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Type 2 Diabetes MellitusPhase 3Lixilan-O-APNCT03798054

Evaluation of Insulin Glargine/Lixisenatide Fixed Ratio Combination in Patients With Type 2 Diabetes Insufficiently Controlled With Oral Antidiabetic Drug(s)

A Phase 3 study testing Insulin glargine/Lixisenatide (HOE901/AVE0010), Insulin glargine (HOE901) and Lixisenatide (AVE0010) in people with Type 2 Diabetes Mellitus, run by Sanofi at 79 sites in 4 countries.

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 Objectives: The co-primary objective of this study is: To demonstrate the superiority of iGlarLixi (fixed ratio combination of insulin glargine and lixisenatide) versus lixisenatide on glycemic control as assessed by glycated hemoglobin A1c (HbA1c) change. 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 Lixisenatide (AVE0010)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
878 participants
Where
79 sitesin 4 countries
Study dates
15 Feb 2019to 1 Mar 2021
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 before the screening visit (V1), treated for at least 3 months prior to the screening visit (V1) with metformin alone or metformin and a second oral antidiabetic treatment that can be a sulfonylurea (SU), a glinide, an alpha-glucosidase inhibitor (alpha-GI), a dipeptidyl peptidase-4 (DPP-4) inhibitor or a sodium-glucose co transporter 2 (SGLT-2) inhibitor and who are not adequately controlled with this treatment.
  • Signed written informed consent.

Who cannot join

  • Age < legal age of majority at the screening visit (V1).
  • Body mass index (BMI) >40 kg/m² at screening.
  • Glycated hemoglobin A1c (HbA1c) at screening visit:
  • <7.5% or >11% for patients previously treated with metformin alone;
  • <7.0% or >10% for patients previously treated with metformin and a second oral antidiabetic treatment.
  • History of hypoglycemia unawareness.
Show all 33Show fewer
  • History of metabolic acidosis, including diabetic ketoacidosis within 1 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 treatment with insulin (except for short-term treatment due to intercurrent illness at the discretion of the Investigator) within 1 year prior to screening.
  • History of discontinuation of a previous treatment with glucagon-like-peptide-1 receptor agonists (GLP-1 RAs) due to safety/tolerability reasons 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 other than specified in this protocol 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 artery 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 (V1):
  • 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 urine pregnancy test in female of childbearing potential.
  • Patient who has a severe renal function impairment with an estimated glomerular filtration rate (eGFR) <30 mL/min/1.73m2 or end-stage renal disease.
  • 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).
  • Use of SU, glinide, alpha-GI, DPP-4 inhibitor, and SGLT-2 inhibitor after start of run-in (from V2 [Week -4]).
  • HbA1c at V4 (Week -1) : <7.0% or >10%.
  • Fasting plasma glucose >250 mg/dL (13.9 mmol/L) at V4 (Week-1) (can be repeated once to confirm).
  • Metformin maximal tolerated dose <1500 mg/day.
  • Amylase and/or lipase >3 ULN at V4 (Week-1).
  • 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

79 sites in 4 countries.

