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Glucagon-like peptide-1 receptor agonist

Semaglutide for Type 2 Diabetes

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 (Ozempic®), 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

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline (less than or equal to 4 weeks prior to the randomization at week 0), year 2 for reporting.

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 more

Side effects data

From 2020 Phase 4 trial • 104 Patients • NCT04189848

21%

Nausea

12%

Decreased Appetite

100%

80%

60%

40%

20%

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

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