Back to resultsEffect of Lixisenatide on Postprandial Lipid Profile in Obese Type 2 Diabetic Patients
Primary Purpose
Type II Diabetes Mellitus
Status
Terminated
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
LIXISENATIDE AVE0010
metformin
Sponsored by
About this trial
This is an interventional treatment trial for Type II Diabetes Mellitus
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
lixisenatide
metformin
Arm Description
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.
Greater than or equal than 1.5 g/day as background therapy for 10 weeks
Outcomes
Primary Outcome Measures
Change in plasma triglycerides after 10 weeks of treatment area under-the-time concentration curve between 0 and 480 minutes (AUC0-480 min)
Secondary Outcome Measures
Change from baseline in plasma triglyceride
Change from baseline in plasma cholesterol
Change from baseline in APO B48
Change from baseline in free fatty acid levels
Change from baseline in lipoprotein distribution
Change from baseline in LDL oxidation
Change from baseline in postprandial plasma glucose
Change from baseline in insulin
Change from baseline in C-peptide
Change from baseline in low grade inflammation (cytokines and stress oxidative markers)
Change in baseline coronary flow reserve to assess the effect of lixisenatide on microvascular dysfunction
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02274740
Brief Title
Effect of Lixisenatide on Postprandial Lipid Profile in Obese Type 2 Diabetic Patients
Official Title
Effect of GLP-1 Receptors Agonist Lixisenatide on Postprandial Lipid Profile in Obese Type 2 Diabetic Patients
Study Type
Interventional
2. Study Status
Record Verification Date
January 2017
Overall Recruitment Status
Terminated
Why Stopped
Sponsor decision not related to safety reasons
Study Start Date
April 2015 (undefined)
Primary Completion Date
August 2015 (Actual)
Study Completion Date
August 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sanofi
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
Detailed Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type II Diabetes Mellitus
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
2 (Actual)
8. Arms, Groups, and Interventions
Arm Title
lixisenatide
Arm Type
Experimental
Arm Description
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.
Arm Title
metformin
Arm Type
No Intervention
Arm Description
Greater than or equal than 1.5 g/day as background therapy for 10 weeks
Intervention Type
Drug
Intervention Name(s)
LIXISENATIDE AVE0010
Intervention Description
Pharmaceutical form:solution Route of administration: subcutaneous
Intervention Type
Drug
Intervention Name(s)
metformin
Intervention Description
Pharmaceutical form:tablet Route of administration: oral
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
Change from baseline in plasma triglyceride
Time Frame
2 days after the basal test and after 10 weeks of treatment
Title
Change from baseline in plasma cholesterol
Time Frame
2 days after the basal test and after 10 weeks of treatment
Title
Change from baseline in APO B48
Time Frame
2 days after the basal test and after 10 weeks of treatment
Title
Change from baseline in free fatty acid levels
Time Frame
2 days after the basal test and after 10 weeks of treatment
Title
Change from baseline in lipoprotein distribution
Time Frame
2 days after the basal test and after 10 weeks of treatment
Title
Change from baseline in LDL oxidation
Time Frame
2 days after the basal test and after 10 weeks of treatment
Title
Change from baseline in postprandial plasma glucose
Time Frame
2 days after the basal test and after 10 weeks of treatment
Title
Change from baseline in insulin
Time Frame
2 days after the basal test and after 10 weeks of treatment
Title
Change from baseline in C-peptide
Time Frame
2 days after the basal test and after 10 weeks of treatment
Title
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
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Sciences & Operations
Organizational Affiliation
Sanofi
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
Effect of Lixisenatide on Postprandial Lipid Profile in Obese Type 2 Diabetic Patients
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