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GLP-1 Receptor Agonist

Semaglutide for Type 2 Diabetes

Phase 2
Waitlist Available
Research Sponsored by Novo Nordisk A/S
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
BMI greater than or equal to 25 and below 40 kg/m^2
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from baseline (week 0) to visit 25 (week 39)
Awards & highlights

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
  • Type 2 Diabetes

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
Your body mass index (BMI) is between 25 and 40.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from baseline (week 0) to visit 25 (week 39)
This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline (week 0) to visit 25 (week 39) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in HbA1c
Secondary outcome measures
Change in body weight (%)
Change in body weight (kg)
Change in fasting plasma glucose (FPG)
+11 more

Side effects data

From 2020 Phase 4 trial • 104 Patients • NCT04189848
21%
Nausea
12%
Decreased Appetite
100%
80%
60%
40%
20%
0%
Study treatment Arm
Overall Study

Trial Design

10Treatment groups
Experimental Treatment
Placebo Group
Group I: Semaglutide 2.4 mg + placebo (NNC0480-0389)Experimental Treatment2 Interventions
subjects will receive once weekly subcutaneous (s.c., under the skin) dose of placebo (NNC0480-0389) co-administered with s.c. semaglutide.
Group II: NNC0480-0389 + placebo (semaglutide)Experimental Treatment2 Interventions
subjects will receive once weekly subcutaneous (s.c., under the skin) dose of NNC0480-0389 co-administered with s.c. placebo (semaglutide)
Group III: 2.4 mg semaglutide + 7.2 mg NNC0480-0389Experimental Treatment2 Interventions
subjects will receive once weekly subcutaneous (s.c., under the skin) dose of NNC0480-0389 co-administered with s.c. semaglutide
Group IV: 2.4 mg semaglutide + 21.6 mg NNC0480-0389Experimental Treatment2 Interventions
subjects will receive once weekly subcutaneous (s.c., under the skin) dose of NNC0480-0389 co-administered with s.c. semaglutide
Group V: 2.4 mg semaglutide + 2.4 mg NNC0480-0389Experimental Treatment2 Interventions
subjects will receive once weekly subcutaneous (s.c., under the skin) dose of NNC0480-0389 co-administered with s.c. semaglutide.
Group VI: 2.4 mg semaglutide + 12.0 mg NNC0480-0389Experimental Treatment2 Interventions
subjects will receive once weekly subcutaneous (s.c., under the skin) dose of NNC0480-0389 co-administered with s.c. semaglutide
Group VII: Placebo (semaglutide) + placebo ( 21.6 mg NNC0480-0389)Placebo Group2 Interventions
subjects will receive once weekly subcutaneous (s.c., under the skin) dose of placebo (NNC0480-0389) co-administered with s.c. placebo (semaglutide).
Group VIII: Placebo (semaglutide) + placebo ( 12.0 mg NNC0480-0389)Placebo Group2 Interventions
subjects will receive once weekly subcutaneous (s.c., under the skin) dose of placebo (NNC0480-0389) co-administered with s.c. placebo (semaglutide).
Group IX: Placebo (semaglutide) + placebo ( 2.4 mg NNC0480-0389)Placebo Group2 Interventions
subjects will receive once weekly subcutaneous (s.c., under the skin) dose of placebo (NNC0480-0389) co-administered with s.c. placebo (semaglutide).
Group X: Placebo (semaglutide) + placebo ( 7.2 mg NNC0480-0389)Placebo Group2 Interventions
subjects will receive once weekly subcutaneous (s.c., under the skin) dose of placebo (NNC0480-0389) co-administered with s.c. placebo (semaglutide).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Placebo (semaglutide)
2021
Completed Phase 3
~25160
NNC0480-0389
2021
Completed Phase 2
~720
Placebo (NNC080-0389)
2021
Completed Phase 2
~500
Semaglutide
2019
Completed Phase 4
~5160

Find a Location

Who is running the clinical trial?

Novo Nordisk A/SLead Sponsor
1,503 Previous Clinical Trials
2,385,314 Total Patients Enrolled
Clinical Transparency (dept. 1452)Study DirectorNovo Nordisk A/S
56 Previous Clinical Trials
44,620 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the FDA sanctioned Semaglutide for use in its treatments?

"Semaglutide has established proof of safety, but not yet evidence of efficacy - this makes it a 2 on our scale from 1 to 3."

Answered by AI

How many individuals are enrolled in this experiment?

"This specific trial is not presently seeking out participants. It was first launched on November 29th 2021 and the most recent changes were made 11/11/2022. For those exploring other studies, there are currently 1390 trials recruiting people with type 2 diabetes mellitus and 58 that focus exclusively on Semaglutide treatment programs actively looking for patients to join their study."

Answered by AI

What health conditions is Semaglutide typically used to treat?

"Semaglutide is typically prescribed for chronic weight management. Furthermore, it can be utilized to combat a range of other ailments when combined with exercise and an altered diet, particularly those related to bodyweight."

Answered by AI

How many hubs are responsible for overseeing this research endeavor?

"This clinical trial is being conducted in a total of 41 distinct medical facilities. To reduce the amount of commuting needed, it is recommended to pick the centre closest to you; locations include Canoga Park, Escondido and Los Angeles."

Answered by AI

Is this clinical trial currently welcoming participants?

"We are not currently recruiting candidates for this trial as the study was last edited on November 11th 2022. If you're looking to participate in other trials, 1390 diabetes mellitus studies and 58 Semaglutide based studies are now open for enrollment."

Answered by AI

Have other testings of Semaglutide been implemented?

"As of now, 58 clinical trials involving Semaglutide are still in progress with a total of 27 studies at Phase 3. Although many investigations occur in Loma Linda, California, there are 3907 facilities conducting experiments concerning this medication."

Answered by AI

Does this research trial permit the inclusion of those aged 30 and over?

"The prescribed age range for this trial is between 18 and 75; however, there are 200 trials available to minors below the age of 18 as well 1114 studies open to those who have surpassed 65 years old."

Answered by AI

Who is eligible for enrollment in this trial?

"This investigation is looking for 495 people aged 18 to 75 who have been diagnosed with type 2 diabetes Mellitus. In addition, enrollees must be on a regimen of at least 1500 mg/day dosage of metformin or other formulae taken in the 90 days prior to screening, and their BMI must range between 25–40 kg/m^2."

Answered by AI

Does this trial mark a precedent for further research?

"Presently, 58 ongoing trials are evaluating the effects of Semaglutide in 55 distinct nations and 772 cities. Beginning with a trial sponsored by Novo Nordisk A/S in 2018 that comprised 1387 participants who completed Phase 4 drug approval, 125 additional studies have since been finished."

Answered by AI

Who else is applying?

What state do they live in?
New York
Texas
How old are they?
18 - 65
What site did they apply to?
Novo Nordisk Investigational Site
What portion of applicants met pre-screening criteria?
Met criteria
~154 spots leftby Mar 2025