None listed
Conditions
Interventions
STUDY SELECTION INCLUDES A PERIOD OF 1 WEEK [VISITS 1 AND 2], A PERIOD OF TRANSITION WITH SIMPLE BLIND PLACEBO FOR 1 WEEK [VISITS 2 AND 3] AND A DOUBLE-BLIND TREATMENT PERIOD, PLACEBO-CONTROLLED, 20 W
Sponsors
MERCK SHARP & DOHME PERU S.R.L.,
Eligibility
Age
10 Years to 17 Years
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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.
Countries
Bulgaria, Canada, Chile, Colombia, Dominican Republic, Germany, Guatemala, Israel, Italy, Latvia, Lithuania, Malasya, Mexico, New Zealand, Romania, Russian Federation, Thailand, United Arab Emirates, United Kindgdom, United States
Outcome results
None listed