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

Type 2 Diabetes Mellitus Clinical Trial

— LIXILAN JP-O1  

Official title:

A Randomized, Active-controlled, Open Label, 2-treatment Arm, and Multicenter Study Comparing the Efficacy and Safety of Insulin Glargine/Lixisenatide Combination to Lixisenatide on Top of OADs in Japanese Patients With Type 2 DM With an Extension Period

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02749890
• Other study ID #: EFC14112
• Secondary ID: U1111-1176-8357
• Status: Completed
• Phase: Phase 3
• Start date: May 9, 2016
• Est. completion date: May 2018

Study information

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

Clinical Trial 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.

Description:

Approximately 55 weeks: an up-to 2-week screening period, a 26-week randomized open-label treatment period, a 26-week safety extension treatment period and a 3-day post-treatment safety follow up period.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 321
• Est. completion date: May 2018
• Est. primary completion date: May 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, alpha-glucosidase-inhibitor, sodium glucose co-transporter 2 inhibitor; sulfonylurea, rapid-acting insulin secretagogue, or dipeptidyl-peptidase-4 inhibitor.

• Signed written informed consent.

Exclusion criteria:

• 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.

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

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, Type 2
• Type 2 Diabetes Mellitus

Intervention

Drug:
• Insulin glargine/Lixisenatide (HOE901/AVE0010)
Pharmaceutical form: solution Route of administration: subcutaneous
• Lixisenatide (AVE0010)
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 392009	Arakawa-Ku
Japan	Investigational Site Number 392025	Atsugi-Shi
Japan	Investigational Site Number 392060	Bunkyo-Ku
Japan	Investigational Site Number 392024	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 392008	Fujimi-Shi
Japan	Investigational Site Number 392054	Fukuoka-Shi
Japan	Investigational Site Number 392094	Fukuoka-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 392079	Hiki-Gun
Japan	Investigational Site Number 392057	Iruma-Shi
Japan	Investigational Site Number 392022	Ise-Shi
Japan	Investigational Site Number 392023	Isehara-Shi
Japan	Investigational Site Number 392020	Izumisano-Shi
Japan	Investigational Site Number 392066	Kashiwa-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 392031	Kitakyushu-Shi
Japan	Investigational Site Number 392041	Kitakyusyu-Shi
Japan	Investigational Site Number 392068	Kitakyusyu-Shi
Japan	Investigational Site Number 392044	Koga-Shi
Japan	Investigational Site Number 392001	Koriyama-Shi
Japan	Investigational Site Number 392032	Kurume-Shi
Japan	Investigational Site Number 392088	Maebashi-Shi
Japan	Investigational Site Number 392014	Mitaka-Shi
Japan	Investigational Site Number 392042	Mito-Shi
Japan	Investigational Site Number 392078	Mito-Shi
Japan	Investigational Site Number 392026	Nagoya-Shi
Japan	Investigational Site Number 392080	Okayama-Shi
Japan	Investigational Site Number 392040	Oyama-Shi
Japan	Investigational Site Number 392038	Sagamihara-Shi
Japan	Investigational Site Number 392069	Saijo-Shi
Japan	Investigational Site Number 392030	Saitama-Shi
Japan	Investigational Site Number 392047	Sapporo-Shi
Japan	Investigational Site Number 392015	Satsumasendai-Shi
Japan	Investigational Site Number 392004	Sendai-Shi
Japan	Investigational Site Number 392034	Shimotsuke-Shi
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 392051	Takatsuki-Shi
Japan	Investigational Site Number 392061	Tokorozawa-Shi
Japan	Investigational Site Number 392029	Toyonaka-Shi
Japan	Investigational Site Number 392093	Ube-Shi
Japan	Investigational Site Number 392067	Yatsushiro-Shi
Japan	Investigational Site Number 392035	Zentsuji-Shi

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Country where clinical trial is conducted

Japan, 

References & 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 Antid — 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 fasting plasma glucose		Baseline, 26 weeks
Secondary	Change in from baseline in 7 point self-monitored plasma profiles		Baseline, 26 weeks
Secondary	Percentage of patients reaching HbA1c <7% with no body weight gain		26 weeks
Secondary	Change from baseline in body weight		Baseline, 26 weeks
Secondary	Percentage of patients requiring a rescue therapy		26 weeks
Secondary	Change in daily dose of insulin glargine for the combination group		Day 1, 26 weeks
Secondary	Number of hypoglycemic events		26 weeks, 52 weeks
Secondary	Number of adverse events		26 weeks, 52 weeks
Secondary	Measurement of anti-lixisenatide antibodies from baseline		Baseline, 26 weeks, 52 weeks
Secondary	Measurement of anti-insulin antibodies from baseline		Baseline, 26 weeks, 52 weeks