ID

16096

Beschrijving

Safety and Efficacy of Saxagliptin vs.Glimepiride as Add-on Therapy in T2DM Patients With Metformin Monotherapytients; ODM derived from: https://clinicaltrials.gov/show/NCT02280486

Link

https://clinicaltrials.gov/show/NCT02280486

Trefwoorden

Versies (1)
  1. 29-06-16 29-06-16 -
Geüploaded op

29 juni 2016

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Type 2 Diabetes NCT02280486

Engels

Eligibility Type 2 Diabetes NCT02280486

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
for inclusion in the study subjects should fulfill the following criteria:
Beschrijving

criteria Following Fulfill

Datatype

boolean

Alias
UMLS CUI [1,1]
C0243161
UMLS CUI [1,2]
C0332282
UMLS CUI [1,3]
C1550543
provision of informed consent prior to any study specific procedures
Beschrijving

Informed consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
type2 diabetic patients had been on stable, maximum tolerated doses of metformin (≧1500mg/d, ≧8 weeks)
Beschrijving

Diabetes Mellitus, Non-Insulin-Dependent | Metformin Dosage Maximum Stable

Datatype

boolean

Alias
UMLS CUI [1]
C0011860
UMLS CUI [2,1]
C0025598
UMLS CUI [2,2]
C0178602
UMLS CUI [2,3]
C0806909
UMLS CUI [2,4]
C0205360
male or female age ≧ 25 years and ≦75 years old
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
hba1c ≧7.0 and ≦9.5%
Beschrijving

Hemoglobin A1c measurement

Datatype

boolean

Alias
UMLS CUI [1]
C0474680
bmi ≧ 20 and ≦ 30 kg/m2
Beschrijving

Body mass index

Datatype

boolean

Alias
UMLS CUI [1]
C1305855
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
subjects should not enter the study if any of the following exclusion criteria are fulfilled:
Beschrijving

Exclusion Criteria Following Fulfill

Datatype

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C0332282
UMLS CUI [1,3]
C1550543
known or suspected allergy to trial products or related products.
Beschrijving

Hypersensitivity Investigational New Drugs | Hypersensitivity Pharmaceutical Preparations Investigational New Drugs Related

Datatype

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0013230
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0013227
UMLS CUI [2,3]
C0013230
UMLS CUI [2,4]
C0439849
impaired renal function defined as serum-creatinine ≥ 1.5 mg/dl (≥ 132.6 μmol/l).
Beschrijving

Renal Insufficiency | Creatinine measurement, serum

Datatype

boolean

Alias
UMLS CUI [1]
C1565489
UMLS CUI [2]
C0201976
acute or chronic disease which may cause tissue hypoxia such as cardiac or respiratory failure, shock.
Beschrijving

Disease Causing Tissue hypoxia | Heart failure | Respiratory Failure | Shock

Datatype

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0678227
UMLS CUI [1,3]
C4061096
UMLS CUI [2]
C0018801
UMLS CUI [3]
C1145670
UMLS CUI [4]
C0036974
hepatic insufficiency, acute alcohol intoxication, alcoholism.
Beschrijving

Hepatic Insufficiency | Acute alcoholic intoxication | Alcoholic Intoxication, Chronic

Datatype

boolean

Alias
UMLS CUI [1]
C1306571
UMLS CUI [2]
C0394996
UMLS CUI [3]
C0001973
subjects has a clinically significant, active (or over the past 12 months) cardiovascular history (including a history of myocardial infarction (mi), arrhythmias or conduction delays on ecg, unstable angina, or decompensated heart failure (new york heart association-class ⅲ and ⅳ).
Beschrijving

Cardiovascular Diseases Clinical Significance | Myocardial Infarction | Cardiac Arrhythmia | Electrocardiography Conduction delay | Angina, Unstable | Decompensated cardiac failure

