NCT03130426

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
161

participants targeted

Target at below P25 for phase_3 type-2-diabetes-mellitus

Timeline
Completed

Started Jun 2017

Longer than P75 for phase_3 type-2-diabetes-mellitus

Geographic Reach
1 country

8 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 23, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 26, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

June 27, 2017

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2019

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2020

Completed
Last Updated

November 13, 2020

Status Verified

November 1, 2020

Enrollment Period

2 years

First QC Date

April 23, 2017

Last Update Submit

November 10, 2020

Conditions

Type 2 Diabetes Mellitus

Keywords

DiabetesiGlarLixiMetforminInsulinDietExerciseLifestyle

Outcome Measures

Primary Outcomes (1)

  • The first occurrence of diabetes relapse

    64 weeks of follow-up

Secondary Outcomes (5)

  • Number of participants achieving drug-free diabetes remission

    24 weeks after randomization

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

    24 weeks after randomization

  • Percentage of weight loss from baseline

    12 weeks

  • Change in waist circumference from baseline

    12 weeks

  • Glycated hemoglobin (HbA1C)

    12 weeks

Study Arms (2)

Intervention

EXPERIMENTAL

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

Drug: iGlarLixiDrug: Insulin GlargineDrug: MetforminBehavioral: Lifestyle therapy

Standard Care

NO INTERVENTION

Standard glycemic care as informed by the current clinical practice guidelines

Interventions

iGlarLixiDRUG

Dose is titrated to achieve fasting normoglycemia

Also known as: glargine insulin / lixisenatide
Intervention
Insulin GlargineDRUG

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

Also known as: Lantus
Intervention
MetforminDRUG

Dose is titrated to 2000 mg daily or maximal tolerated dose

Intervention
Lifestyle therapyBEHAVIORAL

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

Also known as: diet and exercise
Intervention

Eligibility Criteria

Age30 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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;
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

University of Calgary

Calgary, Alberta, T2T 5C7, Canada

Location

LMC

Burlington, Ontario, M4G 3E8, Canada

Location

Joanne Liutkus

Cambridge, Ontario, N1R 7L6, Canada

Location

McMaster University

Hamilton, Ontario, L8N 3Z5, Canada

Location

St. Joseph's Hospital

London, Ontario, N6A 4V2, Canada

Location

Western University

London, Ontario, N6G 2M1, Canada

Location

The Ottawa Hospital

Ottawa, Ontario, K1Y 4E9, Canada

Location

McGill University

Montreal, Quebec, H4A 3J1, Canada

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Diabetes MellitusInsulin ResistanceMotor Activity

Interventions

Insulin GlarginelixisenatideMetforminDietExercise

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesHyperinsulinismBehavior

Intervention Hierarchy (Ancestors)

Insulin, Long-ActingInsulinsPancreatic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and ProteinsBiguanidesGuanidinesAmidinesOrganic ChemicalsNutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological PhenomenaMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Natalia McInnes, MD

    McMaster University

    PRINCIPAL INVESTIGATOR

  • Hertzel Gerstein, MD

    McMaster University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 23, 2017

First Posted

April 26, 2017

Study Start

June 27, 2017

Primary Completion

June 30, 2019

Study Completion

September 30, 2020

Last Updated

November 13, 2020

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will not share

Locations

CA(8)