Primary Objective: To evaluate the ability of lixisenatide to modulate postprandial hyperlipidemia in particular, the effects on plasma changes in triglycerides. Secondary Objectives: The effect of lixisenatide on the following postprandial lipids: apolipoprotein (APO) B48; free fatty acid, lipoprotein distribution, cholesterol, and low-density lipoprotein (LDL) oxidation. The effect of lixisenatide on chronic low-grade inflammation present in non-insulin dependent diabetes mellitus (NIDDM) and obesity. The effect of lixisenatide on microvascular dysfunction. To evaluate the effect of lixisenatide on postprandial plasma glucose, insulin and C-peptide and glucagon.
Maximum study duration of approximately 2.5 months (study treatment) ± 2 days Day 0 (baseline) plus a 10-week open-label, active-controlled treatment period (Final/End-of-treatment Visit).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
2
Pharmaceutical form:solution Route of administration: subcutaneous
Pharmaceutical form:tablet Route of administration: oral
Change in plasma triglycerides after 10 weeks of treatment area under-the-time concentration curve between 0 and 480 minutes (AUC0-480 min)
Time frame: After 10 weeks of treatment
Change from baseline in plasma triglyceride
Time frame: 2 days after the basal test and after 10 weeks of treatment
Change from baseline in plasma cholesterol
Time frame: 2 days after the basal test and after 10 weeks of treatment
Change from baseline in APO B48
Time frame: 2 days after the basal test and after 10 weeks of treatment
Change from baseline in free fatty acid levels
Time frame: 2 days after the basal test and after 10 weeks of treatment
Change from baseline in lipoprotein distribution
Time frame: 2 days after the basal test and after 10 weeks of treatment
Change from baseline in LDL oxidation
Time frame: 2 days after the basal test and after 10 weeks of treatment
Change from baseline in postprandial plasma glucose
Time frame: 2 days after the basal test and after 10 weeks of treatment
Change from baseline in insulin
Time frame: 2 days after the basal test and after 10 weeks of treatment
Change from baseline in C-peptide
Time frame: 2 days after the basal test and after 10 weeks of treatment
Change from baseline in low grade inflammation (cytokines and stress oxidative markers)
Time frame: 2 days after the basal test and after 10 weeks of treatment
Change in baseline coronary flow reserve to assess the effect of lixisenatide on microvascular dysfunction
Time frame: 2 days after the basal test and after 10 weeks of treatment
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.