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Type 2 Diabetes MellitusPhase 3LIXILAN JP-O1NCT02749890

Efficacy and Safety of the Insulin Glargine/Lixisenatide Fixed Ratio Combination (LixiLan) to Lixisenatide on Top of Oral Anti-diabetic Drugs (OADs) With Type 2 Diabetes in Japan

A Phase 3 study testing Insulin glargine/Lixisenatide (HOE901/AVE0010), Lixisenatide (AVE0010) and Oral anti-diabetic drugs in people with Type 2 Diabetes Mellitus, run by Sanofi at 61 sites in Japan.

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 compare LixiLan to lixisenatide in glycated hemoglobin (HbA1c) change from baseline to Week 26 in patients with type 2 diabetes mellitus. Secondary Objective: To compare the overall efficacy and safety of LixiLan to lixisenatide (with or without OADs) over a 52 week treatment period in patients… Read more about this study

Who is it for?
Ages 20 years and older
Conditions the study is for
Type 2 Diabetes Mellitus
What is being tested?
Insulin glargine/Lixisenatide (HOE901/AVE0010), Lixisenatide (AVE0010) and Oral anti-diabetic drugs
Could I receive a placebo?
No, everyone receives an active treatment
How many people
321 participants
Where
61 sitesJapan
Study dates
9 May 2016to May 2018
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 20 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patient with type 2 diabetes mellitus (T2DM) diagnosed for at least 1 year before the screening visit, receiving 1 or 2 OADs that can be biguanide, thiazolidinedione, alpha-glucosidase-inhibitor, sodium glucose co-transporter 2 inhibitor; sulfonylurea, rapid-acting insulin secretagogue, or dipeptidyl-peptidase-4 inhibitor.
  • Signed written informed consent.

Who cannot join

  • At the screening visit: age <20 years.
  • At the screening visit: HbA1c <7.5% or >10%.
  • At the screening visit: fasting plasma glucose (FPG) >250 mg/dL (13.8 mmol/L).
  • Pregnancy or lactation, women of childbearing potential with no effective contraceptive method.
  • Use of oral or injectable glucose-lowering agents other than those stated in the inclusion criteria during the 3 months before the screening visit.
  • Previous treatment with insulin (except for short-term treatment due to intercurrent illness including gestational diabetes at the discretion of the trial physician).
Show all 17Show fewer
  • Laboratory findings at the screening visit, including:
  • Amylase and/or lipase >3 times the upper limit of the normal laboratory range (ULN),
  • Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >3 ULN,
  • Calcitonin ≥20 pg/mL (5.9 pmol/L),
  • Positive serum pregnancy test.
  • Contraindication to use of lixisenatide according to the local labeling. History of hypersensitivity to any glucagon-like peptide-1 receptor agonist (GLP-1RA) or to metacresol.
  • Contraindication to use of insulin glargine according to the local labeling. History of hypersensitivity to insulin glargine or to any of the excipients.
  • Patient who has a severe renal function impairment with estimated glomerular filtration rate (eGFR) <30 mL/min/1.73m^2 or end-stage renal disease for patient not treated with metformin.
  • Personal or immediate family history of medullary thyroid cancer (MTC) or genetic condition that predisposes to MTC (eg, multiple endocrine neoplasia syndromes).
  • History of pancreatitis (unless pancreatitis was related to gallstones and cholecystectomy has been performed), pancreatitis during previous treatment with incretin therapies, chronic pancreatitis, pancreatectomy, stomach/gastric surgery.
  • 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

61 sites in 1 country.

