Trial record 2 of 13 for:    lixisenatide | Open Studies

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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified October 2014 by Sanofi
Sponsor:
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT02274740
First received: October 17, 2014
Last updated: October 22, 2014
Last verified: October 2014
  Purpose

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 Intervention Phase
Type II Diabetes Mellitus
Drug: LIXISENATIDE AVE0010
Drug: metformin
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effect of GLP-1 Receptors Agonist Lixisenatide on Postprandial Lipid Profile in Obese Type 2 Diabetic Patients

Resource links provided by NLM:


Further study details as provided by Sanofi:

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) [ Time Frame: After 10 weeks of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from baseline in plasma triglyceride [ Time Frame: 2 days after the basal test and after 10 weeks of treatment ] [ Designated as safety issue: No ]
  • Change from baseline in plasma cholesterol [ Time Frame: 2 days after the basal test and after 10 weeks of treatment ] [ Designated as safety issue: No ]
  • Change from baseline in APO B48 [ Time Frame: 2 days after the basal test and after 10 weeks of treatment ] [ Designated as safety issue: No ]
  • Change from baseline in free fatty acid levels [ Time Frame: 2 days after the basal test and after 10 weeks of treatment ] [ Designated as safety issue: No ]
  • Change from baseline in lipoprotein distribution [ Time Frame: 2 days after the basal test and after 10 weeks of treatment ] [ Designated as safety issue: No ]
  • Change from baseline in LDL oxidation [ Time Frame: 2 days after the basal test and after 10 weeks of treatment ] [ Designated as safety issue: No ]
  • Change from baseline in postprandial plasma glucose [ Time Frame: 2 days after the basal test and after 10 weeks of treatment ] [ Designated as safety issue: No ]
  • Change from baseline in insulin [ Time Frame: 2 days after the basal test and after 10 weeks of treatment ] [ Designated as safety issue: No ]
  • Change from baseline in C-peptide [ Time Frame: 2 days after the basal test and after 10 weeks of treatment ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 36
Study Start Date: December 2014
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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).

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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&apos;s potential participation in a clinical trial.

  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02274740

Contacts
Contact: Trial Transparency Team Contact-US@sanofi.com

Sponsors and Collaborators
Sanofi
Investigators
Study Director: Clinical Sciences & Operations Sanofi
  More Information

No publications provided

Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT02274740     History of Changes
Other Study ID Numbers: LIXISL07016, U1111-1153-3774
Study First Received: October 17, 2014
Last Updated: October 22, 2014
Health Authority: Italy: The Italian Medicines Agency

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

ClinicalTrials.gov processed this record on October 23, 2014