A randomized, double-blind, parallel-group, placebo-controlled, dose-response, multicentre, multinational study evaluating the efficacy and safety of AVE2268 administered either twice daily (breakfast and lunch) at a dose of 300, 600 and 1200 mg or once daily (breakfast) at a dose of 1200 mg, in patients with type 2 diabetes treated with metformin and not adequately controlled
- Conditions
- Type 2 diabetesMedDRA version: 8.1Level: LLTClassification code 10045242
- Registration Number
- EUCTR2006-001843-74-DK
- Lead Sponsor
- sanofi-aventis recherche & développement
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 300
·Male or female patients aged = 18 years and < 75 years at screening.
·Type 2 diabetes mellitus, as defined by the American Diabetes Association, for at least one year at the time of screening (Appendix A)
·HbA1c measured at visit 1 in the range of = 7.0 and ·Stable metformin treatment (dose = 1.5g/day for at least 3 months prior to enrollment in the study). No other antidiabetic medications are permitted for 3 months prior to enrollment
·Written informed consent/consents.
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
- 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 < 50 ml/min (predicted by using the Cockcroft-Gault formula)
- History of proteinuria >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
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