and 17 phone calls with the study doctor. At 8 clinic visits participants will have blood samples taken. At 4 clinic visits participants cannot eat or drink (except for water) for 8 hours before the visit.
Women cannot take part if pregnant, breast-feeding or plan to become pregnant during the study period.
9,359 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,318 are open to participants now.
This study's enrollment of 588 is above the median of 80 across 7,525 interventional studies indexed under Diabetes Mellitus, Type 2.
Browse Diabetes Mellitus, Type 2 studies →Novo Nordisk A/S is the lead sponsor of 1,370 studies on the registry; 102 are open to participants now.
Of its 198 completed or terminated interventional studies of FDA-regulated products, 94 (47%) have results posted.
Counted across the registry records on this site, refreshed daily.
Stable daily dose(s) greater than or equal to 90 days prior to the day of screening of any of the following anti-diabetic drug(s) or combination regimen(s):
a.) Any metformin formulations greater than or equal to 1500 mg or maximum tolerated or effective dose. b.) Any metformin combination formulations greater than or equal to 1500 mg or maximum tolerated or effective dose. c.) Any of the following oral anti-diabetic drug classes including combinations (greater than or equal to half of the maximum approved dose according to local label or maximum tolerated or effective dose).:Sulfonylureas - Meglitinides (glinides) - DPP-4 inhibitors - SGLT2 inhibitors - Thiazolidinediones - Alpha-glucosidase inhibitors - Oral combination products (for the allowed individual Oral Anti-diabetic Drugs (OADs)) - Oral or injectable GLP-1-receptor agonists
Exclusion Criteria:
Participants will get once daily and once weekly injections
Drug: Insulin icodec · Drug: Placebo insulin degludec
Participants will get once daily and once weekly injections
Drug: Placebo insulin icodec · Drug: Insulin degludec
You will get a pen for weekly injection and one for daily injection. One will be icodec 700 units/mL and the other will be placebo. Subcutaneously (under the skin) injections
You will get a pen for weekly injection and one for daily injection. One will be insulin degludec 100 units/mL and the other will be placebo. Subcutaneously (under the skin) injections
You will get a pen for weekly injection and one for daily injection. One will be degludec 100 units/mL and the other will be placebo. Subcutaneously (under the skin) injections
You will get a pen for weekly injection and one for daily injection. One will be icodec 700 units/mL and the other will be placebo. Subcutaneously (under the skin) injections
Change in Glycated Haemoglobin (HbA1c)
Change in HbA1c from baseline (week 0) to week 26 is presented. The outcome data is evaluated based on the in-trial observation period. The in-trial period started at randomisation and ended at the date of: the last direct participant-site contact, withdrawal for participants who withdrew their informed consent, the last participant-investigator contact as defined by the investigator for participants who were lost to follow-up (i.e., possibly an unscheduled phone visit) and death for participants who died before any of the above.
Time frame: Baseline (Week 0), Week 26
Change in Fasting Plasma Glucose (FPG)
Change in FPG from baseline (week 0) to week 26 is presented. The outcome data was evaluated based on the in-trial observation period. The in-trial period started at randomisation and ended at the date of: the last direct participant-site contact, withdrawal for participants who withdrew their informed consent, the last participant-investigator contact as defined by the investigator for participants who were lost to follow-up (i.e., possibly an unscheduled phone visit) and death for participants who died before any of the above.
Time frame: Baseline (Week 0), Week 26
Number of Severe Hypoglycaemic Episodes (Level 3)
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 on-tratment period. The on-treatment period started at the date of first dose of trial product as recorded on the electronic case report form (eCRF), and ended at the first date of any of the following: The end of trial visit (V30), the last date on trial product + 5 weeks for once daily insulin and + 6 weeks for once weekly insulin (corresponding to 5 weeks after the end of the dosing interval for both treatment arms) and the end-date for the in-trial observation period. The on-treatment period represented the time period in which a participant was considered exposed to trial product.
