Patient case: 54-year-old male with Pancreatic cancer. Genetic variant: CDKN2A. Other conditions: Diabetes, Hypertension.

Clinical trial: Efficacy and Safety of Insulin Glargine/ Lixisenatide Fixed Ratio Combination Compared to Insulin Glargine Alone and Lixisenatide Alone on Top of Metformin in Patients With T2DM

Summary: Primary Objective:
  To compare the insulin glargine/lixisenatide fixed ratio combination to lixisenatide alone and to insulin glargine alone (on top of metformin treatment) in glycated hemoglobin (HbA1c) change from baseline to Week 30.
  Secondary Objective:
  To compare the overall efficacy and safety of insulin glargine/lixisenatide fixed ratio combination (FRC) to insulin glargine alone and to lixisenatide alone (on top of metformin treatment) over a 30 week treatment period in participants with type 2 diabetes.

Detailed description: Approximately 37 weeks including up to 6 weeks of screening, 30-week treatment period, and a 3 days follow-up period.

Eligibility: Inclusion criteria:
  -  Participants with type 2 diabetes mellitus diagnosed for at least 1 year before the screening visit, treated for at least 3 months prior to visit 1 with metformin alone or metformin and a second oral anti-diabetic treatment that could be a sulfonylurea, a glinide, a sodium glucose co-transporter-2 inhibitor or a di-peptidyl peptidase 4 (DPP-4) inhibitors, and who were not adequately controlled with this treatment.
  -  Signed written informed consent.
  Exclusion criteria:
  -  HbA1c at screening visit:
  -  less than 7.5% or more than 10% for participants previously treated with metformin alone,
  -  less than 7.0% or more than 9% for participants previously treated with metformin and a second oral anti-diabetic treatment.
  -  Pregnancy or lactation, women of childbearing potential with no effective contraceptive method.
  -  Use of oral glucose-lowering agents other than those stated in the inclusion criteria or any injectable glucose-lowering agents during the 3 months before screening.
  -  Previous Treatment with insulin (except for short-term treatment due to intercurrent illness including gestational diabetes, at the discretion of the trial physician).
  -  History of discontinuation of a previous treatment with a glucagon-like peptide (GLP-1) receptor agonist (GLP-1 RA) due to safety/tolerability issue or lack of efficacy.
  -  Participant who previously participated in any clinical trial with lixisenatide or the insulin glargine/lixisenatide fixed ratio combination or had previously received lixisenatide.
  -  Any contraindication to metformin use, according to local labeling.
  -  Use of weight loss drugs within 3 months prior to screening visit.
  -  Within the last 6 months prior to screening visit: history of stroke, myocardial infarction, unstable angina, or heart failure requiring hospitalization. Planned coronary, carotid or peripheral artery revascularisation procedures to be performed during the study period.
  -  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, stomach/gastric surgery.
  -  Personal or immediate family history of medullary thyroid cancer (MTC) or genetic conditions that predispose to MTC (e.g, multiple endocrine neoplasia syndromes).
  -  Uncontrolled or inadequately controlled hypertension (systolic blood pressure above 180 mmHg or diastolic blood pressure above 95 mmHg) at screening visit.
  -  At screening visit, Body Mass Index (BMI) less than or equal to 20 or above 40 kg/m^2.
  -  At screening visit amylase and/or lipase more than 3 times the upper limit of the normal (ULN) laboratory range.
  -  At screening visit alanine aminotransferase (ALT) or alkaline phosphatase (AST) more than 3 ULN.
  -  At screening visit calcitonin above or equal to 20 pg/mL (5.9 pmol/L).
  Exclusion Criteria for randomization at the end of the screening period:
  -  HbA1c less than 7% or above 10%;
  -  Fasting Plasma glucose above 250 mg/dL (13.9 mmol/L);
  -  Metformin maximal tolerated dose less than 1500 mg/day;
  -  Amylase and/or lipase more than 3 ULN.
  The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

Relevance to patient case: not relevant