Datatype

boolean

Alias
UMLS CUI [1,1]
C0007222
UMLS CUI [1,2]
C2826293
UMLS CUI [2]
C0027051
UMLS CUI [3]
C0003811
UMLS CUI [4,1]
C1623258
UMLS CUI [4,2]
C1398354
UMLS CUI [5]
C0002965
UMLS CUI [6]
C0581377
proliferative retinopathy or muscular oedema requiring acute treatment.
Beschrijving

Proliferative retinopathy Requirement Therapeutic procedure acute | Muscular edema Requirement Therapeutic procedure acute

Datatype

boolean

Alias
UMLS CUI [1,1]
C0339467
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C0087111
UMLS CUI [1,4]
C0205178
UMLS CUI [2,1]
C4021979
UMLS CUI [2,2]
C1514873
UMLS CUI [2,3]
C0087111
UMLS CUI [2,4]
C0205178
lactation.
Beschrijving

Lactation

Datatype

boolean

Alias
UMLS CUI [1]
C0022925
pregnant or positive pregnancy test at screening, nursing mother, or unwillingness to use adequate contraception (adequate contraceptive measures are sterilization, intrauterine device, oral contraceptives or barrier methods).
Beschrijving

Pregnancy | Pregnancy test positive | Breast Feeding | Contraceptive methods Unwilling | Female Sterilization | Intrauterine Devices | Contraceptives, Oral | Contraception, Barrier

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0240802
UMLS CUI [3]
C0006147
UMLS CUI [4,1]
C0700589
UMLS CUI [4,2]
C0558080
UMLS CUI [5]
C0015787
UMLS CUI [6]
C0021900
UMLS CUI [7]
C0009905
UMLS CUI [8]
C0004764
treatment with systemic corticosteroids within the past two months prior to screening.
Beschrijving

Therapeutic procedure systemic steroids

Datatype

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C2825233
tested positive for glutamic acid decarboxylase antibody.
Beschrijving

serum glutamic acid decarboxylase (GAD) antibody test Positive

Datatype

boolean

Alias
UMLS CUI [1,1]
C2208796
UMLS CUI [1,2]
C1446409
receipt of any investigational drug within 1 month prior to this trial.
Beschrijving

Investigational New Drug Use

Datatype

boolean

Alias
UMLS CUI [1,1]
C0013230
UMLS CUI [1,2]
C1524063
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Similar models

