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 (LIXILAN JP-O2)

June 11, 2020 updated by: Sanofi

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

521

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
      • Annaka-Shi, Japan
        • Investigational Site Number 392132
      • Arakawa-Ku, Japan
        • Investigational Site Number 392009
      • Atsugi-Shi, Japan
        • Investigational Site Number 392025
      • Chiba-Shi, Japan
        • Investigational Site Number 392024
      • Chiba-Shi, Japan
        • Investigational Site Number 392151
      • 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
      • Chuo-Ku, Japan
        • Investigational Site Number 392055
      • Chuo-Ku, Japan
        • Investigational Site Number 392155
      • Fujimi-Shi, Japan
        • Investigational Site Number 392008
      • Fujisawa-Shi, Japan
        • Investigational Site Number 392143
      • Fukuoka-Shi, Japan
        • Investigational Site Number 392094
      • Fukuoka-Shi, Japan
        • Investigational Site Number 392147
      • Fukuoka-Shi, Japan
        • Investigational Site Number 392054
      • Gifu-Shi, Japan
        • Investigational Site Number 392100
      • Hachioji-Shi, Japan
        • Investigational Site Number 392059
      • Hakodate-Shi, Japan
        • Investigational Site Number 392083
      • Hamamatsu-Shi, Japan
        • Investigational Site Number 392048
      • Hamamatsu-Shi, Japan
        • Investigational Site Number 392102
      • Hiki-Gun, Japan
        • Investigational Site Number 392079
      • Hirosaki-Shi, Japan
        • Investigational Site Number 392112
      • Hofu-Shi, Japan
        • Investigational Site Number 392109
      • Iruma-Shi, Japan
        • Investigational Site Number 392057
      • Ise-Shi, Japan
        • Investigational Site Number 392022
      • Izumisano-Shi, Japan
        • Investigational Site Number 392020
      • Kagoshima-Shi, Japan
        • Investigational Site Number 392139
      • Kamogawa-Shi, Japan
        • Investigational Site Number 392136
      • Kashiwa-Shi, Japan
        • Investigational Site Number 392066
      • Kashiwara-Shi, Japan
        • Investigational Site Number 392045
      • 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
      • Kawasaki-Shi, Japan
        • Investigational Site Number 392142
      • Kawasaki-Shi, Japan
        • Investigational Site Number 392091
      • Kitaazumi-Gun, Japan
        • Investigational Site Number 392133
      • Kitakyushu-Shi, Japan
        • Investigational Site Number 392129
      • Kitakyusyu-Shi, Japan
        • Investigational Site Number 392041
      • Kitakyusyu-Shi, Japan
        • Investigational Site Number 392068
      • Kitamoto-Shi, Japan
        • Investigational Site Number 392114
      • Kobe-Shi, Japan
        • Investigational Site Number 392086
      • Koga-Shi, Japan
        • Investigational Site Number 392044
      • Kokubunji-Shi, Japan
        • Investigational Site Number 392119
      • Koriyama-Shi, Japan
        • Investigational Site Number 392001
      • Kumamoto-Shi, Japan
        • Investigational Site Number 392028
      • Kumamoto-Shi, Japan
        • Investigational Site Number 392092
      • Kumamoto-Shi, Japan
        • Investigational Site Number 392108
      • Kure-Shi, Japan
        • Investigational Site Number 392075
      • Kurume-Shi, Japan
        • Investigational Site Number 392032
      • Kushiro-Shi, Japan
        • Investigational Site Number 392118
      • Kyoto-Shi, Japan
        • Investigational Site Number 392107
      • Maebashi-Shi, Japan
        • Investigational Site Number 392088
      • Matsumoto-Shi, Japan
        • Investigational Site Number 392113
      • Minato-Ku, Japan
        • Investigational Site Number 392122
      • Misato-Shi, Japan
        • Investigational Site Number 392076
      • Mito-Shi, Japan
        • Investigational Site Number 392042
      • Mito-Shi, Japan
        • Investigational Site Number 392078
      • Nagano-Shi, Japan
        • Investigational Site Number 392148
      • Nagoya-Shi, Japan
        • Investigational Site Number 392026
      • Nagoya-Shi, Japan
        • Investigational Site Number 392101
      • Nagoya-Shi, Japan
        • Investigational Site Number 392128
      • Nagoya-Shi, Japan
        • Investigational Site Number 392131
      • Nagoya-Shi, Japan
        • Investigational Site Number 392134
      • Naka-Shi, Japan
        • Investigational Site Number 392154
      • Niigata-Shi, Japan
        • Investigational Site Number 392127
      • Niihama-Shi, Japan
        • Investigational Site Number 392050
      • Ogawa-Machi, Hikigun, Japan
        • Investigational Site Number 392115
      • Okayama-Shi, Japan
        • Investigational Site Number 392071
      • Onga-Gun, Japan
        • Investigational Site Number 392095
      • Osaka-Shi, Japan
        • Investigational Site Number 392117
      • Osaka-Shi, Japan
        • Investigational Site Number 392144
      • Oyama-Shi, Japan
        • Investigational Site Number 392040
      • Saga-Shi, Japan
        • Investigational Site Number 392084
      • Saijo-Shi, Japan
        • Investigational Site Number 392069
      • Saitama-Shi, Japan
        • Investigational Site Number 392030
      • Sanda-Shi, Japan
        • Investigational Site Number 392074
      • Sapporo-Shi, Japan
        • Investigational Site Number 392047
      • Sapporo-Shi, Japan
        • Investigational Site Number 392089
      • Sapporo-Shi, Japan
        • Investigational Site Number 392150
      • Sasebo-Shi, Japan
        • Investigational Site Number 392097
      • Sendai-Shi, Japan
        • Investigational Site Number 392004
      • Sendai-Shi, Japan
        • Investigational Site Number 392103
      • Shimonoseki-Shi, Japan
        • Investigational Site Number 392070
      • Shimotsuke-Shi, Japan
        • Investigational Site Number 392034
      • Shinagawa-Ku, Japan
        • Investigational Site Number 392110
      • Shinjuku-Ku, Japan
        • Investigational Site Number 392021
      • Shinjuku-Ku, Japan
        • Investigational Site Number 392098
      • 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
      • Takamatsu-Shi, Japan
        • Investigational Site Number 392146
      • Takatsuki-Shi, Japan
        • Investigational Site Number 392051
      • Tokorozawa-Shi, Japan
        • Investigational Site Number 392061
      • Tomakomai-Shi, Japan
        • Investigational Site Number 392111
      • Toyonaka-Shi, Japan
        • Investigational Site Number 392029
      • Tsu-Shi, Japan
        • Investigational Site Number 392073
      • Ube-Shi, Japan
        • Investigational Site Number 392063
      • Ube-Shi, Japan
        • Investigational Site Number 392093
      • Yamato-Shi, Japan
        • Investigational Site Number 392039
      • Yatsushiro-Shi, Japan
        • Investigational Site Number 392067
      • Yokohama-Shi, Japan
        • Investigational Site Number 392126
      • Yokohama-Shi, Japan
        • Investigational Site Number 392012
      • 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 (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.

