Type 2 Diabetes Mellitus
Conditions
Brief summary
Primary Objective: The primary objective of this study is to assess the overall safety of lixisenatide once daily treatment in combination with background oral anti-diabetic treatment over 52 weeks in patients with type 2 diabetes in Japan. Secondary Objective: To assess the effects of lixisenatide in combination with background oral antidiabetic drug (OAD) on: * HbA1c; * Fasting plasma glucose; * Body weight.
Detailed description
54 weeks +/-11 days
Interventions
Pharmaceutical form:solution Route of administration: Subcutaneous injection
DRUGbiguanide
Pharmaceutical form:tablet Route of administration: oral
DRUGTZD
Pharmaceutical form:tablet Route of administration: oral
DRUGalpha-GI
Pharmaceutical form:tablet Route of administration: oral
DRUGglinide
Pharmaceutical form:tablet Route of administration: oral
Sponsors
Sanofi
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
: * Patients with type 2 diabetes mellitus diagnosed at least 1 year before the screening visit * Patient treated for at least 3 months prior to screening visit with one of following OADs at a stable dose of at least usual maintenance dose as described in the label * a biguanide (metformin hydrochloride); * a thiazolidinedione (TZD) (pioglitazone hydrochloride); * an alpha-glucosidase inhibitor (alpha-GI) (acarbose, voglibose or miglitol); * or a glinide (nateglinide, repaglinide or mitiglinide); * Signed written informed consent
Exclusion criteria
* At screening HbA1c \<7% or \>9.5%; * At screening: fasting plasma glucose \>250 mg/dL (\>13.9 mmol/L); * Use of any glucose-lowering agent(s) other than the authorized patient's background treatment defined in I02 (as given in inclusion critieria) within 3 months prior to screening; * Type 1 diabetes mellitus; * Women of childbearing potential with no effective contraceptive method; * Pregnancy or lactation; * Laboratory findings at the time of screening: * Amylase and/or lipase \>3 times the upper limit of the normal laboratory range (ULN); * ALT \>3 ULN; * Any contra-indication to the patient's background oral anti-diabetic treatment; * 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); * Any previous treatment with lixisenatide (eg, participation in a previous study with lixisenatide) or any other GLP1 receptor agonist. 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 52 weeks assessed by treatment emergent adverse event (TEAE), vital signs, 12-lead electrocardiogram (ECG), and laboratory data | 52 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Absolute change in HbA1c | From baseline to weeks 24 and 52 |
| Absolute change in fasting plasma glucose | From baseline to weeks 24 and 52 |
| Absolute change in body weight | From baseline to weeks 24 and 52 |
Countries
Japan
Outcome results
None listed