Efficacy and Safety of LixiLan Versus Insulin Glargine Alone Both With Metformin in Japanese With Type 2 Diabetes Mellitus Inadequately Controlled on Basal Insulin and Oral Antidiabetic Drugs

NCT02752412 | Completed Phase 3

• 2 other identifiers: EFC14113U1111-1176-8378
• Study Type: interventional
• Target: 513
• Locations: 1 country
• Sites: 122

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 mellitus. Secondary Objective: To compare overall efficacy and safety of LixiLan to insulin glargine over 26 weeks 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 (15)

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

  26 weeks

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

  Baseline, 26 weeks

• Change from baseline in blood glucose excursion during standardized meal test

  Baseline, 26 weeks

• Change from baseline in 7-point self-monitoring plasma glucose (SMPG) profiles (each time point and average daily value)

  Baseline, 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. Metformin will be continued.

Drug: Insulin glargine/Lixisenatide (HOE901/AVE0010); Drug: Metformin

insulin glargine

ACTIVE COMPARATOR

Insulin glargine U100 (Lantus) will be injected subcutaneously (under skin) once daily. Dose will be individually adjusted. Metformin will be continued.

Drug: Insulin glargine U100 (HOE901); Drug: Metformin

Interventions

Insulin glargine/Lixisenatide (HOE901/AVE0010) DRUG

Pharmaceutical form: solution Route of administration: subcutaneous

Also known as: LixiLan

LixiLan

Insulin glargine U100 (HOE901) DRUG

Pharmaceutical form: solution Route of administration: subcutaneous

Also known as: Lantus

insulin glargine

Metformin 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 (V1).
• Patient treated with a stable, once a day basal insulin regimen (ie, type of insulin and time/frequency of the injection), for at least 3 months before the screening visit.
• The total daily basal insulin dose should be stable (± 20%) and \<15 U/day for at least 1 month before the screening visit.
• Patient receiving 1 or 2 oral anti-diabetic drugs (OADs): the OAD dose(s) must be stable during the 3 months before the screening visit. The OADs can be 1 to 2 out of:
• Metformin;
• Sulfonylurea (SU);
• Glinide;
• Dipeptidyl-peptidase-4 (DPP-4) inhibitor;
• Sodium glucose co-transporter 2 (SGLT2) inhibitor;
• Alpha glucosidase inhibitor (alpha-GI).
• Signed written informed consent.

You may not qualify if:

• Age \<20 years at screening visit.
• HbA1c at screening visit \<7.5% or \>9.5%.
• Fasting plasma glucose (FPG) \>180 mg/dL (10.0 mmol/L) at screening visit.
• Pregnancy or lactation, women of childbearing potential with no effective contraceptive method.
• Previous use of insulin regimen other than basal insulin, eg, prandial or pre-mixed insulin.
• Note: Short-term treatment (≤10 days) due to intercurrent illness including gestational diabetes is allowed at the discretion of the Investigator.
• Use of thiazolidinedione (TZD) within 6 months prior to screening visit.
• History of discontinuation of a previous treatment with a glucagon-like peptide-1(GLP-1) receptor agonist due to safety/ tolerability issues or lack of efficacy.
• Laboratory findings at the screening visit; including:
• 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.
• Any contraindication to metformin use according to local labeling.
• History of hypersensitivity to any GLP-1 receptor agonist or to metacresol.

Sponsors & Collaborators

• Sanofi: lead

Study Sites (122)

