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

Phase 3

Completed

• Conditions: Type 2 Diabetes Mellitus
• Interventions: Drug: Insulin glargine U100 (HOE901); Drug: Insulin glargine/Lixisenatide (HOE901/AVE0010); Drug: Metformin

• Registration Number: NCT02752412
• Lead Sponsor: Sanofi

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.

Detailed Description

The maximum study duration per patient will be approximately 41 weeks: an up to 14-week screening period (consisting of an up to 2-week screening phase and a 12-week run-in phase), a 26-week randomized treatment period, and a 3-day post-treatment safety follow-up period.

Study Timeline

• Study First Submitted: 2016-04-20
• Study First Submitted QC: 2016-04-22
• Study First Posted: 2016-04-27
• Study Start: 2016-05-17
• Status Verified: 2018-10
• Primary Completion: 2018-10-04
• Study Completion: 2018-10-04
• Last Update Submitted: 2020-06-11
• Last Update Posted: 2020-06-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 513

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
insulin glargine	Insulin glargine U100 (HOE901)	Insulin glargine U100 (Lantus) will be injected subcutaneously (under skin) once daily. Dose will be individually adjusted. Metformin will be continued.
LixiLan	Metformin	LixiLan (insulin glargine/lixisenatide fixed ratio combination) is injected subcutaneously (under the skin) once daily. Dose is individually adjusted. Metformin will be continued.
insulin glargine	Metformin	Insulin glargine U100 (Lantus) will be injected subcutaneously (under skin) once daily. Dose will be individually adjusted. Metformin will be continued.
LixiLan	Insulin glargine/Lixisenatide (HOE901/AVE0010)	LixiLan (insulin glargine/lixisenatide fixed ratio combination) is injected subcutaneously (under the skin) once daily. Dose is individually adjusted. Metformin will be continued.

Primary Outcome Measures

Name	Time	Method
Change from baseline in HbA1c	Baseline, 26 weeks

Secondary Outcome Measures

Name	Time	Method
Change from baseline in FPG	Baseline, 26 weeks
Change from baseline in daily dose of insulin glargine	Baseline, 26 weeks
Percentage of patients reaching HbA1c <7% or ≤6.5%	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
Percentage of patients reaching HbA1c <7% with no documented (PG ≤70 mg/dL [3.9 mmol/L]) symptomatic hypoglycemia	26 weeks
Percentage of patients requiring a rescue therapy	26 weeks
Change from baseline in 2-hour postprandial plasma glucose (PPG) during standardized meal test	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
Percentage of patients reaching HbA1c <7% with no body weight gain	26 weeks
Number of hypoglycemic events	26 weeks
Number of adverse events	26 weeks
Measurement of anti-lixisenatide antibodies from baseline	Baseline, 26 weeks
Measurement of anti-insulin antibodies from baseline	Baseline, 26 weeks

Trial Locations

Locations (122)