Time frame: From baseline (week 0) to week 31
Number of Clinically Significant Hypoglycaemic Episodes (Level 2) (< 3.0 mmol/L (54 Milligrams Per Deciliter [mg/dL]), Confirmed by Blood Glucose [BG] Meter)
Number of clinically significant hypoglycaemic episodes (level 2) (less than \[\<\] 3.0 millimoles per liter (mmol/L) (54 mg/dL), confirmed by BG meter) is presented. Clinically significant hypoglycaemia (level 2) is defined as plasma glucose value of less than 3.0 mmol/L (54 mg/dL) confirmed by BG meter. The outcome data was evaluated based on the on-treatment period. The on-treatment period started at the date of first dose of trial product as recorded on the electronic case report form (eCRF), and ended at the first date of any of the following: The end of trial visit (V30), the last date on trial product + 5 weeks for once daily insulin and + 6 weeks for once weekly insulin (corresponding to 5 weeks after the end of the dosing interval for both treatment arms) and the end-date for the in-trial observation period. The on-treatment period represented the time period in which a participant was considered exposed to trial product.
Time frame: 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)
Number of clinically significant hypoglycaemic episodes (level 2) (less than 3.0 mmol/L) (54 mg/dL), confirmed by blood glucose \[BG\] meter) or severe hypoglycaemic episodes (level 3) is presented. Severe hypoglycaemia (level 3) is defined as hypoglycaemia with severe cognitive impairment requiring external assistance for recovery. 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 on-treatment period. The on-treatment period started at the date of first dose of trial product as recorded on the electronic case report form (eCRF), and ended at the first date of any of the following: The end of trial visit (V30), the last date on trial product + 5 weeks for once daily insulin and + 6 weeks for once weekly insulin (corresponding to 5 weeks after the end of the dosing interval for both treatment arms) and the end-date for the in-trial observation period.
Time frame: From baseline (week 0) to week 31
Number of Severe Hypoglycaemic Episodes (Level 3)
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.
Time frame: From baseline (week 0) to week 26
Number of Clinically Significant Hypoglycaemic Episodes (Level 2) (<3.0 mmol/L (54 mg/dL), Confirmed by BG Meter)
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 less than (\<) 3.0 mmol/L (54 mg/dL) confirmed by BG meter.
Time frame: From baseline (week 0) to week 26
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)
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. Severe hypoglycaemia (level 3) is defined as hypoglycaemia with severe cognitive impairment requiring external assistance for recovery. Clinically significant hypoglycaemia (level 2) is defined as plasma glucose value of less than (\<) 3.0 millimoles per liter (mmol/L) (54 milligrams per deciliter \[mg/dL\]) confirmed by blood glucose (BG) meter.
Time frame: From baseline (week 0) to week 26
Change in Body Weight
Change in body weight from baseline (week 0) to week 26 is presented. The outcome data was evaluated based on the in-trial observation period. The in-trial period started at randomisation and ended at the date of: the last direct participant-site contact, withdrawal for participants who withdrew their informed consent, the last participant-investigator contact as defined by the investigator for participants who were lost to follow-up (i.e., possibly an unscheduled phone visit) and death for participants who died before any of the above.
Time frame: Baseline (Week 0), Week 26
Mean Weekly Insulin Dose
Estimated mean weekly insulin dose during the last 2 weeks of treatment (from week 24 to week 26) is presented. The outcome data was evaluated based on the on-treatment period. The on-treatment period started at the date of first dose of trial product as recorded on the electronic case report form (eCRF), and ended at the first date of any of the following: The end of trial visit (V30), the last date on trial product + 5 weeks for once daily insulin and + 6 weeks for once weekly insulin (corresponding to 5 weeks after the end of the dosing interval for both treatment arms) and the end-date for the in-trial observation period. The on-treatment period represented the time period in which a participant was considered exposed to trial product.
Time frame: From week 24 to week 26
The trial was conducted at 89 sites in 11 countries as follows (number of sites that screened participants/ number of sites that randomised participants): Argentina (4/4), Austria (3/3), Brazil (4/4), Canada (14/13), China mainland (13/13), Czech Republic (6/6), Denmark (4/4), France (9/8), Mexico (2/2), Taiwan (5/5), United States (28/27).
| Milestone | Insulin Icodec | Insulin Degludec |
|---|---|---|
| Started | 294 | 294 |
| Full analysis set (fas) | 294 | 294 |
| Safety analysis set (sas) | 293 | 294 |
| Treated | 293 | 294 |
| Completed | 288 | 286 |
| Not completed | 6 | 8 |
| Withdrew: Withdrawal by subject | 4 | 4 |
| Withdrew: Lost to follow-up | 0 | 1 |
| Withdrew: Physician decision | 0 | 2 |
| Withdrew: Death | 2 | 1 |
Change in HbA1c from baseline (week 0) to week 26 is presented. The outcome data is evaluated based on the in-trial observation period. The in-trial period started at randomisation and ended at the date of: the last direct participant-site contact, withdrawal for participants who withdrew their informed consent, the last participant-investigator contact as defined by the investigator for participants who were lost to follow-up (i.e., possibly an unscheduled phone visit) and death for participants who died before any of the above.
