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Type 2 Diabetes MellitusPhase 3REMIT-iGLNCT03130426

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

A Phase 3 study testing iGlarLixi, Insulin Glargine 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
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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 iGlarLixi, 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?
iGlarLixi, Insulin Glargine and Metformin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
161 participants
Where
8 sitesCanada
Study dates
27 Jun 2017to 30 Sep 2020
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;
  • type 2 diabetes mellitus within 5 years of diagnosis;
  • stable diabetes drug regimen in the 10 weeks before randomization;
  • HbA1c 6.5-9.5% on no glucose lowering drugs, or </= 8.5% on 1 glucose-lowering drug, or </= 8.0% on 2 glucose lowering drugs;
  • body mass index >/= 23 kg/m2;
  • ability and willingness to perform self-monitoring of capillary blood glucose (SMBG);
  • ability and willingness to self-inject iglarlixi; and
  • 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 renal dysfunction as evidenced by eGFR<45 mL/min/1.73 m2 by MDRD formula;
  • history of lactic acidosis or diabetic ketoacidosis;
  • active liver disease or elevated alanine transferase (ALT) levels >\= 2.5 times upper limit of normal at the time of enrolment;
  • history or clinical suspicion of pancreatitis or medullary thyroid cancer, or a calcitonin level >/= 20 pg/ml;
Show all 14Show fewer
  • 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 glargine, lixisenatide or metformin

Trial locations and contacts

8 sites in 1 country.

8 sites in 1 country

Canada8 sites

  • LMC

    Burlington, Ontario, M4G 3E8

  • University of Calgary

    Calgary, Alberta, T2T 5C7

  • Joanne Liutkus

    Cambridge, Ontario, N1R 7L6

  • McMaster University

    Hamilton, Ontario, L8N 3Z5

  • St. Joseph's Hospital

    London, Ontario, N6A 4V2

  • Western University

    London, Ontario, N6G 2M1

  • McGill University

    Montreal, Quebec, H4A 3J1

  • The Ottawa Hospital

    Ottawa, Ontario, K1Y 4E9

Other trials in Canada

About this study

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

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 12-week course of treatment with iGlarLixi, metformin and lifestyle therapy, and (b) standard diabetes therapy, and followed for a total of 64 weeks (1 year and 3 months). In all participants with HbA1C<7.3% at the 12 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.

Being tested
iGlarLixi, Insulin Glargine, Metformin, Lifestyle therapy
Keywords
Diabetes, iGlarLixi, Metformin, Insulin, Diet, Exercise, Lifestyle
Medical subject headings
Diabetes Mellitus, Type 2, Diabetes Mellitus, Insulin Resistance, Motor Activity

What participants receive

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

  • iGlarLixiDrug

    Also called glargine insulin / lixisenatide

    Dose is titrated to achieve fasting normoglycemia

  • Insulin GlargineDrug

    Also called Lantus

    In those who need additional insulin or who cannot tolerate iGlarLixi, insulin glargine will be used. Dose is titrated to achieve fasting normoglycemia.

  • MetforminDrug

    Dose is titrated to 2000 mg daily or maximal tolerated dose

  • Lifestyle therapyBehavioural

    Also called diet and exercise

    Lifestyle intervention includes individualized dietary and exercise advice and frequent visits for goal reinforcement, behavior modification and problem-solving

Study groups in NCT03130426
Study groupRoleWhat they receive
InterventionExperimentalDrug: iGlarLixi - sc injection; Drug: metformin - oral administration; Drug: insulin glargine - sc injection; Behavioral: lifestyle therapy, diet and exercise
Receives: Drug: iGlarLixi; Drug: Insulin Glargine; Drug: Metformin; Behavioral: Lifestyle therapy
Standard CareNo interventionStandard 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.

  1. The first occurrence of diabetes relapse

    Measured: 64 weeks of follow-up

Secondary outcomes (5)

  1. Number of participants achieving drug-free diabetes remission

    Diabetes remission is defined as HbA1C < 6.5% off diabetes drugs for at least 12 weeks

    Measured: 24 weeks after randomization

  2. Number of participants achieving drug-free normoglycemia defined as HbA1C < 6.0% off diabetes drugs for at least 12 weeks

    Measured: 24 weeks after randomization

  3. Percentage of weight loss from baseline

    (Weight at randomization - weight at 12 weeks)/(weight at randomization)

    Measured: 12 weeks

  4. Change in waist circumference from baseline

    (Waist circumference at 12 weeks - weight circumference at randomization)

    Measured: 12 weeks

  5. Glycated hemoglobin (HbA1C)

    Expressed in Diabetes Control and Complications Trial (DCCT) units

    Measured: 12 weeks

Timeline

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

  1. First posted26 Apr 2017
  2. Study start27 Jun 2017
  3. Primary completion30 Jun 2019
  4. Study completion30 Sep 2020

Resources

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
161 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03130426
Sponsor's protocol ID
REMIT-iGlarLixi
Acronym
REMIT-iGL
Status last verified
Nov 2020
First submitted
23 Apr 2017
Last updated
13 Nov 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing iGlarLixi, Insulin Glargine 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 8 inclusion and 14 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 13 Nov 2020. 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?

The first occurrence of diabetes relapse (time frame: 64 weeks of follow-up). 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 NCT03130426.

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 13 Nov 2020.

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