79 sites in 4 countries

China59 sites

  • Investigational Site Number 1560001

    Beijing, 1000029

  • Investigational Site Number 1560006

    Beijing, 101200

  • Investigational Site Number 1560049

    Beijing, 102218

  • Investigational Site Number 1560039

    Cangzhou, 061000

  • Investigational Site Number 1560009

    Changchun, 130033

  • Investigational Site Number 1560027

    Changchun, 130041

  • Investigational Site Number 1560016

    Changsha, 410013

  • Investigational Site Number 1560053

    Chengdu, 610081

  • Investigational Site Number 1560056

    Chengdu, 611130

  • Investigational Site Number 1560010

    Chenzhou

  • Investigational Site Number 1560037

    Chongqing, 400010

  • Investigational Site Number 1560050

    Chongqing, 400013

  • Investigational Site Number 1560044

    Dongguan

  • Investigational Site Number 1560033

    Guangzhou, 510120

  • Investigational Site Number 1560028

    Guangzhou

  • Investigational Site Number 1560012

    Handan, 056002

  • Investigational Site Number 1560023

    Hangzhou

  • Investigational Site Number 1560035

    Harbin, 150001

  • Investigational Site Number 1560036

    Harbin, 150001

  • Investigational Site Number 1560011

    Hengshui, 053000

  • Investigational Site Number 1560024

    Hohhot, 010017

  • Investigational Site Number 1560047

    Hohhot, 010050

  • Investigational Site Number 3440001

    Hong Kong

  • Investigational Site Number 1560026

    Huanggang

  • Investigational Site Number 1560025

    Huangshi

  • Investigational Site Number 1560048

    Huizhou, 516001

  • Investigational Site Number 1560034

    Huzhou

  • Investigational Site Number 1560005

    Jinan, 250013

  • Investigational Site Number 1560052

    Jinhua, 321000

  • Investigational Site Number 1560031

    Jinzhou, 121000

  • Investigational Site Number 1560022

    Nanjing, 210029

  • Investigational Site Number 1560014

    Nanjing

  • Investigational Site Number 1560043

    Nanjing

  • Investigational Site Number 1560041

    Nanning, 530021

  • Investigational Site Number 1560032

    Qingdao, 266042

  • Investigational Site Number 1560038

    Qinhuangdao

  • Investigational Site Number 1560013

    Shanghai, 200072

  • Investigational Site Number 1560007

    Shanghai, 200240

  • Investigational Site Number 1560004

    Shanghai, 201700

  • Investigational Site Number 1560029

    Shanghai

  • Investigational Site Number 1560003

    Shenyang, 110022

  • Investigational Site Number 1560054

    Shenzhen, 518000

  • Investigational Site Number 1560019

    Suzhou, 215006

  • Investigational Site Number 1560059

    Suzhou

  • Investigational Site Number 1560021

    Tianjin, 300052

  • Investigational Site Number 1560017

    Tianjin, 300121

  • Investigational Site Number 1560058

    Ürümqi, 830000

  • Investigational Site Number 1560018

    Wuhan, 430014

  • Investigational Site Number 1560008

    Xi'an, 710061

  • Investigational Site Number 1560055

    Xi'an

  • Investigational Site Number 1560051

    Xingtai, 054031

  • Investigational Site Number 1560030

    Xining, 810007

  • Investigational Site Number 1560040

    Yanji, 133000

  • Investigational Site Number 1560060

    Yueyang, 414000

  • Investigational Site Number 1560046

    Yueyang

  • Investigational Site Number 1560045

    Zhengzhou

  • Investigational Site Number 1560002

    Zhenjiang, 212001

  • Investigational Site Number 1560015

    Zhuzhou, 412007

  • Investigational Site Number 1560057

    Zigong, 643002

Other trials in China

South Korea11 sites

  • Investigational Site Number 4100009

    Ansan-si, 15355

  • Investigational Site Number 4100012

    Busan, 49241

  • Investigational Site Number 4100010

    Guri-Si, Gyeonggi-Do, 11923

  • Investigational Site Number 4100004

    Gwangju, 61469

  • Investigational Site Number 4100003

    Seongnam-si, 13620

  • Investigational Site Number 4100016

    Seoul, 01832

  • Investigational Site Number 4100011

    Seoul, 03181

  • Investigational Site Number 4100013

    Seoul, 03722

  • Investigational Site Number 4100001

    Seoul, 05278

  • Investigational Site Number 4100002

    Seoul, 08308

  • Investigational Site Number 4100005

    Wŏnju, 26426

Other trials in South Korea

Malaysia6 sites

  • Investigational Site Number 4580001

    Kelantan, 16150

  • Investigational Site Number 4580005

    Kuala Lumpur, 56000

  • Investigational Site Number 4580003

    Kuala Lumpur, 59100

  • Investigational Site Number 4580006

    Kuching, 93586

  • Investigational Site Number 4580002

    Putrajaya

  • Investigational Site Number 4580004

    Seremban, 70300

Other trials in Malaysia

Taiwan3 sites

  • Investigational Site Number 1580003

    Taichung, 407

  • Investigational Site Number 1580005

    Tainan Hsien, 710

  • Investigational Site Number 1580004

    Taipei, 11031

Other trials in Taiwan

About this study

Official title: A Randomized, 24 Week, Active-controlled, Open-label, 3-arm, Parallel-group Multicenter Study Comparing the Efficacy and Safety of iGlarLixi to Insulin Glargine and Lixisenatide in Type 2 Diabetes Mellitus Patients Insufficiently Controlled With Oral Antidiabetic Drug(s)

Primary Objectives:

The co-primary objective of this study is:

  • To demonstrate the superiority of iGlarLixi (fixed ratio combination of insulin glargine and lixisenatide) versus lixisenatide on glycemic control as assessed by glycated hemoglobin A1c (HbA1c) change.
  • To demonstrate the non-inferiority of iGlarLixi versus insulin glargine on glycemic control as assessed by HbA1c change.

Secondary Objectives:

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

The maximum study duration per patient will be approximately 31 weeks: an up-to 6-week screening and run-in period (with an up-to 2-week screening phase and a 4-week run-in phase), followed by a 24-week randomized treatment period and a 3-day post-treatment safety follow up period.

