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

NCT ID: NCT02752828

Last Updated: 2020-06-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 521 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-05-23
• Study Completion Date: 2018-03-12

Brief 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 with type 2 Diabetes.

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.

Conditions

Type 2 Diabetes Mellitus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Insulin glargine/lixisenatide (HOE901/AVE0010)

Intervention Type: DRUG

Pharmaceutical form: solution

Route of administration: subcutaneous

Oral anti-diabetic drugs

Intervention Type: DRUG

Pharmaceutical form: tablet

Route of administration: oral

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.

Group Type: ACTIVE_COMPARATOR

Insulin glargine (HOE901)

Intervention Type: DRUG

Pharmaceutical form: solution

Route of administration: subcutaneous

Oral anti-diabetic drugs

Intervention Type: DRUG

Pharmaceutical form: tablet

Route of administration: oral

Interventions

Insulin glargine/lixisenatide (HOE901/AVE0010)

Pharmaceutical form: solution

Route of administration: subcutaneous

Intervention Type: DRUG

Insulin glargine (HOE901)

Pharmaceutical form: solution

Route of administration: subcutaneous

Intervention Type: DRUG

Oral anti-diabetic drugs

Pharmaceutical form: tablet

Route of administration: oral

Intervention Type: DRUG

Other Intervention Names

LixiLan

Eligibility Criteria

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.

• 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.

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.

