Last updated on January 2018

A 26-Week Randomized, Open-label, Active Controlled, Parallel-group, Study Assessing the Efficacy and Safety of the Insulin Glargine/Lixisenatide Fixed Ratio Combination in Adults With Type 2 Diabetes Inadequately Controlled on GLP-1 Receptor Agonist and Metformin ± Pioglitazone, Followed by a Fixed Ratio Combination Single-arm 26-Week Extension Period


Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: NIDDM | Type 2 | Diabetes Mellitus
  • Age: Between 18 - 100 Years
  • Gender: Male or Female

Inclusion criteria:

  • Patients with type 2 diabetes mellitus diagnosed at least 1 year prior to screening visit.
  • Patients who have been treated with one of the following glucagon-like peptide 1 (GLP-1) receptor agonists for at least 4 months prior to screening visit (V1), and with stable dose for at least 3 months prior to screening visit (V1):
  • Liraglutide (Victoza®) 1.8 mg QD or 1.2 mg QD, if the 1.8 mg QD dose is not well tolerated according to the Investigator's judgment or
  • Exenatide (Byetta®) 10 µg BID or of 5 µg BID, if 10 µg BID dose is not well tolerated according to the Investigator's judgment in combination with metformin (daily dose =1500 mg/day or maximum tolerated dose [MTD]), with or without pioglitazone, both at stable dose for at least 3 months prior to screening. or Patients who have been treated with stable dose of one of the following GLP-1 receptor agonists for at least 6 months prior to screening visit (V1):
  • Exenatide extended-release (Bydureon®) 2 mg once weekly (QW), if well tolerated according to Investigator's judgment,
  • Albiglutide (Tanzeum®) 50 mg QW or 30 mg QW, if 50 mg QW is not well tolerated according to Investigator's judgment,
  • Dulaglutide (Trulicity®) 1.5 mg QW or 0.75 mg QW, if 1.5 mg QW is not well tolerated according to Investigator's judgment in combination with metformin (daily dose =1500 mg/day or MTD), with or without pioglitazone, both at stable dose for at least 3 months prior to screening;
  • Signed written informed consent.

Exclusion criteria:

  • At screening visit, age
  • Screening HbA1c <7% and >9%.
  • Pregnancy or lactation, women of childbearing potential with no effective contraceptive method.
  • Any use of antidiabetic drugs within 3 months prior to the screening visit other than those described in the inclusion criteria.
  • Previous treatment with insulin in the year prior to screening visit (note: short-term treatment with insulin [=10 days] due to intercurrent illness including gestational diabetes is allowed at the discretion of the study physician).
  • Laboratory findings at the time of screening, including:
  • Fasting plasma glucose (FPG) >250 mg/dL (13.9 mmol/L),
  • Amylase and/or lipase >3 times the upper limit of the normal laboratory range (ULN),
  • Alanine transaminase or aspartate transaminase >3 ULN,
  • Calcitonin =20 pg/mL (5.9 pmol/L),
  • Positive pregnancy test.
  • Patient who has renal function impairment with estimated glomerular filtration rate
  • Contraindication to use of insulin glargine, or lixisenatide or GLP-1 receptor agonist (Victoza®, Byetta®, Bydureon®, Tanzeum® or Trulicity®) according to local labeling.
  • Any contraindication to metformin or pioglitazone use, according to local labeling.
  • History of hypersensitivity to insulin glargine, or to any of the excipients.
  • History of allergic reaction to any GLP-1 receptor agonist or to meta-cresol.
  • Personal or immediate family history of medullary thyroid cancer (MTC) or genetic condition that predisposes to MTC (eg, multiple endocrine neoplasia type 2 syndromes).
  • History of pancreatitis (unless pancreatitis was related to gallstones and cholecystectomy was already performed), chronic pancreatitis, pancreatitis during a previous treatment with incretin therapies, pancreatectomy.
  • Body mass index =20 or >40 kg/m^2

Exclusion criteria for the extension period:

  • Patients in the FRC arm with a rescue therapy and HbA1c >8% at week 22.
  • Patients in the FRC arm who discontinued prematurely from FRC treatment before week 26.
  • Patients in the GLP-1RA treatment arm after randomization.

Recruitment Status: Open


Brief Description Eligibility Contact Research Team


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