| Primary | Change in Glycosylated Haemoglobin (HbA1c) | 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. | Full analysis set included all randomised participants. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | Percentage of glycosylated haemoglobin | | From baseline (week 0) to end of treatment (week 28) | | | | ID | Title | Description |
|---|
| OG000 | Semaglutide J | Participants 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. | | OG001 | Semaglutide B | Participants 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. |
| | | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| - OG000-1.7± 1.0
- OG001-1.6± 1.0
|
|
| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
|---|
| | ANCOVA | | <.0001 | | Treatment difference | -0.11 | | | 2-Sided | 95 | -0.30 | 0.08 | | | | | Non-Inferiority | Non-inferiority of insulin semaglutide J versus insulin semaglutide B was considered as confirmed if the 95% confidence interval (CI) for the mean treatment difference lied entirely below 2.5%. Non-inferiority was investigated on the FAS. | |
|
| Secondary | Change in Body Weight | 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. | Full analysis set included all randomised participants. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | Kilogram (kg) | | From baseline (week 0) to end of treatment (week 28) | | | | ID | Title | Description |
|---|
| OG000 | Semaglutide J | Participants 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. | | OG001 | Semaglutide B | Participants 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. |
| |
| Secondary | Number of Treatment-Emergent Adverse Events (TEAEs) | 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. | Safety analysis set included all participants who are exposed to study intervention. | Posted | | Number | | Events | | From the time of first dosing (week 0) to end of study (week 33) | | | | ID | Title | Description |
|---|
| OG000 | Semaglutide J | Participants 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. | | OG001 | Semaglutide B | Participants 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. |
|
| Secondary | Occurrence of Anti-semaglutide Antibodies (Yes/no) | 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. | Safety analysis set included all participants who are exposed to study intervention. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure. | Posted | | Count of Participants | | Participants | | From baseline (week 0) to end of study (week 33) | | | | ID | Title | Description |
|---|
| OG000 | Semaglutide J | Participants 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. | | OG001 | Semaglutide B | Participants 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. |
|
| Secondary | Occurrence of Anti-semaglutide Antibodies With In-vitro Neutralising Effect (Yes/no) | 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. | 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. | Posted | | | | | | From baseline (week 0) to end of study (week 33) | | | | ID | Title | Description |
|---|
| OG000 | Semaglutide J | Participants 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. | | OG001 | Semaglutide B | Participants 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. |
|
| Secondary | Occurrence of Anti-semaglutide Binding Antibodies Cross-reacting With Endogenous Glucagon Like Peptide-1 (GLP-1) (Yes/no) | 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). | Safety analysis set included all participants who are exposed to study intervention. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure. | Posted | | Count of Participants | | Participants | | From baseline (week 0) to end of study (week 33) | | | | ID | Title | Description |
|---|
| OG000 | Semaglutide J | Participants 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. | | OG001 | Semaglutide B | Participants 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. |
|
| Secondary | Occurrence of In-vitro Neutralising Cross-reacting Antibodies to Endogenous GLP-1 (Yes/no) | 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. | Safety analysis set included all participants who are exposed to study intervention. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure. | Posted | | Count of Participants | | Participants | | At week 33 | | | | ID | Title | Description |
|---|
| OG000 | Semaglutide J | Participants 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. | | OG001 | Semaglutide B | Participants 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. |
|
| Secondary | Anti-semaglutide Antibodies Level Measured as Percentage (%) Bound/Total | Anti-semaglutide antibodies level measured as %Bound/Total at week 33 is presented. | Safety analysis set included all participants who are exposed to study intervention. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | Percentage of Antisemaglutide Antibodies | | At week 33 | | | | ID | Title | Description |
|---|
| OG000 | Semaglutide J | Participants 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. | | OG001 | Semaglutide B | Participants 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. |
| |
| Secondary | Anti-semaglutide Antibodies Level (Measured as Titre) | Anti-semaglutide antibodies level measured as titre at week 33 is presented. | Safety analysis set included all participants who are exposed to study intervention. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | Titre | | At week 33 | | | | ID | Title | Description |
|---|
| OG000 | Semaglutide J | Participants 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. | | OG001 | Semaglutide B | Participants 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. |
| |