A Research Study to Compare Two Semaglutide Medicines in People With Type 2 Diabetes
- Conditions
- Diabetes Mellitus, Type 2
- Interventions
- Registration Number
- NCT05478252
- Lead Sponsor
- Novo Nordisk A/S
- Brief 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 388
- 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).
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Semaglutide J 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 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 Outcome Measures
Name Time Method Change in Glycosylated Haemoglobin (HbA1c) From baseline (week 0) to end of treatment (week 28) 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 Outcome Measures
Name Time Method Change in Body Weight From baseline (week 0) to end of treatment (week 28) 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) From the time of first dosing (week 0) to end of study (week 33) 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) From baseline (week 0) to end of study (week 33) 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) From baseline (week 0) to end of study (week 33) 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) 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) 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) At week 33 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 At week 33 Anti-semaglutide antibodies level measured as %Bound/Total at week 33 is presented.
Anti-semaglutide Antibodies Level (Measured as Titre) At week 33 Anti-semaglutide antibodies level measured as titre at week 33 is presented.
Trial Locations
- Locations (63)
Innovative Research of W FL
🇺🇸Clearwater, Florida, United States
Velocity Clinical Research San Diego
🇺🇸La Mesa, California, United States
Velocity Clin Res Wstlke
🇺🇸Los Angeles, California, United States
LCGK Research
🇺🇸San Carlos, California, United States
San Diego Family Care_San Diego
🇺🇸San Diego, California, United States
Med Partners, Inc.
🇺🇸Toluca Lake, California, United States
University Clin Investigators
🇺🇸Tustin, California, United States
Innovative Research of W Florida Inc.
🇺🇸Clearwater, Florida, United States
Encore Medical Research LLC
🇺🇸Hollywood, Florida, United States
New Horizon Research Center
🇺🇸Miami, Florida, United States
Scroll for more (53 remaining)Innovative Research of W FL🇺🇸Clearwater, Florida, United States