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 (LIXILAN JP-O2)
Type 2 Diabetes Mellitus
About this trial
This is an interventional treatment trial for Type 2 Diabetes Mellitus
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 (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.
Sites / Locations
- Investigational Site Number 392002
- Investigational Site Number 392132
- Investigational Site Number 392009
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Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
LixiLan
insulin glargine
LixiLan (insulin glargine/lixisenatide) is injected subcutaneously (under the skin) once daily. Dose is individually adjusted. Background therapy with OADs (except dipeptidyl-peptidase-4 inhibitor) should be continued during the treatment period.
Insulin glargine (HOE901) is injected subcutaneously (under the skin) once daily. Dose is individually adjusted. Background therapy with OADs (except dipeptidyl-peptidase-4 inhibitor) should be continued during the treatment period.