A randomized, double-blind, placebo-controlled, 2-arm parallel-group, multicenter study with a 24-week main treatment period and an extension assessing the efficacy and safety of AVE0010 on top of pioglitazone in patients with type 2 diabetes not adequately controlled with pioglitazone. - GETGOAL-P

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

• Registration Number: EUCTR2007-005884-92-GR
• Lead Sponsor: Sanofi-Aventis Recherche & Développement

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-01-30
• Last Update Posted: 3 September 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 450

Inclusion Criteria

• 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 the screening visit, insufficiently controlled with pioglitazone.

• 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

• Related to study methodo
- HbA1c <7.0 % or HbA1c >10 % at screening.
- At the time of screening age - 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.
- No stable treatment with pioglitazone at a stable dose of at least 30 mg/day for at least 3 months prior to screening.
- If treatment with metformin: no stable dose of at least 1.5 g/day for at least 3 months prior to screening visit.
- Fasting Plasma Glucose at screening >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 or stroke.
- 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 proto requirements, such as scheduled visits, being able to do self-injections...).
- Use of other oral or injectable antidiabetic or hypoglycemic agents other than metformin or pioglitazone (e.g., sulfonylurea, alpha glucosidase inhibitor, other thiazolidinediones, rimonabant, exenatide,...) within 3 months prior to the time of screening.
- Use of systemic glucocorticoids (excluding topical application or inhaled forms

Study & Design

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