Primary outcomeMean· From baseline (week 0) to end of treatment (week 28)
Change in Glycosylated Haemoglobin (HbA1c)
| Group | Value (Percentage of glycosylated haemoglobin) | Spread |
|---|---|---|
| Semaglutide J | -1.7 | 1.0 |
| Semaglutide B | -1.6 | 1.0 |
Trial · Interventional
CompletedPhase 3Results postedRegistry dataA Research Study to Compare Two Semaglutide Medicines in People With Type 2 Diabetes
NCTNCT05478252 (opens ClinicalTrials.gov in a new tab)Other idNN9535-4820Other idU1111-1266-2391Other id2021-001501-69
Overview
- Status
- Completed
- Phase
- Phase 3
- Enrollment
- 388 participants (actual)
- Sponsor
- Novo Nordisk A/S · Industry
- Design
- Randomized · Triple masking
- Countries
5 countries
United States, Canada, Poland, Slovakia, South Africa
- Start
- 3 Aug 2022
- Primary completion
- 9 Aug 2023
- Completion
- 18 Sept 2023
- First posted
- 28 Jul 2022
- Last update posted
- 12 Dec 2025
- Conditions
- Diabetes Mellitus, Type 2
Timeline
1 trial · 1 completed · 1 with posted results
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
202220232024
- Ph 3
A Research Study to Compare Two Semaglutide Medicines in People With Type 2 Diabetes
NCT054782523 Aug 2022 to 18 Sept 2023
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
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).
Interventions
- Semaglutide JDrug
- Semaglutide BDrug
Arms2
Experimental
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.
Active comparator
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.
Primary outcomes1
Outcomes the sponsor listed as primary.
Change in Glycosylated Haemoglobin (HbA1c)
Time frame · From baseline (week 0) to end of treatment (week 28)
Registry description
Change in HbA1c from baseline (week 0) to end of treatment (week 28) is presented. The endpoint was evaluated based on the data from in-study period. The in-study period is defined as the uninterrupted time interval from date of randomisation to date of least contact with trial site.
Secondary outcomes(8)
Change in Body Weight
Time frame · From baseline (week 0) to end of treatment (week 28)
Registry description
Change in body weight from baseline (week 0) to end of treatment (week 28) is presented. The endpoint was evaluated based on the data from in-study period. The in-study period is defined as the uninterrupted time interval from date of randomisation to date of least contact with trial site.
Number of Treatment-Emergent Adverse Events (TEAEs)
Time frame · From the time of first dosing (week 0) to end of study (week 33)
Registry description
An AE is any untoward medical occurrence in a clinical study participant that is temporally associated with the use of IMP, whether or not considered related to the IMP. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom or disease (new or exacerbated) temporally associated with the use of an IMP. All presented adverse events are TEAE. A TEAE is defined as an adverse event with an onset date (or increase in severity) during the on-treatment observation period. On-treatment observation period is defined as from first drug date until the end of study.
Occurrence of Anti-semaglutide Antibodies (Yes/no)
Time frame · From baseline (week 0) to end of study (week 33)
Registry description
Occurrence of anti-semaglutide antibodies for in-study observation period is presented. The in-study period is defined as the uninterrupted time interval from date of randomisation to date of last contact with trial site. In the reported data 'yes' infers who tested positive for anti-semaglutide antibodies, whereas 'No' infers who tested negative for anti semaglutide antibodies.
Occurrence of Anti-semaglutide Antibodies With In-vitro Neutralising Effect (Yes/no)
Time frame · From baseline (week 0) to end of study (week 33)
Registry description
Occurrence of anti-semaglutide antibodies with in-vitro neutralizing effect was to be performed based on positive cross -reactivity to GLP-1. Since there was no sample with positive cross -reactivity to GLP-1, no further analysis was performed for invitro neutralizing effect towards native-GLP1. Therefore, no data is available for this end point. In the reported data 'yes' infers who tested positive for anti-semaglutide antibodies whereas 'No' infers who tested negative for anti-semaglutide antibodies.
Occurrence of Anti-semaglutide Binding Antibodies Cross-reacting With Endogenous Glucagon Like Peptide-1 (GLP-1) (Yes/no)
Time frame · From baseline (week 0) to end of study (week 33)
Registry description
Occurrence of anti-semaglutide binding antibodies cross-reacting with endogenous glucagon like peptide-1 (GLP-1) for in-study observation period is presented. The in-study period is defined as the uninterrupted time interval from date of randomisation to date of last contact with trial site. In the reported data 'yes' infers who tested positive for anti-semaglutide binding antibodies cross-reacting with endogenous glucagon like peptide-1 (GLP-1) whereas 'No' infers who tested negative for anti-semaglutide binding antibodies cross-reacting with endogenous glucagon like peptide-1 (GLP-1).
