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

NCT02752828 | Completed Phase 3

• 2 other identifiers: EFC14114U1111-1176-8450
• Study Type: interventional
• Target: 521
• Locations: 1 country
• Sites: 113

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.

Conditions

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• Change from baseline in HbA1c

  Baseline, 26 weeks

Secondary Outcomes (11)

• Percentage of patients reaching HbA1c <7% or ≤6.5%

  26 weeks

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

  Baseline, 26 weeks

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

  Baseline, 26 weeks

• Change from baseline in body weight

  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

  26 weeks

Study Arms (2)

LixiLan

EXPERIMENTAL

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); Drug: Oral anti-diabetic drugs

insulin glargine

ACTIVE COMPARATOR

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); Drug: Oral anti-diabetic drugs

Interventions

Insulin glargine/lixisenatide (HOE901/AVE0010) DRUG

Pharmaceutical form: solution Route of administration: subcutaneous

Also known as: LixiLan

LixiLan

Insulin glargine (HOE901) DRUG

Pharmaceutical form: solution Route of administration: subcutaneous

insulin glargine

Oral anti-diabetic drugs DRUG

Pharmaceutical form: tablet Route of administration: oral

LixiLan; insulin glargine

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Sanofi: lead

Study Sites (113)

Investigational Site Number 392002

Adachi-Ku, Japan

Location

Investigational Site Number 392132

Annaka-Shi, Japan

Location

Investigational Site Number 392009

Arakawa-Ku, Japan

Location

Investigational Site Number 392025

Atsugi-Shi, Japan

Location

Investigational Site Number 392024

Chiba, Japan

Location

Investigational Site Number 392151

Chiba, Japan

Location

Investigational Site Number 392011

Chigasaki-Shi, Japan

Location

Investigational Site Number 392013

Chiyoda-Ku, Japan

Location

Investigational Site Number 392052

Chiyoda-Ku, Japan

Location

Investigational Site Number 392003

Chūōku, Japan

Location

Investigational Site Number 392017

Chūōku, Japan

Location

Investigational Site Number 392055

Chūōku, Japan

Location

Investigational Site Number 392155

Chūōku, Japan

Location

Investigational Site Number 392008

Fujimi-Shi, Japan

Location

Investigational Site Number 392143

Fujisawa-Shi, Japan

Location

Investigational Site Number 392054

Fukuoka, Japan

Location

Investigational Site Number 392094

Fukuoka, Japan

Location

Investigational Site Number 392147

Fukuoka, Japan

Location

Investigational Site Number 392100

Gifu, Japan

Location

Investigational Site Number 392059

Hachioji-Shi, Japan

Location

Investigational Site Number 392083

Hakodate-Shi, Japan

Location

Investigational Site Number 392048

Hamamatsu, Japan

Location

Investigational Site Number 392102

Hamamatsu, Japan

Location

Investigational Site Number 392079

Hiki-Gun, Japan

Location

Investigational Site Number 392112

Hirosaki-Shi, Japan

Location

Investigational Site Number 392109

Hofu-Shi, Japan

Location

Investigational Site Number 392057

Iruma-Shi, Japan

Location

Investigational Site Number 392022

Ise-Shi, Japan

Location

Investigational Site Number 392020

Izumisano, Japan

Location

Investigational Site Number 392139

Kagoshima, Japan

Location

Investigational Site Number 392136

Kamogawa-Shi, Japan

Location

Investigational Site Number 392066

Kashiwa-Shi, Japan

Location

Investigational Site Number 392045

Kashiwara-Shi, Japan

Location

Investigational Site Number 392006

Kasugai-Shi, Japan

Location

Investigational Site Number 392053

Kawagoe-Shi, Japan

Location

Investigational Site Number 392065

Kawagoe-Shi, Japan

Location

Investigational Site Number 392007

Kawaguchi-Shi, Japan

Location

Investigational Site Number 392062

Kawaguchi-Shi, Japan

Location

Investigational Site Number 392077

Kawasaki-Shi, Japan

Location

Investigational Site Number 392082

Kawasaki-Shi, Japan

Location

Investigational Site Number 392091

Kawasaki-Shi, Japan

Location

Investigational Site Number 392142

Kawasaki-Shi, Japan

Location

Investigational Site Number 392133

Kitaazumi-Gun, Japan

Location

Investigational Site Number 392129

Kitakyushu-Shi, Japan

Location

Investigational Site Number 392041

Kitakyusyu-Shi, Japan

Location

Investigational Site Number 392068

Kitakyusyu-Shi, Japan

Location

Investigational Site Number 392114

Kitamoto-Shi, Japan

Location

Investigational Site Number 392086

Kobe, Japan

Location

Investigational Site Number 392044

Koga-Shi, Japan

Location

Investigational Site Number 392119

