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Type 2 Diabetes MellitusPhase 3LIXILAN JP-LNCT02752412

Efficacy and Safety of LixiLan Versus Insulin Glargine Alone Both With Metformin in Japanese With Type 2 Diabetes Mellitus Inadequately Controlled on Basal Insulin and Oral Antidiabetic Drugs

A Phase 3 study testing Insulin glargine/Lixisenatide (HOE901/AVE0010), Insulin glargine U100 (HOE901) and Metformin in people with Type 2 Diabetes Mellitus, run by Sanofi at 122 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 mellitus. Secondary Objective: To compare overall efficacy and safety of LixiLan to insulin glargine over 26 weeks in patients with type 2 diabetes mellitus. 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 U100 (HOE901) and Metformin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
513 participants
Where
122 sitesJapan
Study dates
17 May 2016to 4 Oct 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 (V1).
  • Patient treated with a stable, once a day basal insulin regimen (ie, type of insulin and time/frequency of the injection), for at least 3 months before the screening visit.
  • The total daily basal insulin dose should be stable (± 20%) and <15 U/day for at least 1 month before the screening visit.
  • Patient receiving 1 or 2 oral anti-diabetic drugs (OADs): the OAD dose(s) must be stable during the 3 months before the screening visit. The OADs can be 1 to 2 out of:
  • Metformin;
  • Sulfonylurea (SU);
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  • Glinide;
  • Dipeptidyl-peptidase-4 (DPP-4) inhibitor;
  • Sodium glucose co-transporter 2 (SGLT2) inhibitor;
  • Alpha glucosidase inhibitor (alpha-GI).
  • Signed written informed consent.

Who cannot join

  • Age <20 years at screening visit.
  • HbA1c at screening visit <7.5% or >9.5%.
  • Fasting plasma glucose (FPG) >180 mg/dL (10.0 mmol/L) at screening visit.
  • 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 in the 3 months before screening visit.
  • Previous use of insulin regimen other than basal insulin, eg, prandial or pre-mixed insulin.
Show all 27Show fewer
  • Note: Short-term treatment (≤10 days) due to intercurrent illness including gestational diabetes is allowed at the discretion of the Investigator.
  • Use of thiazolidinedione (TZD) within 6 months prior to screening visit.
  • History of discontinuation of a previous treatment with a glucagon-like peptide-1(GLP-1) receptor agonist due to safety/ tolerability issues or lack of efficacy.
  • Laboratory findings at the screening visit; including:
  • 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.
  • Any contraindication to metformin use according to local labeling.
  • History of hypersensitivity to any GLP-1 receptor agonist or to metacresol.
  • Contraindication to use of insulin glargine or lixisenatide according to local labeling. History of hypersensitivity to insulin glargine or to any of the excipients.
  • 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 now been performed), pancreatitis during previous treatment with incretin therapies, chronic pancreatitis, pancreatectomy, stomach/gastric surgery.
  • Exclusion criteria for randomization at the end of the run-in phase:
  • HbA1c <7.5% or >9.5% at visit 6 (Week -1).
  • Mean fasting self monitored plasma glucose (SMPG) >160 mg/dL (8.9 mmol/L), calculated from all available (minimum of 4 self-measurements) values during the 7 days prior to randomization.
  • Note:fasting SMPG on the day of randomization can be included if assessed before randomization.
  • Average insulin glargine daily dose ≥15 U/day or <5U/day calculated for the last 3 days before Visit 7.
  • Metformin total daily dose <750 mg/day.
  • Amylase and/or lipase >3 ULN at Visit 6 (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

122 sites in 1 country.

