Semaglutide for Diabetes Mellitus, Type 2

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

Study Summary

This trial is testing a new combination therapy for type 2 diabetes, to see if it is more effective than current treatments. The study will last for 41 weeks, and participants will be given injections of either the new combination therapy or a placebo.

Eligible Conditions
  • Diabetes Mellitus, Type 2

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Diabetes Mellitus, Type 2

Study Objectives

1 Primary · 14 Secondary · Reporting Duration: From baseline (week 0) to visit 25 (week 39)

Week 34
Change in HbA1c
Change in body weight (%)
Change in body weight (kg)
Change in fasting plasma glucose (FPG)
Change in systolic blood pressure (SBP)
Change in waist circumference
Relative change in Apolipoprotein B (ApoB)
Relative change in free fatty acids
Relative change in high sensitivity C-Reactive Protein (hsCRP)
Relative change in high-density lipoprotein (HDL) cholesterol
Relative change in low-density lipoprotein (LDL) cholesterol
Relative change in total cholesterol
Relative change in triglycerides
Relative change in very-low-density lipoprotein (VLDL) cholesterol
Week 39
Number of treatment-emergent adverse events (TEAEs)

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

10 Treatment Groups

2.4 mg semaglutide + 12.0 mg NNC0480-0389
1 of 10
2.4 mg semaglutide + 2.4 mg NNC0480-0389
1 of 10
2.4 mg semaglutide + 7.2 mg NNC0480-0389
1 of 10
2.4 mg semaglutide + 21.6 mg NNC0480-0389
1 of 10
NNC0480-0389 + placebo (semaglutide)
1 of 10
Semaglutide 2.4 mg + placebo (NNC0480-0389)
1 of 10
Placebo (semaglutide) + placebo ( 21.6 mg NNC0480-0389)
1 of 10
Placebo (semaglutide) + placebo ( 12.0 mg NNC0480-0389)
1 of 10
Placebo (semaglutide) + placebo ( 2.4 mg NNC0480-0389)
1 of 10
Placebo (semaglutide) + placebo ( 7.2 mg NNC0480-0389)
1 of 10
Experimental Treatment
Non-Treatment Group

495 Total Participants · 10 Treatment Groups

Primary Treatment: Semaglutide · Has Placebo Group · Phase 2

2.4 mg semaglutide + 12.0 mg NNC0480-0389Experimental Group · 2 Interventions: NNC0480-0389, Semaglutide · Intervention Types: Drug, Drug
2.4 mg semaglutide + 2.4 mg NNC0480-0389Experimental Group · 2 Interventions: NNC0480-0389, Semaglutide · Intervention Types: Drug, Drug
2.4 mg semaglutide + 7.2 mg NNC0480-0389Experimental Group · 2 Interventions: NNC0480-0389, Semaglutide · Intervention Types: Drug, Drug
2.4 mg semaglutide + 21.6 mg NNC0480-0389Experimental Group · 2 Interventions: NNC0480-0389, Semaglutide · Intervention Types: Drug, Drug
NNC0480-0389 + placebo (semaglutide)Experimental Group · 2 Interventions: Placebo (semaglutide), NNC0480-0389 · Intervention Types: Drug, Drug
Semaglutide 2.4 mg + placebo (NNC0480-0389)Experimental Group · 2 Interventions: Placebo (NNC080-0389), Semaglutide · Intervention Types: Drug, Drug
Placebo (semaglutide) + placebo ( 21.6 mg NNC0480-0389)PlaceboComparator Group · 2 Interventions: Placebo (semaglutide), Placebo (NNC080-0389) · Intervention Types: Drug, Drug
Placebo (semaglutide) + placebo ( 12.0 mg NNC0480-0389)PlaceboComparator Group · 2 Interventions: Placebo (semaglutide), Placebo (NNC080-0389) · Intervention Types: Drug, Drug
Placebo (semaglutide) + placebo ( 2.4 mg NNC0480-0389)PlaceboComparator Group · 2 Interventions: Placebo (semaglutide), Placebo (NNC080-0389) · Intervention Types: Drug, Drug
Placebo (semaglutide) + placebo ( 7.2 mg NNC0480-0389)PlaceboComparator Group · 2 Interventions: Placebo (semaglutide), Placebo (NNC080-0389) · Intervention Types: Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Placebo (semaglutide)
2021
Completed Phase 3
~5750
NNC0480-0389
2021
Completed Phase 1
~220
Semaglutide
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: from baseline (week 0) to visit 25 (week 39)

Who is running the clinical trial?

Novo Nordisk A/SLead Sponsor
1,390 Previous Clinical Trials
2,293,108 Total Patients Enrolled
634 Trials studying Diabetes Mellitus, Type 2
1,446,518 Patients Enrolled for Diabetes Mellitus, Type 2
Clinical Transparency (dept. 1452)Study DirectorNovo Nordisk A/S
56 Previous Clinical Trials
53,372 Total Patients Enrolled
23 Trials studying Diabetes Mellitus, Type 2
11,937 Patients Enrolled for Diabetes Mellitus, Type 2

Eligibility Criteria

Age 18+ · All Participants · 4 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have type 2 diabetes mellitus.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 15th, 2021

Last Reviewed: October 8th, 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.

Who else is applying?

What state do they live in?
Texas83.3%
New York16.7%
How old are they?
18 - 65100.0%
What site did they apply to?
Novo Nordisk Investigational Site100.0%
What portion of applicants met pre-screening criteria?
Met criteria100.0%