Primary outcome
What NCT05478252 measured first
| Semaglutide Jn=285 | Semaglutide Bn=91 |
|---|---|
| -1.7(1.0) | -1.6(1.0) |
Phase 3 · Semaglutide
NCT05478252 trial results
Investigation of Clinical Comparability of Semaglutide Drug Products Based on the Proposed and the Approved Drug Substance Manufacturing Processes in Participants With Type 2 Diabetes
Change in Glycosylated Haemoglobin (HbA1c) (Percentage of glycosylated haemoglobin), From baseline (week 0) to end of treatment (week 28). Semaglutide J: -1.7; Semaglutide B: -1.6.
- Participants
- 388
- Status
- completed
- Completed
- 2023-09-18
- Sponsor
- Novo Nordisk A/S
As posted on ClinicalTrials.gov (NCT05478252), updated at source Dec 12, 2025. Read again whenever the registry updates it. Registry figures can differ from a published paper, which may use another analysis.
Side effects by arm
Side effects in NCT05478252
Percent of participants affected, From the time of first dosing (week 0) to end of study (week 33). The most common events the registry lists.
| Event | Semaglutide J | Semaglutide B |
|---|---|---|
| Any serious event | 2.7% | 5.2% |
| Nausea | 12% | 15.5% |
| Diarrhoea | 8.9% | 7.2% |
| Headache | 5.8% | 2.1% |
| Vomiting | 5.2% | 5.2% |
Secondary outcomes
What else it measured
| Semaglutide Jn=284 | Semaglutide Bn=91 |
|---|---|
| -5.0(5.0) | -4.6(4.4) |
| Semaglutide Jn=291 | Semaglutide Bn=97 |
|---|---|
| 156 | 52 |
| Measure | Semaglutide Jn=282 | Semaglutide Bn=90 |
|---|---|---|
| Yes | 1 | 0 |
| No | 281 | 90 |
| Measure | Semaglutide Jn=1 | Semaglutide Bn=0 |
|---|---|---|
| Yes | 0 | 0 |
| No | 1 | 0 |
| Measure | Semaglutide Jn=1 | Semaglutide Bn=0 |
|---|---|---|
| Yes | 0 | 0 |
| No | 1 | 0 |
| Semaglutide Jn=1 | Semaglutide Bn=0 |
|---|---|
| 3.47(0.00) | not reported |
| Semaglutide Jn=1 | Semaglutide Bn=0 |
|---|---|
| 15.00(0.00) | not reported |
The trial
How NCT05478252 was run
The study compares two semaglutide medicines and looks at how well they control blood sugar levels, in participants with type 2 diabetes (T2D). Participants will either get the currently available semaglutide or the semaglutide which is produced through a new manufacturing process. Participants need to take one injection of semaglutide once a week, on the same day of every week. Participants will have a total of 11 clinic visits and the study will last for about 35 weeks (approximately 8 months).
- Semaglutide J: Participants will initially receive 0.25 milligrams (mg) subcutaneous injections of semaglutide J once weekly (OW) and the dose will be then escalated once in 4 weeks for 8 weeks until the target maintenance dose of 1.0 mg is reached which will be maintained for a period of 20 weeks. Metformin will be considered as background therapy during the trial.
- Semaglutide B: Participants will initially receive 0.25 mg subcutaneous injections of semaglutide B OW and the dose will be then escalated once in 4 weeks for 8 weeks until the target maintenance dose of 1.0 mg is reached which will be maintained for a period of 20 weeks. Metformin will be considered as background therapy during the trial.
Who could join the trial
Inclusion Criteria: * Diagnosed with type 2 diabetes (T2D) mellitus greater than equal to (≥) 180 days before screening. * Stable daily dose(s) ≥ 90 days prior to the day of screening of metformin ≥ 1500 milligrams (mg) or maximum tolerated or effective dose. * HbA1c of 7.0-10.5 percentage (%) \[53-91.3 millimoles per mole (mmol/mol)\] (both inclusive). Exclusion Criteria: * Known or suspected hypersensitivity to study intervention(s) or related products. * Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria within 90 days before screening. However, short term insulin treatment for a maximum of 14 days and prior insulin treatment for gestational diabetes are allowed. * Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a fundus examination performed within 90 days before screening or in the period between screening and randomisation. Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for nondilated examination.
Trial averages do not predict what one person will experience. Results are shown as the registry posts them, without interpretation.
GLPcompare is an informational data platform, not a medical provider or pharmacy. Nothing here is medical advice, a diagnosis, or a recommendation to start, stop, or change any treatment. Data is aggregated from public sources and can be incomplete or out of date. Always confirm with a licensed clinician and the current FDA label.