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Clinical Trials/PER-117-11
PER-117-11
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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 sites0 target enrollmentJuly 24, 2012
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Overview

Phase
未知
Intervention
Not specified
Conditions
Not specified
Sponsor
MERCK SHARP & DOHME PERU S.R.L.,
Last Updated
2 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
July 24, 2012
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional

Investigators

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

Eligibility 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

  • •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.

Outcomes

Primary Outcomes

Not specified

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