Eligibility Type 2 Diabetes NCT02280486

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
criteria Following Fulfill
Item
for inclusion in the study subjects should fulfill the following criteria:
boolean
C0243161 (UMLS CUI [1,1])
C0332282 (UMLS CUI [1,2])
C1550543 (UMLS CUI [1,3])
Informed consent
Item
provision of informed consent prior to any study specific procedures
boolean
C0021430 (UMLS CUI [1])
Diabetes Mellitus, Non-Insulin-Dependent | Metformin Dosage Maximum Stable
Item
type2 diabetic patients had been on stable, maximum tolerated doses of metformin (≧1500mg/d, ≧8 weeks)
boolean
C0011860 (UMLS CUI [1])
C0025598 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C0806909 (UMLS CUI [2,3])
C0205360 (UMLS CUI [2,4])
Age
Item
male or female age ≧ 25 years and ≦75 years old
boolean
C0001779 (UMLS CUI [1])
Hemoglobin A1c measurement
Item
hba1c ≧7.0 and ≦9.5%
boolean
C0474680 (UMLS CUI [1])
Body mass index
Item
bmi ≧ 20 and ≦ 30 kg/m2
boolean
C1305855 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Exclusion Criteria Following Fulfill
Item
subjects should not enter the study if any of the following exclusion criteria are fulfilled:
boolean
C0680251 (UMLS CUI [1,1])
C0332282 (UMLS CUI [1,2])
C1550543 (UMLS CUI [1,3])
Hypersensitivity Investigational New Drugs | Hypersensitivity Pharmaceutical Preparations Investigational New Drugs Related
Item
known or suspected allergy to trial products or related products.
boolean
C0020517 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0013227 (UMLS CUI [2,2])
C0013230 (UMLS CUI [2,3])
C0439849 (UMLS CUI [2,4])
Renal Insufficiency | Creatinine measurement, serum
Item
impaired renal function defined as serum-creatinine ≥ 1.5 mg/dl (≥ 132.6 μmol/l).
boolean
C1565489 (UMLS CUI [1])
C0201976 (UMLS CUI [2])
Disease Causing Tissue hypoxia | Heart failure | Respiratory Failure | Shock
Item
acute or chronic disease which may cause tissue hypoxia such as cardiac or respiratory failure, shock.
boolean
C0012634 (UMLS CUI [1,1])
C0678227 (UMLS CUI [1,2])
C4061096 (UMLS CUI [1,3])
C0018801 (UMLS CUI [2])
C1145670 (UMLS CUI [3])
C0036974 (UMLS CUI [4])
Hepatic Insufficiency | Acute alcoholic intoxication | Alcoholic Intoxication, Chronic
Item
hepatic insufficiency, acute alcohol intoxication, alcoholism.
boolean
C1306571 (UMLS CUI [1])
C0394996 (UMLS CUI [2])
C0001973 (UMLS CUI [3])
Cardiovascular Diseases Clinical Significance | Myocardial Infarction | Cardiac Arrhythmia | Electrocardiography Conduction delay | Angina, Unstable | Decompensated cardiac failure
Item
subjects has a clinically significant, active (or over the past 12 months) cardiovascular history (including a history of myocardial infarction (mi), arrhythmias or conduction delays on ecg, unstable angina, or decompensated heart failure (new york heart association-class ⅲ and ⅳ).
boolean
C0007222 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])
C0027051 (UMLS CUI [2])
C0003811 (UMLS CUI [3])
C1623258 (UMLS CUI [4,1])
C1398354 (UMLS CUI [4,2])
C0002965 (UMLS CUI [5])
C0581377 (UMLS CUI [6])
Proliferative retinopathy Requirement Therapeutic procedure acute | Muscular edema Requirement Therapeutic procedure acute
Item
proliferative retinopathy or muscular oedema requiring acute treatment.
boolean
C0339467 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0087111 (UMLS CUI [1,3])
C0205178 (UMLS CUI [1,4])
C4021979 (UMLS CUI [2,1])
C1514873 (UMLS CUI [2,2])
C0087111 (UMLS CUI [2,3])
C0205178 (UMLS CUI [2,4])
Lactation
Item
lactation.
boolean
C0022925 (UMLS CUI [1])
Pregnancy | Pregnancy test positive | Breast Feeding | Contraceptive methods Unwilling | Female Sterilization | Intrauterine Devices | Contraceptives, Oral | Contraception, Barrier
Item
pregnant or positive pregnancy test at screening, nursing mother, or unwillingness to use adequate contraception (adequate contraceptive measures are sterilization, intrauterine device, oral contraceptives or barrier methods).
boolean
C0032961 (UMLS CUI [1])
C0240802 (UMLS CUI [2])
C0006147 (UMLS CUI [3])
C0700589 (UMLS CUI [4,1])
C0558080 (UMLS CUI [4,2])
C0015787 (UMLS CUI [5])
C0021900 (UMLS CUI [6])
C0009905 (UMLS CUI [7])
C0004764 (UMLS CUI [8])
Therapeutic procedure systemic steroids
Item
treatment with systemic corticosteroids within the past two months prior to screening.
boolean
C0087111 (UMLS CUI [1,1])
C2825233 (UMLS CUI [1,2])
serum glutamic acid decarboxylase (GAD) antibody test Positive
Item
tested positive for glutamic acid decarboxylase antibody.
boolean
C2208796 (UMLS CUI [1,1])
C1446409 (UMLS CUI [1,2])
Investigational New Drug Use
Item
receipt of any investigational drug within 1 month prior to this trial.
boolean
C0013230 (UMLS CUI [1,1])
C1524063 (UMLS CUI [1,2])
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