Type II Diabetes MedDRA version: 10.1 Level: LLT Classification code 10067585 Term:
Conditions
Sponsors
Sanofi-Aventis Recherche & Développement
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients meeting all the following inclusion criteria will be screened: - Patients with type 2 diabetes mellitus, as defined by WHO (Fasting plasma glucose = 7 mmol/L (126 mg/dL) or 2 hours postprandial plasma glucose = 11.1 mmol/L (200 mg/dL)), diagnosed for at least 1 year at the time of screening visit, insufficiently controlled with metformin at a stable dose of at least 1.5 g/day for at least 3 months prior to screening visit. - Written informed consent obtained. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Related to study methodo: - HbA1c 10% at screening - At the time of screening age 250 mg/dL (> 13.9 mmol/L) - Body Mass Index =20 kg/m2 - Weight change of more than 5 kg during the 3 months preceding the screening visit - History of unexplained pancreatitis, chronic pancreatitis, pancreatectomy, stomach/gastric surgery, inflammatory bowel disease - History of metabolic acidosis, including diabetic ketoacidosis within 1 year prior to screening - Hemoglobinopathy or hemolytic anemia, receipt of blood or plasma products within 3 months prior to the time of screening - Within the last 6 months prior to screening: history of myocardial infarction, stroke, or heart failure requiring hospitalization - Known history of drug or alcohol abuse within 6 months prior to the time of screening - Cardiovascular, hepatic, neurological, endocrine disease, active malignant tumor or other major systemic disease or patients with short life expectancy making implementation of the protocol or interpretation of the study results difficult, history or presence of clinically significant diabetic retinopathy, history or presence of macular edema likely to require laser treatment within the study period - Uncontrolled or inadequately controlled hypertension at the time of screening with a resting supine systolic or diastolic blood pressure > 180 mmHg or > 95 mmHg, respectively - Laboratory findings at the time of screening: AST, ALT or ALP: > 2 times the upper limit of the normal laboratory range, Amylase and/or lipase > 3 times the upper limit of the normal laboratory range, Total bilirubin: > 1.5 times the upper limit of the normal laboratory range (except in case of Gilbert’s syndrome), Hemoglobin < 11 g/dL and/or neutrophils < 1,500/mm3 and/or platelets < 100,000/mm3, Positive test for Hepatitis B surface antigen and/or Hepatitis C antibody, Positive serum pregnancy test in females of childbearing potential - Any clinically significant abnormality identified on physical examination, laboratory tests, ECG or vital signs at the time of screening that in the judgment of the investigator or any sub investigator would preclude safe completion of the study or constrains efficacy assessment - Patients considered by the investigator or any sub-investigator as inappropriatefor this study for any reason (e.g. impossibility to meet specific protocol requirements, such as scheduled visits, being able to do self-injections, etc), likelihood of requiring treatment during the screening phase and treatment phase with drugs not permitted by the clinical study protocol; investigator or any sub-investigator, pharmacist, study coordinator, other study staff or relative thereof directly involved in the conduct of the protocol, etc.) - Use of oral or injectable antidiabetic or hypoglycemic agents other than metformin (e.g., sulfonylurea, alpha gl
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to assess the effects of AVE0010 as an add-on treatment to metformin on glycemic control using a two-step dose titration regimen in comparison to placebo in terms of HbA1c reduction (absolute change) over a period of 24 weeks in patients with type 2 diabetes.;Secondary Objective: The secondary objectives of this study are: • To assess the effects of AVE0010 on: - Glycemic control in comparison to placebo in terms of HbA1c reduction when it is used in a one-step dose titration regimen, - Percentage of patients reaching HbA1c <7% or HbA1c<6.5%, - Body weight, - Fasting plasma glucose, • To assess AVE0010 safety and tolerability, • To assess AVE0010 PK and anti-AVE0010 antibody development.;Primary end point(s): Absolute change of HbA1c from baseline to week 24. | — |
Countries
Estonia, Germany, Italy, Lithuania, Slovakia
Outcome results
None listed