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

NCT02749890

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