A randomized, double-blind, placebo-controlled, 2-arm parallel-group, multicenter 24-week study followed by an extension assessing the efficacy and safety of AVE0010 on top of a sulfonylurea in patients with type 2 diabetes not adequately controlled with sulfonylurea - GETGOAL-S
- Conditions
- Type II DiabetesMedDRA version: 10.1Level: LLTClassification code 10067585Term: <Manually entered code. Term in E.1.1>
- Registration Number
- EUCTR2007-005881-11-CZ
- Lead Sponsor
- Sanofi-Aventis Recherche&Développement
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 855
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 before screening visit, insufficiently controlled with a sulfonylurea alone or with sulfonylurea in association with metformin
- 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
;
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 before screening visit, insufficiently controlled with a sulfonylurea alone or with sulfonylurea in association with metformin
- 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
•Related to study methodo:
- 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 women 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 agree to repeat serum ß-HCG pregnancy test at designated visits)
- Type 1 diabetes mellitus
- Sulfonylurea less than the max effective dose according to local labeling
- Sulfonylurea not at a stable dose for at least 3 months prior to screening
- In case of treatment with metformin in association with sulfonylurea, no stable treatment with metformin of at least 1.5 g/day (except at least 0.75 g/day in JP and at least 1.0 g/day in KR), for at least 3 months prior to screening visit
- Fasting Plasma Glucose at screening >250 mg/dL (>13.9 mmol/L)
- History of hypoglycemia unawareness
- 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 proto 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 < 1500/mm3 and/or platelets <100 000/mm3, Positive test for Hepatitis B surface antigen and/or Hepatitis C antibody
- Any clinically significant abnormality identified on physical examination, laboratory tests 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 (eg, impossibility to meet specific proto requirements, such as scheduled visits, being able to do self-injections, other study staff or relative thereof directly involved in the conduct of the proto...)
- Patients with condition/concomitant diseases making them non evaluable for the efficacy assessment
- Us;
•Related to study methodo:
- 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 women 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 agree to repeat serum ß-HCG pregnancy test at designated visits)
- Type 1 diabetes mellitus
- Sulfonylurea less than the max effective dose according to local labeling
- Sulfonylurea not at a stable dose for at least 3 months prior to screening
- In case of treatment with metformin in association with sulfonylurea, no stable treatment with metformin of at least 1.5 g/day (except at least 0.75 g/day in JP and at least 1.0 g/day in KR), for at least 3 months prior to screening visit
- Fasting Plasma Glucose at screening >250 mg/dL (>13.9 mmol/L)
- History of hypoglycemia unawareness
- 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 proto 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 < 1500/mm3 and/or platelets <100 000/mm3, Positive test for Hepatitis B surface antigen and/or Hepatitis C antibody
- Any clinically significant abnormality identified on physical examination, laboratory tests 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 (eg, impossibility to meet specific proto requirements, such as scheduled visits, being able to do self-injections, other study staff or relative thereof directly involved in the conduct of the proto...)
- Patients with condition/concomitant diseases making them non evaluable for the efficacy assessment
- Us
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method