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GLP-1 Receptor Agonist

IDegLira for Type 2 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
T2D diagnosed within 5 years
willingness to wear a continuous glucose monitor on at least 3 occasions;
Must not have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up16, 28, 40, 52 and 68 week visit as well as the overall change
Awards & highlights
Pivotal Trial
No Placebo-Only Group

REMITiDegLira Trial Summary

This trial will compare the effects of two different diabetes treatment approaches in people with early type 2 diabetes.

Eligible Conditions
  • Type 2 Diabetes

REMITiDegLira Trial Eligibility Criteria

Inclusion Criteria

You will be eligible if you check “Yes” for the criteria below
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willingness to test blood sugar levels with a meter at least 3 times in a week; willingness to test blood sugar levels at least 3 times per week.
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Your body mass index (BMI) is equal to or greater than 23 kg/m2.
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You are willing to wear a device that measures your blood sugar levels continuously on at least 3 occasions.
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You need to be able to and willing to give yourself injections of IDegLira and insulin.

REMITiDegLira Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~16, 28, 40, 52 and 68 week visit as well as the overall change
This trial's timeline: 3 weeks for screening, Varies for treatment, and 16, 28, 40, 52 and 68 week visit as well as the overall change for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Secondary outcome measures
Proportion of participants achieving drug-free diabetes regression
Proportion of participants achieving drug-free diabetes remission
Proportion of participants achieving drug-free normoglycemia
Other outcome measures
the change in HbA1c
the change in body mass index
the change in coefficient of variation over 2 weeks (defined as 4-8 mmol/l), based on up to 2 weeks of Abbott Freestyle Libre ProTM sensor wear
+7 more

Side effects data

From 2022 Phase 3 trial • 145 Patients • NCT03737240
16%
Emergency Room Visits
8%
Diarrhea
8%
Abdominal Pain
5%
Hospital Readmissions
4%
Nausea
1%
Vomiting
100%
80%
60%
40%
20%
0%
Study treatment Arm
Basal-Bolus Insulin
IDegLira

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.

REMITiDegLira 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
Completed Phase 3
~4690
Lifestyle Therapy
2015
Completed Phase 3
~420
Metformin
2006
Completed Phase 4
~2430

Find a Location

Who is running the clinical trial?

Novo Nordisk A/SIndustry Sponsor
1,476 Previous Clinical Trials
2,368,417 Total Patients Enrolled
Population Health Research InstituteLead Sponsor
151 Previous Clinical Trials
678,252 Total Patients Enrolled
Zubin Punthakee, MDPrincipal InvestigatorMcMaster University

Frequently Asked Questions

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

For this particular test, are elderly citizens able to participate?

"People aged 30 to 80 who meet the other specified inclusion criteria can apply for this trial. In contrast, there are 227 clinical trials specifically for people under 18 and 1330 research studies for patients over 65."

Answered by AI

Could you please list any other research studies that have included IDegLira?

"IDegLira was first trialled in America, at George Washington University, back in 2002. Since then, a total of 1467 clinical trials have completed. At the moment, there are 218 live studies being conducted; many of these taking place in London and Nova Scotia."

Answered by AI

How is IDegLira being used to improve patient outcomes?

"IDegLira is a medication most commonly used to treat cardiovascular disease, but it can also be given to patients with type 1 diabetest cardiovascular disease, but it can also be given to patients with type 1 diabetes mellitus as well as those looking to improve their liraglutide levels through exercise."

Answered by AI

How do I sign up for this experiment?

"This clinical study is accepting 159 participants that have type 2 diabetes mellitus and are between 30 and 80 years old."

Answered by AI

What is the IDegLira drug's official medical standing?

"IDegLira received a safety score of 3 because there is both efficacy data and multiple rounds of supportive safety data from Phase 3 trials."

Answered by AI

In how many different geographical areas is this trial being run?

"Currently, this trial is open to enrolment at 8 clinics. These locations are situated in London, Ottawa and Hamilton as well as 8 other cities. If you want to make the process of enrolling simpler, choose the clinic nearest to your home."

Answered by AI

How many people are taking part in this experiment at most?

"Unfortunately, this study has already ended recruitment and is no longer admitting patients. The trial was initially posted on April 23rd, 2019 but was most recently updated on October 19th, 2020. For those still searching for studies, there are currently 1508 trials actively admitting patients with type 2 diabetes mellitus and 218 studies for IDegLira actively searching for patients."

Answered by AI

Can new participants still join this experiment?

"This study is not enrolling new patients at this time, however that may change in the future as the clinical trial was most recently updated on 10/19/2022. There are 1726 other trials that you might be eligible for if you meet their inclusion criteria."

Answered by AI

Who else is applying?

What state do they live in?
Ontario
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0
Recent research and studies
clinicaltrials.govStudy
Remission Evaluation of a Metabolic Intervention for Type 2 Diabetes With IDegLira
2019. "Remission Evaluation of a Metabolic Intervention for Type 2 Diabetes With IDegLira". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03862716.
~28 spots leftby Dec 2024
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