Investigational Site Number 392013; 🇯🇵 Chiyoda-Ku, Japan

Investigational Site Number 392142; 🇯🇵 Kawasaki-Shi, Japan

Investigational Site Number 392132; 🇯🇵 Annaka-Shi, Japan

Investigational Site Number 392009; 🇯🇵 Arakawa-Ku, Japan

Investigational Site Number 392151; 🇯🇵 Chiba-Shi, Japan

Investigational Site Number 392055; 🇯🇵 Chuo-Ku, Japan

Investigational Site Number 392008; 🇯🇵 Fujimi-Shi, Japan

Investigational Site Number 392011; 🇯🇵 Chigasaki-Shi, Japan

Investigational Site Number 392003; 🇯🇵 Chuo-Ku, Japan

Investigational Site Number 392147; 🇯🇵 Fukuoka-Shi, Japan

Investigational Site Number 392135; 🇯🇵 Higashiosaka-Shi, Japan

Investigational Site Number 392066; 🇯🇵 Kashiwa-Shi, Japan

Investigational Site Number 392006; 🇯🇵 Kasugai-Shi, Japan

Investigational Site Number 392065; 🇯🇵 Kawagoe-Shi, Japan

Investigational Site Number 392007; 🇯🇵 Kawaguchi-Shi, Japan

Investigational Site Number 392077; 🇯🇵 Kawasaki-Shi, Japan

Investigational Site Number 392016; 🇯🇵 Kisarazu-Shi, Japan

Investigational Site Number 392086; 🇯🇵 Kobe-Shi, Japan

Investigational Site Number 392031; 🇯🇵 Kitakyushu-Shi, Japan

Investigational Site Number 392122; 🇯🇵 Minato-Ku, Japan

Investigational Site Number 392128; 🇯🇵 Nagoya-Shi, Japan

Investigational Site Number 392068; 🇯🇵 Kitakyushu-Shi, Japan

Investigational Site Number 392049; 🇯🇵 Kyoto-Shi, Japan

Investigational Site Number 392088; 🇯🇵 Maebashi-Shi, Japan

Investigational Site Number 392014; 🇯🇵 Mitaka-Shi, Japan

Investigational Site Number 392043; 🇯🇵 Mito-Shi, Japan

Investigational Site Number 392046; 🇯🇵 Miyazaki-Shi, Japan

Investigational Site Number 392026; 🇯🇵 Nagoya-Shi, Japan

Investigational Site Number 392134; 🇯🇵 Nagoya-Shi, Japan

Investigational Site Number 392005; 🇯🇵 Okawa-Shi, Japan

Investigational Site Number 392040; 🇯🇵 Oyama-Shi, Japan

Investigational Site Number 392125; 🇯🇵 Osaki-Shi, Japan

Investigational Site Number 392034; 🇯🇵 Shimotsuke-Shi, Japan

Investigational Site Number 392069; 🇯🇵 Saijo-Shi, Japan

Investigational Site Number 392098; 🇯🇵 Shinjuku-Ku, Japan

Investigational Site Number 392104; 🇯🇵 Shiogama-Shi, Japan

Investigational Site Number 392018; 🇯🇵 Shunan-Shi, Japan

Investigational Site Number 392037; 🇯🇵 Shizuoka-Shi, Japan

Investigational Site Number 392051; 🇯🇵 Takatsuki-Shi, Japan

Investigational Site Number 392156; 🇯🇵 Takatsuki-Shi, Japan

Investigational Site Number 392061; 🇯🇵 Tokorozawa-Shi, Japan

Investigational Site Number 392063; 🇯🇵 Ube-Shi, Japan

Investigational Site Number 392111; 🇯🇵 Tomakomai-Shi, Japan

Investigational Site Number 392073; 🇯🇵 Tsu-Shi, Japan

Investigational Site Number 392085; 🇯🇵 Yokohama-Shi, Japan

Investigational Site Number 392126; 🇯🇵 Yokohama-Shi, Japan

Investigational Site Number 392035; 🇯🇵 Zentsuji-Shi, Japan

Investigational Site Number 392002; 🇯🇵 Adachi-Ku, Japan

Investigational Site Number 392017; 🇯🇵 Chuo-Ku, Japan

Investigational Site Number 392100; 🇯🇵 Gifu-Shi, Japan

Investigational Site Number 392123; 🇯🇵 Higashiosaka-Shi, Japan

Investigational Site Number 392079; 🇯🇵 Hiki-Gun, Japan

Investigational Site Number 392057; 🇯🇵 Iruma-Shi, Japan

Investigational Site Number 392022; 🇯🇵 Ise-Shi, Japan

Investigational Site Number 392020; 🇯🇵 Izumisano-Shi, Japan

Investigational Site Number 392136; 🇯🇵 Kamogawa-Shi, Japan

Investigational Site Number 392149; 🇯🇵 Kasugai-Shi, Japan

Investigational Site Number 392101; 🇯🇵 Nagoya-Shi, Japan

Investigational Site Number 392080; 🇯🇵 Okayama-Shi, Japan

Investigational Site Number 392095; 🇯🇵 Onga-Gun, Japan

Investigational Site Number 392144; 🇯🇵 Osaka-Shi, Japan

