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: 10.1Level: LLTClassification code 10067585Term: <Manually entered code. Term in E.1.1>

• Registration Number: EUCTR2007-005886-36-GB
• Lead Sponsor: Sanofi -Aventis Recherche & Développement

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-12-17
• 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 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. - Use of other oral or injectable antid

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary objective of this study is to assess the efficacy of AVE0010 on glycemic control in comparison to placebo as an add-on treatment to basal insulin in Type 2 Diabetes patients treated with basal insulin in terms of absolute HbA1c reduction over a period of 24 weeks.;Secondary Objective: The secondary objectives of this study are: To assess the effects of AVE0010 on • Body weight, • 2-hour postprandial plasma glucose after standardized meal challenge test, • Percentage of patients reaching HbA1c <7%, • Percentage of patients reaching HbA1c =6.5%, • Fasting Plasma Glucose (FPG), • Change in 7-point Self Monitored Plasma Glucose (SMPG) profiles, • Change in basal insulin and total insulin doses. To assess AVE0010 safety and tolerability. To assess AVE0010 PK. To assess anti-AVE0010 antibody development.;Primary end point(s): Absolute change of HbA1c from baseline to week 24.