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 (LIXILAN JP-O1)

June 11, 2020 updated by: Sanofi

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

321

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Adachi-Ku, Japan
        • Investigational Site Number 392002
      • Arakawa-Ku, Japan
        • Investigational Site Number 392009
      • Atsugi-Shi, Japan
        • Investigational Site Number 392025
      • Bunkyo-Ku, Japan
        • Investigational Site Number 392060
      • Chiba-Shi, Japan
        • Investigational Site Number 392024
      • Chigasaki-Shi, Japan
        • Investigational Site Number 392011
      • Chiyoda-Ku, Japan
        • Investigational Site Number 392013
      • Chiyoda-Ku, Japan
        • Investigational Site Number 392052
      • Chuo-Ku, Japan
        • Investigational Site Number 392003
      • Chuo-Ku, Japan
        • Investigational Site Number 392017
      • Fujimi-Shi, Japan
        • Investigational Site Number 392008
      • Fukuoka-Shi, Japan
        • Investigational Site Number 392094
      • Fukuoka-Shi, Japan
        • Investigational Site Number 392054
      • Hachioji-Shi, Japan
        • Investigational Site Number 392059
      • Hakodate-Shi, Japan
        • Investigational Site Number 392083
      • Hamamatsu-Shi, Japan
        • Investigational Site Number 392048
      • Hiki-Gun, Japan
        • Investigational Site Number 392079
      • Iruma-Shi, Japan
        • Investigational Site Number 392057
      • Ise-Shi, Japan
        • Investigational Site Number 392022
      • Isehara-Shi, Japan
        • Investigational Site Number 392023
      • Izumisano-Shi, Japan
        • Investigational Site Number 392020
      • Kashiwa-Shi, Japan
        • Investigational Site Number 392066
      • Kasugai-Shi, Japan
        • Investigational Site Number 392006
      • Kawagoe-Shi, Japan
        • Investigational Site Number 392053
      • Kawagoe-Shi, Japan
        • Investigational Site Number 392065
      • Kawaguchi-Shi, Japan
        • Investigational Site Number 392007
      • Kawaguchi-Shi, Japan
        • Investigational Site Number 392062
      • Kawasaki-Shi, Japan
        • Investigational Site Number 392077
      • Kawasaki-Shi, Japan
        • Investigational Site Number 392082
      • Kitakyushu-Shi, Japan
        • Investigational Site Number 392031
      • Kitakyusyu-Shi, Japan
        • Investigational Site Number 392041
      • Kitakyusyu-Shi, Japan
        • Investigational Site Number 392068
      • Koga-Shi, Japan
        • Investigational Site Number 392044
      • Koriyama-Shi, Japan
        • Investigational Site Number 392001
      • Kurume-Shi, Japan
        • Investigational Site Number 392032
      • Maebashi-Shi, Japan
        • Investigational Site Number 392088
      • Mitaka-Shi, Japan
        • Investigational Site Number 392014
      • Mito-Shi, Japan
        • Investigational Site Number 392042
      • Mito-Shi, Japan
        • Investigational Site Number 392078
      • Nagoya-Shi, Japan
        • Investigational Site Number 392026
      • Okayama-Shi, Japan
        • Investigational Site Number 392080
      • Oyama-Shi, Japan
        • Investigational Site Number 392040
      • Sagamihara-Shi, Japan
        • Investigational Site Number 392038
      • Saijo-Shi, Japan
        • Investigational Site Number 392069
      • Saitama-Shi, Japan
        • Investigational Site Number 392030
      • Sapporo-Shi, Japan
        • Investigational Site Number 392047
      • Satsumasendai-Shi, Japan
        • Investigational Site Number 392015
      • Sendai-Shi, Japan
        • Investigational Site Number 392004
      • Shimotsuke-Shi, Japan
        • Investigational Site Number 392034
      • Shizuoka-Shi, Japan
        • Investigational Site Number 392037
      • Shizuoka-Shi, Japan
        • Investigational Site Number 392081
      • Shobara-Shi, Japan
        • Investigational Site Number 392019
      • Shunan-Shi, Japan
        • Investigational Site Number 392018
      • Suita-Shi, Japan
        • Investigational Site Number 392027
      • Taito-Ku, Japan
        • Investigational Site Number 392056
      • Takatsuki-Shi, Japan
        • Investigational Site Number 392051
      • Tokorozawa-Shi, Japan
        • Investigational Site Number 392061
      • Toyonaka-Shi, Japan
        • Investigational Site Number 392029
      • Ube-Shi, Japan
        • Investigational Site Number 392093
      • Yatsushiro-Shi, Japan
        • Investigational Site Number 392067
      • Zentsuji-Shi, Japan
        • Investigational Site Number 392035

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion criteria :

  • 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.

Exclusion criteria:

  • 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).
  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: LixiLan

LixiLan (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.
Drug: Insulin glargine/Lixisenatide (HOE901/AVE0010)

Pharmaceutical form: solution

Route of administration: subcutaneous

Other Names:
  • LixiLan
Drug: Oral anti-diabetic drugs

Pharmaceutical form: tablet

Route of administration: Oral
ACTIVE_COMPARATOR: lixisenatide

Lixisenatide (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.
Drug: Lixisenatide (AVE0010)

Pharmaceutical form: solution

Route of administration: subcutaneous

Drug: Oral anti-diabetic drugs

Pharmaceutical form: tablet

Route of administration: Oral

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change from baseline in HbA1c
Time Frame: Baseline, 26 weeks
Baseline, 26 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Percentage of patients reaching HbA1c <7% or ≤6.5%
Time Frame: 26 weeks
26 weeks
Change from baseline in body weight
Time Frame: Baseline, 26 weeks
Baseline, 26 weeks
Percentage of patients reaching HbA1c <7% with no body weight gain
Time Frame: 26 weeks
26 weeks
Percentage of patients requiring a rescue therapy
Time Frame: 26 weeks
26 weeks
Change from baseline in fasting plasma glucose
Time Frame: Baseline, 26 weeks
Baseline, 26 weeks
Change in from baseline in 7 point self-monitored plasma profiles
Time Frame: Baseline, 26 weeks
Baseline, 26 weeks
Change in daily dose of insulin glargine for the combination group
Time Frame: Day 1, 26 weeks
Day 1, 26 weeks
Number of hypoglycemic events
Time Frame: 26 weeks, 52 weeks
26 weeks, 52 weeks
Number of adverse events
Time Frame: 26 weeks, 52 weeks
26 weeks, 52 weeks
Measurement of anti-lixisenatide antibodies from baseline
Time Frame: Baseline, 26 weeks, 52 weeks
Baseline, 26 weeks, 52 weeks
Measurement of anti-insulin antibodies from baseline
Time Frame: Baseline, 26 weeks, 52 weeks
Baseline, 26 weeks, 52 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sanofi

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

May 9, 2016

Primary Completion (ACTUAL)

May 1, 2018

Study Completion (ACTUAL)

May 1, 2018

Study Registration Dates

First Submitted

April 20, 2016

First Submitted That Met QC Criteria

April 22, 2016

First Posted (ESTIMATE)

April 25, 2016

Study Record Updates

Last Update Posted (ACTUAL)

June 16, 2020

Last Update Submitted That Met QC Criteria

June 11, 2020

Last Verified

July 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EFC14112
  • U1111-1176-8357 (OTHER: UTN)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Type 2 Diabetes Mellitus

Clinical Trials on Insulin glargine/Lixisenatide (HOE901/AVE0010)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in South Africa

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe