AzTrials
AzTrials

Type 2 Diabetes MellitusPhase 3Lixilan-L-CNNCT03798080

Comparison of the Efficacy and Safety of Insulin Glargine/Lixisenatide Fixed Ratio Combination to Insulin Glargine in Patients With Type 2 Diabetes Insufficiently Controlled on Basal Insulin

A Phase 3 study testing Insulin glargine/Lixisenatide (HOE901/AVE0010), Insulin glargine (HOE901) and Metformin in people with Type 2 Diabetes Mellitus, run by Sanofi at 45 sites in China.

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 the superiority of iGlarLixi (fixed ratio combination of insulin glargine and lixisenatide) to insulin glargine on glycemic control as assessed by glycated hemoglobin A1c (HbA1c) change in patients with type 2 diabetes mellitus (T2DM) who are not sufficiently controlled with basal… 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), Insulin glargine (HOE901) and Metformin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
426 participants
Where
45 sitesChina
Study dates
19 Feb 2019to 1 Dec 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

  • Patients with type 2 diabetes mellitus (T2DM) diagnosed for at least 1 year and treated with basal insulin for at least 6 months before screening visit (V1).
  • Patients who have been treated with a stable basal insulin regimen (ie, type of insulin and time/frequency of the injection), for at least 3 months before screening visit (V1).
  • Stable total daily basal insulin dose (±20 %) in the range of 10 and 25 U/day for at least 2 months before screening visit (V1). Total daily dose should be within the range of 10-25 U, both inclusive, on the day of screening, but individual fluctuations of ±20% within 2 months prior to screening are acceptable.
  • For patients receiving basal insulin AND 1 or 2 oral anti-diabetic drugs (OADs): the OAD dose(s) must be stable during the 3 months prior to screening. The OAD(s) can be 1 to 2 out of:
  • Metformin (≥1500 mg/day or maximal tolerated dose).
  • Sulfonylurea (SU)/glinide.
Show all 11Show fewer
  • Alpha-glucosidase inhibitor (alpha-GI).
  • Sodium-glucose co-transporter 2 (SGLT2) inhibitor.
  • Dipeptidyl-peptidase-4 (DPP-4) inhibitor.
  • Fasting plasma glucose (FPG) ≤160 mg/dL (8.9 mmol/L) at screening visit (V1) (can be repeated once to confirm).
  • Signed written informed consent.

