CLINICAL EFFICACY AND SAFETY OF AMARYL M ® (FIXED COMBINATION GLIMEPIRIDE AND METFORMIN) IN THE TREATMENT OF TYPE 2 DIABETIC PATIENTS, NOT CONTROLLED OR GLIMEPIRIDE MONOTHERAPY OF METFORMIN.

Sanofi-Aventis del Peru S.A.,0 个研究点目标入组 0 人开始时间: 2011年3月10日最近更新: 2023年9月4日

试验速览

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•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

•. 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).

发起方

Sanofi-Aventis del Peru S.A.,