| Percentage of HbA1c | Insulin Icodec | Insulin Degludec |
|---|---|---|
| Change in Glycated Haemoglobin (HbA1c) | -1.57 ± 0.05 | -1.36 ± 0.05 |
Change in FPG from baseline (week 0) to week 26 is presented. The outcome data was evaluated based on the in-trial observation period. The in-trial period started at randomisation and ended at the date of: the last direct participant-site contact, withdrawal for participants who withdrew their informed consent, the last participant-investigator contact as defined by the investigator for participants who were lost to follow-up (i.e., possibly an unscheduled phone visit) and death for participants who died before any of the above.
| millimoles per liter (mmol/L) | Insulin Icodec | Insulin Degludec |
|---|---|---|
| Change in Fasting Plasma Glucose (FPG) | -3.01 ± 0.11 | -2.99 ± 0.11 |
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 on-tratment period. The on-treatment period started at the date of first dose of trial product as recorded on the electronic case report form (eCRF), and ended at the first date of any of the following: The end of trial visit (V30), the last date on trial product + 5 weeks for once daily insulin and + 6 weeks for once weekly insulin (corresponding to 5 weeks after the end of the dosing interval for both treatment arms) and the end-date for the in-trial observation period. The on-treatment period represented the time period in which a participant was considered exposed to trial product.
| Episodes | Insulin Icodec | Insulin Degludec |
|---|---|---|
| Number of Severe Hypoglycaemic Episodes (Level 3) | 0 | 2 |
Number of clinically significant hypoglycaemic episodes (level 2) (less than \[\<\] 3.0 millimoles per liter (mmol/L) (54 mg/dL), confirmed by BG meter) is presented. Clinically significant hypoglycaemia (level 2) is defined as plasma glucose value of less than 3.0 mmol/L (54 mg/dL) confirmed by BG meter. The outcome data was evaluated based on the on-treatment period. The on-treatment period started at the date of first dose of trial product as recorded on the electronic case report form (eCRF), and ended at the first date of any of the following: The end of trial visit (V30), the last date on trial product + 5 weeks for once daily insulin and + 6 weeks for once weekly insulin (corresponding to 5 weeks after the end of the dosing interval for both treatment arms) and the end-date for the in-trial observation period. The on-treatment period represented the time period in which a participant was considered exposed to trial product.
| Episodes | Insulin Icodec | Insulin Degludec |
|---|---|---|
| Number of Clinically Significant Hypoglycaemic Episodes (Level 2) (< 3.0 mmol/L (54 Milligrams Per Deciliter [mg/dL]), Confirmed by Blood Glucose [BG] Meter) | 53 | 23 |
Number of clinically significant hypoglycaemic episodes (level 2) (less than 3.0 mmol/L) (54 mg/dL), confirmed by blood glucose \[BG\] meter) or severe hypoglycaemic episodes (level 3) is presented. Severe hypoglycaemia (level 3) is defined as hypoglycaemia with severe cognitive impairment requiring external assistance for recovery. 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 on-treatment period. The on-treatment period started at the date of first dose of trial product as recorded on the electronic case report form (eCRF), and ended at the first date of any of the following: The end of trial visit (V30), the last date on trial product + 5 weeks for once daily insulin and + 6 weeks for once weekly insulin (corresponding to 5 weeks after the end of the dosing interval for both treatment arms) and the end-date for the in-trial observation period.
| Episodes | Insulin Icodec | Insulin Degludec |
|---|---|---|
| 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) | 53 | 25 |
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.
| Episodes | Insulin Icodec | Insulin Degludec |
|---|---|---|
| Number of Severe Hypoglycaemic Episodes (Level 3) | 0 | 0 |
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 less than (\<) 3.0 mmol/L (54 mg/dL) confirmed by BG meter.
| Episodes | Insulin Icodec | Insulin Degludec |
|---|---|---|
| Number of Clinically Significant Hypoglycaemic Episodes (Level 2) (<3.0 mmol/L (54 mg/dL), Confirmed by BG Meter) | 50 | 17 |
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. Severe hypoglycaemia (level 3) is defined as hypoglycaemia with severe cognitive impairment requiring external assistance for recovery. Clinically significant hypoglycaemia (level 2) is defined as plasma glucose value of less than (\<) 3.0 millimoles per liter (mmol/L) (54 milligrams per deciliter \[mg/dL\]) confirmed by blood glucose (BG) meter.