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sanofi

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Sciences & Operations

Role: STUDY_DIRECTOR

Sanofi

Locations

Investigational Site Number 392002

Adachi-Ku, , Japan

Investigational Site Number 392132

Annaka-Shi, , Japan

Investigational Site Number 392009

Arakawa-Ku, , Japan

Investigational Site Number 392025

Atsugi-Shi, , Japan

Investigational Site Number 392024

Chiba, , Japan

Investigational Site Number 392151

Chiba, , Japan

Investigational Site Number 392011

Chigasaki-Shi, , Japan

Investigational Site Number 392013

Chiyoda-Ku, , Japan

Investigational Site Number 392052

Chiyoda-Ku, , Japan

Investigational Site Number 392003

Chūōku, , Japan

Investigational Site Number 392017

Chūōku, , Japan

Investigational Site Number 392055

Chūōku, , Japan

Investigational Site Number 392155

Chūōku, , Japan

Investigational Site Number 392008

Fujimi-Shi, , Japan

Investigational Site Number 392143

Fujisawa-Shi, , Japan

Investigational Site Number 392054

Fukuoka, , Japan

Investigational Site Number 392094

Fukuoka, , Japan

Investigational Site Number 392147

Fukuoka, , Japan

Investigational Site Number 392100

Gifu, , Japan

Investigational Site Number 392059

Hachioji-Shi, , Japan

Investigational Site Number 392083

Hakodate-Shi, , Japan

Investigational Site Number 392048

Hamamatsu, , Japan

Investigational Site Number 392102

Hamamatsu, , Japan

Investigational Site Number 392079

Hiki-Gun, , Japan

Investigational Site Number 392112

Hirosaki-Shi, , Japan

Investigational Site Number 392109

Hofu-Shi, , Japan

Investigational Site Number 392057

Iruma-Shi, , Japan

Investigational Site Number 392022

Ise-Shi, , Japan

Investigational Site Number 392020

Izumisano, , Japan

Investigational Site Number 392139

Kagoshima, , Japan

Investigational Site Number 392136

Kamogawa-Shi, , Japan

Investigational Site Number 392066

Kashiwa-Shi, , Japan

Investigational Site Number 392045

Kashiwara-Shi, , Japan

Investigational Site Number 392006

Kasugai-Shi, , Japan

Investigational Site Number 392053

Kawagoe-Shi, , Japan

Investigational Site Number 392065

Kawagoe-Shi, , Japan

Investigational Site Number 392007

Kawaguchi-Shi, , Japan

Investigational Site Number 392062

Kawaguchi-Shi, , Japan

Investigational Site Number 392077

Kawasaki-Shi, , Japan

Investigational Site Number 392082

Kawasaki-Shi, , Japan

Investigational Site Number 392091

Kawasaki-Shi, , Japan

Investigational Site Number 392142

Kawasaki-Shi, , Japan

Investigational Site Number 392133

Kitaazumi-Gun, , Japan

Investigational Site Number 392129

Kitakyushu-Shi, , Japan

Investigational Site Number 392041

Kitakyusyu-Shi, , Japan

Investigational Site Number 392068

Kitakyusyu-Shi, , Japan

Investigational Site Number 392114

Kitamoto-Shi, , Japan

Investigational Site Number 392086

Kobe, , Japan

Investigational Site Number 392044

Koga-Shi, , Japan

Investigational Site Number 392119

Kokubunji-Shi, , Japan

Investigational Site Number 392001

Koriyama-Shi, , Japan

Investigational Site Number 392028

Kumamoto, , Japan

Investigational Site Number 392092

Kumamoto, , Japan

Investigational Site Number 392108

Kumamoto, , Japan

Investigational Site Number 392075

Kure-Shi, , Japan

Investigational Site Number 392032

Kurume-Shi, , Japan

Investigational Site Number 392118

Kushiro, , Japan

Investigational Site Number 392107

Kyoto, , Japan

Investigational Site Number 392088

Maebashi, , Japan

Investigational Site Number 392113

Matsumoto-Shi, , Japan

Investigational Site Number 392122

Minatoku, , Japan

Investigational Site Number 392076

Misato-Shi, , Japan

Investigational Site Number 392042

Mito, , Japan

Investigational Site Number 392078

Mito, , Japan

Investigational Site Number 392148

Nagano, , Japan

Investigational Site Number 392026

Nagoya, , Japan

Investigational Site Number 392101

Nagoya, , Japan

Investigational Site Number 392128

Nagoya, , Japan

Investigational Site Number 392131

Nagoya, , Japan

Investigational Site Number 392134

Nagoya, , Japan

Investigational Site Number 392154

Naka, , Japan

Investigational Site Number 392127

Niigata, , Japan

Investigational Site Number 392050

Niihama-Shi, , Japan

Investigational Site Number 392115

Ogawa-Machi, Hikigun, , Japan

Investigational Site Number 392071

Okayama, , Japan

Investigational Site Number 392095

Onga-Gun, , Japan

Investigational Site Number 392117

Osaka, , Japan

Investigational Site Number 392144

Osaka, , Japan

Investigational Site Number 392040

Oyama-Shi, , Japan

Investigational Site Number 392084

Saga, , Japan

Investigational Site Number 392069

Saijo-Shi, , Japan

Investigational Site Number 392030

Saitama-Shi, , Japan

Investigational Site Number 392074

Sanda-Shi, , Japan

Investigational Site Number 392047

Sapporo, , Japan

Investigational Site Number 392089

Sapporo, , Japan

Investigational Site Number 392150

Sapporo, , Japan

Investigational Site Number 392097

Sasebo-Shi, , Japan

Investigational Site Number 392004

Sendai, , Japan

Investigational Site Number 392103

Sendai, , Japan

Investigational Site Number 392070

Shimonoseki-Shi, , Japan

Investigational Site Number 392034

Shimotsuke-Shi, , Japan

Investigational Site Number 392110

Shinagawa-Ku, , Japan

Investigational Site Number 392021

Shinjuku-Ku, , Japan

Investigational Site Number 392098

Shinjuku-Ku, , Japan

Investigational Site Number 392037

Shizuoka, , Japan

Investigational Site Number 392081

Shizuoka, , Japan

Investigational Site Number 392019

Shobara-Shi, , Japan

Investigational Site Number 392018

Shunan-Shi, , Japan

Investigational Site Number 392027

Suita-Shi, , Japan

Investigational Site Number 392056

Taito-Ku, , Japan

Investigational Site Number 392146

Takamatsu, , Japan

Investigational Site Number 392051

Takatsuki-Shi, , Japan

Investigational Site Number 392061

Tokorozawa-Shi, , Japan

Investigational Site Number 392111

Tomakomai-Shi, , Japan

Investigational Site Number 392029

Toyonaka-Shi, , Japan

Investigational Site Number 392073

Tsu, , Japan

Investigational Site Number 392063

Ube-Shi, , Japan

Investigational Site Number 392093

Ube-Shi, , Japan

Investigational Site Number 392039

Yamato-Shi, , Japan

Investigational Site Number 392067

Yatsushiro-Shi, , Japan

Investigational Site Number 392012

Yokohama, , Japan

Investigational Site Number 392126

Yokohama, , Japan

Investigational Site Number 392035

Zentsuji-Shi, , Japan

Countries

Japan

References

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.

Reference Type: RESULT

PMID: 32291880 (View on PubMed)

Other Identifiers

U1111-1176-8450

Identifier Type: OTHER

Identifier Source: secondary_id

EFC14114

Identifier Type: -

Identifier Source: org_study_id