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

NCT02749890 | Completed Phase 3

• 2 other identifiers: EFC14112U1111-1176-8357
• Study Type: interventional
• Target: 321
• Locations: 1 country
• Sites: 61

Brief Summary

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.

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 fasting plasma glucose

  Baseline, 26 weeks

• Change in from baseline in 7 point self-monitored plasma profiles

  Baseline, 26 weeks

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

  26 weeks

• Change from baseline in body weight

  Baseline, 26 weeks

Study Arms (2)

LixiLan

EXPERIMENTAL

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); Drug: Oral anti-diabetic drugs

lixisenatide

ACTIVE COMPARATOR

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); Drug: Oral anti-diabetic drugs

Interventions

Insulin glargine/Lixisenatide (HOE901/AVE0010) DRUG

Pharmaceutical form: solution Route of administration: subcutaneous

Also known as: LixiLan

LixiLan

Lixisenatide (AVE0010) DRUG

Pharmaceutical form: solution Route of administration: subcutaneous

lixisenatide

Oral anti-diabetic drugs DRUG

Pharmaceutical form: tablet Route of administration: Oral

LixiLan; lixisenatide

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, alpha-glucosidase-inhibitor, sodium glucose co-transporter 2 inhibitor; sulfonylurea, rapid-acting insulin secretagogue, or dipeptidyl-peptidase-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 \>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.
• 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.

Sponsors & Collaborators

• Sanofi: lead

Study Sites (61)

Investigational Site Number 392002

Adachi-Ku, Japan

Location

Investigational Site Number 392009

Arakawa-Ku, Japan

Location

Investigational Site Number 392025

Atsugi-Shi, Japan

Location

Investigational Site Number 392060

Bunkyō City, Japan

Location

Investigational Site Number 392024

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 392008

Fujimi-Shi, Japan

Location

Investigational Site Number 392054

Fukuoka, Japan

Location

Investigational Site Number 392094

Fukuoka, 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 392079

Hiki-Gun, Japan

Location

Investigational Site Number 392057

Iruma-Shi, Japan

Location

Investigational Site Number 392022

Ise-Shi, Japan

Location

Investigational Site Number 392023

Isehara-Shi, Japan

Location

Investigational Site Number 392020

Izumisano, Japan

Location

Investigational Site Number 392066

Kashiwa-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 392031

Kitakyushu-Shi, Japan

Location

Investigational Site Number 392041

Kitakyusyu-Shi, Japan

Location

Investigational Site Number 392068

Kitakyusyu-Shi, Japan

Location

Investigational Site Number 392044

Koga-Shi, Japan

Location

Investigational Site Number 392001

Koriyama-Shi, Japan

Location

Investigational Site Number 392032

Kurume-Shi, Japan

Location

Investigational Site Number 392088

Maebashi, Japan

Location

Investigational Site Number 392014

Mitaka-Shi, Japan

Location

Investigational Site Number 392042

Mito, Japan

Location

Investigational Site Number 392078

Mito, Japan

Location

Investigational Site Number 392026

Nagoya, Japan

Location

Investigational Site Number 392080

Okayama, Japan

Location

Investigational Site Number 392040

Oyama-Shi, Japan

Location

Investigational Site Number 392038

Sagamihara-Shi, Japan

Location

Investigational Site Number 392069

Saijo-Shi, Japan

Location

Investigational Site Number 392030

Saitama-Shi, Japan

Location

Investigational Site Number 392047

Sapporo, Japan

Location

Investigational Site Number 392015

Satsumasendai-Shi, Japan

Location

Investigational Site Number 392004

Sendai, Japan

Location

Investigational Site Number 392034

Shimotsuke-Shi, 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 392051

Takatsuki-Shi, Japan

Location

Investigational Site Number 392061

Tokorozawa-Shi, Japan

Location

Investigational Site Number 392029

Toyonaka-Shi, Japan

Location

Investigational Site Number 392093

Ube-Shi, Japan

Location

Investigational Site Number 392067

Yatsushiro-Shi, Japan

Location

Investigational Site Number 392035

Zentsuji-Shi, Japan

Location

Related Publications (1)

• Watada H, Takami A, Spranger R, Amano A, Hashimoto Y, Niemoeller E. Efficacy and Safety of 1:1 Fixed-Ratio Combination of Insulin Glargine and Lixisenatide Versus Lixisenatide in Japanese Patients With Type 2 Diabetes Inadequately Controlled on Oral Antidiabetic Drugs: The LixiLan JP-O1 Randomized Clinical Trial. Diabetes Care. 2020 Jun;43(6):1249-1257. doi: 10.2337/dc19-2452. Epub 2020 Apr 15.

  PMID: 32295808 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 25, 2016
• Study Start: May 9, 2016
• Primary Completion: May 1, 2018
• Study Completion: May 1, 2018
• Last Updated: June 16, 2020

Record last verified: 2018-07

Locations

JP (61)