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

• Status: Completed
• Trial end date: 2015-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sanofi
• Treatments: Lixisenatide

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.