61 sites in 1 country

Japan61 sites

  • Investigational Site Number 392002

    Adachi-Ku

  • Investigational Site Number 392009

    Arakawa-Ku

  • Investigational Site Number 392025

    Atsugi-Shi

  • Investigational Site Number 392060

    Bunkyō City

  • Investigational Site Number 392024

    Chiba

  • Investigational Site Number 392011

    Chigasaki-Shi

  • Investigational Site Number 392013

    Chiyoda-Ku

  • Investigational Site Number 392052

    Chiyoda-Ku

  • Investigational Site Number 392003

    Chūōku

  • Investigational Site Number 392017

    Chūōku

  • Investigational Site Number 392008

    Fujimi-Shi

  • Investigational Site Number 392054

    Fukuoka

  • Investigational Site Number 392094

    Fukuoka

  • Investigational Site Number 392059

    Hachioji-Shi

  • Investigational Site Number 392083

    Hakodate-Shi

  • Investigational Site Number 392048

    Hamamatsu

  • Investigational Site Number 392079

    Hiki-Gun

  • Investigational Site Number 392057

    Iruma-Shi

  • Investigational Site Number 392022

    Ise-Shi

  • Investigational Site Number 392023

    Isehara-Shi

  • Investigational Site Number 392020

    Izumisano

  • Investigational Site Number 392066

    Kashiwa-Shi

  • Investigational Site Number 392006

    Kasugai-Shi

  • Investigational Site Number 392053

    Kawagoe-Shi

  • Investigational Site Number 392065

    Kawagoe-Shi

  • Investigational Site Number 392007

    Kawaguchi-Shi

  • Investigational Site Number 392062

    Kawaguchi-Shi

  • Investigational Site Number 392077

    Kawasaki-Shi

  • Investigational Site Number 392082

    Kawasaki-Shi

  • Investigational Site Number 392031

    Kitakyushu-Shi

  • Investigational Site Number 392041

    Kitakyusyu-Shi

  • Investigational Site Number 392068

    Kitakyusyu-Shi

  • Investigational Site Number 392044

    Koga-Shi

  • Investigational Site Number 392001

    Koriyama-Shi

  • Investigational Site Number 392032

    Kurume-Shi

  • Investigational Site Number 392088

    Maebashi

  • Investigational Site Number 392014

    Mitaka-Shi

  • Investigational Site Number 392042

    Mito

  • Investigational Site Number 392078

    Mito

  • Investigational Site Number 392026

    Nagoya

  • Investigational Site Number 392080

    Okayama

  • Investigational Site Number 392040

    Oyama-Shi

  • Investigational Site Number 392038

    Sagamihara-Shi

  • Investigational Site Number 392069

    Saijo-Shi

  • Investigational Site Number 392030

    Saitama-Shi

  • Investigational Site Number 392047

    Sapporo

  • Investigational Site Number 392015

    Satsumasendai-Shi

  • Investigational Site Number 392004

    Sendai

  • Investigational Site Number 392034

    Shimotsuke-Shi

  • Investigational Site Number 392037

    Shizuoka

  • Investigational Site Number 392081

    Shizuoka

  • Investigational Site Number 392019

    Shobara-Shi

  • Investigational Site Number 392018

    Shunan-Shi

  • Investigational Site Number 392027

    Suita-Shi

  • Investigational Site Number 392056

    Taito-Ku

  • Investigational Site Number 392051

    Takatsuki-Shi

  • Investigational Site Number 392061

    Tokorozawa-Shi

  • Investigational Site Number 392029

    Toyonaka-Shi

  • Investigational Site Number 392093

    Ube-Shi

  • Investigational Site Number 392067

    Yatsushiro-Shi

  • Investigational Site Number 392035

    Zentsuji-Shi

Other trials in Japan

About this study

Official title: A Randomized, Active-controlled, Open Label, 2-treatment Arm, and Multicenter Study Comparing the Efficacy and Safety of Insulin Glargine/Lixisenatide Combination to Lixisenatide on Top of OADs in Japanese Patients With Type 2 DM With an Extension Period

Primary Objective:

To compare LixiLan to lixisenatide in glycated hemoglobin (HbA1c) change from baseline to Week 26 in patients with type 2 diabetes mellitus.

Secondary Objective:

To compare the overall efficacy and safety of LixiLan to lixisenatide (with or without OADs) over a 52 week treatment period in patients with type 2 diabetes mellitus.

Read the detailed description

Approximately 55 weeks: an up-to 2-week screening period, a 26-week randomized open-label treatment period, a 26-week safety extension treatment period and a 3-day post-treatment safety follow up period.

