Patient case: 58-year-old female with Lung cancer. Genetic variant: NTRK1. Other conditions: Depression, Hypertension, Diabetes.

Clinical trial: A Study to Assess the Safety and Efficacy of SAR425899 in Patients With Type 2 Diabetes Mellitus

Summary: Primary Objective:
  The primary objective of this study is to assess the dose-response relationship of SAR425899 versus placebo in terms of glycemic control as measured by the change in glycosylated hemoglobin (HbA1c).
  Secondary Objectives:
  -  To assess the effect of SAR425899 on body weight.
  -  To assess the safety and immunogenicity profile of SAR425899, including assessment of the heart rate (HR) change by electrocardiogram (ECG) and Holter monitor.
  -  To assess the proportion of patients achieving predefined HbA1c targets of <7% and <6.5% as well as the proportion of patients achieving ≥5% and ≥10% body weight loss.
  -  To assess the effect of once daily dosing of SAR425899 on additional parameters of glycemic control and lipid metabolism.
  -  To assess the effect of once daily dosing of SAR425899 on additional pharmacodynamic (PD) biomarkers.
  -  To assess the pharmacokinetic (PK) profile and parameters of SAR425899, inter-individual and inter-occasion variability in PK parameters using a population PK approach.

Detailed description: The total study duration will be approximately 30 weeks, consisting of 3 weeks screening period at the site, a 26 weeks treatment period, and 3 days post treatment follow up period.

Eligibility: Inclusion criteria :
  -  Patients with type-2 diabetes mellitus (T2DM) for at least 3 months before the screening visit.
  -  On diet/exercise and/or treatment with metformin (stable dose of ≥1500 mg/day or maximal tolerated dose) for at least 3 months prior to screening.
  -  Signed informed consent.
  Exclusion criteria:
  -  At screening, patient's age < legal age of adulthood and >80 years.
  -  Glycated hemoglobin at screening visit <7.0% or >10.0%.
  -  Body mass index (BMI) <25 kg/m^2 or >45.0 kg/m^2.
  -  Pregnant or lactating women.
  -  Women of childbearing potential (WOCBP) not protected by highly-effective method(s) of birth control and/or who are unwilling or unable to be tested for pregnancy.
  -  Diagnosis of type 1 diabetes mellitus.
  -  Fasting plasma glucose of >15 mmol/L (270 mg/dL) measured by the central laboratory at screening (Visit 1), and confirmed (>15 mmol/L [270 mg/dL]) by a repeat test before randomization.
  -  Treatment with glucose-lowering agents(s) other than metformin, currently or within the 3 months prior to screening.
  -  Previous insulin use, except for episode(s) of short-term treatment (≤15 consecutive days) for intercurrent illness or pregnancy, or use of insulin within the last 6 months.
  -  Contraindication(s) to metformin use.
  -  Contraindication(s) to liraglutide use.
  -  Significant change in body weight in the 3 months before screening.
  -  Poorly controlled hypertension (a resting systolic blood pressure (SBP) >160 mm Hg and/or diastolic blood pressure (DBP) >95 mm Hg at screening).
  -  History of long QT syndrome and/or QTc more than 450 ms at screening visit.
  -  History of pancreatitis or pancreatectomy.
  -  History of weight loss surgery.
  -  Personal or immediate family history of medullary thyroid cancer (MTC) or genetic conditions that predispose to MTC.
  -  Any prior exposure to drugs belonging to the class of glucagon-like peptide-1 (GLP-1) receptor agonists/GLP-1 analogs.
  -  Contraindications or known hypersensitivity reaction to glucagon.
  The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Relevance to patient case: not relevant