None listed
Conditions
Interventions
THE STUDY HAS THE FOLLOWING STEPS:
- VISIT PATIENT SELECTION (Day -5), WHICH SEEK TO PATIENT IDEAL FOR STUDY.
- INCLUSION VISIT WHERE TITLE BEGINS PHASE FORCED (WEEK OR / DAY 1 ± 3 DAYS), FOLLOW
Sponsors
Sanofi-Aventis del Peru S.A.,
Eligibility
Age
35 Years to 75 Years
Inclusion criteria
Inclusion criteria: • MALE PATIENTS OR FEMALE BETWEEN 35 AND 75 YEARS WITH TYPE 2 DIABETES WHO HAVE COME TO BE TREATED WITH A STABLE DOSE OF METFORMIN (≥ 1500 MG) OR GLIMEPIRIDE (≤ 4 MG) FOR NOT LESS THAN 8 WEEKS BEFORE STARTING THE STUDY . • BODY MASS INDEX (BMI) BETWEEN 20 AND 40 KG / M ² • HbA1c ≥ 7.5% and <9.5% • FASTING PLASMA GLUCOSE (FBG) ≥ 126 MG / DL
Exclusion criteria
Exclusion criteria: . SECONDARY OR DIABETES INSULIN DEPENDENT DIABETES. . ADO TREATMENT THAN 8 WEEKS GLIMEPIRIDE OR METFORMIN BEFORE BEGINNING THE STUDY. . KNOWN LIVER FAILURE. . RENAL FAILURE: SERUM CREATININE> 1.4MG/DL IN WOMEN AND> 1.5MG/DL IN MEN OR GFR <30 mL / min per 1.73 M ² . MAJOR CARDIOVASCULAR EVENT HISTORY IN THE LAST 6 MONTHS. . PRESENCE OF CONDITIONS TO ALTER POTENTIAL ACUTE RENAL FUNCTION AS: DEHYDRATION, INFECTION SEVERE SHOCK INTRAVENOUS ADMINISTRATION OF CONTRAST AGENTS IONIZED. . SULPHONYLUREA ALLERGY AND / OR METFORMIN . ALCOHOL AND / OR DRUG . WOMEN PREGNANT OR NURSING. . PATIENT CONSIDERED BY THE RESEARCHER AS INAPPROPRIATE FOR THIS STUDY FOR ANY REASON (EG INABILITY TO MEET SPECIFIC PROTOCOL REQUIREMENTS SUCH AS PLANNED VISITS, PATIENTS WHO ARE UNABLE TO BE SELF-MONITORING GLUCOSE).
Countries
Lebano, Russian Federation
Contacts
Public ContactShellah Albites
SANOFI AVENTIS DEL PERU S.A.
Outcome results
None listed