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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01960179
First Posted: October 10, 2013
Last Update Posted: April 9, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Sanofi
  Purpose

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.

Condition Intervention Phase
Type 2 Diabetes Mellitus Drug: lixisenatide AVE0010 Phase 3

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • Absolute change in HbA1c [ Time Frame: from baseline to week 24 and week 52 ]
  • Absolute change in fasting plasma glucose [ Time Frame: from baseline to week 24 and week 52 ]
  • Absolute change in body weight [ Time Frame: from baseline to week 24 and week 52 ]

Enrollment: 361
Study Start Date: November 2013
Study Completion Date: March 2015
Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01960179


Locations
Japan
Investigational Site Number 392006
Adachi-Ku, Japan
Investigational Site Number 392005
Chiba-Shi, Japan
Investigational Site Number 392010
Chiyoda-Ku, Japan
Investigational Site Number 392004
Chuo-Ku, Japan
Investigational Site Number 392015
Chuo-Ku, Japan
Investigational Site Number 392003
Chuoh-Ku, 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
Koganei-Shi, Japan
Investigational Site Number 392007
Koriyama-Shi, Japan
Investigational Site Number 392011
Mitaka-Shi, Japan
Investigational Site Number 392025
Nagoya-Shi, Japan
Investigational Site Number 392026
Nagoya-Shi, 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-Shi, Japan
Investigational Site Number 392028
Osaka-Shi, Japan
Investigational Site Number 392029
Osaka-Shi, Japan
Investigational Site Number 392030
Sapporo-Shi, Japan
Investigational Site Number 392018
Sendai-Shi, 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-Shi, Japan
Investigational Site Number 392019
Yokohama-Shi, Japan
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Clinical Sciences & Operations Sanofi
  More Information

Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT01960179     History of Changes
Other Study ID Numbers: SFY13476
U1111-1134-2695 ( Other Identifier: UTN )
First Submitted: September 27, 2013
First Posted: October 10, 2013
Last Update Posted: April 9, 2015
Last Verified: April 2015

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases