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

Sanofi

Status and phase: Completed; Phase 3

Conditions: Type 2 Diabetes Mellitus

Treatments: Drug: lixisenatide AVE0010

Study type: Interventional

Funder types: Industry

Identifiers

NCT01960179

SFY13476

U1111-1134-2695 (Other Identifier)

Details and patient eligibility

About

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.

Full description

• Group 1: 60 weeks ± 11 days
• Group 2: 32 weeks ± 7 days

Enrollment: 361 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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361 participants in 1 patient group

lixisenatide

Experimental group

Description:

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

Treatment:

Drug: lixisenatide AVE0010