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Type 2 Diabetes MellitusPhase 3LIXILAN JP-O2NCT02752828

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

A Phase 3 study testing Insulin glargine/lixisenatide (HOE901/AVE0010), Insulin glargine (HOE901) and Oral anti-diabetic drugs in people with Type 2 Diabetes Mellitus, run by Sanofi at 113 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 insulin glargine in glycated hemoglobin (HbA1c) change from baseline to Week 26 in patients with type 2 Diabetes. Secondary Objective: To compare the overall efficacy and safety of LixiLan to insulin glargine (with or without OADs) over a 26 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), Insulin glargine (HOE901) and Oral anti-diabetic drugs
Could I receive a placebo?
No, everyone receives an active treatment
How many people
521 participants
Where
113 sitesJapan
Study dates
23 May 2016to 12 Mar 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 (TZD), -Alpha-glucosidase-inhibitor (alpha-GI),Sodium glucose co-transporter 2 (SGLT2) inhibitor,Sulfonylurea (SU),Rapid-acting insulin secretagogue (Glinide),diphenyl-peptidase -4 inhibitor (DPP-4 inhibitor).
  • Signed written informed consent.

Who cannot join

  • At the screening visit: Age <20 years.
  • At the screening visit: HbA1c <7.5% or >9.5%.
  • At the screening visit: fasting plasma glucose (FPG) >180 mg/dL (10.0 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 during the inclusion criteria in 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 time of screening:
  • Amylase and/or lipase: >3 times the upper limit of the normal (ULN) laboratory range,
  • Alanine aminotransferase (ALT) or aspartate aminotransferase (AST): >3 ULN,
  • Calcitonin ≥20 pg/mL (5.9 pmol/L),
  • Positive serum pregnancy test in female of childbearing potential.
  • Contraindication to use of lixisenatide according to the local labeling. History of hypersensitivity to any Glucagon-Like Peptide-1 Receptor Agonists or to metacresol.
  • Contraindication to use of insulin glargine according to 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/1.73 m^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

113 sites in 1 country.