Occurrence of In-vitro Neutralising Cross-reacting Antibodies to Endogenous GLP-1 (Yes/no)
Time frame · At week 33
Registry description
Occurrence of in-vitro neutralising cross-reacting antibodies to endogenous GLP-1 at week 33 is presented. In the reported data 'yes' infers who tested positive for in-vitro neutralising cross-reacting antibodies to endogenous GLP-1 whereas 'No' infers who tested negative for in-vitro neutralising cross-reacting antibodies to endogenous GLP-1.
Anti-semaglutide Antibodies Level Measured as Percentage (%) Bound/Total
Time frame · At week 33
Registry description
Anti-semaglutide antibodies level measured as %Bound/Total at week 33 is presented.
Anti-semaglutide Antibodies Level (Measured as Titre)
Time frame · At week 33
Registry description
Anti-semaglutide antibodies level measured as titre at week 33 is presented.
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
Primary outcome results
Secondary and other outcome results(7)
Secondary outcomeMean· From baseline (week 0) to end of treatment (week 28)
Change in Body Weight
| Group | Value (Kilogram (kg)) | Spread |
|---|---|---|
| Semaglutide J | -5.0 | 5.0 |
| Semaglutide B | -4.6 | 4.4 |
Secondary outcomeNumber· From the time of first dosing (week 0) to end of study (week 33)
Number of Treatment-Emergent Adverse Events (TEAEs)
| Group | Value (Events) |
|---|---|
| Semaglutide J | 156 |
| Semaglutide B | 52 |
Secondary outcomeCount of participants· From baseline (week 0) to end of study (week 33)
Occurrence of Anti-semaglutide Antibodies (Yes/no)
| Group | Value (Participants) |
|---|---|
| Semaglutide J | 1 |
| Semaglutide B | 0 |
Secondary outcome· From baseline (week 0) to end of study (week 33)
Occurrence of Anti-semaglutide Antibodies With In-vitro Neutralising Effect (Yes/no)
| Group | Value |
|---|---|
| Semaglutide J | not posted |
| Semaglutide B | not posted |
Secondary outcomeCount of participants· From baseline (week 0) to end of study (week 33)
Occurrence of Anti-semaglutide Binding Antibodies Cross-reacting With Endogenous Glucagon Like Peptide-1 (GLP-1) (Yes/no)
| Group | Value (Participants) |
|---|---|
| Semaglutide J | 0 |
| Semaglutide B | 0 |
Secondary outcomeCount of participants· At week 33
Occurrence of In-vitro Neutralising Cross-reacting Antibodies to Endogenous GLP-1 (Yes/no)
| Group | Value (Participants) |
|---|---|
| Semaglutide J | 0 |
| Semaglutide B | 0 |
Secondary outcomeMean· At week 33
Anti-semaglutide Antibodies Level Measured as Percentage (%) Bound/Total
| Group | Value (Percentage of Antisemaglutide Antibodies) | Spread |
|---|---|---|
| Semaglutide J | 3.47 | 0.00 |
| Semaglutide B | not posted | – |
Adverse events, as posted
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| Semaglutide JParticipants initially received 0.25 mg subcutaneous injections of semaglutide J once weekly and the dose was then escalated (0.25 mg in week 0 to week 4 and 0.5 mg in week 4 to week 8) once in 4 weeks until the target maintenance dose of 1.0 mg was reached which was maintained for a period of 20 weeks. Total treatment period was 28 weeks. | 1 / 291 | 8 / 291 | 64 / 291 |
| Semaglutide BParticipants initially received 0.25 mg subcutaneous injections of semaglutide B once weekly and the dose was then escalated (0.25 mg in week 0 to week 4 and 0.5 mg in week 4 to week 8) once in 4 weeks until the target maintenance dose of 1.0 mg was reached which was maintained for a period of 20 weeks. Total treatment period was 28 weeks. | 0 / 97 | 5 / 97 | 24 / 97 |
Each cell reads participants affected / participants at risk, as the registry posted them.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies0
Studies that cite this trial.
No study cites this trial.
Eligibility
Who could join, as posted.
- Sex
- All
- Age
- from 18 Years up to 64 Years
- Healthy volunteers
- Not accepted
Inclusion and exclusion criteria, as posted
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.
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