Semaglutide for Diabetes Mellitus, Type 2

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Novo Nordisk Investigational Site, Birmingham, AL
Diabetes Mellitus, Type 2+2 More
Semaglutide - Drug
Eligibility
18 - 65
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing whether semaglutide can help control blood sugar and weight in people with type 2 diabetes who are also overweight, when taken with metformin. It will compare different doses of semaglutide, given by injection, to placebo (a dummy medicine). The trial will last for 52 weeks, with participants having 13 clinic visits and 4 phone calls. Semaglutide is used to treat Diabetes Mellitus, Type 2 and has been previously approved by the FDA for a different condition.

Eligible Conditions

  • Diabetes Mellitus, Type 2

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Diabetes Mellitus, Type 2

Study Objectives

1 Primary · 3 Secondary · Reporting Duration: From baseline (week 0) to end of study (week 49)

Week 49
Number of Treatment-emergent Adverse Events (TEAEs)
Number of Treatment-emergent Severe Hypoglycaemic Episodes
Week 40
Change in Body Weight
Change in Glycosylated Haemoglobin (HbA1c)

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Other trials for Diabetes Mellitus, Type 2

Side Effects for

Overall Study
21%Nausea
12%Decreased Appetite
This histogram enumerates side effects from a completed 2020 Phase 4 trial (NCT04189848) in the Overall Study ARM group. Side effects include: Nausea with 21%, Decreased Appetite with 12%.

Trial Design

6 Treatment Groups

Semaglutide 2 mg
1 of 6
Semaglutide 8 mg
1 of 6
Semaglutide 16 mg
1 of 6
Semaglutide placebo 16 mg
1 of 6
Semaglutide placebo 2 mg
1 of 6
Semaglutide placebo 8 mg
1 of 6
Experimental Treatment
Non-Treatment Group

240 Total Participants · 6 Treatment Groups

Primary Treatment: Semaglutide · Has Placebo Group · Phase 2

Semaglutide 2 mg
Drug
Experimental Group · 1 Intervention: Semaglutide · Intervention Types: Drug
Semaglutide 8 mg
Drug
Experimental Group · 1 Intervention: Semaglutide · Intervention Types: Drug
Semaglutide 16 mg
Drug
Experimental Group · 1 Intervention: Semaglutide · Intervention Types: Drug
Semaglutide placebo 16 mg
Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Drug
Semaglutide placebo 2 mg
Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Drug
Semaglutide placebo 8 mg
Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Semaglutide
2019
Completed Phase 4
~5490

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: from baseline (week 0) to end of study (week 49)
Closest Location: Novo Nordisk Investigational Site · Birmingham, AL
Photo of Birmingham 1Photo of Birmingham 2Photo of Birmingham 3
2004First Recorded Clinical Trial
474 TrialsResearching Diabetes Mellitus, Type 2
853 CompletedClinical Trials

Who is running the clinical trial?

Novo Nordisk A/SLead Sponsor
1,380 Previous Clinical Trials
2,289,726 Total Patients Enrolled
634 Trials studying Diabetes Mellitus, Type 2
1,448,055 Patients Enrolled for Diabetes Mellitus, Type 2
Clinical Transparency (dept. 2834)Study DirectorNovo Nordisk A/S
34 Previous Clinical Trials
55,528 Total Patients Enrolled
16 Trials studying Diabetes Mellitus, Type 2
13,142 Patients Enrolled for Diabetes Mellitus, Type 2

Eligibility Criteria

Age 18 - 65 · All Participants · 6 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have a body mass index (BMI) of 27.0 or greater.
You are taking metformin for more than 90 days prior to the day of screening.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 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.