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Trial record 59 of 61 for:    Lixisenatide

Remission Evaluation of a Metabolic Intervention for Type 2 Diabetes With IGlarLixi (REMIT-iGL)

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ClinicalTrials.gov Identifier: NCT03130426
Recruitment Status : Active, not recruiting
First Posted : April 26, 2017
Last Update Posted : August 28, 2019
Sponsor:
Collaborator:
Sanofi
Information provided by (Responsible Party):
Population Health Research Institute

Brief 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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Drug: iGlarLixi Drug: Insulin Glargine Drug: Metformin Behavioral: Lifestyle therapy Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Remission Evaluation of a Metabolic Intervention for Type 2 Diabetes With IGlarLixi
Actual Study Start Date : June 27, 2017
Actual Primary Completion Date : June 30, 2019
Estimated Study Completion Date : September 30, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Intervention
Drug: iGlarLixi - sc injection; Drug: metformin - oral administration; Drug: insulin glargine - sc injection; Behavioral: lifestyle therapy, diet and exercise
Drug: iGlarLixi
Dose is titrated to achieve fasting normoglycemia
Other Name: glargine insulin / lixisenatide

Drug: Insulin Glargine
In those who need additional insulin or who cannot tolerate iGlarLixi, insulin glargine will be used. Dose is titrated to achieve fasting normoglycemia.
Other Name: Lantus

Drug: Metformin
Dose is titrated to 2000 mg daily or maximal tolerated dose

Behavioral: Lifestyle therapy
Lifestyle intervention includes individualized dietary and exercise advice and frequent visits for goal reinforcement, behavior modification and problem-solving
Other Name: diet and exercise

No Intervention: Standard Care
Standard glycemic care as informed by the current clinical practice guidelines



Primary Outcome Measures :
  1. Proportion of participants achieving drug-free diabetes remission [ Time Frame: 24 weeks after randomization ]
    Drug-free diabetes remission is defined as HbA1C < 6.5 % off glucose-lowering agents for at least 12 weeks.


Secondary Outcome Measures :
  1. Proportion of participants achieving drug-free diabetes remission [ Time Frame: 36 weeks, 48 weeks and 64 weeks after randomization ]
  2. Proportion of participants achieving drug-free normoglycemia defined as HbA1C < 6.0% [ Time Frame: 24 weeks, 36 weeks, 48 weeks and 64 weeks after randomization ]
  3. Proportion of participants achieving drug-free normoglycemia defined as HbA1C < 5.7% [ Time Frame: 24 weeks, 36 weeks, 48 weeks and 64 weeks after randomization ]
  4. Proportion of participants achieving drug-free diabetes regression [ Time Frame: 24 weeks, 36 weeks, 48 weeks and 64 weeks after randomization ]
    Diabetes regression is defined as HbA1C 6.5-6.9% off glucose-lowering agents for at least 12 weeks.

  5. Weight loss from baseline [ Time Frame: 12 weeks, 24 weeks, 36 weeks, 48 weeks and 64 weeks ]
  6. Change in waist circumference [ Time Frame: 12 weeks, 24 weeks, 36 weeks, 48 weeks and 64 weeks ]
  7. 6-point capillary glucose profile [ Time Frame: 1 week, 6 weeks, 12 weeks, 24 weeks and 48 weeks ]
    measured on 2 days



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Ages Eligible for Study:   30 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03130426


Locations
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Canada, Alberta
University of Calgary
Calgary, Alberta, Canada, T2T 5C7
Canada, Ontario
LMC
Burlington, Ontario, Canada, M4G 3E8
Joanne Liutkus
Cambridge, Ontario, Canada, N1R 7L6
McMaster University
Hamilton, Ontario, Canada, L8N 3Z5
St. Joseph's Hospital
London, Ontario, Canada, N6A 4V2
Western University
London, Ontario, Canada, N6G 2M1
The Ottawa Hospital
Ottawa, Ontario, Canada, K1Y 4E9
Canada, Quebec
McGill University
Montreal, Quebec, Canada, H4A 3J1
Sponsors and Collaborators
Population Health Research Institute
Sanofi
Investigators
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Principal Investigator: Natalia McInnes, MD McMaster University
Principal Investigator: Hertzel Gerstein, MD McMaster University

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Responsible Party: Population Health Research Institute
ClinicalTrials.gov Identifier: NCT03130426     History of Changes
Other Study ID Numbers: REMIT-iGlarLixi
First Posted: April 26, 2017    Key Record Dates
Last Update Posted: August 28, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Population Health Research Institute:
Diabetes
iGlarLixi
Metformin
Insulin
Diet
Exercise
Lifestyle
Additional relevant MeSH terms:
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Lixisenatide
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin
Insulin, Globin Zinc
Metformin
Insulin Glargine
Hypoglycemic Agents
Physiological Effects of Drugs