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GLP-1 Receptor Agonist
GLUCOSE-MGH Study for Metabolic Diseases (GLUCOSE-MGH Trial)
Phase 4
Recruiting
Led By Josephine Li, MD
Research Sponsored by Massachusetts General Hospital
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 120 minutes during visit 1
Awards & highlights
GLUCOSE-MGH Trial Summary
This trial aims to understand how genetic differences affect the way the body responds to a medication called oral semaglutide, commonly used to treat diabetes and obesity. Participants will have their blood tested before and
Who is the study for?
This trial is for adults aged 18-50 who can consent and have blood sugar levels indicating they are between normal health and pre-diabetes. It's not suitable for pregnant individuals or those outside the age range.Check my eligibility
What is being tested?
The study tests how genetic differences affect responses to Rybelsus, a diabetes/obesity drug, by analyzing blood factors after a standard meal before and after two weeks of taking the drug.See study design
What are the potential side effects?
While specific side effects aren't listed here, common ones for Rybelsus may include stomach pain, nausea, diarrhea, weight loss, and potential changes in blood sugar levels.
GLUCOSE-MGH Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 120 minutes during visit 1
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~120 minutes during visit 1
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Insulin response to oral semaglutide treatment
Secondary outcome measures
Baseline incretin level
Cumulative glucose response to oral semaglutide treatment
Fasting glucose response to oral semaglutide treatment
GLUCOSE-MGH Trial Design
1Treatment groups
Experimental Treatment
Group I: GLUCOSE-MGH StudyExperimental Treatment2 Interventions
Day 1: Mixed meal tolerance test
Day 3-15: 7 mg oral semaglutide, once daily
Day 16: 1 dose of 7 mg oral semaglutide, Mixed meal tolerance test in the presence of semaglutide
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Who is running the clinical trial?
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,378 Previous Clinical Trials
4,315,346 Total Patients Enrolled
27 Trials studying Metabolic Diseases
6,114 Patients Enrolled for Metabolic Diseases
Massachusetts General HospitalLead Sponsor
2,945 Previous Clinical Trials
13,203,753 Total Patients Enrolled
6 Trials studying Metabolic Diseases
471 Patients Enrolled for Metabolic Diseases
Josephine Li, MDPrincipal InvestigatorMGH
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