- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02274740
Effect of Lixisenatide on Postprandial Lipid Profile in Obese Type 2 Diabetic Patients
Effect of GLP-1 Receptors Agonist Lixisenatide on Postprandial Lipid Profile in Obese Type 2 Diabetic Patients
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 2
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion criteria:
Male and female patients, 18-70 years of age.
Diagnosis of Type 2 diabetes treated with metformin and obesity (body mass index [BMI] >30 kg/m^2) and the following other abnormalities:
- Abdominal obesity (waist circumference >102 cm in men and >88 cm in women). According to National Cholesterol Education Program-Adult Treatment Panel (NCEP-ATP) III (2001).
- Glycated hemoglobin A1c (HbA1c) ≥7 and ≤8.5% (after Sponsor approval providers might reasonably suggest more stringent A1c goals [such as 6.5%] for selected individual patients, if this can be achieved without significant hypoglycemia or other adverse effects of treatment. Appropriate patients might include those with short duration of diabetes, long life expectancy, and no significant cardiovascular disease).
- Hypertriglyceridemia (fasting triglyceride levels between 150 mg/dL and 600 mg/dL, cholesterol <300 mg/dL. In order to exclude patients who might be suffering from a primitive dyslipidemia).
- Low high-density lipoprotein (HDL) cholesterol (serum HDL-cholesterol <40 mg/dL in men and <50 mg/dL in women).
Written informed consent.
Exclusion criteria:
Smoking. Thyroid disease even if under appropriate hormonal replacement therapy or thyroid suppressant (Thyroid Stimulating Hormone [TSH] >5 mU/L with clinical symptoms of hypothyroidism).
Hepatic disease (Aspartate Aminotransferase [ASAT] or Alanine Aminotransferase [ALAT] >2 times the upper limit of normal).
Renal disease (serum creatinine >1.7 times the upper limit of normal). A history of coronary heart disease, cerebrovascular disease, or peripheral arterial disease in the 6 months before enrollment.
History of malignancies. Use of lipid lowering therapy. Systolic blood pressure ≥180 mmHg and/or diastolic blood pressure ≥110 mmHg. Triglycerides >600 mg/dL. History of chronic pancreatitis or of idiopathic acute pancreatitis.
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: lixisenatide
Lixisenatide injection should be performed in the morning, within 1 hour (ie, 0-60 minutes), prior to breakfast (or standardized meal). Lixisenatide is to be started with once daily injections of 10 μg per day for 2 weeks then to be continued by the maintenance dose (8 weeks) of 20 μg/d up to the end of the treatment period. |
Pharmaceutical form:solution Route of administration: subcutaneous
Pharmaceutical form:tablet Route of administration: oral
|
NO_INTERVENTION: metformin
Greater than or equal than 1.5 g/day as background therapy for 10 weeks
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
After 10 weeks of treatment
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change from baseline in plasma triglyceride
Time Frame: 2 days after the basal test and after 10 weeks of treatment
|
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
|
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
|
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
|
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
|
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
|
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
|
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
|
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
|
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
|
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
|
2 days after the basal test and after 10 weeks of treatment
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- LIXISL07016
- U1111-1153-3774 (OTHER: UTN)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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