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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
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

NCT02752828

CompletedPhase 3

Sponsor: Sanofi

Conditions: Type 2 Diabetes Mellitus

Interventions: Insulin glargine/lixisenatide (HOE901/AVE0010), Insulin glargine (HOE901), Oral anti-diabetic drugs

Countries: Japan

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.

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 (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.
Locations (113)
  • Adachi-Ku, Japan
  • Annaka-Shi, Japan
  • Arakawa-Ku, Japan
  • Atsugi-Shi, Japan
  • Chiba, Japan
  • Chiba, Japan
  • Chigasaki-Shi, Japan
  • Chiyoda-Ku, Japan
  • Chiyoda-Ku, Japan
  • Chūōku, Japan
  • Chūōku, Japan
  • Chūōku, Japan
  • Chūōku, Japan
  • Fujimi-Shi, Japan
  • Fujisawa-Shi, Japan
  • Fukuoka, Japan
  • Fukuoka, Japan
  • Fukuoka, Japan
  • Gifu, Japan
  • Hachioji-Shi, Japan
  • Hakodate-Shi, Japan
  • Hamamatsu, Japan
  • Hamamatsu, Japan
  • Hiki-Gun, Japan
  • Hirosaki-Shi, Japan
  • Hofu-Shi, Japan
  • Iruma-Shi, Japan
  • Ise-Shi, Japan
  • Izumisano, Japan
  • Kagoshima, Japan
  • + 83 more on CT.gov