Exclusion criteria:

  • 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).
  • 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.

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 Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: LixiLan

LixiLan (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.
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: insulin glargine

Insulin 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.
Drug: Insulin glargine (HOE901)

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 and with no documented (PG ≤70 mg/dL [3.9 mmol/L]) symptomatic hypoglycemia
Time Frame: 26 weeks
26 weeks
Percentage of patients requiring a rescue therapy
Time Frame: 26 weeks
26 weeks
Number of hypoglycemic events
Time Frame: 26 weeks
26 weeks
Number of adverse events
Time Frame: 26 weeks
26 weeks
Measurement of anti-lixisenatide antibodies from baseline
Time Frame: Baseline, 26 weeks
Baseline, 26 weeks
Measurement of anti-insulin antibodies from baseline
Time Frame: Baseline, 26 weeks
Baseline, 26 weeks
Change from baseline in 2-hour postprandial glucose (PPG) during standardized meal test
Time Frame: Baseline, 26 weeks
Baseline, 26 weeks
Change from baseline in 7 point self monitored plasma glucose (SMPG) profiles during standardized meal test
Time Frame: Baseline, 26 weeks
Baseline, 26 weeks
Percentage of patients reaching HbA1c <7% at Week 26 with no documented (PG ≤70 mg/dL [3.9 mmol/L]) symptomatic hypoglycemia
Time Frame: 26 weeks
26 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

May 23, 2016

Primary Completion (Actual)

March 12, 2018

Study Completion (Actual)

March 12, 2018

Study Registration Dates

First Submitted

April 20, 2016

First Submitted That Met QC Criteria

April 22, 2016

First Posted (Estimate)

April 27, 2016

Study Record Updates

Last Update Posted (Actual)

June 16, 2020

Last Update Submitted That Met QC Criteria

June 11, 2020

Last Verified

March 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EFC14114
  • U1111-1176-8450 (Other Identifier: 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.

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