Effect of GLP-1 receptor agonist lixisenatide on post-prandial lipid profile in obese patients
Conditions
Interventions
Trade Name: Lyxumia
Product Name: Lyxumia
Product Code: AVE0010
Pharmaceutical Form: Solution for injection in pre-filled pen
INN or Proposed INN: LIXISENATIDE
CAS Number: 320367-13-3
Current Sponsor
Sponsors
sanofi aventis S.p.A
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male and female patients, 18-70 years of age 2. Diagnosis of Type 2 diabetes mellitus (T2DM) treated with Metformin (= 1.5 g/day) and Obesity (BMI > 30 kg/m2) and the following other abnormalities: • Abdominal obesity (waist circumference > 102 cm in men and > 88 cm in women), according to NCEP-ATP III (2001) • HbA1c = 7 and = 8.5 %. After Sponsor approval, providers might reasonably suggest more stringent HbA1c values (such as 6.5%) for selected individual patients, if this can be managed without significant hypoglycemia or other treatment adverse effects.. Appropriate patients might include those with short duration of diabetes, long life expectancy, and no significant CVD • Hypertriglyceridemia (fasting triglyceride levels between 150 mg/dl and 600 mg/dl), cholesterol =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. At screening: age 5 mU/l with clinical symptoms of hypothyroidism) 6. Hepatic disease (AST or ALT > 2 times the upper limit of normal) 7. Renal disease (serum creatinine > 1.7 times the upper limit of normal). 8. A history of coronary heart disease, cerebrovascular disease or peripheral arterial disease in the 6 months before enrolment and/or concomitant treatment with calcium antagonists, Beta blockers and/or nitrates. 9. Women of childbearing potential with no effective contraceptive method, pregnancy or lactation. Women of childbearing potential (pre-menopausal, or women not surgically sterile for at least 3 months prior to the time of screening) must have a confirmed negative pregnancy test at screening visit. They must use an effective contraceptive method throughout the study. 10. History of malignancies 11. Known history of drug or alcohol abuse within 6 months prior to the time of screening 12. Uncontrolled or inadequately controlled hypertension at the time of screening with a resting systolic or diastolic blood pressure >180 mmHg or >95 mmHg, respectively 13. Triglycerides > 600 mg/dl 14. History of chronic pancreatitis or of idiopathic acute pancreatitis 15. History of metabolic acidosis, including diabetic ketoacidosis within 1 year prior to screening 16. Hemoglobinopathy or hemolytic anemia, receipt of blood or plasma products within 3 months prior to the time of screening 17. Any other clinically significant abnormality identified on physical examination, laboratory tests, ECG or vital signs at the time of screening that in the judgment of the investigator or any sub- investigator would make implementation of the protocol or interpretation of the study results difficult or would preclude the safe participation of the subject in this protocol. 18. Use of any glucose-lowering agent(s) other than metformin in the 3 months prior to screening 19. Treatment with metformin at a daily dose < 1.5 g/day 20. Use of lipid lowering therapy and/or weight lowering drugs within 3 months prior to screening 21. Use of systemic glucocorticoids (excluding topical application or inhaled forms) for one consecutive week or more within 3 months prior to the time of screening 22. Use of any investigational drug within 3 months prior to screening 23. Patients considered by the investigator or any sub investigator as inappropriate for this study for any medical, psychological, social, or geographical reason (e.g. patients that do not take their breakfast in the morning, patients unable to fully understand the nature, scope, and possible consequences of the study; patients unable to fully understand patient’s study documents; impossibility to meet specific protocol requirements, such as scheduled visits; being unable or unwilling to do blood glucose monitoring using the sponsor-provided blood glucose meter at home; likelihood of requiring treatment with drugs not permitted by the clinical study protocol, night shift workers, etc) 24. Patient is the Investigator or any Sub-Investigator, research assistant, pharmacist, study coordinator, other staff or relative thereof directly involved in the conduct of the protocol. 25. Patient who withdraws consent during the screening. 26. Any contra-indication to metformin accordin
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the ability of lixisenatide to modulate post-prandial hyperlipidemia: in particular the effects on plasma changes in triglycerides in obese Type II diabetes patients. ;Secondary Objective: to evaluate: The effect of lixisenatide on the following post prandial lipids: plasma cholesterol, APO B48; free fatty acid, lipoprotein distribution and LDL oxidation. The effect of lixisenatide on post-prandial plasma glucose, insulin and C-peptide and glucagon The effect of lixisenatide on low-grade inflammation (cytokines and stress oxidative markers), present in NIDDM and obesity. The effect of lixisenatide on microvascular dysfunction. ;Primary end point(s): • Effect of lixisenatide on plasma changes on tryglycerides after 10 weeks of treatment (AUC0-480 min);Timepoint(s) of evaluation of this end point: 10 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Effect of lixisenatide on plasma changes of: - triglycerides, on the 2nd day of treatment (AUC0-480 min) - plasma cholesterol, APO B48 on the 2nd day and after 10 weeks of treatment - free fatty acid on the 2nd day and after 10 weeks of treatment - lipoprotein distribution on the 2nd day and after 10 weeks of treatment - LDL oxidation on the 2nd day and after 10 weeks of treatment - post-prandial plasma glucose, insulin and C-peptide, glucagon (AUC0-480 min) • Effect of lixisenatide on low grade inflammation (cytokines and stress oxidative markers) on the 2nd day and after 10 weeks of treatment • Effect of lixisenatide on microvascular dysfunction on the 2nd day and after 10 weeks of treatment. ;Timepoint(s) of evaluation of this end point: 10 weeks | — |
Countries
Italy
Contacts
Public Contactgianfrancesco sartini
quintiles spa
Outcome results
None listed