Who cannot join

  • Age <18 years at screening visit (V1).
  • Screening glycated hemoglobin A1c(HbA1c) <7.0% or >10.5%.
  • History of hypoglycemia unawareness.
  • History of metabolic acidosis, including diabetic ketoacidosis within one year prior to screening.
  • Use of oral or injectable glucose-lowering agents other than those stated in the inclusion criteria within 3 months prior to screening.
  • Previous use of insulin regimen other than basal insulin, eg, prandial or pre-mixed insulin, within one year prior to screening (Note: Short term treatment [≤10 days] due to intercurrent illness is allowed).
Show all 28Show fewer
  • History of discontinuation of a previous treatment with glucagon-like-peptide-1 receptor agonists (GLP-1 RAs) due to safety/tolerability reason or lack of efficacy.
  • Use of systemic glucocorticoids (excluding topical application or inhaled forms) for 1 week or more within 3 months prior to screening.
  • Use of weight loss drugs within 3 months prior to screening.
  • Use of any investigational drug within 1 month or 5 half-lives, whichever is longer, prior to screening.
  • Within 6 months prior to screening: history of myocardial infarction, stroke, or heart failure requiring hospitalization.
  • Planned coronary, carotid, or peripheral revascularization procedures to be performed during the study period.
  • Known history of drug or alcohol abuse within 6 months prior to screening.
  • Uncontrolled or inadequately controlled hypertension at the time of screening with a resting systolic blood pressure >180 mmHg or diastolic blood pressure >95 mmHg.
  • Laboratory findings at screening visit:
  • Amylase and/or lipase >3 times the upper limit of normal (ULN) laboratory range.
  • Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >3 ULN.
  • Total bilirubin >1.5 ULN (except in case of Gilbert's syndrome).
  • Calcitonin ≥20 pg/mL (5.9 pmol/L).
  • Hemoglobin <10.5 g/dL and/or neutrophils <1500/mm3 and/or platelets <100 000/mm3.
  • Positive test for hepatitis B surface antigen (HBsAg) and/or hepatitis C antibody (HCAb).
  • Positive urine pregnancy test in female of childbearing potential.
  • For patient not treated with metformin at screening: severe renal function impairment with an estimated glomerular filtration rate (eGFR) <30 mL/min/1.73m2 or end-stage renal disease.
  • Clinically relevant history of gastrointestinal disease associated with prolonged nausea and vomiting, including (but not limited to): gastroparesis, unstable (ie, worsening) or not controlled (ie, prolonged nausea and vomiting) gastroesophageal reflux disease requiring medical treatment, within 6 months prior to the time of screening visit; or history of surgery affecting gastric emptying.
  • History of pancreatitis (unless pancreatitis was related to gallstones and cholecystectomy has been performed), pancreatitis during previous treatment with incretin therapies, chronic pancreatitis, pancreatectomy.
  • Personal or immediate family history of medullary thyroid cancer (MTC) or genetic conditions that predispose to MTC (eg, multiple endocrine neoplasia syndromes).
  • Mean fasting self-monitored plasma glucose (SMPG) is >160 mg/dL (8.9 mmol/L), calculated from all available (minimum of 4 self-measurements) values during the 7 days prior to randomization.
  • 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

45 sites in 1 country.