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 392152

Asahikawa-Shi, 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 392008

Fujimi-Shi, Japan

Location

Investigational Site Number 392143

Fujisawa-Shi, 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 392048

Hamamatsu, Japan

Location

Investigational Site Number 392102

Hamamatsu, Japan

Location

Investigational Site Number 392123

Higashiosaka-Shi, Japan

Location

Investigational Site Number 392135

Higashiosaka-Shi, Japan

Location

Investigational Site Number 392079

Hiki-Gun, Japan

Location

Investigational Site Number 392141

Himeji-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 392036

Kamakura-Shi, 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 392149

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 392090

Kawaguchi-Shi, Japan

Location

Investigational Site Number 392077

Kawasaki-Shi, Japan

Location

Investigational Site Number 392082

Kawasaki-Shi, Japan

Location

Investigational Site Number 392142

Kawasaki-Shi, Japan

Location

Investigational Site Number 392010

Kisarazu-Shi, Japan

Location

Investigational Site Number 392016

Kisarazu-Shi, Japan

Location

Investigational Site Number 392031

Kitakyushu-Shi, Japan

Location

Investigational Site Number 392068

Kitakyushu-Shi, Japan

Location

Investigational Site Number 392041

Kitakyusyu-Shi, Japan

Location

Investigational Site Number 392086

Kobe, Japan

Location

Investigational Site Number 392044

Koga-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 392116

Kumamoto, Japan

Location

Investigational Site Number 392099

Kushiro, Japan

Location

Investigational Site Number 392049

Kyoto, Japan

Location

Investigational Site Number 392107

Kyoto, Japan

Location

Investigational Site Number 392088

Maebashi, Japan

Location

Investigational Site Number 392158

Maebashi, Japan

Location

Investigational Site Number 392121

Matsuyama, Japan

Location

Investigational Site Number 392122

Minatoku, Japan

Location

Investigational Site Number 392076

Misato-Shi, Japan

Location

Investigational Site Number 392014

Mitaka-Shi, Japan

Location

Investigational Site Number 392042

Mito, Japan

Location

Investigational Site Number 392043

Mito, Japan

Location

Investigational Site Number 392078

Mito, Japan

Location

Investigational Site Number 392046

Miyazaki, 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 392137

Nagoya, Japan

Location

Investigational Site Number 392140

Nagoya, Japan

Location

Investigational Site Number 392154

Naka, Japan

Location

Investigational Site Number 392050

Niihama-Shi, Japan

Location

Investigational Site Number 392159

Obihiro-Shi, Japan

Location

Investigational Site Number 392145

Ogaki-Shi, Japan

Location

Investigational Site Number 392005

Okawa-Shi, Japan

Location

Investigational Site Number 392071

Okayama, Japan

Location

Investigational Site Number 392080

Okayama, Japan

Location

Investigational Site Number 392095

Onga-Gun, Japan

Location

Investigational Site Number 392105

Osaka, Japan

Location

Investigational Site Number 392117

Osaka, Japan

Location

Investigational Site Number 392144

Osaka, Japan

Location

Investigational Site Number 392125

Osaki-Shi, Japan

Location

Investigational Site Number 392157

Ota-Shi, Japan

Location

Investigational Site Number 392040

Oyama-Shi, Japan

Location

Investigational Site Number 392153

Ōita, Japan

Location

Investigational Site Number 392120

Ōta-ku, 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 392058

Saitama-Shi, Japan

Location

Investigational Site Number 392074

Sanda-Shi, Japan

Location

Investigational Site Number 392047

Sapporo, Japan

Location

Investigational Site Number 392106

Sapporo, Japan

Location

Investigational Site Number 392097

Sasebo-Shi, 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 392110

Shinagawa-Ku, Japan

Location

Investigational Site Number 392021

Shinjuku-Ku, Japan

Location

Investigational Site Number 392098

Shinjuku-Ku, Japan

Location

Investigational Site Number 392104

Shiogama-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 392156

Takatsuki-Shi, Japan

Location

Investigational Site Number 392061

Tokorozawa-Shi, Japan

Location

Investigational Site Number 392111

Tomakomai-Shi, Japan

Location

Investigational Site Number 392073

Tsu, Japan

Location

Investigational Site Number 392063

Ube-Shi, Japan

Location

Investigational Site Number 392124

Ushiku-Shi, Japan

Location

Investigational Site Number 392067

Yatsushiro-Shi, Japan

Location

Investigational Site Number 392085

Yokohama, Japan

Location

Investigational Site Number 392126

Yokohama, Japan

Location

Investigational Site Number 392035

Zentsuji-Shi, Japan

Location

Related Publications (1)

• Kaneto H, Takami A, Spranger R, Amano A, Watanabe D, Niemoeller E. Efficacy and safety of insulin glargine/lixisenatide fixed-ratio combination (iGlarLixi) in Japanese patients with type 2 diabetes mellitus inadequately controlled on basal insulin and oral antidiabetic drugs: The LixiLan JP-L randomized clinical trial. Diabetes Obes Metab. 2020 Sep;22 Suppl 4:3-13. doi: 10.1111/dom.14005.

  PMID: 32072742 RESULT

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Insulin Glargine; lixisenatide; Metformin

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; Biguanides; Guanidines; Amidines; Organic Chemicals

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 17, 2016
• Primary Completion: October 4, 2018
• Study Completion: October 4, 2018
• Last Updated: June 16, 2020

Record last verified: 2018-10

Locations

JP (122)