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Glucagon-like peptide-1 receptor agonist

Sequence A for Type 2 Diabetes

Phase 1

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

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 0-840 hours after a single dose of s.c. semaglutide 0.5 mg

Awards & highlights

Study Summary

This trial studies two drug concentrations of semaglutide for the treatment of type 2 diabetes. Participants will get two injections with the drug, and must agree to not get vaccinations during the study period. Women cannot take part if pregnant or breast-feeding.

Eligible Conditions

Type 2 Diabetes
Healthy Subjects

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 0-840 hours after a single dose of s.c. semaglutide 0.5 mg

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~0-840 hours after a single dose of s.c. semaglutide 0.5 mg

This trial's timeline: 3 weeks for screening, Varies for treatment, and 0-840 hours after a single dose of s.c. semaglutide 0.5 mg for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

AUC0-last,sema 0.5mg: Area under the semaglutide concentration time curve from time 0 until last quantifiable measurement after single dose of subcutaneous semaglutide 0.5 mg

Cmax,sema,0.5mg: maximum observed semaglutide concentration-time after single dose of subcutaneous semaglutide 0.5 mg administration

Trial Design

2Treatment groups

Experimental Treatment

Group I: Sequence BExperimental Treatment2 Interventions

Participants will be administered a single s.c. dose of 0.5 mg semaglutide B (0.68 mg/mL) in Period 1 followed by a single s.c. dose of 0.5 mg semaglutide B (1.34 mg/mL) in Period 2.

Group II: Sequence AExperimental Treatment2 Interventions

Participants will be administered a single subcutaneous (s.c.) dose of 0.5 mg semaglutide B (1.34 mg/mL) in Period 1 followed by a single s.c. dose of 0.5 mg semaglutide B (0.68 mg/mL) in Period 2.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Semaglutide B, 1.34 mg/mL

2023

Completed Phase 1

~40

Semaglutide B, 0.68 mg/mL

2023

Completed Phase 1

~20

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Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Novo Nordisk A/SLead Sponsor

1,514 Previous Clinical Trials

2,415,045 Total Patients Enrolled

Clinical Transparency dept. 2834Study DirectorNovo Nordisk A/S

36 Previous Clinical Trials

522,984 Total Patients Enrolled

Frequently Asked Questions

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

What type of participant would be most suitable for this research endeavor?

"Applicants to this study must have type 2 diabetes and be between the ages of 18-55. To date, 20 individuals are being sought for enrolment in the trial."

Answered by AI

Has Sequence A been approved by the US Food and Drug Administration?

"Owing to the limited data available, Sequence A received a score of 1 in regards to safety from our experts at Power. This is consistent with its Phase 1 status, which suggests there are only preliminary results regarding both safety and efficacy."

Answered by AI

Are geriatric individuals excluded from this research protocol?

"Eligibility requirements for this study necessitate that potential participants are between 18 and 55. There are 95 trials specifically aimed at minors, while 1006 exist to help seniors manage their medical conditions."

Answered by AI

Is this experiment presently enrolling participants?

"As per details stored on clinicaltrials.gov, this particular trial is not actively seeking subjects. This study was initially posted on January 13th 2023 and has since been updated on the 9th of that same month; however, 1557 other studies are presently accepting participants."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Research Trial Looking at the Comparability of 2 Different Concentrations of Semaglutide for the 0.5 Milligram (mg) Dose

2023. "A Research Trial Looking at the Comparability of 2 Different Concentrations of Semaglutide for the 0.5 Milligram (mg) Dose". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05689099.