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

April 8, 2015 updated by: Sanofi

An Open-label, Multicenter 24-Week And 52-Week Study Assessing The Safety And Tolerability Of Lixisenatide In Monotherapy In Patients With Type 2 Diabetes

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

361

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Adachi-Ku, Japan
        • Investigational Site Number 392006
      • Chiba-Shi, Japan
        • Investigational Site Number 392005
      • Chiyoda-Ku, Japan
        • Investigational Site Number 392010
      • Chuo-Ku, Japan
        • Investigational Site Number 392004
      • Chuo-Ku, Japan
        • Investigational Site Number 392015
      • Chuoh-Ku, Japan
        • Investigational Site Number 392003
      • Ebina-Shi, Japan
        • Investigational Site Number 392012
      • Higashiosaka-Shi, Japan
        • Investigational Site Number 392024
      • Kashiwara-Shi, Japan
        • Investigational Site Number 392023
      • Kawagoe-Shi, Japan
        • Investigational Site Number 392008
      • Kisarazu-Shi, Japan
        • Investigational Site Number 392009
      • Koganei-Shi, Japan
        • Investigational Site Number 392002
      • Koriyama-Shi, Japan
        • Investigational Site Number 392007
      • Mitaka-Shi, Japan
        • Investigational Site Number 392011
      • Nagoya-Shi, Japan
        • Investigational Site Number 392025
      • Nagoya-Shi, Japan
        • Investigational Site Number 392026
      • Ogawa-Machi, Hikigun, Japan
        • Investigational Site Number 392013
      • Ohta-Ku, Japan
        • Investigational Site Number 392014
      • Okawa-Shi, Japan
        • Investigational Site Number 392022
      • Osaka-Shi, Japan
        • Investigational Site Number 392021
      • Osaka-Shi, Japan
        • Investigational Site Number 392028
      • Osaka-Shi, Japan
        • Investigational Site Number 392029
      • Sapporo-Shi, Japan
        • Investigational Site Number 392030
      • Sendai-Shi, Japan
        • Investigational Site Number 392018
      • Shinjuku-Ku, Japan
        • Investigational Site Number 392001
      • Suita-Shi, Japan
        • Investigational Site Number 392020
      • Toshima-Ku, Japan
        • Investigational Site Number 392017
      • Toyonaka-Shi, Japan
        • Investigational Site Number 392027
      • Yokohama-Shi, Japan
        • Investigational Site Number 392016
      • Yokohama-Shi, Japan
        • Investigational Site Number 392019

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: lixisenatide
lixisenatide monotherapy by group (Group 1: 52-week treatment; Group 2: 24-week treatment)
Drug: lixisenatide AVE0010
Pharmaceutical form:solution Route of administration: Subcutaneous injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Safety over 24 and 52 weeks assessed by treatment emergent adverse event (TEAE), vital signs, 12-lead electrocardiogram (ECG), and laboratory data.
Time Frame: from baseline to 24 weeks and 52 weeks
from baseline to 24 weeks and 52 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Absolute change in HbA1c
Time Frame: from baseline to week 24 and week 52
from baseline to week 24 and week 52
Absolute change in fasting plasma glucose
Time Frame: from baseline to week 24 and week 52
from baseline to week 24 and week 52
Absolute change in body weight
Time Frame: from baseline to week 24 and week 52
from baseline to week 24 and week 52

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sanofi

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2013

Primary Completion (Actual)

March 1, 2015

Study Completion (Actual)

March 1, 2015

Study Registration Dates

First Submitted

September 27, 2013

First Submitted That Met QC Criteria

October 8, 2013

First Posted (Estimate)

October 10, 2013

Study Record Updates

Last Update Posted (Estimate)

April 9, 2015

Last Update Submitted That Met QC Criteria

April 8, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SFY13476
  • U1111-1134-2695 (Other Identifier: UTN)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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