Clinical trial NCT01960179: Safety And Tolerability Of Lixisenatide In Monotherapy In Patients With Type 2 Diabetes
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Type 2 Diabetes Mellitus
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2013-10-10
Enrollment: 361
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Detailed description: * Group 1: 60 weeks ± 11 days
* Group 2: 32 weeks ± 7 days

Eligibility 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.

Primary outcomes:
measure: Safety over 24 and 52 weeks assessed by treatment emergent adverse event (TEAE), vital signs, 12-lead electrocardiogram (ECG), and laboratory data.
timeFrame: from baseline to 24 weeks and 52 weeks
Secondary outcomes:
measure: Absolute change in HbA1c
timeFrame: from baseline to week 24 and week 52
measure: Absolute change in fasting plasma glucose
timeFrame: from baseline to week 24 and week 52
measure: Absolute change in body weight
timeFrame: from baseline to week 24 and week 52
Other outcomes:
Locations:
city: Adachi-Ku
country: Japan
facility: Investigational Site Number 392006
city: Chiba-Shi
country: Japan
facility: Investigational Site Number 392005
city: Chiyoda-Ku
country: Japan
facility: Investigational Site Number 392010
city: Chuo-Ku
country: Japan
facility: Investigational Site Number 392004
city: Chuo-Ku
country: Japan
facility: Investigational Site Number 392015
city: Chuoh-Ku
country: Japan
facility: Investigational Site Number 392003
city: Ebina-Shi
country: Japan
facility: Investigational Site Number 392012
city: Higashiosaka-Shi
country: Japan
facility: Investigational Site Number 392024
city: Kashiwara-Shi
country: Japan
facility: Investigational Site Number 392023
city: Kawagoe-Shi
country: Japan
facility: Investigational Site Number 392008
city: Kisarazu-Shi
country: Japan
facility: Investigational Site Number 392009
city: Koganei-Shi
country: Japan
facility: Investigational Site Number 392002
city: Koriyama-Shi
country: Japan
facility: Investigational Site Number 392007
city: Mitaka-Shi
country: Japan
facility: Investigational Site Number 392011
city: Nagoya-Shi
country: Japan
facility: Investigational Site Number 392025
city: Nagoya-Shi
country: Japan
facility: Investigational Site Number 392026
city: Ogawa-Machi, Hikigun
country: Japan
facility: Investigational Site Number 392013
city: Ohta-Ku
country: Japan
facility: Investigational Site Number 392014
city: Okawa-Shi
country: Japan
facility: Investigational Site Number 392022
city: Osaka-Shi
country: Japan
facility: Investigational Site Number 392021
city: Osaka-Shi
country: Japan
facility: Investigational Site Number 392028
city: Osaka-Shi
country: Japan
facility: Investigational Site Number 392029
city: Sapporo-Shi
country: Japan
facility: Investigational Site Number 392030
city: Sendai-Shi
country: Japan
facility: Investigational Site Number 392018
city: Shinjuku-Ku
country: Japan
facility: Investigational Site Number 392001
city: Suita-Shi
country: Japan
facility: Investigational Site Number 392020
city: Toshima-Ku
country: Japan
facility: Investigational Site Number 392017
city: Toyonaka-Shi
country: Japan
facility: Investigational Site Number 392027
city: Yokohama-Shi
country: Japan
facility: Investigational Site Number 392016
city: Yokohama-Shi
country: Japan
facility: Investigational Site Number 392019
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References: