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Type 2 Diabetes MellitusPhase 3LixilanOne CANNCT03767543

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)

A Phase 3 study testing INSULIN GLARGINE/LIXISENATIDE HOE901/AVE0010 in people with Type 2 Diabetes Mellitus, run by Sanofi at 32 sites in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Type 2 Diabetes Mellitus
What is being tested?
INSULIN GLARGINE/LIXISENATIDE HOE901/AVE0010
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
265 participants
Where
32 sitesCanada
Study dates
11 Mar 2019to 23 Oct 2020
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 13Show fewer
  • 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.

Trial locations and contacts

32 sites in 1 country.

32 sites in 1 country

Canada32 sites

  • Investigational Site Number 1240004

    Barrie, L4N4L3

  • Investigational Site Number 1240006

    Brampton, L6S0C9

  • Investigational Site Number 1240002

    Brampton, L6T4V3

  • Investigational Site Number 1240005

    Burlington, L7R1A4

  • Investigational Site Number 1240003

    Calgary, T2H2G4

  • Investigational Site Number 1240024

    Chicoutimi, G7H7K9

  • Investigational Site Number 1240014

    Concord, L4K4M2

  • Investigational Site Number 1240017

    Etobicoke, M9R4E1

  • Investigational Site Number 1240030

    Greenfield Park, J4V2G8

  • Investigational Site Number 1240031

    Halifax, B3H1V7

  • Investigational Site Number 1240026

    Hamilton, L8S4K1

  • Investigational Site Number 1240011

    Laval, H7T 2P5

  • Investigational Site Number 1240016

    London, N6A 4V2

  • Investigational Site Number 1240015

    London, N6G 4X8

  • Investigational Site Number 1240019

    Mirabel, J7J2K8

  • Investigational Site Number 1240018

    Montreal, H1M1B1

  • Investigational Site Number 1240023

    Montreal, H4A2C6

  • Investigational Site Number 1240020

    Montreal, H4A3T2

  • Investigational Site Number 1240029

    Montreal, H4T1Z9

  • Investigational Site Number 1240027

    Nepan, K2J0V2

  • Investigational Site Number 1240025

    Newmarket

  • Investigational Site Number 1240021

    Oakville, L6M1M1

  • Investigational Site Number 1240009

    Oshawa, L1H7K4

  • Investigational Site Number 1240008

    Québec, G1G3Y8

  • Investigational Site Number 1240022

    Québec, G1V4W2

  • Investigational Site Number 1240028

    Saint-Lambert, J4P2H4

  • Investigational Site Number 1240013

    Saint-Marc-des-Carrieres

  • Investigational Site Number 1240033

    Toronto, M3J0K2

  • Investigational Site Number 1240001

    Toronto, M4G3E8

  • Investigational Site Number 1240012

    Vancouver, V5Y3W2

  • Investigational Site Number 1240007

    Victoriaville, G6P6P6

  • Investigational Site Number 1240032

    Winnipeg, R2V4W3

Other trials in Canada

About this study

Official title: A Randomized, 26-week, Open-label, 2-treatment Arm, Parallel Group Multicenter Study Comparing the Efficacy and Safety of Insulin Glargine/Lixisenatide Fixed-ratio Combination (Soliqua™) Titrated Using a Simple Titration Algorithm (One Unit Daily Adjustment) Compared With Insulin Glargine/Lixisenatide Fixed-ratio Combination (Soliqua™) Titrated by Weekly Adjustment in Patients With Type 2 Diabetes Mellitus (T2DM)

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).

Read the detailed description

The maximum duration of study per patient is approximately 29 weeks including a 2-week screening, a 26-week randomized active-controlled treatment period, and 3-day post-treatment safety follow-up period.

Being tested
INSULIN GLARGINE/LIXISENATIDE HOE901/AVE0010
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • INSULIN GLARGINE/LIXISENATIDE HOE901/AVE0010Drug

    Pharmaceutical form: Solution for injection Route of administration: Subcutaneous

Study groups in NCT03767543
Study groupRoleWhat they receive
iGlarlixi DAILYExperimentalTitration Group 1: Addition of 1 unit per day until pre-stated fasting self-monitoring plasma glucose (SMBG) level is reached
Receives: Drug: INSULIN GLARGINE/LIXISENATIDE HOE901/AVE0010
iGlarlixi WEEKLYActive comparatorTitration Group 2: Algorithm of weekly adjustment until pre-stated fasting self-monitoring plasma glucose (SMBG) level is reached
Receives: Drug: INSULIN GLARGINE/LIXISENATIDE HOE901/AVE0010

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in glycated hemoglobin (HbA1c)%

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

    Measured: Baseline to Week 26

Secondary outcomes (15)

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

    Percentage of patients achieving A1c ≤7%

    Measured: At Week 26

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

    Change in FPG from baseline to Week 12

    Measured: Baseline to Week 12

  3. Change in FPG from baseline to Week 26

    Change in FPG from baseline to Week 26

    Measured: Baseline to Week 26

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

    Change in fasting SMPG from baseline to Week 12

    Measured: Baseline to Week 12

  5. Change in fasting SMPG from baseline to Week 26

    Change in fasting SMPG from baseline to Week 26

    Measured: Baseline to Week 26

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

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

    Measured: Baseline to Week 12

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

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

    Measured: Baseline to Week 26

  8. Change in body weight from baseline to Week 26

    Change in body weight (kg)

    Measured: Baseline to Week 26

  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

    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)

    Measured: Baseline to Week 26

  10. Insulin glargine dose

    Insulin glargine dose (expressed in units)

    Measured: At Week 26

  11. Percentage of patients requiring rescue therapy

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

    Measured: Baseline to Week 26

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

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

    Measured: Baseline to Week 26

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

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

    Measured: Baseline to Week 26

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

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

    Measured: Baseline to Week 26

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

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

    Measured: Baseline to Week 26

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Dec 2018
  2. Study start11 Mar 2019
  3. Primary completion23 Oct 2020
  4. Study completion23 Oct 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
265 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03767543
Sponsor's protocol ID
LPS15544
Other IDs
U1111-1215-0238
Acronym
LixilanOne CAN
Status last verified
Apr 2022
First submitted
5 Dec 2018
Last updated
25 Apr 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

Publications

  • Yale JF, Roborel de Climens A, Aggarwal N, Dex T, Gerstein HC, Harris S, Hramiak I, Stewart J, Leiter LA. 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. Diabetes Ther. 2023 Feb;14(2):377-386. doi: 10.1007/s13300-022-01353-6. Epub 2022 Dec 27.

    PubMed 36574199

  • Hramiak 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.

    PubMed 35670659

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing INSULIN GLARGINE/LIXISENATIDE HOE901/AVE0010 in people with Type 2 Diabetes Mellitus, run by Sanofi at 32 sites in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 32 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in glycated hemoglobin (HbA1c)% (time frame: Baseline to Week 26). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03767543, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2022.

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