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
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05813912
- Acronym / sponsor ID
- NN1436-4910
- Conditions
- Diabetes Mellitus, Type 2
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 148 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 22 Sep 2023 (actual)
- Primary completion
- 14 Apr 2025 (actual)
- Study completion
- 16 May 2025 (actual)
- First posted
- 14 Apr 2023 (actual)
- Results
- Posted 3 Jun 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Insulin Icodec + Semaglutide | Experimental | Drug: Insulin Icodec, Drug: SemaglutideParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Insulin IcodecParticipants will receive subcutaneously insulin icodec once weekly for 52 weeks. | Drug | Insulin Icodec + Semaglutide |
| SemaglutideParticipants will receive once weekly semaglutide subcutaneously starting from 0.25 mg and dose increased up to 1 mg for 26 weeks. | Drug | Insulin Icodec + Semaglutide |
Primary outcome
Change in Glycated Haemoglobin (HbA1c)
Time frame: 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.
8 secondary outcomes
Change in Mean 7-point Self-measured Plasma Glucose (SMPG) Profiles
Time frame: Baseline (Week 26), Week 52
Change in Mean Post-prandial Glucose Increment (Over All Meals)
Time frame: Baseline (Week 26), Week 52
Change in Fasting Plasma Glucose (FPG)
Time frame: Baseline (Week 26), Week 52
Number of Severe Hypoglycaemic Episodes (Level 3)
Time frame: 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)
Time frame: 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)
Time frame: From baseline (week 26) to week 57
Change in Body Weight
Time frame: Baseline (Week 26), Week 52
Relative Change in Weekly Insulin Icodec Dose
Time frame: From week 25 to week 52
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42387310Strojek 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.
- Individual participant dataSharing planned: Yes. According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Transparency (dept. 2834) study director
Novo Nordisk A/S
39 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 39 sites in Poland, Czechia, Malaysia, Serbia, Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Jun 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Glycated Haemoglobin (HbA1c) (time frame: Baseline (Week 26), Week 52). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05813912, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2026.