A Research Study to Compare Two Semaglutide Medicines in People With Type 2 Diabetes

Study Overview
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Brief Summary
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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).

Official Title
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Investigation of Clinical Comparability of Semaglutide Drug Products Based on the Proposed and the Approved Drug Substance Manufacturing Processes in Participants With Type 2 Diabetes

Conditions
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Diabetes Mellitus, Type 2

Intervention / Treatment
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* Drug: Semaglutide J
* Drug: Semaglutide B


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Semaglutide J<br>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. | Drug: Semaglutide J<br>* 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).<br>|
| Active Comparator: Semaglutide B<br>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. | Drug: Semaglutide B<br>* 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).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Glycated Haemoglobin (HbA1c) | Measured as Percentage | From baseline visit (visit 2; week 0) to end of treatment visit (visit 10; week 28) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Body Weight | Measured in Kilogram | From baseline visit (visit 2; week 0) to end of treatment visit (visit 10; week 28) | 
| Number of Treatment-Emergent Adverse Events | Measured as Number of events | From the time of first dosing (visit 2; week 0) to end of study visit (visit 11; week 33) | 
| Occurence of Anti-semaglutide Antibodies (Yes/no) | Measured as Number of participants | From baseline visit (visit 2; week 0) to end of study visit (visit 11; week 33) | 
| Occurence of Anti-semaglutide Antibodies With In-vitro Neutralising Effect (Yes/no) | Measured as Number of participants | From baseline visit (visit 2; week 0) to end of study visit (visit 11; week 33) | 
| Occurence of Anti-semaglutide Binding Antibodies Cross-reacting With Endogenous Glucagon Like Peptide-1 (GLP-1) (Yes/no) | Measured as Number of participants | From baseline visit (visit 2; week 0) to end of study visit (visit 11; week 33) | 
| Occurence of In-vitro Neutralising Cross-reacting Antibodies to Endogenous GLP-1 (Yes/no) | Measured as Number of participants | From baseline visit (visit 2; week 0) to end of study visit (visit 11; week 33) | 
| Anti-semaglutide Antibodies Level Measured as %Bound/Total | Antibody levels will be measured in percentage of bound radioactivity-labelled semaglutide/total added radioactivity-labelled semaglutide (%B/T; B =Bound, T = Total). | From baseline visit (visit 2; week 0) to end of study visit (visit 11; week 33) | 
| Anti-semaglutide Antibodies Level (Measured as Titre) | Measured as Titre | From baseline visit (visit 2; week 0) to end of study visit (visit 11; week 33) |