NCT lookup
Pull any trial record directly from ClinicalTrials.gov.
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
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
CompletedPhase 3
Sponsor: Sanofi
Conditions: Type 2 Diabetes Mellitus
Interventions: Insulin glargine/Lixisenatide (HOE901/AVE0010), Lixisenatide (AVE0010), Oral anti-diabetic drugs
Countries: Japan
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.
Eligibility overview
Sex: ALL
Age: 20 Years to —
Healthy volunteers: No
Study type: INTERVENTIONAL
Eligibility criteria
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.
Locations (61)
- Adachi-Ku, Japan
- Arakawa-Ku, Japan
- Atsugi-Shi, Japan
- Bunkyō City, Japan
- Chiba, Japan
- Chigasaki-Shi, Japan
- Chiyoda-Ku, Japan
- Chiyoda-Ku, Japan
- Chūōku, Japan
- Chūōku, Japan
- Fujimi-Shi, Japan
- Fukuoka, Japan
- Fukuoka, Japan
- Hachioji-Shi, Japan
- Hakodate-Shi, Japan
- Hamamatsu, Japan
- Hiki-Gun, Japan
- Iruma-Shi, Japan
- Ise-Shi, Japan
- Isehara-Shi, Japan
- Izumisano, Japan
- Kashiwa-Shi, Japan
- Kasugai-Shi, Japan
- Kawagoe-Shi, Japan
- Kawagoe-Shi, Japan
- Kawaguchi-Shi, Japan
- Kawaguchi-Shi, Japan
- Kawasaki-Shi, Japan
- Kawasaki-Shi, Japan
- Kitakyushu-Shi, Japan
- + 31 more on CT.gov