ID

18446

Beschrijving

AVANDAMET Versus Metformin And Sulphonylurea In People With Poorly Controlled Type 2 Diabetes; ODM derived from: https://clinicaltrials.gov/show/NCT00359112

Link

https://clinicaltrials.gov/show/NCT00359112

Trefwoorden

Versies (1)
  1. 05-11-16 05-11-16 -
Geüploaded op

5 november 2016

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Non-Insulin-Dependent Diabetes Mellitus NCT00359112

Engels

Eligibility Non-Insulin-Dependent Diabetes Mellitus NCT00359112

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
body mass index > or = to 25 kg/m2.
Beschrijving

Body mass index

Datatype

boolean

Alias
UMLS CUI [1]
C1305855
hba1c > or =7% and < or =10% at screening.
Beschrijving

Glycosylated hemoglobin A

Datatype

boolean

Alias
UMLS CUI [1]
C0019018
fpg > or = 7.0mmol/l (126mg/dl) at visit 2.
Beschrijving

Plasma fasting glucose measurement

Datatype

boolean

Alias
UMLS CUI [1]
C0583513
receiving at least 0.85g of metformin at constant dose(s) for at least 8 weeks prior to visit 1a.
Beschrijving

Metformin Dose Constant

Datatype

boolean

Alias
UMLS CUI [1,1]
C0025598
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C1948059
female subjects must be postmenopausal or using effective contraceptive measures.
Beschrijving

Gender Contraceptive methods | Postmenopausal state

Datatype

boolean

Alias
UMLS CUI [1,1]
C0079399
UMLS CUI [1,2]
C0700589
UMLS CUI [2]
C0232970
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
use of any other oral antidiabetic drug other than metformin within 12 weeks prior to screening.
Beschrijving

Antidiabetics Oral | Metformin

Datatype

boolean

Alias
UMLS CUI [1,1]
C0935929
UMLS CUI [1,2]
C1527415
UMLS CUI [2]
C0025598
subjects with clinically significant ongoing oedema requiring pharmacological treatment or with a history of oedema requiring pharmacological treatment.
Beschrijving

Edema Clinical Significance Requirement Pharmacotherapy | Edema Requirement Pharmacotherapy

Datatype

boolean

Alias
UMLS CUI [1,1]
C0013604
UMLS CUI [1,2]
C2826293
UMLS CUI [1,3]
C1514873
UMLS CUI [1,4]
C0013216
UMLS CUI [2,1]
C0013604
UMLS CUI [2,2]
C1514873
UMLS CUI [2,3]
C0013216
subjects with a history of severe hypoglycaemia.
Beschrijving

Hypoglycemia Severe

Datatype

boolean

Alias
UMLS CUI [1,1]
C0020615
UMLS CUI [1,2]
C0205082
renal disease or renal dysfunction.
Beschrijving

Kidney Disease | Renal dysfunction

Datatype

boolean

Alias
UMLS CUI [1]
C0022658
UMLS CUI [2]
C3279454
presence of clinically significant hepatic disease.
Beschrijving

Liver disease Clinical Significance

Datatype

boolean

Alias
UMLS CUI [1,1]
C0023895
UMLS CUI [1,2]
C2826293
presence of unstable or severe angina or known nyha grade i-iv congestive heart failure.
Beschrijving

Angina, Unstable | Angina Pectoris Severe | Congestive heart failure | New York Heart Association Classification

Datatype

boolean

Alias
UMLS CUI [1]
C0002965
UMLS CUI [2,1]
C0002962
UMLS CUI [2,2]
C0205082
UMLS CUI [3]
C0018802
UMLS CUI [4]
C1275491
subjects who have had a previous myocardial infarction, percutaneous transluminal coronary angioplasty, coronary artery bypass graft or cerebrovascular accident within 3 months prior to screening.
Beschrijving

Myocardial Infarction | Percutaneous Transluminal Coronary Angioplasty | Coronary Artery Bypass Surgery | Cerebrovascular accident

Datatype

boolean

Alias
UMLS CUI [1]
C0027051
UMLS CUI [2]
C2936173
UMLS CUI [3]
C0010055
UMLS CUI [4]
C0038454
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Similar models

Eligibility Non-Insulin-Dependent Diabetes Mellitus NCT00359112

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Body mass index
Item
body mass index > or = to 25 kg/m2.
boolean
C1305855 (UMLS CUI [1])
Glycosylated hemoglobin A
Item
hba1c > or =7% and < or =10% at screening.
boolean
C0019018 (UMLS CUI [1])
Plasma fasting glucose measurement
Item
fpg > or = 7.0mmol/l (126mg/dl) at visit 2.
boolean
C0583513 (UMLS CUI [1])
Metformin Dose Constant
Item
receiving at least 0.85g of metformin at constant dose(s) for at least 8 weeks prior to visit 1a.
boolean
C0025598 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C1948059 (UMLS CUI [1,3])
Gender Contraceptive methods | Postmenopausal state
Item
female subjects must be postmenopausal or using effective contraceptive measures.
boolean
C0079399 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0232970 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Antidiabetics Oral | Metformin
Item
use of any other oral antidiabetic drug other than metformin within 12 weeks prior to screening.
boolean
C0935929 (UMLS CUI [1,1])
C1527415 (UMLS CUI [1,2])
C0025598 (UMLS CUI [2])
Edema Clinical Significance Requirement Pharmacotherapy | Edema Requirement Pharmacotherapy
Item
subjects with clinically significant ongoing oedema requiring pharmacological treatment or with a history of oedema requiring pharmacological treatment.
boolean
C0013604 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])
C1514873 (UMLS CUI [1,3])
C0013216 (UMLS CUI [1,4])
C0013604 (UMLS CUI [2,1])
C1514873 (UMLS CUI [2,2])
C0013216 (UMLS CUI [2,3])
Hypoglycemia Severe
Item
subjects with a history of severe hypoglycaemia.
boolean
C0020615 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
Kidney Disease | Renal dysfunction
Item
renal disease or renal dysfunction.
boolean
C0022658 (UMLS CUI [1])
C3279454 (UMLS CUI [2])
Liver disease Clinical Significance
Item
presence of clinically significant hepatic disease.
boolean
C0023895 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])
Angina, Unstable | Angina Pectoris Severe | Congestive heart failure | New York Heart Association Classification
Item
presence of unstable or severe angina or known nyha grade i-iv congestive heart failure.
boolean
C0002965 (UMLS CUI [1])
C0002962 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C0018802 (UMLS CUI [3])
C1275491 (UMLS CUI [4])
Myocardial Infarction | Percutaneous Transluminal Coronary Angioplasty | Coronary Artery Bypass Surgery | Cerebrovascular accident
Item
subjects who have had a previous myocardial infarction, percutaneous transluminal coronary angioplasty, coronary artery bypass graft or cerebrovascular accident within 3 months prior to screening.
boolean
C0027051 (UMLS CUI [1])
C2936173 (UMLS CUI [2])
C0010055 (UMLS CUI [3])
C0038454 (UMLS CUI [4])
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