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 in patients with Type 2 diabetes insufficiently controlled with basal insulin. - GETGOAL

• Conditions: Type II Diabetes; MedDRA version: 9.1Level: LLTClassification code 10045242Term: Type II diabetes mellitus

• Registration Number: EUCTR2007-005886-36-IT
• Lead Sponsor: Sanofi -Aventis Recherche & De'veloppement

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-09-29
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

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

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 the screening visit, insufficiently controlled with basal insulin, i.e. the clinical need of treatment intensification with a short-acting insulin or the inability to increase the baseline basal insulin dose due to hypoglycemia. 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 will not 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 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 MI, 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.- Use of other oral or injectable antidiabetic or hypoglycemic agents other than metformin or basal insulin within 3 months prior to the time of screening. - Use of systemic glucocorticoids (excluding topical application or inhaled forms) for one week or more within 3 months prior to the time of screening. - Use of any investigational drug within 3 months prior to screening. - Pregnancy, lactation. - Any previous treatment with AVE0010 or participation in a previous study with AVE0010. Exclusion criteria related to background therapy (i.e. metformin). - Renal impairment defined with Creatinine >1.4 mg/dL in women and Creatinine >1.5 mg/dL in men (applicable only for patients with metformin treatment). Exclusion criteria related to AVE0010 - End-stage renal disease defined by a serum

Study & Design

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