A randomized, open-label, active-controlled, 2-arm parallel-group, multicenter 24-week study followed by an extension assessing the efficacy and safety of AVE0010 versus exenatide on top of metformin in patients with type 2 diabetes not adequately controlled with metformin----------------------------------------------------------------------------------------------------------Estudio multicéntrico, de 24 semanas seguido por una extensión, aleatorizado, abierto, con control activo y con 2 grupos paralelos,para evaluar la eficacia y seguridad de AVE0010 en comparación con exenatida añadida a metformina en pacientes con diabetes tipo 2 no controlados adecuadamente con metformina” - GETGOAL-X

• Conditions: Type II Diabetes---------------------Diabetes tipo II; MedDRA version: 10.1Level: LLTClassification code 10067585Term: <Manually entered code. Term in E.1.1>

• Registration Number: EUCTR2007-005883-28-ES
• Lead Sponsor: Sanofi-Aventis Recherche & Développement

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-04-28
• Last Update Posted: 24 April 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 600

Inclusion Criteria

Patients meeting all of the following inclusion criteria will be screened:
- Patients with type 2 diabetes mellitus, as defined by fasting plasma glucose = 7 mmol/L (126 mg/dL) or 2 hours postprandial plasma glucose = 11.1 mmol/L (200 mg/dL), and 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

Patients presenting with any of the following criteria cannot be included in the study:
• Exclusion criteria related to study methodology:
- HbA1c < 7.0% or HbA1c >10% at screening
- At the time of screening age < legal age of majority
- Women of childbearing potential with no effective contraceptive method (women of
childbearing potential (pre-menopausal, not surgically sterile for at least 3 months prior to the time of screening) must have a confirmed negative serum ß-hCG pregnancy test at screening Visit. They must use an effective contraceptive method throughout the study, and accept to repeat serum ß-HCG pregnancy test at designated visits)
- Type 1 diabetes mellitus
- Treatment with another antidiabetic pharmacological agent than metformin within the three months preceding the screening
- Fasting Plasma Glucose at screening > 250 mg/dL (> 13.9 mmol/L)
- Body Mass Index (BMI) =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 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 inappropriate for this study for any reason (e.g. impossibility to meet specific protocol requirements, such as attending scheduled visits, being able to do self-injections; 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 invo

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified