Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 14 of 61 for:    Lixisenatide

Effect of Lixisenatide on Postprandial Lipid Profile in Obese Type 2 Diabetic Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02274740
Recruitment Status : Terminated (Sponsor decision not related to safety reasons)
First Posted : October 24, 2014
Last Update Posted : January 30, 2017
Sponsor:
Information provided by (Responsible Party):
Sanofi

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.


Condition or disease Intervention/treatment Phase
Type II Diabetes Mellitus Drug: LIXISENATIDE AVE0010 Drug: metformin Phase 2

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).

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of GLP-1 Receptors Agonist Lixisenatide on Postprandial Lipid Profile in Obese Type 2 Diabetic Patients
Study Start Date : April 2015
Actual Primary Completion Date : August 2015
Actual Study Completion Date : August 2015

Resource links provided by the National Library of Medicine


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.

Drug: LIXISENATIDE AVE0010
Pharmaceutical form:solution Route of administration: subcutaneous

Drug: metformin
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



Primary Outcome Measures :
  1. 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 Measures :
  1. Change from baseline in plasma triglyceride [ Time Frame: 2 days after the basal test and after 10 weeks of treatment ]
  2. Change from baseline in plasma cholesterol [ Time Frame: 2 days after the basal test and after 10 weeks of treatment ]
  3. Change from baseline in APO B48 [ Time Frame: 2 days after the basal test and after 10 weeks of treatment ]
  4. Change from baseline in free fatty acid levels [ Time Frame: 2 days after the basal test and after 10 weeks of treatment ]
  5. Change from baseline in lipoprotein distribution [ Time Frame: 2 days after the basal test and after 10 weeks of treatment ]
  6. Change from baseline in LDL oxidation [ Time Frame: 2 days after the basal test and after 10 weeks of treatment ]
  7. Change from baseline in postprandial plasma glucose [ Time Frame: 2 days after the basal test and after 10 weeks of treatment ]
  8. Change from baseline in insulin [ Time Frame: 2 days after the basal test and after 10 weeks of treatment ]
  9. Change from baseline in C-peptide [ Time Frame: 2 days after the basal test and after 10 weeks of treatment ]
  10. 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 ]
  11. 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 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02274740


Sponsors and Collaborators
Sanofi
Investigators
Layout table for investigator information
Study Director: Clinical Sciences & Operations Sanofi

Layout table for additonal information
Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT02274740     History of Changes
Other Study ID Numbers: LIXISL07016
U1111-1153-3774 ( Other Identifier: UTN )
First Posted: October 24, 2014    Key Record Dates
Last Update Posted: January 30, 2017
Last Verified: January 2017

Additional relevant MeSH terms:
Layout table for MeSH terms
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Metformin
Lixisenatide
Hypoglycemic Agents
Physiological Effects of Drugs