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

NCT ID: NCT02274740

Last Updated: 2017-01-30

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 2 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-04-30
• Study Completion Date: 2015-08-31

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).

Conditions

Type II Diabetes Mellitus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

LIXISENATIDE AVE0010

Intervention Type: DRUG

Pharmaceutical form:solution Route of administration: subcutaneous

metformin

Intervention Type: DRUG

Pharmaceutical form:tablet Route of administration: oral

metformin

Greater than or equal than 1.5 g/day as background therapy for 10 weeks

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

LIXISENATIDE AVE0010

Pharmaceutical form:solution Route of administration: subcutaneous

Intervention Type: DRUG

metformin

Pharmaceutical form:tablet Route of administration: oral

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sanofi

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Sciences & Operations

Role: STUDY_DIRECTOR

Sanofi

Other Identifiers

U1111-1153-3774

Identifier Type: OTHER

Identifier Source: secondary_id

LIXISL07016

Identifier Type: -

Identifier Source: org_study_id