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

NCT01960179 | Completed Phase 3

• 2 other identifiers: SFY13476U1111-1134-2695
• Study Type: interventional
• Target: 361
• Locations: 1 country
• Sites: 30

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.

Conditions

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• Safety over 24 and 52 weeks assessed by treatment emergent adverse event (TEAE), vital signs, 12-lead electrocardiogram (ECG), and laboratory data.

  from baseline to 24 weeks and 52 weeks

Secondary Outcomes (3)

• Absolute change in HbA1c

  from baseline to week 24 and week 52

• Absolute change in fasting plasma glucose

  from baseline to week 24 and week 52

• Absolute change in body weight

  from baseline to week 24 and week 52

Study Arms (1)

lixisenatide

EXPERIMENTAL

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

Drug: lixisenatide AVE0010

Interventions

lixisenatide AVE0010 DRUG

Pharmaceutical form:solution Route of administration: Subcutaneous injection

lixisenatide

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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);

Sponsors & Collaborators

• Sanofi: lead

Study Sites (30)

Investigational Site Number 392006

Adachi-Ku, Japan

Location

Investigational Site Number 392005

Chiba, Japan

Location

Investigational Site Number 392010

Chiyoda-Ku, Japan

Location

Investigational Site Number 392003

Chuoh-Ku, Japan

Location

Investigational Site Number 392004

Chūōku, Japan

Location

Investigational Site Number 392015

Chūōku, Japan

Location

Investigational Site Number 392012

Ebina-Shi, Japan

Location

Investigational Site Number 392024

Higashiosaka-Shi, Japan

Location

Investigational Site Number 392023

Kashiwara-Shi, Japan

Location

Investigational Site Number 392008

Kawagoe-Shi, Japan

Location

Investigational Site Number 392009

Kisarazu-Shi, Japan

Location

Investigational Site Number 392002

Koganeishi, Japan

Location

Investigational Site Number 392007

Koriyama-Shi, Japan

Location

Investigational Site Number 392011

Mitaka-Shi, Japan

Location

Investigational Site Number 392025

Nagoya, Japan

Location

Investigational Site Number 392026

Nagoya, Japan

Location

Investigational Site Number 392013

Ogawa-Machi, Hikigun, Japan

Location

Investigational Site Number 392014

Ohta-Ku, Japan

Location

Investigational Site Number 392022

Okawa-Shi, Japan

Location

Investigational Site Number 392021

Osaka, Japan

Location

Investigational Site Number 392028

Osaka, Japan

Location

Investigational Site Number 392029

Osaka, Japan

Location

Investigational Site Number 392030

Sapporo, Japan

Location

Investigational Site Number 392018

Sendai, Japan

Location

Investigational Site Number 392001

Shinjuku-Ku, Japan

Location

Investigational Site Number 392020

Suita-Shi, Japan

Location

Investigational Site Number 392017

Toshima-Ku, Japan

Location

Investigational Site Number 392027

Toyonaka-Shi, Japan

Location

Investigational Site Number 392016

Yokohama, Japan

Location

Investigational Site Number 392019

Yokohama, Japan

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

lixisenatide

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Clinical Sciences & Operations

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 27, 2013
• First Posted: October 10, 2013
• Study Start: November 1, 2013
• Primary Completion: March 1, 2015
• Study Completion: March 1, 2015
• Last Updated: April 9, 2015

Record last verified: 2015-04

Locations

JP (30)