45 sites in 1 country

China45 sites

  • Investigational Site Number 1560044

    Baotou, 014010

  • Investigational Site Number 1560001

    Beijing, 100034

  • Investigational Site Number 1560039

    Beijing, 102218

  • Investigational Site Number 1560005

    Changchun, 130033

  • Investigational Site Number 1560054

    Changchun, 130041

  • Investigational Site Number 1560015

    Changsha, 410013

  • Investigational Site Number 1560010

    Chenzhou

  • Investigational Site Number 1560030

    Chongqing, 400010

  • Investigational Site Number 1560025

    Fuzhou, 354200

  • Investigational Site Number 1560016

    Guangzhou, 510080

  • Investigational Site Number 1560053

    Guangzhou, 510080

  • Investigational Site Number 1560045

    Guangzhou, 510515

  • Investigational Site Number 1560021

    Hefei, 230022

  • Investigational Site Number 1560018

    Hohhot, 010017

  • Investigational Site Number 1560019

    Huanggang

  • Investigational Site Number 1560041

    Jiaxing

  • Investigational Site Number 1560040

    Jinan, 250000

  • Investigational Site Number 1560007

    Jinan, 250013

  • Investigational Site Number 1560026

    Jinzhou, 121000

  • Investigational Site Number 1560042

    Kaifeng, 475000

  • Investigational Site Number 1560003

    Kunming, 650032

  • Investigational Site Number 1560032

    Lanzhou, 730000

  • Investigational Site Number 1560033

    Luoyang

  • Investigational Site Number 1560028

    Nanjing, 210008

  • Investigational Site Number 1560013

    Nanjing, 210011

  • Investigational Site Number 1560017

    Nanjing, 210029

  • Investigational Site Number 1560035

    Nanjing

  • Investigational Site Number 1560038

    Nanjing

  • Investigational Site Number 1560046

    Nantong, 226001

  • Investigational Site Number 1560008

    Pingxiang, 337055

  • Investigational Site Number 1560037

    Qingdao, 266003

  • Investigational Site Number 1560031

    Qinhuangdao

  • Investigational Site Number 1560011

    Shanghai, 200240

  • Investigational Site Number 1560002

    Shanghai, 201700

  • Investigational Site Number 1560027

    Shanghai

  • Investigational Site Number 1560047

    Shanghai

  • Investigational Site Number 1560012

    Shenyang, 110004

  • Investigational Site Number 1560006

    Tianjin, 300121

  • Investigational Site Number 1560049

    Ürümqi, 830000

  • Investigational Site Number 1560020

    Xining, 810007

  • Investigational Site Number 1560050

    Xining, 810016

  • Investigational Site Number 1560036

    Xuzhou

  • Investigational Site Number 1560023

    Yangzhou, 225001

  • Investigational Site Number 1560022

    Zhuzhou, 412007

  • Investigational Site Number 1560052

    Zigong, 643002

Other trials in China

About this study

Official title: A Randomized, 30-week, Active-controlled, Open-label, 2 Treatment-arm, Parallel Group, Multicenter Study Comparing Efficacy and Safety of iGlarLixi to Insulin Glargine With or Without Metformin in Patients With Type 2 Diabetes Mellitus Insufficiently Controlled on Basal Insulin With or Without Oral Antidiabetic Drug(s)

Primary Objective:

To demonstrate the superiority of iGlarLixi (fixed ratio combination of insulin glargine and lixisenatide) to insulin glargine on glycemic control as assessed by glycated hemoglobin A1c (HbA1c) change in patients with type 2 diabetes mellitus (T2DM) who are not sufficiently controlled with basal insulin.

Secondary Objectives:

  • To assess the effects of iGlarLixi in comparison with insulin glargine
  • To assess the safety in each treatment group
Read the detailed description

The maximum study duration per patient will be approximately 33 weeks: an up to 2-week screening period (it can be exceptionally extended up to one additional week), a 30-week, open label randomized treatment period comparing iGlarLixi to insulin glargine (± metformin for both treatments), and a 3-day post-treatment safety follow-up period.

Being tested
Insulin glargine/Lixisenatide (HOE901/AVE0010), Insulin glargine (HOE901), Metformin
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/AVE0010)Drug

    Also called Soliqua, iGlarLixi

    Pharmaceutical form: solution

    Route of administration: subcutaneous

  • Insulin glargine (HOE901)Drug

    Also called Lantus

    Pharmaceutical form: solution

    Route of administration: subcutaneous

  • MetforminDrug

    Pharmaceutical form: tablet

    Route of administration: oral

Study groups in NCT03798080
Study groupRoleWhat they receive
Soliqua (insulin glargine/lixisenatide)ExperimentaliGlarLixi (insulin glargine/lixisenatide) will be self-administered subcutaneously once daily in the morning with or without metformin for 30 weeks
Receives: Drug: Insulin glargine/Lixisenatide (HOE901/AVE0010); Drug: Metformin
Lantus (insulin glargine)Active comparatorInsulin glargine will be self-administered subcutaneously once daily at any time of the day with or without metformin for 30 weeks
Receives: Drug: Insulin glargine (HOE901); Drug: Metformin

What is being measured

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

  1. Change in HbA1c

    Change in glycated hemoglobin (HbA1c) from baseline to Week 30

    Measured: From Baseline to Week 30

Secondary outcomes (12)

  1. Patients with HbA1c <7.0%

    Percentage of patients reaching HbA1c <7% at Week 30

    Measured: At Week 30

  2. Patients with HbA1c ≤ 6.5%

    Percentage of patients reaching HbA1c ≤ 6.5% at Week 30

    Measured: At Week 30

  3. Change in postprandial plasma glucose (PPG)

    Absolute change in 2-hour blood glucose excursion and PPG during meal test from baseline to Week 30

    Measured: From Baseline to Week 30

  4. Change in self-monitored plasma glucose (SMPG) profile

    Absolute change in 7-point SMPG profiles from baseline to Week 30 (each time point and average daily value)