122 sites in 1 country

Japan122 sites

  • Investigational Site Number 392002

    Adachi-Ku

  • Investigational Site Number 392132

    Annaka-Shi

  • Investigational Site Number 392009

    Arakawa-Ku

  • Investigational Site Number 392152

    Asahikawa-Shi

  • 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 392008

    Fujimi-Shi

  • Investigational Site Number 392143

    Fujisawa-Shi

  • Investigational Site Number 392094

    Fukuoka

  • Investigational Site Number 392147

    Fukuoka

  • Investigational Site Number 392100

    Gifu

  • Investigational Site Number 392059

    Hachioji-Shi

  • Investigational Site Number 392048

    Hamamatsu

  • Investigational Site Number 392102

    Hamamatsu

  • Investigational Site Number 392123

    Higashiosaka-Shi

  • Investigational Site Number 392135

    Higashiosaka-Shi

  • Investigational Site Number 392079

    Hiki-Gun

  • Investigational Site Number 392141

    Himeji-Shi

  • Investigational Site Number 392057

    Iruma-Shi

  • Investigational Site Number 392022

    Ise-Shi

  • Investigational Site Number 392020

    Izumisano

  • Investigational Site Number 392036

    Kamakura-Shi

  • 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 392149

    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 392090

    Kawaguchi-Shi

  • Investigational Site Number 392077

    Kawasaki-Shi

  • Investigational Site Number 392082

    Kawasaki-Shi

  • Investigational Site Number 392142

    Kawasaki-Shi

  • Investigational Site Number 392010

    Kisarazu-Shi

  • Investigational Site Number 392016

    Kisarazu-Shi

  • Investigational Site Number 392031

    Kitakyushu-Shi

  • Investigational Site Number 392068

    Kitakyushu-Shi

  • Investigational Site Number 392041

    Kitakyusyu-Shi

  • Investigational Site Number 392086

    Kobe

  • Investigational Site Number 392044

    Koga-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 392116

    Kumamoto

  • Investigational Site Number 392099

    Kushiro

  • Investigational Site Number 392049

    Kyoto

  • Investigational Site Number 392107

    Kyoto

  • Investigational Site Number 392088

    Maebashi

  • Investigational Site Number 392158

    Maebashi

  • Investigational Site Number 392121

    Matsuyama

  • Investigational Site Number 392122

    Minatoku

  • Investigational Site Number 392076

    Misato-Shi

  • Investigational Site Number 392014

    Mitaka-Shi

  • Investigational Site Number 392042

    Mito

  • Investigational Site Number 392043

    Mito

  • Investigational Site Number 392078

    Mito

  • Investigational Site Number 392046

    Miyazaki

  • 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 392137

    Nagoya

  • Investigational Site Number 392140

    Nagoya

  • Investigational Site Number 392154

    Naka

  • Investigational Site Number 392050

    Niihama-Shi

  • Investigational Site Number 392159

    Obihiro-Shi

  • Investigational Site Number 392145

    Ogaki-Shi

  • Investigational Site Number 392153

    Ōita

  • Investigational Site Number 392005

    Okawa-Shi

  • Investigational Site Number 392071

    Okayama

  • Investigational Site Number 392080

    Okayama

  • Investigational Site Number 392095

    Onga-Gun

  • Investigational Site Number 392105

    Osaka

  • Investigational Site Number 392117

    Osaka

  • Investigational Site Number 392144

    Osaka

  • Investigational Site Number 392125

    Osaki-Shi

  • Investigational Site Number 392120

    Ōta-ku

  • Investigational Site Number 392157

    Ota-Shi

  • 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 392058

    Saitama-Shi

  • Investigational Site Number 392074

    Sanda-Shi

  • Investigational Site Number 392047

    Sapporo

  • Investigational Site Number 392106

    Sapporo

  • Investigational Site Number 392097

    Sasebo-Shi

  • Investigational Site Number 392015

    Satsumasendai-Shi

  • Investigational Site Number 392004

    Sendai

  • 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 392104

    Shiogama-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 392156

    Takatsuki-Shi

  • Investigational Site Number 392061

    Tokorozawa-Shi

  • Investigational Site Number 392111

    Tomakomai-Shi

  • Investigational Site Number 392073

    Tsu

  • Investigational Site Number 392063

    Ube-Shi

  • Investigational Site Number 392124

    Ushiku-Shi

  • Investigational Site Number 392067

    Yatsushiro-Shi

  • Investigational Site Number 392085

    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 With Metformin in Japanese Patients With Type 2 Diabetes Mellitus Inadequately Controlled on Basal Insulin and Oral Antidiabetic Drugs

Primary Objective:

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

Secondary Objective:

To compare overall efficacy and safety of LixiLan to insulin glargine over 26 weeks in patients with type 2 diabetes mellitus.

