Diabetes Mellitus, Type 2Phase 3NCT05813912
A Research Study to See How a New Weekly Insulin, Insulin Icodec When Given Along With Semaglutide Helps in Reducing the Blood Sugar Level in Patients With Type 2 Diabetes
A Phase 3 study testing Insulin Icodec and Semaglutide in people with Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 39 sites in 5 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Insulin Icodec and Semaglutide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 148 participants
- Where
- 39 sitesin 5 countries
- Study dates
- 22 Sep 2023to 16 May 2025
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
39 sites in 5 countries.
39 sites in 5 countries
Poland16 sites
Osteo-Medic s.c. A. Racewicz, J. Supronik
Bialystok, 15-351
Centrum Badan Klinicznych PI-House Sp. z o.o.
Gdansk, 80-546
NZOZ Gdanska Poradnia Cukrzycowa Sp.z o.o.
Gdansk, 80-858
NZOZ Gdanska Poradnia Cukrzycowa
Gdansk, 80-858
Specjalistyczny Gabinet Diabetologiczny Radoslaw Rumianowski
Gorzów Wielkopolski, Lubusz Voivodeship, 66-400
Specjalistyczny Gabinet Diabetologiczny Radoslaw Rumianowski
Gorzów Wielkopolski, 66-400
Centrum Medyczne Pratia Katowice
Katowice, 40-081
Med. Cent. Diabet. Endo. Metabol. DIAB-ENDO-MET
Krakow, Lesser Poland Voivodeship, 31-261
Santa Sp. z o.o, Santa Familia Centrum Badan, Profilaktyki i Leczenia
Lodz, 90-302
Santa Sp. z o.o, Santa Familia Centrum Badan, Profilaktyki i Leczenia
Lodz, Łódź Voivodeship, 90-302
Metabolica Sp. z o.o.
Tarnów, Lesser Poland Voivodeship, 33-100
Osrodek Badan Klinicznych "METABOLICA" lek. Robert Witek
Tarnów, Lesser Poland Voivodeship, 33-100
NBR Polska
Warsaw, Masovian Voivodeship, 00-710
NBR Polska Tomasz Klodawski
Warsaw, 00-710
Poradnia Chorob Metabolicznych w Wierzchoslawicach
Wierzchosławice, 33-122
Wojewodzka Poradnia dla Chorych na Cukrzyce w Zabrzu
Zabrze, 41-800
Czechia10 sites
Edumed Broumov
Broumov, 550 01
DIAMIN
Chrudim, 537 01
Diabetologické centrum s.r.o.
Olomouc, 779 00
DIALINE s.r.o.
Plzeň 3, 301 00
Diabet2 s.r.o.
Prague, 110 00
Medicon a.s.
Prague, 140 00
Diabetologická a endokrinologická ambulance Praha
Prague, 140 21
EUC Klinika Praha a.s.
Prague, 150 00
Comfort Care Praha s.r.o.
Praha 4 - Chodov, 148 00
DiaPodi care s.r.o.
Soběslav I, 39201
Malaysia5 sites
Hospital Canselor Tuanku Muhriz UKM
Cheras, Kuala Lumpur, 56000
Hospital Miri
Miri, Sarawak, 98000
Hospital Putrajaya
Putrajaya, Putrajaya, 62250
Hospital Seri Manjung
Seri Manjung, Perak, 32040
Universiti Teknologi MARA, Sungai Buloh Campus
Sungai Buloh, Selangor, 47000
Serbia4 sites
CHC Zvezdara, Clinical department for endocrinology
Belgrade, 11000
Clinical Hospital Centre Zemun
Belgrade, 11080
Clinical Centre Kragujevac, Internal Diseases Clinic, Endocrinology department
Kragujevac, 34000
Clin. Centre Vojvodina, Clin. endocr., diab. and met. dis.
Novi Sad, Vojvodina, 21000
Thailand4 sites
King Chulalongkorn Memorial Hospital
Bangkok, 10330
Rajavithi Hospital_Diabetes and Endocrinology
Bangkok, 10400
Rajavithi Hospital
Bangkok, 10400
Ramathibodi Hospital - Ped-Endo and Metabolism
Bangkok, 10400
About this study
Official title: Protocol Title: A Single Arm Study Investigating the Glycaemic Control and Safety of Adding Semaglutide to Insulin Icodec in Participants With Type 2 Diabetes Qualifying for Treatment Intensification Short Title: A Research Study to See How a New Weekly Insulin, Insulin Icodec When Given Along With Semaglutide Helps in Reducing the Blood Sugar Level in Patients With Type 2 Diabetes
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.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Insulin Icodec, Semaglutide
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Insulin IcodecDrug
Participants will receive subcutaneously insulin icodec once weekly for 52 weeks.
SemaglutideDrug
Participants will receive once weekly semaglutide subcutaneously starting from 0.25 mg and dose increased up to 1 mg for 26 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Insulin Icodec + Semaglutide | Experimental | Participants will receive insulin icodec once weekly for 26 weeks in run-in period to ensure the dose optimization. Thereafter, participants meeting intensification criteria will proceed to the 26-week treatment period to receive once weekly semaglutide subcutaneously starting from 0.25 milligrams (mg) and dose increased up to 1 mg along with 700 units per milliliter (U/mL) insulin icodec therapy. There are no maximum or minimum insulin doses. Receives: Drug: Insulin Icodec; Drug: Semaglutide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Glycated Haemoglobin (HbA1c)
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.
Measured: Baseline (Week 26), Week 52
Secondary outcomes (8)
Change in Mean 7-point Self-measured Plasma Glucose (SMPG) Profiles
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.
Measured: Baseline (Week 26), Week 52
Change in Mean Post-prandial Glucose Increment (Over All Meals)
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.
Measured: Baseline (Week 26), Week 52
Change in Fasting Plasma Glucose (FPG)
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.
Measured: Baseline (Week 26), Week 52
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 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).
Measured: From baseline (week 26) to week 57
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)
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).
Measured: 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)
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).
Measured: From baseline (week 26) to week 57
Change in Body Weight
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).
Measured: Baseline (Week 26), Week 52
Relative Change in Weekly Insulin Icodec Dose
Relative change in weekly insulin icodec dose from week 25 to week 52 is presented.
Measured: From week 25 to week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2023
- Study start22 Sep 2023
- Primary completion14 Apr 2025
- Study completion16 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by Novo Nordisk A/SThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 148 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novo Nordisk A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Transparency (dept. 2834), Study director, Novo Nordisk A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05813912
- Sponsor's protocol ID
- NN1436-4910
- Other IDs
- 2022-002847-24, U1111-1281-4752
- Status last verified
- May 2026
- First submitted
- 3 Apr 2023
- Last updated
- 3 Jun 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
Publications
Strojek K, Liebl A, Mumbaikar NN, Sogaard SB, Kehlet Watt S, Philis-Tsimikas A. Efficacy and Safety of Intensifying Once-Weekly Insulin Icodec Treatment With Once-Weekly Semaglutide in Adults With Type 2 Diabetes: A Single-Arm, Open-Label, Treat-to-Target, Phase 3b Trial (ONWARDS 8). Diabetes Obes Metab. 2026 Jul 1. doi: 10.1111/dom.71049. Online ahead of print.
PubMed 42387310