    Measured: From Baseline to Week 30

  5. Patients with HbA1c <7.0% with no body weight gain

    Percentage of patients reaching HbA1c <7% with no body weight gain at Week 30

    Measured: At Week 30

  6. Change in body weight

    Absolute change in body weight from baseline to Week 30

    Measured: From Baseline to Week 30

  7. Patients with HbA1c <7.0% with no body weight gain and no documented symptomatic hypoglycemia

    Percentage of patients reaching HbA1c <7% with no body weight gain at Week 30 and no documented (plasma glucose [PG] ≤70 mg/dL [3.9mmol/L]) symptomatic hypoglycemia during the 30-week randomized treatment period

    Measured: At Week 30

  8. Patients requiring rescue therapy

    Percentage of patients requiring rescue therapy during the 30-week randomized treatment period

    Measured: From Baseline to Week 30

  9. Change in fasting plasma glucose (FPG)

    Absolute change in FPG from baseline to Week 30

    Measured: From Baseline to Week 30

  10. Confirmed hypoglycemia

    Severe hypoglycemia and episodes of hypoglycemia documented with PG ≤ 70 mg/dL (3.9mmol/L) regardless of symptoms

    Measured: From Baseline to Week 30

  11. Adverse events (AEs)

    Number of AEs, Serious AEs, AEs of Special Interest, and AEs requiring specific monitoring from baseline to Week 30

    Measured: From Baseline to Week 30

  12. Immunogenicity (antibody variables)

    Anti-lixisenatide antibodies (in iGlarLixi group) and anti-insulin antibodies from baseline to Week 30

    Measured: From Baseline to Week 30

Timeline

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

  1. First posted9 Jan 2019
  2. Study start19 Feb 2019
  3. Primary completion1 Dec 2020
  4. Study completion1 Dec 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
426 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03798080
Sponsor's protocol ID
EFC14944
Other IDs
U1111-1190-7781
Acronym
Lixilan-L-CN
Status last verified
Apr 2022
First submitted
7 Jan 2019
Last updated
19 Jul 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

  • Yuan X, Guo X, Zhang J, Dong X, Lu Y, Pang W, Gu S, Niemoeller E, Ping L, Nian G, Souhami E; LixiLan-L-CN investigators. Improved glycaemic control and weight benefit with iGlarLixi versus insulin glargine 100 U/mL in Chinese people with type 2 diabetes advancing their therapy from basal insulin plus oral antihyperglycaemic drugs: Results from the LixiLan-L-CN randomized controlled trial. Diabetes Obes Metab. 2022 Nov;24(11):2182-2191. doi: 10.1111/dom.14803. Epub 2022 Jul 25.

    PubMed 35762489

  • Yuan X, Li D, Wang K, Lauand F, Zhang M, Fang H, Du Q, Kang L, Alvarez A, Guo X. iGlarLixi effectively reduces residual hyperglycaemia in Chinese people with type 2 diabetes on basal insulin: A post hoc analysis of the LixiLan-L-CN study. Diabetes Obes Metab. 2024 Dec;26(12):5942-5949. doi: 10.1111/dom.15968. Epub 2024 Oct 3.

    PubMed 39360440

  • Guo X, Yang W, Zhang J, Dong X, Liu M, Gu S, Lauand F, Li L, Huang Q, Kang L, Souhami E. iGlarLixi provides a higher derived time-in-range versus insulin glargine 100 U/mL or lixisenatide in Asian Pacific people with type 2 diabetes: A post hoc analysis. Diabetes Obes Metab. 2023 Jul;25(7):2005-2011. doi: 10.1111/dom.15074. Epub 2023 May 3.

    PubMed 36999231

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Insulin glargine/Lixisenatide (HOE901/AVE0010), Insulin glargine (HOE901) and Metformin in people with Type 2 Diabetes Mellitus, run by Sanofi at 45 sites in China.

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 11 inclusion and 28 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 19 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 45 sites in China. 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 HbA1c (time frame: From Baseline to Week 30). 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 NCT03798080, which also lists 3 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 19 Jul 2022.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in