A CLINICAL TRIAL PHASE III, MULTICENTER, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED TO EVALUATE THE SAFETY AND EFFICACY OF MK-0431A (TAB OF A FIXED DOSE COMBINATION OF SITAGLIPTIN AND METFORMIN) IN PEDIATRIC PATIENTS WITH TYPE 2 DIABETES MELLITUS

MERCK SHARP & DOHME PERU S.R.L.,0 个研究点目标入组 0 人开始时间: 2012年7月24日最近更新: 2023年9月4日

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•IN THE VISIT 1
•1. THE PATIENT SUFFERS OF T2DM, AS INDICATED BY AFFIRMATIVE ANSWER (YES) TO ALL THE FOLLOWING:
•A) THE PATIENT HAS DIABETES, DIAGNOSED BY THE CRITERIA OF THE AMERICAN DIABETES ASSOCIATION (ADA) (LABORATORY DETERMINATIONS OF FASTING PLASMA GLUCOSE ≥ 126 mg/dL [6.99 mmol/L] OR RANDOM PLASMA GLUCOSE ≥ 200 mg / dL[11.11 mmol/L], OR BY PLASMA GLUCOSE ACCORDING TO ORAL GLUCOSE TOLERANCE TEST (OGTT) ≥ 200 mg/dL [11 .11 mmol/L] AT TWO HOURS AND CONFIRMED BY THE GUIDELINES OF THE ADA) AND DOCUMENTED IN THE MEDICAL RECORD.
•B) THE PATIENT HAS, AS EVALUATED, A CLINICAL PROFILE CONSISTENT WITH T2DM (EG: BASED ON BODY WEIGHT, FAMILY HISTORY, PRESENTATION).
•C) THE PATIENT HAS A SCORE OF BMI ≥ 1.04 SD (≥ 85th PERCENTILE) IN THE SELECTION (OR THE PATIENT HAS A HISTORY OF OVERWEIGHT OR OBESITY AT TIME OF DIAGNOSIS OF T2DM). SEE APPENDIX 6.7.
•NOTE: IF THE PATIENT DOES NOT HAVE A SCORE OF BMI ≥ 1.04 SD (≥ 85th PERCENTILE) AT THE TIME OF THE SELECTION, DOCUMENTATION OF OVERWEIGHT OR OBESITY AT TIME OF DIAGNOSIS MUST BE INCLUDED IN THE ORIGINAL DOCUMENTS ON THE SITE.

•DURING THE VISIT 1
•METABOLISM OF GLUCOSE AND CRITERIA FOR THERAPY
•1. THE PATIENT HAS A KNOWN CLINICAL SETTING OF DIABETES MELLITUS TYPE 1 OR DOCUMENTED EVIDENCE OF POSITIVE AUTOANTIBODIES OF DIABETES (IF CONDUCTED WHEN THE PATIENT WAS DIAGNOSED WITH DIABETES).
•2. THE PATIENT HAS A KNOWN CLINICAL SETTING OF MONOGENIC DIABETES, SECONDARY DIABETES OR A SYNDROME OR GENETIC DISORDER KNOWN THAT AFFECTS GLUCOSE TOLERANCE APART OF DIABETES.
•3. THE PATIENT SUFFERS FROM SYMPTOMATIC HYPERGLYCEMIA AND / OR MODERATE TO ELEVATED KETONURIA REQUIRING IMMEDIATE START OF TREATMENT WITH ANOTHER ANTIHYPERGLYCEMIC AGENT.
•SPECIFIC TREATMENTS
•4. THE PATIENT HAS BEEN TAKEN AN DPP-4 INHIBITOR PREVIOUSLY (AS SITAGLIPTIN, VILDAGLIPTIN, ALOGLIPTIN OR SAXAGLIPTIN) OR A GLP-1 RECEPTOR AGONIST (AS EXENATIDE OR LIRAGLUTIDE).
•NOTE: PATIENTS WHO HAVE PARTICIPATED IN SINGLE DOSE STUDIES WITH THESE AGENTS, AT LEAST 12 WEEKS PRIOR TO SELECTION ARE ELIGIBLE TO PARTICIPATE.

发起方

MERCK SHARP & DOHME PERU S.R.L.,