Type 2 Diabetes MellitusPhase 3REMITiDegLiraNCT03862716

Remission Evaluation of a Metabolic Intervention for Type 2 Diabetes With IDegLira

A Phase 3 study testing IDegLira, insulin degludec and Metformin in people with Type 2 Diabetes Mellitus, run by Population Health Research Institute at 8 sites in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

The purpose of the study is to determine whether in patients with early type 2 diabetes, a short-term intensive metabolic intervention comprising IDegLira, metformin, and lifestyle approaches will be superior to standard diabetes therapy in achieving sustained diabetes remission. Read more about this study

Who is it for?: Ages 30 to 80 years
Conditions the study is for: Type 2 Diabetes Mellitus
What is being tested?: IDegLira, insulin degludec and Metformin
Type of treatment: Pill or oral medicine, Injection or infusion, Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 159 participants
Where: 8 sitesCanada
Study dates: 23 Apr 2019to 31 Jul 2023
Phase: Phase 3
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 30 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

men and women aged 30-80 years;
T2D diagnosed within 5 years
stable T2D drug regimen in the 8 weeks before randomization;
HbA1c 6.5-9.5% on no glucose lowering drugs, or 6.5%-8.0% on up to 2 glucose lowering drugs;
body mass index ≥ 23 kg/m2;
ability and willingness to perform self-monitoring of capillary blood glucose (SMBG);

Show all 9Show fewer

willingness to wear a continuous glucose monitor on at least 3 occasions;
ability and willingness to self-inject IDegLira and insulin;
provision of informed consent.

Who cannot join

current use of insulin therapy;
history of hypoglycemia unawareness, or severe hypoglycemia requiring assistance;
history of end-stage renal disease or eGFR<45 mL/min/1.73 m2 by MDRD formula;
active liver disease or elevated alanine transferase (ALT) levels ≥ 2.5 times the upper limit of normal at the time of enrolment;
history or clinical suspicion of pancreatitis or medullary thyroid cancer;
diagnosis or first degree relative with Multiple Endocrine Neoplasia Type 2 (MEN2);

Show all 15Show fewer

history of diabetic retinopathy requiring photocoagulation, injection therapy or vitrectomy;
history of cardiovascular disease (unless cleared for a moderate intensity exercise program by a specialist) including: i. acute coronary syndrome, hospitalization for unstable angina, myocardial infarction, or revascularization with coronary artery bypass grafting or percutaneous coronary intervention; ii. peripheral vascular disease, valvular heart disease, cardiomyopathy, aortic dissection, tachyarrhythmias, bradyarrhythmias, prior stroke or TIA; iii. prior hospitalization for heart failure; or iv. ECG findings concerning for ischemic heart disease (i.e. pathological Q-waves, ST-segment-T-wave abnormalities in contiguous leads, left anterior hemiblock, left bundle branch block, second or third degree atrioventricular block).
history of any disease requiring frequent intermittent or continuous systemic glucocorticoid treatment;
history of bariatric surgery, or planned bariatric surgery in the next 1.5 years;
history of any major illness with a life expectancy of < 3 years;
history of injury or any other condition that significantly limits participant's ability to achieve moderate levels of physical activity;
excessive alcohol intake, acute or chronic;
currently pregnant, or breastfeeding, or not using a reliable method of birth control for the duration of the trial in all females with childbearing potential;
inability to take insulin degludec, liraglutide or metformin.

Trial locations and contacts

8 sites in 1 country.

