Type 2 diabetes MedDRA version: 8.1 Level: LLT Classification code 10045242
Conditions
Interventions
Product Name: NA
Product Code: AVE2268
Pharmaceutical Form: Film-coated tablet
CAS Number: 647834-15-9
Current Sponsor code: AVE2268
Other descriptive name: (3-(2-(4-methoxybenzyl)-thiophenyl)-ß-D-glu
Sponsors
Sanofi-Synthelabo Recherche
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: ·Male or female patients aged = 18 years and =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Modification of metformin treatment within 3 months prior to screening visit. - BMI >40kg/m2 - Administration of other investigational drugs within 60 days prior to screening visit. -Presence of any clinically significant endocrine disease (other than type 2 diabetes). Note: euthyroid patients on replacement therapy can be included if the dosage of thyroxine is stable for at least 3 months prior to screening visit - Diabetes other than type 2 diabetes - Subjects with “brittle-diabetes” or any hospitalization or emergency room visit due to poor diabetic control within the past 6 months, previous history of diabetes related dehydration leading to hospitalization, history or evidence of ketoacidosis - Presence or history of cancer within the past five years with the exception of adequately treated localized basal skin cancer or in situ uterine cervical cancer - History or presence of pancreatitis - Evidence of clinically relevant uncontrolled hypertension - Evidence within the past 6 months of myocardial infarction, stroke, retinopathy requiring laser surgery, or heart failure requiring hospitalization - Positive test for hepatitis B surface antigen and/or hepatitis C antibody - Impaired hepatic tests as shown but not limited to ALT, AST > 3 x ULN, AP > 2 x ULN and Bilirubin >1.5 x ULN If Bilirubin is >1.5 ULN, and all other liver parameters are within the limits described above, a measurement of direct and indirect Bilirubin will be done to diagnose a potential Gilbert's disease which will not be an exclusion criteria - Impaired renal function, as shown but not limited to creatinine clearance 1g/24h or presence at screening of a protein : creatinine ratio > 0.7 (g protein: mmol creatinine) in the absence of excessive exercise - Presence of urinary tract infection at screening - Presence of any clinically significant abnormality in blood or urinary laboratory tests performed at screening - Presence of any clinically significant abnormality on the ECG performed at the screening visit - Treatment with other antidiabetic agents (including insulin) other than metformin in the last 3 months before study entry - Prolonged use (more than 10 days) of systemic corticosteroids (or if daily dosage> 1000 µg equivalent beclomethasone) within the past 3 months or administration of systemic long-acting corticosteroids within the past 3 months or anticipated need for systemic glucocorticoids during the study -Thyroid replacement therapy if the dosage has been modified during the 3 months prior to screening visit. - Pregnant or breast-feeding women - Women of childbearing potential not protected by medically approved contraceptive method of birth control, or who are unwilling or unable to be tested for pregnancy. Pregnancy status should be checked by serum pregnancy testing prior to exposure to the investigational product and at the end of the study. - History or evidence of clinically relevant renal or urological disorder (i.e. obstructive renal disease, prostatic disorder with significant impact on miction, primary glomerular diseases...), significant hematuria (++ quantitatively assessed) - History or presence of gastrointestinal disorder, i.e. chronic diarrhea, stomach/gastric surgery, irritable bowel syndrome
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate the efficacy of AVE2268 in reducing mean plasma glucose calculated from 10-points plasma glucose profiles after a four-week treatment period. ;Secondary Objective: To assess the effects of AVE2268 on fasting plasma glucose and 2-hour post prandial plasma glucose after standardized test breakfast, lunch and dinner test meals To assess the safety and tolerabillity of AVE2268 ;Primary end point(s): Change in Mean Plasma Glucose (MPG) from baseline to week 4 calculated from 10-point profiles (before, 90 and 120 min after standardized breakfast, lunch and dinner test meals and at bedtime) | — |
Countries
Denmark, Germany, Italy, Netherlands
Outcome results
None listed