Semaglutide J for Diabetes Mellitus, Type 2

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Diabetes Mellitus, Type 2+1 More
Semaglutide J - Drug
Eligibility
18 - 65
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing a new way to make the diabetes drug semaglutide, to see if it controls blood sugar better than the current version.

Eligible Conditions
  • Diabetes Mellitus, Type 2

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Study Objectives

1 Primary · 8 Secondary · Reporting Duration: From baseline visit (visit 2; week 0) to end of study visit (visit 11; week 33)

Week 33
Antibodies
Anti-semaglutide Antibodies Level Measured as %Bound/Total
Occurence of Anti-semaglutide Antibodies (Yes/no)
Occurence of Anti-semaglutide Antibodies With In-vitro Neutralising Effect (Yes/no)
Occurence of Anti-semaglutide Binding Antibodies Cross-reacting With Endogenous Glucagon Like Peptide-1 (GLP-1) (Yes/no)
Occurence of In-vitro Neutralising Cross-reacting Antibodies to Endogenous GLP-1 (Yes/no)
Week 28
Change in Body Weight
Body Weight Changes
Week 33
Number of Treatment-Emergent Adverse Events

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Trial Design

2 Treatment Groups

Semaglutide B
1 of 2
Semaglutide J
1 of 2

Active Control

Experimental Treatment

332 Total Participants · 2 Treatment Groups

Primary Treatment: Semaglutide J · No Placebo Group · Phase 3

Semaglutide J
Drug
Experimental Group · 1 Intervention: Semaglutide J · Intervention Types: Drug
Semaglutide B
Drug
ActiveComparator Group · 1 Intervention: Semaglutide B · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: from baseline visit (visit 2; week 0) to end of study visit (visit 11; week 33)

Who is running the clinical trial?

Novo Nordisk A/SLead Sponsor
1,390 Previous Clinical Trials
2,293,271 Total Patients Enrolled
634 Trials studying Diabetes Mellitus, Type 2
1,446,681 Patients Enrolled for Diabetes Mellitus, Type 2
Clinical Transparency (dept. 2834)Study DirectorNovo Nordisk A/S
36 Previous Clinical Trials
55,769 Total Patients Enrolled
16 Trials studying Diabetes Mellitus, Type 2
12,693 Patients Enrolled for Diabetes Mellitus, Type 2

Eligibility Criteria

Age 18 - 65 · All Participants · 3 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have type 2 diabetes mellitus (T2D) greater than equal to (≥) 180 days before screening.
HbA1c is 7.0-10.5% (53-91.3 mmol/mol).

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 17th, 2021

Last Reviewed: November 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.