City, postcode or hospital

8 sites in 1 country

Canada8 sites

University of Calgary
Calgary, Alberta, T2T 5C7
University of Alberta
Edmonton, Alberta, T6G 2E1
Nova Scotia Health Authority
Halifax, Nova Scotia, B3H 1V7
McMaster University
Hamilton, Ontario
St. Joseph's Hospital
London, Ontario, N6A 4V2
Western University
London, Ontario, N6G 2M1
LMC Manna Research
Oakville, Ontario, L6M 1M1
The Ottawa Hospital
Ottawa, Ontario, K1Y 4E9

Other trials in Canada

About this study

Official title: Remission Evaluation of a Metabolic Intervention for Type 2 Diabetes With IDegLira (REMIT IDegLira): A Randomized Controlled Trial

Read the detailed description

This is a multicentre, open-label, randomized controlled trial in 160 patients with recently-diagnosed T2DM. Participants will be randomized to 2 treatment groups: (a) a 16-week course of treatment with IDegLira, metformin and lifestyle therapy, and (b) standard diabetes therapy, and followed for a total of 68 weeks (1 year and 4 months). In all participants with HbA1C<7.3% at the 16 week visit, glucose-lowering medications will be discontinued and participants will be encouraged to continue with lifestyle modifications and regular glucose monitoring. Participants with HbA1C ≥ 7.3% at this visit or who experience hyperglycemia relapse after stopping drugs will receive standard glycemic management as informed by the current Canadian Diabetes Association clinical practice guidelines.

Conditions: Type 2 Diabetes Mellitus
Being tested: IDegLira, insulin degludec, Metformin, Lifestyle Therapy
Keywords: Diabetes, IDegLira, Metformin, Insulin, Diet, Excercise, Lifestyle
Medical subject headings: Diabetes Mellitus, Type 2, Diabetes Mellitus, Insulin Resistance

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

IDegLiraDrug
Also called insulin degludec / liraglutide
Dose is titrated to achieve fasting normoglycemia
insulin degludecDrug
In those who need additional insulin or who cannot tolerate IDegLira, insulin degludec will be used. Dose is titrated to achieve fasting normoglycemia.
MetforminDrug
Dose is titrated to 2000 mg per day or maximal tolerated dose
Lifestyle TherapyBehavioural
Also called diet and exercise
Lifestyle intervention includes individualized dietary and exercise advice targeting at least 5% weight loss with frequent visits and coaching for goal reinforcement, behavior modification and problem-solving

Study groups in NCT03862716
Study group	Role	What they receive
Intervention	Experimental	Drug: IDegLira - sc injection; Drug: metformin - oral administration; Drug: insulin degludec - sc injection; Behavioral: lifestyle therapy, diet and exercise Receives: Drug: IDegLira; Drug: insulin degludec; Drug: Metformin; Behavioral: Lifestyle Therapy
Standard Care	No intervention	Standard glycemic care as informed by the current clinical practice guidelines

What is being measured

The primary outcome is the main question the study is designed to answer.

Proportion of participants achieving drug-free diabetes remission
Drug-free diabetes remission is defined as HbA1C < 6.5 % off glucose-lowering agents for at least 12 weeks.
Measured: 28 weeks after randomization

Secondary outcomes (3)

Proportion of participants achieving drug-free diabetes remission
Measured: 28 weeks, 40 weeks, 52 weeks and 68 weeks after randomization
Proportion of participants achieving drug-free normoglycemia
defined as HbA1C < 6.0% off glucose-lowering agents for at least 12 weeks.
Measured: 28 weeks, 40 weeks, 52 weeks and 68 weeks after randomization
Proportion of participants achieving drug-free diabetes regression
defined as HbA1C <7.0% off glucose-lowering agents for at least 12 weeks.
Measured: 28 weeks, 40 weeks, 52 weeks and 68 weeks after randomization

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

23 Apr 201931 Jul 2023

First posted5 Mar 2019
Study start23 Apr 2019
Primary completion15 Jun 2022
Study completion31 Jul 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 159 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03862716
Sponsor's protocol ID: REMITiDegLira
Acronym: REMITiDegLira
Status last verified: Oct 2023
First submitted: 25 Feb 2019
Last updated: 25 Oct 2023
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
Not yet recruiting
Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
Type 2 Diabetes Mellitus (T2D), Obesity (BMI>30)