Kokubunji-Shi, Japan

Location

Investigational Site Number 392001

Koriyama-Shi, Japan

Location

Investigational Site Number 392028

Kumamoto, Japan

Location

Investigational Site Number 392092

Kumamoto, Japan

Location

Investigational Site Number 392108

Kumamoto, Japan

Location

Investigational Site Number 392075

Kure-Shi, Japan

Location

Investigational Site Number 392032

Kurume-Shi, Japan

Location

Investigational Site Number 392118

Kushiro, Japan

Location

Investigational Site Number 392107

Kyoto, Japan

Location

Investigational Site Number 392088

Maebashi, Japan

Location

Investigational Site Number 392113

Matsumoto-Shi, Japan

Location

Investigational Site Number 392122

Minatoku, Japan

Location

Investigational Site Number 392076

Misato-Shi, Japan

Location

Investigational Site Number 392042

Mito, Japan

Location

Investigational Site Number 392078

Mito, Japan

Location

Investigational Site Number 392148

Nagano, Japan

Location

Investigational Site Number 392026

Nagoya, Japan

Location

Investigational Site Number 392101

Nagoya, Japan

Location

Investigational Site Number 392128

Nagoya, Japan

Location

Investigational Site Number 392131

Nagoya, Japan

Location

Investigational Site Number 392134

Nagoya, Japan

Location

Investigational Site Number 392154

Naka, Japan

Location

Investigational Site Number 392127

Niigata, Japan

Location

Investigational Site Number 392050

Niihama-Shi, Japan

Location

Investigational Site Number 392115

Ogawa-Machi, Hikigun, Japan

Location

Investigational Site Number 392071

Okayama, Japan

Location

Investigational Site Number 392095

Onga-Gun, Japan

Location

Investigational Site Number 392117

Osaka, Japan

Location

Investigational Site Number 392144

Osaka, Japan

Location

Investigational Site Number 392040

Oyama-Shi, Japan

Location

Investigational Site Number 392084

Saga, Japan

Location

Investigational Site Number 392069

Saijo-Shi, Japan

Location

Investigational Site Number 392030

Saitama-Shi, Japan

Location

Investigational Site Number 392074

Sanda-Shi, Japan

Location

Investigational Site Number 392047

Sapporo, Japan

Location

Investigational Site Number 392089

Sapporo, Japan

Location

Investigational Site Number 392150

Sapporo, Japan

Location

Investigational Site Number 392097

Sasebo-Shi, Japan

Location

Investigational Site Number 392004

Sendai, Japan

Location

Investigational Site Number 392103

Sendai, Japan

Location

Investigational Site Number 392070

Shimonoseki-Shi, Japan

Location

Investigational Site Number 392034

Shimotsuke-Shi, Japan

Location

Investigational Site Number 392110

Shinagawa-Ku, Japan

Location

Investigational Site Number 392021

Shinjuku-Ku, Japan

Location

Investigational Site Number 392098

Shinjuku-Ku, Japan

Location

Investigational Site Number 392037

Shizuoka, Japan

Location

Investigational Site Number 392081

Shizuoka, Japan

Location

Investigational Site Number 392019

Shobara-Shi, Japan

Location

Investigational Site Number 392018

Shunan-Shi, Japan

Location

Investigational Site Number 392027

Suita-Shi, Japan

Location

Investigational Site Number 392056

Taito-Ku, Japan

Location

Investigational Site Number 392146

Takamatsu, Japan

Location

Investigational Site Number 392051

Takatsuki-Shi, Japan

Location

Investigational Site Number 392061

Tokorozawa-Shi, Japan

Location

Investigational Site Number 392111

Tomakomai-Shi, Japan

Location

Investigational Site Number 392029

Toyonaka-Shi, Japan

Location

Investigational Site Number 392073

Tsu, Japan

Location

Investigational Site Number 392063

Ube-Shi, Japan

Location

Investigational Site Number 392093

Ube-Shi, Japan

Location

Investigational Site Number 392039

Yamato-Shi, Japan

Location

Investigational Site Number 392067

Yatsushiro-Shi, Japan

Location

Investigational Site Number 392012

Yokohama, Japan

Location

Investigational Site Number 392126

Yokohama, Japan

Location

Investigational Site Number 392035

Zentsuji-Shi, Japan

Location

Related Publications (1)

• 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.

  PMID: 32291880 RESULT

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Insulin Glargine; lixisenatide

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Insulin, Long-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Clinical Sciences & Operations

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 20, 2016
• First Posted: April 27, 2016
• Study Start: May 23, 2016
• Primary Completion: March 12, 2018
• Study Completion: March 12, 2018
• Last Updated: June 16, 2020

Record last verified: 2018-03

Locations

JP (113)