Phase 3
N=388
A Research Study to Compare Two Semaglutide Medicines in People With Type 2 Diabetes
Diabetes Mellitus, Type 2
Bottom Line
View on ClinicalTrials.gov: NCT05478252 ↗Enrolled (actual)
388
Serious AEs
3.4%
Results posted
Oct 2024
Primary outcome: Primary: Change in Glycosylated Haemoglobin (HbA1c) — -1.7; -1.6 Percentage of glycosylated haemoglobin — p=<.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Semaglutide J (Drug); Semaglutide B (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Novo Nordisk A/S
- Primary completion
- Aug 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Glycosylated Haemoglobin (HbA1c) |
-1.7; -1.6 | <.0001 sig |
| SECONDARY Change in Body Weight |
-5.0; -4.6 | — |
| SECONDARY Number of Treatment-Emergent Adverse Events (TEAEs) |
156; 52 | — |
| SECONDARY Occurrence of Anti-semaglutide Antibodies (Yes/no) |
1; 0; 281; 90 | — |
| SECONDARY Occurrence of Anti-semaglutide Antibodies With In-vitro Neutralising Effect (Yes/no) |
— | — |
| SECONDARY Occurrence of Anti-semaglutide Binding Antibodies Cross-reacting With Endogenous Glucagon Like Peptide-1 (GLP-1) (Yes/no) |
0; 0; 1; 0 | — |
| SECONDARY Occurrence of In-vitro Neutralising Cross-reacting Antibodies to Endogenous GLP-1 (Yes/no) |
0; 0; 1; 0 | — |
| SECONDARY Anti-semaglutide Antibodies Level Measured as Percentage (%) Bound/Total |
3.47 | — |
| SECONDARY Anti-semaglutide Antibodies Level (Measured as Titre) |
15.00 | — |
Summary
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).
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT05478252). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.