| Episodes | Insulin Icodec | Insulin Degludec |
|---|---|---|
| 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) | 50 | 17 |
Change in body weight from baseline (week 0) to week 26 is presented. The outcome data was evaluated based on the in-trial observation period. The in-trial period started at randomisation and ended at the date of: the last direct participant-site contact, withdrawal for participants who withdrew their informed consent, the last participant-investigator contact as defined by the investigator for participants who were lost to follow-up (i.e., possibly an unscheduled phone visit) and death for participants who died before any of the above.
| Kilograms (kg) | Insulin Icodec | Insulin Degludec |
|---|---|---|
| Change in Body Weight | 2.77 ± 0.22 | 2.32 ± 0.24 |
Estimated mean weekly insulin dose during the last 2 weeks of treatment (from week 24 to week 26) is presented. The outcome data was evaluated based on the on-treatment period. The on-treatment period started at the date of first dose of trial product as recorded on the electronic case report form (eCRF), and ended at the first date of any of the following: The end of trial visit (V30), the last date on trial product + 5 weeks for once daily insulin and + 6 weeks for once weekly insulin (corresponding to 5 weeks after the end of the dosing interval for both treatment arms) and the end-date for the in-trial observation period. The on-treatment period represented the time period in which a participant was considered exposed to trial product.
| Units (U) of insulin | Insulin Icodec | Insulin Degludec |
|---|---|---|
| Mean Weekly Insulin Dose | 204.28 (189.44 to 220.29) | 186.52 (173.06 to 201.02) |
Collected over From baseline (Week 0) to Week 31. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Insulin Icodec | 2/293 (0.7%) | 15/293 (5.1%) | 52/293 (17.7%) |
| Insulin Degludec | 1/294 (0.3%) | 15/294 (5.1%) | 29/294 (9.9%) |
| Event | Insulin Icodec | Insulin Degludec |
|---|---|---|
| Acute kidney injuryRenal and urinary disorders | 1/293 | 0/294 |
| Acute myocardial infarctionCardiac disorders | 1/293 | 1/294 |
| Adenocarcinoma pancreasNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 1/293 | 0/294 |
| AstheniaGeneral disorders | 1/293 | 0/294 |
| COVID-19Infections and infestations | 1/293 | 0/294 |
| Cardiac failureCardiac disorders | 1/293 | 0/294 |
| Cardio-respiratory arrestCardiac disorders | 1/293 | 0/294 |
| Chest discomfortGeneral disorders | 1/293 | 0/294 |
| Colorectal cancerNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 1/293 | 0/294 |
| CystitisInfections and infestations | 1/293 | 0/294 |
| Event | Insulin Icodec | Insulin Degludec |
|---|---|---|
| COVID-19Infections and infestations | 24/293 | 14/294 |
| Diabetic retinopathyEye disorders | 15/293 | 6/294 |
| InfluenzaInfections and infestations | 15/293 | 9/294 |
Full analysis set (FAS) included all randomised participants.
| Age, Continuous(Years) | Insulin Icodec | Insulin Degludec | Total |
|---|---|---|---|
| Mean | 57.70 ± 10.19 | 58.56 ± 9.74 | 58.13 ± 9.97 |
| Sex: Female, Male(Participants) | Insulin Icodec | Insulin Degludec | Total |
|---|---|---|---|
| Female | 109 | 110 | 219 |
| Male | 185 | 184 | 369 |
| Ethnicity (NIH/OMB)(Participants) | Insulin Icodec | Insulin Degludec | Total |
|---|---|---|---|
| Hispanic or Latino | 76 | 88 | 164 |
| Not Hispanic or Latino | 203 | 190 | 393 |
| Unknown or Not Reported | 15 | 16 | 31 |
| Race (NIH/OMB)(Participants) | Insulin Icodec | Insulin Degludec | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 1 | 1 |
| Asian | 80 | 85 | 165 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 9 | 6 | 15 |
| White | 179 | 175 | 354 |
| More than one race | 11 | 11 | 22 |
| Unknown or Not Reported | 15 | 16 | 31 |
Showing the first 100 of 190 sites across 12 countries.
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
This study is completed, as verified in May 2026. You cannot join it, but the record below documents what was studied.
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