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

Type 2 Diabetes Mellitus Clinical Trial

— LIXILAN JP-O2  

Official title:

A Randomized, Active-controlled, Open Label, 2-treatment Arm, and Multicenter Study Comparing the Efficacy and Safety of the Insulin Glargine/Lixisenatide Combination to Insulin Glargine on Top of OADs in Japanese Patients With Type 2 Diabetes Mellitus (T2DM)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02752828
• Other study ID #: EFC14114
• Secondary ID: U1111-1176-8450
• Status: Completed
• Phase: Phase 3
• Start date: May 23, 2016
• Est. completion date: March 12, 2018

Study information

• Verified date: March 2018
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 521
• Est. completion date: March 12, 2018
• Est. primary completion date: March 12, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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.

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.

• Use of oral or injectable glucose-lowering agents other than those stated during the inclusion criteria in the 3 months before the screening visit.

• 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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Drug:
• Insulin glargine/lixisenatide (HOE901/AVE0010)
Pharmaceutical form: solution Route of administration: subcutaneous
• Insulin glargine (HOE901)
Pharmaceutical form: solution Route of administration: subcutaneous
• Oral anti-diabetic drugs
Pharmaceutical form: tablet Route of administration: oral

Locations

Country	Name	City	State
Japan	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-Shi
Japan	Investigational Site Number 392151	Chiba-Shi
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	Chuo-Ku
Japan	Investigational Site Number 392017	Chuo-Ku
Japan	Investigational Site Number 392055	Chuo-Ku
Japan	Investigational Site Number 392155	Chuo-Ku
Japan	Investigational Site Number 392008	Fujimi-Shi
Japan	Investigational Site Number 392143	Fujisawa-Shi
Japan	Investigational Site Number 392054	Fukuoka-Shi
Japan	Investigational Site Number 392094	Fukuoka-Shi
Japan	Investigational Site Number 392147	Fukuoka-Shi
Japan	Investigational Site Number 392100	Gifu-Shi
Japan	Investigational Site Number 392059	Hachioji-Shi
Japan	Investigational Site Number 392083	Hakodate-Shi
Japan	Investigational Site Number 392048	Hamamatsu-Shi
Japan	Investigational Site Number 392102	Hamamatsu-Shi
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-Shi
Japan	Investigational Site Number 392139	Kagoshima-Shi
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-Shi
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-Shi
Japan	Investigational Site Number 392092	Kumamoto-Shi
Japan	Investigational Site Number 392108	Kumamoto-Shi
Japan	Investigational Site Number 392075	Kure-Shi
Japan	Investigational Site Number 392032	Kurume-Shi
Japan	Investigational Site Number 392118	Kushiro-Shi
Japan	Investigational Site Number 392107	Kyoto-Shi
Japan	Investigational Site Number 392088	Maebashi-Shi
Japan	Investigational Site Number 392113	Matsumoto-Shi
Japan	Investigational Site Number 392122	Minato-Ku
Japan	Investigational Site Number 392076	Misato-Shi
Japan	Investigational Site Number 392042	Mito-Shi
Japan	Investigational Site Number 392078	Mito-Shi
Japan	Investigational Site Number 392148	Nagano-Shi
Japan	Investigational Site Number 392026	Nagoya-Shi
Japan	Investigational Site Number 392101	Nagoya-Shi
Japan	Investigational Site Number 392128	Nagoya-Shi
Japan	Investigational Site Number 392131	Nagoya-Shi
Japan	Investigational Site Number 392134	Nagoya-Shi
Japan	Investigational Site Number 392154	Naka-Shi
Japan	Investigational Site Number 392127	Niigata-Shi
Japan	Investigational Site Number 392050	Niihama-Shi
Japan	Investigational Site Number 392115	Ogawa-Machi, Hikigun
Japan	Investigational Site Number 392071	Okayama-Shi
Japan	Investigational Site Number 392095	Onga-Gun
Japan	Investigational Site Number 392117	Osaka-Shi
Japan	Investigational Site Number 392144	Osaka-Shi
Japan	Investigational Site Number 392040	Oyama-Shi
Japan	Investigational Site Number 392084	Saga-Shi
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-Shi
Japan	Investigational Site Number 392089	Sapporo-Shi
Japan	Investigational Site Number 392150	Sapporo-Shi
Japan	Investigational Site Number 392097	Sasebo-Shi
Japan	Investigational Site Number 392004	Sendai-Shi
Japan	Investigational Site Number 392103	Sendai-Shi
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-Shi
Japan	Investigational Site Number 392081	Shizuoka-Shi
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-Shi
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-Shi
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-Shi
Japan	Investigational Site Number 392126	Yokohama-Shi
Japan	Investigational Site Number 392035	Zentsuji-Shi

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Country where clinical trial is conducted

Japan, 

References & 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in HbA1c		Baseline, 26 weeks
Secondary	Percentage of patients reaching HbA1c <7% or =6.5%		26 weeks
Secondary	Change from baseline in 2-hour postprandial glucose (PPG) during standardized meal test		Baseline, 26 weeks
Secondary	Change from baseline in 7 point self monitored plasma glucose (SMPG) profiles during standardized meal test		Baseline, 26 weeks
Secondary	Change from baseline in body weight		Baseline, 26 weeks
Secondary	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
Secondary	Percentage of patients reaching HbA1c <7% at Week 26 with no documented (PG =70 mg/dL [3.9 mmol/L]) symptomatic hypoglycemia		26 weeks
Secondary	Percentage of patients requiring a rescue therapy		26 weeks
Secondary	Number of adverse events		26 weeks
Secondary	Number of hypoglycemic events		26 weeks
Secondary	Measurement of anti-lixisenatide antibodies from baseline		Baseline, 26 weeks
Secondary	Measurement of anti-insulin antibodies from baseline		Baseline, 26 weeks