Investigational Site Number 392047; 🇯🇵 Sapporo-Shi, Japan

Investigational Site Number 392117; 🇯🇵 Osaka-Shi, Japan

Investigational Site Number 392157; 🇯🇵 Ota-Shi, Japan

Investigational Site Number 392038; 🇯🇵 Sagamihara-Shi, Japan

Investigational Site Number 392030; 🇯🇵 Saitama-Shi, Japan

Investigational Site Number 392081; 🇯🇵 Shizuoka-Shi, Japan

Investigational Site Number 392056; 🇯🇵 Taito-Ku, Japan

Investigational Site Number 392152; 🇯🇵 Asahikawa-Shi, Japan

Investigational Site Number 392024; 🇯🇵 Chiba-Shi, Japan

Investigational Site Number 392074; 🇯🇵 Sanda-Shi, Japan

Investigational Site Number 392106; 🇯🇵 Sapporo-Shi, Japan

Investigational Site Number 392154; 🇯🇵 Naka-Shi, Japan

Investigational Site Number 392097; 🇯🇵 Sasebo-Shi, Japan

Investigational Site Number 392015; 🇯🇵 Satsumasendai-Shi, Japan

Investigational Site Number 392021; 🇯🇵 Shinjuku-Ku, Japan

Investigational Site Number 392025; 🇯🇵 Atsugi-Shi, Japan

Investigational Site Number 392094; 🇯🇵 Fukuoka-Shi, Japan

Investigational Site Number 392048; 🇯🇵 Hamamatsu-Shi, Japan

Investigational Site Number 392053; 🇯🇵 Kawagoe-Shi, Japan

Investigational Site Number 392062; 🇯🇵 Kawaguchi-Shi, Japan

Investigational Site Number 392082; 🇯🇵 Kawasaki-Shi, Japan

Investigational Site Number 392041; 🇯🇵 Kitakyusyu-Shi, Japan

Investigational Site Number 392001; 🇯🇵 Koriyama-Shi, Japan

Investigational Site Number 392092; 🇯🇵 Kumamoto-Shi, Japan

Investigational Site Number 392108; 🇯🇵 Kumamoto-Shi, Japan

Investigational Site Number 392116; 🇯🇵 Kumamoto-Shi, Japan

Investigational Site Number 392099; 🇯🇵 Kushiro-Shi, Japan

Investigational Site Number 392107; 🇯🇵 Kyoto-Shi, Japan

Investigational Site Number 392121; 🇯🇵 Matsuyama-Shi, Japan

Investigational Site Number 392042; 🇯🇵 Mito-Shi, Japan

Investigational Site Number 392078; 🇯🇵 Mito-Shi, Japan

Investigational Site Number 392131; 🇯🇵 Nagoya-Shi, Japan

Investigational Site Number 392140; 🇯🇵 Nagoya-Shi, Japan

Investigational Site Number 392050; 🇯🇵 Niihama-Shi, Japan

Investigational Site Number 392058; 🇯🇵 Saitama-Shi, Japan

Investigational Site Number 392027; 🇯🇵 Suita-Shi, Japan

Investigational Site Number 392052; 🇯🇵 Chiyoda-Ku, Japan

Investigational Site Number 392143; 🇯🇵 Fujisawa-Shi, Japan

Investigational Site Number 392141; 🇯🇵 Himeji-Shi, Japan

Investigational Site Number 392036; 🇯🇵 Kamakura-Shi, Japan

Investigational Site Number 392045; 🇯🇵 Kashiwara-Shi, Japan

Investigational Site Number 392090; 🇯🇵 Kawaguchi-Shi, Japan

Investigational Site Number 392010; 🇯🇵 Kisarazu-Shi, Japan

Investigational Site Number 392044; 🇯🇵 Koga-Shi, Japan

Investigational Site Number 392028; 🇯🇵 Kumamoto-Shi, Japan

Investigational Site Number 392158; 🇯🇵 Maebashi-Shi, Japan

Investigational Site Number 392076; 🇯🇵 Misato-Shi, Japan

Investigational Site Number 392137; 🇯🇵 Nagoya-Shi, Japan

Investigational Site Number 392145; 🇯🇵 Ogaki-Shi, Japan

Investigational Site Number 392153; 🇯🇵 Oita-Shi, Japan

Investigational Site Number 392071; 🇯🇵 Okayama-Shi, Japan

Investigational Site Number 392110; 🇯🇵 Shinagawa-Ku, Japan

Investigational Site Number 392019; 🇯🇵 Shobara-Shi, Japan

Investigational Site Number 392059; 🇯🇵 Hachioji-Shi, Japan

Investigational Site Number 392102; 🇯🇵 Hamamatsu-Shi, Japan

Investigational Site Number 392159; 🇯🇵 Obihiro-Shi, Japan

Investigational Site Number 392105; 🇯🇵 Osaka-Shi, Japan

Investigational Site Number 392120; 🇯🇵 Ota-Ku, Japan

Investigational Site Number 392004; 🇯🇵 Sendai-Shi, Japan

Investigational Site Number 392124; 🇯🇵 Ushiku-Shi, Japan

Investigational Site Number 392067; 🇯🇵 Yatsushiro-Shi, Japan