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

Study Overview
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Brief Summary
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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
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Group 1: 60 weeks ± 11 days Group 2: 32 weeks ± 7 days

Official Title
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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

Conditions
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Type 2 Diabetes Mellitus

Intervention / Treatment
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* Drug: lixisenatide AVE0010


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: lixisenatide<br>lixisenatide monotherapy by group (Group 1: 52-week treatment; Group 2: 24-week treatment) | Drug: lixisenatide AVE0010<br>* Pharmaceutical form:solution Route of administration: Subcutaneous injection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |