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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
388
Participants will initially receive 0.25 mg subcutaneous injections of semaglutide J 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: 0.25 mg (week 1 to week 4), 0.5 mg (week 5 to week 8), 1.0 mg (week 9 to week 28).
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: 0.25 mg (week 1 to week 4), 0.5 mg (week 5 to week 8), 1.0 mg (week 9 to week 28).
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.
Time frame: From baseline (week 0) to end of treatment (week 28)
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.
Time frame: From baseline (week 0) to end of treatment (week 28)
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.
Time frame: From the time of first dosing (week 0) to end of study (week 33)
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.
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Prime Medical Group, LLC
Gilbert, Arizona, United States
FDRC
Costa Mesa, California, United States
Velocity Clinical Research San Diego
La Mesa, California, United States
Velocity Clin Res Los Angeles
Los Angeles, California, United States
LCGK Research
San Carlos, California, United States
San Diego Family Care_San Diego
San Diego, California, United States
Encompass Clinical Research_Spring Valley
Spring Valley, California, United States
Med Partners, Inc.
Toluca Lake, California, United States
University Clin Investigators
Tustin, California, United States
Diablo Clinical Research, Inc.
Walnut Creek, California, United States
...and 94 more locations
Time frame: From baseline (week 0) to end of study (week 33)
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.
Time frame: 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)
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).
Time frame: From baseline (week 0) to end of study (week 33)
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.
Time frame: At week 33
Anti-semaglutide Antibodies Level Measured as Percentage (%) Bound/Total
Anti-semaglutide antibodies level measured as %Bound/Total at week 33 is presented.
Time frame: At week 33
Anti-semaglutide Antibodies Level (Measured as Titre)
Anti-semaglutide antibodies level measured as titre at week 33 is presented.
Time frame: At week 33