Lixisenatide for Restoration of Insulin Release in Subjects With Diabetes Mellitus Type 2

Sanofi22 enrolled

Overview

The objective of this study is to test whether Lixisenatide (AVE0010) restores first phase and improves second phase insulin response in subjects with diabetes mellitus type 2.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Diabetes Mellitus, Type 2

Interventions

Lixisenatide (AVE0010)DRUG

Solution for subcutaneous injection 100 µg/mL

PlaceboDRUG

Subcutaneous injection

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Male and female subjects with type 2 diabetes mellitus on diet and exercise with/without metformin * HbA1c\>=6,0 % and \<=8,5 % at screening * BMI 25 to 35 kg/m² * 155\>=BP systolic \>=90 mmHg * 100\>=BP diastolic\>=45 mmHg The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Locations (1)

Sanofi-Aventis Administrative Office

Berlin, Germany

Outcomes

Primary Outcomes

Area under the insulin secretion curve

Time frame: within 10 minutes after I.V. glucose challenge

Secondary Outcomes

Area under the insulin secretion curve

Time frame: within 10 to 120 minutes after I.V. glucose challenge

Data from ClinicalTrials.gov

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