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GLP-1 Receptor Agonist

IDegLira for Diabetes (REMITiDegLira Trial)

Phase 3

Waitlist Available

Led By Zubin Punthakee, MD

Research Sponsored by Population Health Research Institute

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 28 weeks after randomization

Awards & highlights

Pivotal Trial

No Placebo-Only Group

Summary

This trial is testing if an intensive treatment with specific medications and lifestyle changes can help people with newly diagnosed type 2 diabetes manage their condition over time. The study involves 160 patients who will receive either this intensive treatment or regular diabetes care. The goal is to see if the intensive approach can lead to sustained diabetes remission without ongoing medication.

Eligible Conditions

Diabetes

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 28 weeks after randomization

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~28 weeks after randomization

This trial's timeline: 3 weeks for screening, Varies for treatment, and 28 weeks after randomization for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Proportion of participants achieving drug-free diabetes remission

Secondary study objectives

Proportion of participants achieving drug-free diabetes regression

Proportion of participants achieving drug-free normoglycemia

Side effects data

From 2022 Phase 3 trial • 145 Patients • NCT03737240

38%

Nausea

19%

Emergency Room Visits

18%

Abdominal Pain

13%

Vomiting

11%

Diarrhea

100%

80%

60%

40%

20%

Study treatment Arm

IDegLira

Basal-Bolus Insulin

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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: InterventionExperimental Treatment4 Interventions

Drug: IDegLira - sc injection; Drug: metformin - oral administration; Drug: insulin degludec - sc injection; Behavioral: lifestyle therapy, diet and exercise

Group II: Standard CareActive Control1 Intervention

Standard glycemic care as informed by the current clinical practice guidelines

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

IDegLira

2021

Completed Phase 4

~1020

insulin degludec

2015