Being tested
Insulin glargine/Lixisenatide (HOE901/AVE0010), Insulin glargine (HOE901), Lixisenatide (AVE0010), Metformin, SGLT2 inhibitor
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

  • Lixisenatide (AVE0010)Drug

    Also called Lyxumia

    Pharmaceutical form: solution

    Route of administration: subcutaneous

  • MetforminDrug

    Pharmaceutical form: tablet

    Route of administration: oral

  • SGLT2 inhibitorDrug

    Pharmaceutical form:tablet

    Route of administration: oral

Study groups in NCT03798054
Study groupRoleWhat they receive
Soliqua (insulin glargine/lixisenatide)ExperimentaliGlarLixi (insulin glargine/lixisenatide) will be self-administered subcutaneously once daily in the morning on top of metformin for 24 weeks.
Receives: Drug: Insulin glargine/Lixisenatide (HOE901/AVE0010); Drug: Metformin; Drug: SGLT2 inhibitor
Lantus (insulin glargine)Active comparatorInsulin glargine will be self-administered subcutaneously once daily at any time of the day on top of metformin for 24 weeks. Injection time should be determined on the day of randomization, and should remain about the same until the end of the treatment period.
Receives: Drug: Insulin glargine (HOE901); Drug: Metformin; Drug: SGLT2 inhibitor
Lyxumia (lixisenatide)Active comparatorLixisenatide will be self-administered subcutaneously once daily according to the locally approved label on top of metformin for 24 weeks. Injection time should be determined on the day of randomization, and should remain about the same until the end of the treatment period.
Receives: Drug: Lixisenatide (AVE0010); Drug: Metformin; Drug: SGLT2 inhibitor

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 24

    Measured: From Baseline to Week 24

Secondary outcomes (11)

  1. Change in postprandial plasma glucose (PPG)

    Absolute change in 2-hour blood glucose excursion and PPG during meal test from baseline to Week 24 (for all patients in iGlarLixi or insulin glargine group and patients who receive morning injection in the lixisenatide group)

    Measured: From Baseline to Week 24

  2. Change in fasting plasma glucose (FPG)

    Absolute change in FPG from baseline to Week 24

    Measured: From Baseline to Week 24

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

    Absolute change in 7-point SMPG profiles from baseline to Week 24 (each time point and average daily value)

    Measured: From Baseline to Week 24

  4. Patients with HbA1c <7.0%

    Percentage of patients reaching HbA1c <7% at Week 24

    Measured: At Week 24

  5. Patients with HbA1c ≤ 6.5%

    Percentage of patients reaching HbA1c ≤ 6.5% at Week 24

    Measured: At Week 24

  6. Change in body weight

    Absolute change in body weight from baseline to Week 24

    Measured: From Baseline to Week 24

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

    Percentage of patients reaching HbA1c <7% with no body weight gain at Week 24

    Measured: At Week 24

  8. 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 24 and no documented (plasma glucose [PG] ≤70 mg/dL [3.9 mmol/L]) symptomatic hypoglycemia during the 24 week treatment period

    Measured: At Week 24

  9. Confirmed hypoglycemia

    Including severe hypoglycemia and episodes of hypoglycemia documented with PG ≤70 mg/dL (3.9 mmol/L) regardless of symptoms from baseline to Week 24

    Measured: From Baseline to Week 24

  10. Adverse events (AEs)

    Number of AEs, serious AEs, AEs of Special Interest, and AEs requiring specific monitoring from baseline to Week 24

    Measured: From Baseline to Week 24

  11. Immunogenicity (antibody variables)

    Anti-lixisenatide antibodies and anti-insulin antibodies (depending on the treatment group) from baseline to Week 24

    Measured: From Baseline to Week 24

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 start15 Feb 2019
  3. Primary completion1 Mar 2021
  4. Study completion1 Mar 2021

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
878 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03798054
Sponsor's protocol ID
EFC14943
Other IDs
U1111-1190-7669
Acronym
Lixilan-O-AP
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

  • Yang W, Dong X, Li Q, Cheng Z, Yuan G, Liu M, Xiao J, Gu S, Niemoeller E, Chen L, Ping L, Souhami E; LixiLan-O-AP trial investigators. Efficacy and safety benefits of iGlarLixi versus insulin glargine 100 U/mL or lixisenatide in Asian Pacific people with suboptimally controlled type 2 diabetes on oral agents: The LixiLan-O-AP randomized controlled trial. Diabetes Obes Metab. 2022 Aug;24(8):1522-1533. doi: 10.1111/dom.14722. Epub 2022 May 12.

    PubMed 35441412

  • 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 Lixisenatide (AVE0010) in people with Type 2 Diabetes Mellitus, run by Sanofi at 79 sites in 4 countries.

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 2 inclusion and 33 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 79 sites in China, South Korea, Malaysia, Taiwan. 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 24). 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 NCT03798054, 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 19 Jul 2022.

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