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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Sanofi
Sponsor:
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT01960179
First received: September 27, 2013
Last updated: May 15, 2014
Last verified: May 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: March 2015
Estimated 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

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
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, see Learn About Clinical Studies.

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: May 15, 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 August 28, 2014