113 sites in 1 country

Japan113 sites

  • Investigational Site Number 392002

    Adachi-Ku

  • Investigational Site Number 392132

    Annaka-Shi

  • Investigational Site Number 392009

    Arakawa-Ku

  • Investigational Site Number 392025

    Atsugi-Shi

  • Investigational Site Number 392024

    Chiba

  • Investigational Site Number 392151

    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 392055

    Chūōku

  • Investigational Site Number 392155

    Chūōku

  • Investigational Site Number 392008

    Fujimi-Shi

  • Investigational Site Number 392143

    Fujisawa-Shi

  • Investigational Site Number 392054

    Fukuoka

  • Investigational Site Number 392094

    Fukuoka

  • Investigational Site Number 392147

    Fukuoka

  • Investigational Site Number 392100

    Gifu

  • Investigational Site Number 392059

    Hachioji-Shi

  • Investigational Site Number 392083

    Hakodate-Shi

  • Investigational Site Number 392048

    Hamamatsu

  • Investigational Site Number 392102

    Hamamatsu

  • Investigational Site Number 392079

    Hiki-Gun

  • Investigational Site Number 392112

    Hirosaki-Shi

  • Investigational Site Number 392109

    Hofu-Shi

  • Investigational Site Number 392057

    Iruma-Shi

  • Investigational Site Number 392022

    Ise-Shi

  • Investigational Site Number 392020

    Izumisano

  • Investigational Site Number 392139

    Kagoshima

  • Investigational Site Number 392136

    Kamogawa-Shi

  • Investigational Site Number 392066

    Kashiwa-Shi

  • Investigational Site Number 392045

    Kashiwara-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 392091

    Kawasaki-Shi

  • Investigational Site Number 392142

    Kawasaki-Shi

  • Investigational Site Number 392133

    Kitaazumi-Gun

  • Investigational Site Number 392129

    Kitakyushu-Shi

  • Investigational Site Number 392041

    Kitakyusyu-Shi

  • Investigational Site Number 392068

    Kitakyusyu-Shi

  • Investigational Site Number 392114

    Kitamoto-Shi

  • Investigational Site Number 392086

    Kobe

  • Investigational Site Number 392044

    Koga-Shi

  • Investigational Site Number 392119

    Kokubunji-Shi

  • Investigational Site Number 392001

    Koriyama-Shi

  • Investigational Site Number 392028

    Kumamoto

  • Investigational Site Number 392092

    Kumamoto

  • Investigational Site Number 392108

    Kumamoto

  • Investigational Site Number 392075

    Kure-Shi

  • Investigational Site Number 392032

    Kurume-Shi

  • Investigational Site Number 392118

    Kushiro

  • Investigational Site Number 392107

    Kyoto

  • Investigational Site Number 392088

    Maebashi

  • Investigational Site Number 392113

    Matsumoto-Shi

  • Investigational Site Number 392122

    Minatoku

  • Investigational Site Number 392076

    Misato-Shi

  • Investigational Site Number 392042

    Mito

  • Investigational Site Number 392078

    Mito

  • Investigational Site Number 392148

    Nagano

  • Investigational Site Number 392026

    Nagoya

  • Investigational Site Number 392101

    Nagoya

  • Investigational Site Number 392128

    Nagoya

  • Investigational Site Number 392131

    Nagoya

  • Investigational Site Number 392134

    Nagoya

  • Investigational Site Number 392154

    Naka

  • Investigational Site Number 392127

    Niigata

  • Investigational Site Number 392050

    Niihama-Shi

  • Investigational Site Number 392115

    Ogawa-Machi, Hikigun

  • Investigational Site Number 392071

    Okayama

  • Investigational Site Number 392095

    Onga-Gun

  • Investigational Site Number 392117

    Osaka

  • Investigational Site Number 392144

    Osaka

  • Investigational Site Number 392040

    Oyama-Shi

  • Investigational Site Number 392084

    Saga

  • Investigational Site Number 392069

    Saijo-Shi

  • Investigational Site Number 392030

    Saitama-Shi

  • Investigational Site Number 392074

    Sanda-Shi

  • Investigational Site Number 392047

    Sapporo

  • Investigational Site Number 392089

    Sapporo

  • Investigational Site Number 392150

    Sapporo

  • Investigational Site Number 392097

    Sasebo-Shi

  • Investigational Site Number 392004

    Sendai

  • Investigational Site Number 392103

    Sendai

  • Investigational Site Number 392070

    Shimonoseki-Shi

  • Investigational Site Number 392034

    Shimotsuke-Shi

  • Investigational Site Number 392110

    Shinagawa-Ku

  • Investigational Site Number 392021

    Shinjuku-Ku

  • Investigational Site Number 392098

    Shinjuku-Ku

  • 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 392146

    Takamatsu

  • Investigational Site Number 392051

    Takatsuki-Shi

  • Investigational Site Number 392061

    Tokorozawa-Shi

  • Investigational Site Number 392111

    Tomakomai-Shi

  • Investigational Site Number 392029

    Toyonaka-Shi

  • Investigational Site Number 392073

    Tsu

  • Investigational Site Number 392063

    Ube-Shi

  • Investigational Site Number 392093

    Ube-Shi

  • Investigational Site Number 392039

    Yamato-Shi

  • Investigational Site Number 392067

    Yatsushiro-Shi

  • Investigational Site Number 392012

    Yokohama

  • Investigational Site Number 392126

    Yokohama

  • 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 the Insulin Glargine/Lixisenatide Combination to Insulin Glargine on Top of OADs in Japanese Patients With Type 2 Diabetes Mellitus (T2DM)

Primary Objective:

To compare LixiLan to insulin glargine in glycated hemoglobin (HbA1c) change from baseline to Week 26 in patients with type 2 Diabetes.

Secondary Objective:

To compare the overall efficacy and safety of LixiLan to insulin glargine (with or without OADs) over a 26 Week treatment period in patients with type 2 Diabetes.

Read the detailed description

The maximum study duration per patient will be approximately 29 weeks: an up to 2-week screening period, a 26-week randomized open-label treatment period and a 3-day post-treatment safety follow up period.

Being tested
Insulin glargine/lixisenatide (HOE901/AVE0010), Insulin glargine (HOE901), 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

  • Insulin glargine (HOE901)Drug

    Pharmaceutical form: solution

    Route of administration: subcutaneous

  • Oral anti-diabetic drugsDrug

    Pharmaceutical form: tablet

    Route of administration: oral

Study groups in NCT02752828
Study groupRoleWhat they receive
LixiLanExperimentalLixiLan (insulin glargine/lixisenatide) 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
insulin glargineActive comparatorInsulin glargine (HOE901) 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 (HOE901); 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 2-hour postprandial glucose (PPG) during standardized meal test

    Measured: Baseline, 26 weeks

  3. Change from baseline in 7 point self monitored plasma glucose (SMPG) profiles during standardized meal test

    Measured: Baseline, 26 weeks

  4. Change from baseline in body weight

    Measured: Baseline, 26 weeks

  5. Percentage of patients reaching HbA1c <7% with no body weight gain and with no documented (PG ≤70 mg/dL [3.9 mmol/L]) symptomatic hypoglycemia

    Measured: 26 weeks

  6. Percentage of patients reaching HbA1c <7% at Week 26 with no documented (PG ≤70 mg/dL [3.9 mmol/L]) symptomatic hypoglycemia

    Measured: 26 weeks

  7. Percentage of patients requiring a rescue therapy

    Measured: 26 weeks

  8. Number of adverse events

    Measured: 26 weeks

  9. Number of hypoglycemic events

    Measured: 26 weeks

  10. Measurement of anti-lixisenatide antibodies from baseline

    Measured: Baseline, 26 weeks

  11. Measurement of anti-insulin antibodies from baseline

    Measured: Baseline, 26 weeks

Timeline

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

  1. First posted27 Apr 2016 (estimated)
  2. Study start23 May 2016
  3. Primary completion12 Mar 2018
  4. Study completion12 Mar 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
521 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02752828
Sponsor's protocol ID
EFC14114
Other IDs
U1111-1176-8450
Acronym
LIXILAN JP-O2
Status last verified
Mar 2018
First submitted
20 Apr 2016
Last updated
16 Jun 2020
Results posted
No
Data monitoring committee
No

Publications

  • Terauchi Y, Nakama T, Spranger R, Amano A, Inoue T, Niemoeller E. Efficacy and safety of insulin glargine/lixisenatide fixed-ratio combination (iGlarLixi 1:1) in Japanese patients with type 2 diabetes mellitus inadequately controlled on oral antidiabetic drugs: A randomized, 26-week, open-label, multicentre study: The LixiLan JP-O2 randomized clinical trial. Diabetes Obes Metab. 2020 Sep;22 Suppl 4:14-23. doi: 10.1111/dom.14036.

    PubMed 32291880

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Insulin glargine/lixisenatide (HOE901/AVE0010), Insulin glargine (HOE901) and Oral anti-diabetic drugs in people with Type 2 Diabetes Mellitus, run by Sanofi at 113 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 113 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 NCT02752828, 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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