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

This study is currently recruiting participants.
Verified April 2014 by Sanofi
Sponsor:
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT01960179
First received: September 27, 2013
Last updated: April 2, 2014
Last verified: April 2014
  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: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Absolute change in HbA1c [ Time Frame: from baseline to week 24 and week 52 ] [ Designated as safety issue: No ]
  • Absolute change in fasting plasma glucose [ Time Frame: from baseline to week 24 and week 52 ] [ Designated as safety issue: No ]
  • Absolute change in body weight [ Time Frame: from baseline to week 24 and week 52 ] [ Designated as safety issue: No ]

Estimated Enrollment: 360
Study Start Date: November 2013
Estimated Study Completion Date: May 2015
Estimated Primary Completion Date: May 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

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01960179

Contacts
Contact: For site information, send an email with site number to Contact-Us@sanofi.com

Locations
Japan
Investigational Site Number 392006 Recruiting
Adachi-Ku, Japan
Investigational Site Number 392005 Recruiting
Chiba-Shi, Japan
Investigational Site Number 392010 Recruiting
Chiyoda-Ku, Japan
Investigational Site Number 392015 Recruiting
Chuo-Ku, Japan
Investigational Site Number 392004 Recruiting
Chuo-Ku, Japan
Investigational Site Number 392003 Recruiting
Chuoh-Ku, Japan
Investigational Site Number 392012 Recruiting
Ebina-Shi, Japan
Investigational Site Number 392024 Recruiting
Higashiosaka-Shi, Japan
Investigational Site Number 392023 Recruiting
Kashiwara-Shi, Japan
Investigational Site Number 392008 Recruiting
Kawagoe-Shi, Japan
Investigational Site Number 392009 Recruiting
Kisarazu-Shi, Japan
Investigational Site Number 392002 Recruiting
Koganei-Shi, Japan
Investigational Site Number 392007 Recruiting
Koriyama-Shi, Japan
Investigational Site Number 392011 Recruiting
Mitaka-Shi, Japan
Investigational Site Number 392026 Recruiting
Nagoya-Shi, Japan
Investigational Site Number 392025 Recruiting
Nagoya-Shi, Japan
Investigational Site Number 392013 Recruiting
Ogawa-Machi, Hikigun, Japan
Investigational Site Number 392014 Recruiting
Ohta-Ku, Japan
Investigational Site Number 392022 Recruiting
Okawa-Shi, Japan
Investigational Site Number 392029 Recruiting
Osaka-Shi, Japan
Investigational Site Number 392028 Recruiting
Osaka-Shi, Japan
Investigational Site Number 392021 Recruiting
Osaka-Shi, Japan
Investigational Site Number 392030 Recruiting
Sapporo-Shi, Japan
Investigational Site Number 392018 Recruiting
Sendai-Shi, Japan
Investigational Site Number 392001 Recruiting
Shinjuku-Ku, Japan
Investigational Site Number 392020 Recruiting
Suita-Shi, Japan
Investigational Site Number 392017 Recruiting
Toshima-Ku, Japan
Investigational Site Number 392027 Recruiting
Toyonaka-Shi, Japan
Investigational Site Number 392016 Recruiting
Yokohama-Shi, Japan
Investigational Site Number 392019 Recruiting
Yokohama-Shi, Japan
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Clinical Sciences & Operations Sanofi
  More Information

No publications provided

Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT01960179     History of Changes
Other Study ID Numbers: SFY13476, U1111-1134-2695
Study First Received: September 27, 2013
Last Updated: April 2, 2014
Health Authority: Japan: Ministry of Health, Labor and Welfare

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

ClinicalTrials.gov processed this record on April 17, 2014