Type 2 Diabetes Mellitus
Conditions
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
Interventions
Pharmaceutical form:solution Route of administration: Subcutaneous injection
Sponsors
Sanofi
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | 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
| Measure | 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 |
Countries
Japan
Outcome results
None listed