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

Type 2 Diabetes Mellitus Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01960179
• Other study ID #: SFY13476
• Secondary ID: U1111-1134-2695
• Status: Completed
• Phase: Phase 3
• First received: September 27, 2013
• Last updated: April 8, 2015
• Start date: November 2013
• Est. completion date: March 2015

Study information

• Verified date: April 2015
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial 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.

Description:

• Group 1: 60 weeks ± 11 days

• Group 2: 32 weeks ± 7 days

Recruitment information / eligibility

• Status: Completed
• Enrollment: 361
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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.

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Drug:
• lixisenatide AVE0010
Pharmaceutical form:solution Route of administration: Subcutaneous injection

Locations

Country	Name	City	State
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

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Absolute change in HbA1c		from baseline to week 24 and week 52	No
Secondary	Absolute change in fasting plasma glucose		from baseline to week 24 and week 52	No
Secondary	Absolute change in body weight		from baseline to week 24 and week 52	No