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Trial · Interventional

CompletedPhase 3Registry data

Study Comparing the Efficacy and Safety of Insulin Glargine (Basal Insulin)/Lixisenatide (GLP-1 Receptor Agonist) Combination (Soliqua™) in Patients With Type 2 Diabetes Mellitus (T2DM)

Short name LixilanOne CAN

NCTNCT03767543 (opens ClinicalTrials.gov in a new tab)Other idLPS15544Other idU1111-1215-0238
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 3
Enrollment
265 participants (actual)
Sponsor
Sanofi · Industry
Design
Randomized · Open label (no masking)
Countries
1 country

Canada

Start
11 Mar 2019
Primary completion
23 Oct 2020
Completion
23 Oct 2020
First posted
6 Dec 2018
Last update posted
25 Apr 2022
Conditions
Type 2 Diabetes Mellitus

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
201920202021
  1. Ph 3

    LixilanOne CAN

    NCT03767543

    11 Mar 2019 to 23 Oct 2020

Registry summary

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

Primary Objective: To demonstrate that the simple daily titration algorithm is non-inferior to the weekly titration algorithm according to Canadian labeling. Secondary Objective: To gain additional information on the efficacy and safety of using a simple patient-titration protocol for administration of insulin glargine/lixisenatide fixed-ratio combination (iGlarLixi).

Interventions

  • INSULIN GLARGINE/LIXISENATIDE HOE901/AVE0010Drug

Arms2

  • Experimental

    iGlarlixi DAILY

    Titration Group 1: Addition of 1 unit per day until pre-stated fasting self-monitoring plasma glucose (SMBG) level is reached

  • Active comparator

    iGlarlixi WEEKLY

    Titration Group 2: Algorithm of weekly adjustment until pre-stated fasting self-monitoring plasma glucose (SMBG) level is reached

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Change in glycated hemoglobin (HbA1c)%

    Time frame · Baseline to Week 26

    Registry description

    Absolute mean change in HbA1c from baseline to Week 26; HbA1c is expressed in % (unit)

Secondary outcomes(15)

  1. Percentage of patients achieving HbA1c ≤7% at Week 26

    Time frame · At Week 26

    Registry description

    Percentage of patients achieving A1c ≤7%

  2. Change in fasting plasma glucose (FPG) from baseline to Week 12

    Time frame · Baseline to Week 12

    Registry description

    Change in FPG from baseline to Week 12

  3. Change in FPG from baseline to Week 26

    Time frame · Baseline to Week 26

    Registry description

    Change in FPG from baseline to Week 26

  4. Change in fasting self-monitoring plasma glucose (SMPG) from baseline to Week 12

    Time frame · Baseline to Week 12

    Registry description

    Change in fasting SMPG from baseline to Week 12

  5. Change in fasting SMPG from baseline to Week 26

    Time frame · Baseline to Week 26

    Registry description

    Change in fasting SMPG from baseline to Week 26

  6. Change in 7-point SMPG profile from baseline to Week 12

    Time frame · Baseline to Week 12

    Registry description

    Change in 7-point SMPG profile from baseline to Week 12

  7. Change in 7-point SMPG profile from baseline to Week 26

    Time frame · Baseline to Week 26

    Registry description

    Change in 7-point SMPG profile from baseline to Week 26

  8. Change in body weight from baseline to Week 26

    Time frame · Baseline to Week 26

    Registry description

    Change in body weight (kg)

  9. Percentage of patients achieving A1c ≤7% with no body weight gain and/or hypoglycemia (severe or documented symptomatic (≤3.9 mmol/L) at Week 26

    Time frame · Baseline to Week 26

    Registry description

    Composite endpoint expressed as percentage of patients A1c ≤7% with no body weight gain and/or hypoglycemia (severe or documented symptomatic (≤3.9 mmol/L)

  10. Insulin glargine dose

    Time frame · At Week 26

    Registry description

    Insulin glargine dose (expressed in units)

  11. Percentage of patients requiring rescue therapy

    Time frame · Baseline to Week 26

    Registry description

    Percentage of patients requiring rescue therapy during the 26-week open-label treatment period

  12. Percentage of patients experiencing at least 1 hypoglycemia episode (≤3.9 mmol/L) over 26 weeks

    Time frame · Baseline to Week 26

    Registry description

    Percentage of patients experiencing at least 1 hypoglycemia episode defined as ≤3.9 mmol/L

  13. Percentage of patients experiencing at least 1 hypoglycemia episode (<3.0 mmol/L) over 26 weeks

    Time frame · Baseline to Week 26

    Registry description

    Percentage of patients experiencing at least 1 hypoglycemia episode defined as \<3.0 mmol/L

  14. Annualized rate of hypoglycemia (≤3.9 mmol/L) over 26 weeks

    Time frame · Baseline to Week 26

    Registry description

    Mean number of hypoglycemia episodes (≤3.9 mmol/L) per patient year of exposure over 1 year

  15. Annualized rate of hypoglycemia (<3.0 mmol/L) over 26 weeks

    Time frame · Baseline to Week 26

    Registry description

    Mean number of hypoglycemia episodes (\<3.0 mmol/L) per patient year of exposure over 1 year

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

Studies1

Studies that cite this trial.

More studies

1 study on this page

PubMed tag: none · 2023

Ease of Use of the iGlarLixi SoloStar Pen from the LixiLan ONE CAN Pen Sub-Study: Questionnaire Findings from People Living with Type 2 Diabetes and Their HealthCare Providers.

Yale et al. 2023Diabetes therapy : research, treatment and education of diabetes and related disorders

PMID 36574199PMC9943797DOI 10.1007/s13300-022-01353-6PUB-36574199

Free to read · publisher termsCC BY-NC
Read at source

Other registry references

References listed at the registry that are not in PepBank. They link to PubMed.

  • DerivedHramiak I, Gerstein HC, Leiter LA, Yale JF, Bajaj HS, Stewart J, Toutounji MJ, Harris SB. Comparing a daily versus weekly titration algorithm in people with type 2 diabetes switching from basal insulin to iGlarLixi in the LixiLan ONE CAN randomized trial. Diabetes Obes Metab. 2022 Oct;24(10):1998-2007. doi: 10.1111/dom.14787. Epub 2022 Jun 29. PMID 35670659

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion criteria: * Adult subject ≥ 18 years * Patients with type 2 diabetes mellitus (T2DM) based on Diabetes Canada 2018 Clinical Practice Guidelines criteria and diagnosed at least 6 months prior to the screening visit * Uncontrolled glycemia with an A1c ≥7.5% and ≤10.5% * Patients treated for at least 6 months on any basal insulin (including but not limited to insulin glargine, Toujeo®, Degludec®, etc.) ± oral anti-diabetic drug (OADs) * The total basal insulin dose must be ≤ 40 units/day * The OADs allowed at inclusion are metformin, insulin secretagogues, dipeptidyl-peptidase-4 inhibitors (DPP4) inhibitors and SGLT2 inhibitors; with no change in OAD dose for at least 2 months prior to randomization * Body mass index (BMI) between 20 kg/m2 and 40 kg/m2 inclusively Exclusion criteria: * History of severe hypoglycemia or hypoglycemia unawareness * History of metabolic acidosis, including diabetic ketoacidosis within 1 year prior to screening visit * Current or previous (known intolerance to GLP-1s) treatment with glucagon like peptide-1 (GLP-1) receptor agonist * Current use of rapid-acting insulin or premix insulins or use of these insulins within 3 months prior to the screening visit * Use of systemic glucocorticoids (excluding topical and inhaled forms) for a total duration of 1 week or more within 3 months prior to the screening visit * Use of weight loss drugs within 3 months prior to the screening visit * Patients with conditions/concomitant diseases that will affect safe participation in this study (e.g. active malignant tumor, major systemic diseases, presence of clinically significant diabetic retinopathy or presence of macular edema likely to require treatment within the study period, etc.) * Women of childbearing potential (WOCBP) not protected by an effective contraceptive method of birth control and/or who are unwilling or unable to be tested for pregnancy * Positive serum pregnancy test in WOCBP, pregnancy or lactation * Clinically relevant history of gastrointestinal disease associated with prolonged nausea and vomiting, including (but not limited to): gastroparesis, unstable (i.e. worsening) or uncontrolled (i.e. prolonged nausea and vomiting) gastroesophageal reflux disease requiring medical treatment within 6 months prior to the time of screening visit * History of pancreatitis (unless pancreatitis was related to gallstones and treated with cholecystectomy), pancreatitis during previous treatment with incretin therapies, chronic pancreatitis, pancreatectomy, or stomach/gastric surgery * Personal or immediate family history of medullary thyroid cancer or genetic conditions that predispose the patient to medullary thyroid cancer (e.g. multiple endocrine neoplasia syndromes) The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

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