Safety And Tolerability Of Lixisenatide In Monotherapy In Patients With Type 2 Diabetes

NCT ID: NCT01960179

Last Updated: 2015-04-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 361 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-11-30
• Study Completion Date: 2015-03-31

Brief Summary

Primary Objective:

To assess the overall safety of lixisenatide once daily treatment in monotherapy over 24 and 52 weeks in patients with type 2 diabetes in Japan

Secondary Objective:

To assess the effects of lixisenatide once daily treatment in monotherapy over 24 and 52 weeks on:

• HbA1c (Glycated hemoglobin A1c) reduction;
• Fasting plasma glucose;
• Body weight.

Detailed Description

• Group 1: 60 weeks ± 11 days
• Group 2: 32 weeks ± 7 days

Conditions

Type 2 Diabetes Mellitus

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

lixisenatide

lixisenatide monotherapy by group (Group 1: 52-week treatment; Group 2: 24-week treatment)

Group Type: EXPERIMENTAL

lixisenatide AVE0010

Intervention Type: DRUG

Pharmaceutical form:solution Route of administration: Subcutaneous injection

Interventions

lixisenatide AVE0010

Pharmaceutical form:solution Route of administration: Subcutaneous injection

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Patients with type 2 diabetes mellitus diagnosed for at least 2 months.
• Not treated with anti-diabetic drug or treated with a stable dose of 1 oral anti-diabetic drug (OAD) for at least 3 months prior to screening visit. Previous OAD (if any) have to be stopped at Visit 1.1 to be washed out during the run-in period at least for 6 weeks;
• Signed written informed consent.

Exclusion Criteria

• At screening
• age <20 years;
• HbA1c <7% or >9.5% (for patients on OAD <6.5% or >8.5%);
• fasting plasma glucose >250 mg/dL (>13.9 mmol/L);
• Use of more than one OAD within 3 months prior to screening;
• Use of Thiazolidinedione (TZD) within 6 months prior to screening;
• Use of insulin within 3 months prior to screening; Note: Short time use (≤10 days) of insulin due to acute illness or surgery (eg, infectious disease) is allowed.
• Any previous treatment with lixisenatide (eg, participation in a previous study with lixisenatide) or any other GLP-1 receptor agonist;
• Type 1 diabetes mellitus
• Women of childbearing potential with no effective contraceptive method;
• Pregnancy or lactation;
• Laboratory findings at the time of screening:

oAmylase and/or lipase >3 times the upper limit of the normal laboratory range (ULN);

• ALT >3 ULN;
• Calcitonin ≥20 pg/mL (5.9 pmol/L);
• Positive serum pregnancy test in women of childbearing potential;
• History of acute or chronic pancreatitis, pancreatectomy, stomach/gastric surgery, inflammatory bowel disease;
• Personal or immediate family history of medullary thyroid cancer (MTC) or genetic conditions that predispose to MTC (eg, multiple endocrine neoplasia syndromes);
• Allergic reaction to metacresol.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

• Minimum Eligible Age: 20 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

Locations

Investigational Site Number 392006

Adachi-Ku, , Japan

Investigational Site Number 392005

Chiba, , Japan

Investigational Site Number 392010

Chiyoda-Ku, , Japan

Investigational Site Number 392003

Chuoh-Ku, , Japan

Investigational Site Number 392004

Chūōku, , Japan

Investigational Site Number 392015

Chūōku, , Japan

Investigational Site Number 392012

Ebina-Shi, , Japan

Investigational Site Number 392024

Higashiosaka-Shi, , Japan

Investigational Site Number 392023

Kashiwara-Shi, , Japan

Investigational Site Number 392008

Kawagoe-Shi, , Japan

Investigational Site Number 392009

Kisarazu-Shi, , Japan

Investigational Site Number 392002

Koganeishi, , Japan

Investigational Site Number 392007

Koriyama-Shi, , Japan

Investigational Site Number 392011

Mitaka-Shi, , Japan

Investigational Site Number 392025

Nagoya, , Japan

Investigational Site Number 392026

Nagoya, , Japan

Investigational Site Number 392013

Ogawa-Machi, Hikigun, , Japan

Investigational Site Number 392014

Ohta-Ku, , Japan

Investigational Site Number 392022

Okawa-Shi, , Japan

Investigational Site Number 392021

Osaka, , Japan

Investigational Site Number 392028

Osaka, , Japan

Investigational Site Number 392029

Osaka, , Japan

Investigational Site Number 392030

Sapporo, , Japan

Investigational Site Number 392018

Sendai, , Japan

Investigational Site Number 392001

Shinjuku-Ku, , Japan

Investigational Site Number 392020

Suita-Shi, , Japan

Investigational Site Number 392017

Toshima-Ku, , Japan

Investigational Site Number 392027

Toyonaka-Shi, , Japan

Investigational Site Number 392016

Yokohama, , Japan

Investigational Site Number 392019

Yokohama, , Japan

Countries

Japan

Other Identifiers

U1111-1134-2695

Identifier Type: OTHER

Identifier Source: secondary_id

SFY13476

Identifier Type: -

Identifier Source: org_study_id