Read the detailed description

The maximum study duration per patient will be approximately 41 weeks: an up to 14-week screening period (consisting of an up to 2-week screening phase and a 12-week run-in phase), a 26-week randomized treatment period, and a 3-day post-treatment safety follow-up period.

Being tested
Insulin glargine/Lixisenatide (HOE901/AVE0010), Insulin glargine U100 (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 LixiLan

    Pharmaceutical form: solution

    Route of administration: subcutaneous

  • Insulin glargine U100 (HOE901)Drug

    Also called Lantus

    Pharmaceutical form: solution

    Route of administration: subcutaneous

  • MetforminDrug

    Pharmaceutical form: tablet

    Route of administration: oral

Study groups in NCT02752412
Study groupRoleWhat they receive
LixiLanExperimentalLixiLan (insulin glargine/lixisenatide fixed ratio combination) is injected subcutaneously (under the skin) once daily. Dose is individually adjusted. Metformin will be continued.
Receives: Drug: Insulin glargine/Lixisenatide (HOE901/AVE0010); Drug: Metformin
insulin glargineActive comparatorInsulin glargine U100 (Lantus) will be injected subcutaneously (under skin) once daily. Dose will be individually adjusted. Metformin will be continued.
Receives: Drug: Insulin glargine U100 (HOE901); Drug: Metformin

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 (15)

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

    Measured: 26 weeks

  2. Change from baseline in 2-hour postprandial plasma glucose (PPG) during standardized meal test

    Measured: Baseline, 26 weeks

  3. Change from baseline in blood glucose excursion during standardized meal test

    Measured: Baseline, 26 weeks

  4. Change from baseline in 7-point self-monitoring plasma glucose (SMPG) profiles (each time point and average daily value)

    Measured: Baseline, 26 weeks

  5. Change from baseline in body weight

    Measured: Baseline, 26 weeks

  6. Change from baseline in FPG

    Measured: Baseline, 26 weeks

  7. Change from baseline in daily dose of insulin glargine

    Measured: Baseline, 26 weeks

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

    Measured: 26 weeks

  9. 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

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

    Measured: 26 weeks

  11. Percentage of patients requiring a rescue therapy

    Measured: 26 weeks

  12. Number of hypoglycemic events

    Measured: 26 weeks

  13. Number of adverse events

    Measured: 26 weeks

  14. Measurement of anti-lixisenatide antibodies from baseline

    Measured: Baseline, 26 weeks

  15. 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 start17 May 2016
  3. Primary completion4 Oct 2018
  4. Study completion4 Oct 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
513 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02752412
Sponsor's protocol ID
EFC14113
Other IDs
U1111-1176-8378
Acronym
LIXILAN JP-L
Status last verified
Oct 2018
First submitted
20 Apr 2016
Last updated
16 Jun 2020
Results posted
No
Data monitoring committee
No

Publications

  • Kaneto H, Takami A, Spranger R, Amano A, Watanabe D, Niemoeller E. Efficacy and safety of insulin glargine/lixisenatide fixed-ratio combination (iGlarLixi) in Japanese patients with type 2 diabetes mellitus inadequately controlled on basal insulin and oral antidiabetic drugs: The LixiLan JP-L randomized clinical trial. Diabetes Obes Metab. 2020 Sep;22 Suppl 4:3-13. doi: 10.1111/dom.14005.

    PubMed 32072742

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Insulin glargine/Lixisenatide (HOE901/AVE0010), Insulin glargine U100 (HOE901) and Metformin in people with Type 2 Diabetes Mellitus, run by Sanofi at 122 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 11 inclusion and 27 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 122 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 NCT02752412, 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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