Being tested
Insulin glargine/Lixisenatide (HOE901/AVE0010), Lixisenatide (AVE0010), Oral anti-diabetic drugs
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 LixiLan

    Pharmaceutical form: solution

    Route of administration: subcutaneous

  • Lixisenatide (AVE0010)Drug

    Pharmaceutical form: solution

    Route of administration: subcutaneous

  • Oral anti-diabetic drugsDrug

    Pharmaceutical form: tablet

    Route of administration: Oral

Study groups in NCT02749890
Study groupRoleWhat they receive
LixiLanExperimentalLixiLan (insulin glargine/lixisenatide fixed ratio combination) is injected subcutaneously (under the skin) once daily. Dose is individually adjusted. Background therapy with OADs (except dipeptidyl-peptidase-4 inhibitor) should be continued during the treatment period.
Receives: Drug: Insulin glargine/Lixisenatide (HOE901/AVE0010); Drug: Oral anti-diabetic drugs
lixisenatideActive comparatorLixisenatide (AVE0010) is injected subcutaneously (under the skin) once daily. It will be initiated with Dose 1 for 1 week and then continue with Dose 2 for 1 week followed by the maintenance dose of Dose 3 up to the end of treatment period. Background therapy with OADs (except dipeptidyl-peptidase-4 inhibitor) should be continued during the treatment period.
Receives: Drug: Lixisenatide (AVE0010); Drug: Oral anti-diabetic drugs

What is being measured

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

  1. Change from baseline in HbA1c

    Measured: Baseline, 26 weeks

Secondary outcomes (11)

  1. Percentage of patients reaching HbA1c <7% or ≤6.5%

    Measured: 26 weeks

  2. Change from baseline in fasting plasma glucose

    Measured: Baseline, 26 weeks

  3. Change in from baseline in 7 point self-monitored plasma profiles

    Measured: Baseline, 26 weeks

  4. Percentage of patients reaching HbA1c <7% with no body weight gain

    Measured: 26 weeks

  5. Change from baseline in body weight

    Measured: Baseline, 26 weeks

  6. Percentage of patients requiring a rescue therapy

    Measured: 26 weeks

  7. Change in daily dose of insulin glargine for the combination group

    Measured: Day 1, 26 weeks

  8. Number of hypoglycemic events

    Measured: 26 weeks, 52 weeks

  9. Number of adverse events

    Measured: 26 weeks, 52 weeks

  10. Measurement of anti-lixisenatide antibodies from baseline

    Measured: Baseline, 26 weeks, 52 weeks

  11. Measurement of anti-insulin antibodies from baseline

    Measured: Baseline, 26 weeks, 52 weeks

Timeline

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

  1. First posted25 Apr 2016 (estimated)
  2. Study start9 May 2016
  3. Primary completionMay 2018
  4. Study completionMay 2018

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
321 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02749890
Sponsor's protocol ID
EFC14112
Other IDs
U1111-1176-8357
Acronym
LIXILAN JP-O1
Status last verified
Jul 2018
First submitted
20 Apr 2016
Last updated
16 Jun 2020
Results posted
No
Data monitoring committee
No

Publications

  • Watada H, Takami A, Spranger R, Amano A, Hashimoto Y, Niemoeller E. Efficacy and Safety of 1:1 Fixed-Ratio Combination of Insulin Glargine and Lixisenatide Versus Lixisenatide in Japanese Patients With Type 2 Diabetes Inadequately Controlled on Oral Antidiabetic Drugs: The LixiLan JP-O1 Randomized Clinical Trial. Diabetes Care. 2020 Jun;43(6):1249-1257. doi: 10.2337/dc19-2452. Epub 2020 Apr 15.

    PubMed 32295808

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Insulin glargine/Lixisenatide (HOE901/AVE0010), Lixisenatide (AVE0010) and Oral anti-diabetic drugs in people with Type 2 Diabetes Mellitus, run by Sanofi at 61 sites in Japan.

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 17 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 16 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 61 sites in Japan. 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 from baseline in HbA1c (time frame: Baseline, 26 weeks). 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 NCT02749890, which also lists 1 linked publication.

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 16 Jun 2020.

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