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Trial · Interventional

CompletedPhase 3Registry data

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

Short name REMIT-iGL

NCTNCT03130426 (opens ClinicalTrials.gov in a new tab)Other idREMIT-iGlarLixi
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 3
Enrollment
161 participants (actual)
Sponsor
Population Health Research Institute · Other
Design
Randomized · Open label (no masking)
Countries
1 country

Canada

Start
27 Jun 2017
Primary completion
30 Jun 2019
Completion
30 Sept 2020
First posted
26 Apr 2017
Last update posted
13 Nov 2020
Conditions
Type 2 Diabetes Mellitus

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20172018201920202021
  1. Ph 3

    REMIT-iGL

    NCT03130426

    27 Jun 2017 to 30 Sept 2020

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • iGlarLixiDrug
  • Insulin GlargineDrug
  • MetforminDrug
  • Lifestyle therapyBehavioral

Arms2

  • Experimental

    Intervention

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

  • No intervention

    Standard Care

    Standard glycemic care as informed by the current clinical practice guidelines

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. The first occurrence of diabetes relapse

    Time frame · 64 weeks of follow-up

Secondary outcomes(5)

  1. Number of participants achieving drug-free diabetes remission

    Time frame · 24 weeks after randomization

    Registry description

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

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

    Time frame · 24 weeks after randomization

  3. Percentage of weight loss from baseline

    Time frame · 12 weeks

    Registry description

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

  4. Change in waist circumference from baseline

    Time frame · 12 weeks

    Registry description

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

  5. Glycated hemoglobin (HbA1C)

    Time frame · 12 weeks

    Registry description

    Expressed in Diabetes Control and Complications Trial (DCCT) units

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 30 Years up to 80 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: 1. men and women aged 30-80 years; 2. type 2 diabetes mellitus within 5 years of diagnosis; 3. stable diabetes drug regimen in the 10 weeks before randomization; 4. 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; 5. body mass index \>/= 23 kg/m2; 6. ability and willingness to perform self-monitoring of capillary blood glucose (SMBG); 7. ability and willingness to self-inject iglarlixi; and 8. provision of informed consent. Exclusion Criteria: 1. current use of insulin therapy; 2. history of hypoglycemia unawareness, or severe hypoglycemia requiring assistance; 3. history of end-stage renal disease or renal dysfunction as evidenced by eGFR\<45 mL/min/1.73 m2 by MDRD formula; 4. history of lactic acidosis or diabetic ketoacidosis; 5. active liver disease or elevated alanine transferase (ALT) levels \>\\= 2.5 times upper limit of normal at the time of enrolment; 6. history or clinical suspicion of pancreatitis or medullary thyroid cancer, or a calcitonin level \>/= 20 pg/ml; 7. 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). 8. history of any disease requiring frequent intermittent or continuous systemic glucocorticoid treatment; 9. history of bariatric surgery, or planned bariatric surgery in the next 1.5 years; 10. history of any major illness with a life expectancy of \< 3 years; 11. history of injury or any other condition that significantly limits participant's ability to achieve moderate levels of physical activity; 12. excessive alcohol intake, acute or chronic; 13. 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; 14. inability to take glargine, lixisenatide or metformin

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