Current partner codePEPTIDESDE
NCT03130426·Phase 3·INTERVENTIONAL

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

Status

Completed

Phase

Phase 3

Enrollment

161

Locations

8

Results

Not posted

Publications

0

Study summary

What the protocol is testing.

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.

Full 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.

Interventions

Treatment arms and agents.

DRUG

iGlarLixi

Dose is titrated to achieve fasting normoglycemia

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.

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

Timeline

From registration to results.

  1. First posted

    Apr 26, 2017

  2. Study start

    Jun 27, 2017

  3. Primary completion

    Jun 30, 2019

  4. Study completion

    Sep 30, 2020

  5. Results posted

    Not reported

  6. Registry updated

    Nov 13, 2020

Outcomes

What the study measures.

Primary outcomes

The first occurrence of diabetes relapse

Time frame · 64 weeks of follow-up

Secondary outcomes

Number of participants achieving drug-free diabetes remission

Time frame · 24 weeks after randomization

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

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

Percentage of weight loss from baseline

Time frame · 12 weeks

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

Change in waist circumference from baseline

Time frame · 12 weeks

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

Glycated hemoglobin (HbA1C)

Time frame · 12 weeks

Expressed in Diabetes Control and Complications Trial (DCCT) units

Eligibility

Who can take part.

Minimum age
30 Years
Maximum age
80 Years
Sex
ALL
Healthy volunteers
No

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

Study locations

8 registered sites.

Canada. Showing up to 24 locations stored in the fast local snapshot.

University of Calgary

Calgary, Alberta, Canada

LMC

Burlington, Ontario, Canada

Joanne Liutkus

Cambridge, Ontario, Canada

McMaster University

Hamilton, Ontario, Canada

St. Joseph's Hospital

London, Ontario, Canada

Western University

London, Ontario, Canada

The Ottawa Hospital

Ottawa, Ontario, Canada

McGill University

Montreal, Quebec, Canada

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

Related trials

More studies on Lixisenatide.

Related PeptideStat pages

Put the record in context.

Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.