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Glucagon-like peptide-1 receptor agonist
Long Term Comparative Effectiveness of Once Weekly Semaglutide Versus Standard of Care in a Real World Adult US Population With Type 2 Diabetes - a Randomized Pragmatic Trial
Phase 4
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 older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline (less than or equal to 4 weeks prior to the randomization at week 0), year 2
Awards & highlights
Pivotal Trial
Drug Has Already Been Approved
No Placebo-Only Group
Summary
This trial aims to compare semaglutide (OzempicĀ®), an injectable medication, with other standard treatments for type 2 diabetes. Participants will receive either semaglutide or another diabetes medication. Semaglutide helps control blood sugar by increasing insulin production and reducing sugar production in the liver. The study will last several years. Semaglutide has been shown to be effective in improving blood sugar levels and promoting weight loss in patients with type 2 diabetes.
Eligible Conditions
- Type 2 Diabetes
- Diabetes
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline (less than or equal to 4 weeks prior to the randomization at week 0), year 2
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline (less than or equal to 4 weeks prior to the randomization at week 0), year 2
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Number of Participants With Glycosylated Haemoglobin (HbA1c) Less Than 7.0 Percentage (%) (53 Millimoles Per Mole [mmol/Mol]) at Year 1 (Yes/No)
Secondary study objectives
All Cause HCRU: Mean Cumulative Length of Stay for Inpatient Admissions Per Participant From Baseline to Year 2
All Cause HCRU: Mean Number of Emergency Room (ER) Encounters Per Participant From Baseline to Year 2
All Cause HCRU: Mean Number of Medication Visits Per Participant From Baseline to Year 2
+65 moreSide effects data
From 2020 Phase 4 trial ā¢ 104 Patients ā¢ NCT0418984821%
Nausea
12%
Decreased Appetite
100%
80%
60%
40%
20%
0%
Study treatment Arm
Overall Study
Awards & Highlights
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: SemaglutideExperimental Treatment1 Intervention
Participants will receive semaglutide subcutaneously (s.c.) in addition to metformin monotherapy as treatment intensification in the course of routine clinical practice. Participants will be followed for 2 years, regardless of changes in antidiabetic treatment over the course of the study.
Group II: Standard of careActive Control1 Intervention
Participants will receive standard of care in addition to metformin monotherapy as treatment intensification in the course of routine clinical practice. Participants will be followed for 2 years, regardless of changes in antidiabetic treatment over the course of the study.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Semaglutide
2021
Completed Phase 4
~5160
Find a Location
Who is running the clinical trial?
Novo Nordisk A/SLead Sponsor
1,557 Previous Clinical Trials
2,445,032 Total Patients Enrolled
Clinical Reporting Anchor and Disclosure (1452)Study DirectorNovo Nordisk A/S
104 Previous Clinical Trials
101,980 Total Patients Enrolled