All Type 2 Diabetes Mellitus trials

Study at a glance

From the registry record, last updated by the sponsor on 25 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Remission Evaluation of a Metabolic Intervention for Type 2 Diabetes With IDegLira (REMIT IDegLira): A Randomized Controlled Trial
ClinicalTrials.gov ID: NCT03862716
Acronym / sponsor ID: REMITiDegLira / REMITiDegLira
Conditions: Type 2 Diabetes Mellitus
Keywords: Diabetes, IDegLira, Metformin, Insulin, Diet, Excercise, Lifestyle
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 159 participants (actual)
Lead sponsor: Population Health Research InstituteUniversity, hospital or other
Collaborators: Novo Nordisk A/S
Study start: 23 Apr 2019 (actual)
Primary completion: 15 Jun 2022 (actual)
Study completion: 31 Jul 2023 (actual)
First posted: 5 Mar 2019 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Intervention	Experimental	Drug: IDegLira, Drug: insulin degludec, Drug: Metformin, Behavioral: Lifestyle TherapyDrug: IDegLira - sc injection; Drug: metformin - oral administration; Drug: insulin degludec - sc injection; Behavioral: lifestyle therapy, diet and exercise
Standard Care	No intervention	–Standard glycemic care as informed by the current clinical practice guidelines

Who may qualify

Ages: 30 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

men and women aged 30-80 years;
T2D diagnosed within 5 years
stable T2D drug regimen in the 8 weeks before randomization;
HbA1c 6.5-9.5% on no glucose lowering drugs, or 6.5%-8.0% on up to 2 glucose lowering drugs;
body mass index ≥ 23 kg/m2;

Key exclusion criteria (15 listed)

current use of insulin therapy;
history of hypoglycemia unawareness, or severe hypoglycemia requiring assistance;
history of end-stage renal disease or eGFR<45 mL/min/1.73 m2 by MDRD formula;
active liver disease or elevated alanine transferase (ALT) levels ≥ 2.5 times the upper limit of normal at the time of enrolment;
history or clinical suspicion of pancreatitis or medullary thyroid cancer;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
IDegLiraAlso: insulin degludec / liraglutideDose is titrated to achieve fasting normoglycemia	Drug	Intervention
insulin degludecIn those who need additional insulin or who cannot tolerate IDegLira, insulin degludec will be used. Dose is titrated to achieve fasting normoglycemia.	Drug	Intervention
MetforminDose is titrated to 2000 mg per day or maximal tolerated dose	Drug	Intervention
Lifestyle TherapyAlso: diet and exerciseLifestyle intervention includes individualized dietary and exercise advice targeting at least 5% weight loss with frequent visits and coaching for goal reinforcement, behavior modification and problem-solving	Behavioural	Intervention

Primary outcome

Proportion of participants achieving drug-free diabetes remission
Time frame: 28 weeks after randomization
Drug-free diabetes remission is defined as HbA1C < 6.5 % off glucose-lowering agents for at least 12 weeks.

3 secondary outcomes

Proportion of participants achieving drug-free diabetes remission
Time frame: 28 weeks, 40 weeks, 52 weeks and 68 weeks after randomization
Proportion of participants achieving drug-free normoglycemia
Time frame: 28 weeks, 40 weeks, 52 weeks and 68 weeks after randomization
Proportion of participants achieving drug-free diabetes regression
Time frame: 28 weeks, 40 weeks, 52 weeks and 68 weeks after randomization

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2023.

Related trials for Type 2 Diabetes Mellitus

Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
Not yet recruiting
Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
Type 2 Diabetes Mellitus (T2D), Obesity (BMI>30)

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Zubin Punthakee, MD principal investigator

McMaster University

Hertzel Gerstein, MD study chair

McMaster University

8 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing IDegLira, insulin degludec and Metformin in people with Type 2 Diabetes Mellitus, run by Population Health Research Institute at 8 sites in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of participants achieving drug-free diabetes remission (time frame: 28 weeks after randomization). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03862716.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Oct 2023.