ID

32932

Beschreibung

Effects of Dapagliflozin on Kidney Function (Glomerular Filtration Rate) in Subjects With Type 2 Diabetes; ODM derived from: https://clinicaltrials.gov/show/NCT00976495

Link

https://clinicaltrials.gov/show/NCT00976495

Stichworte

Versionen (1)
  1. 20.11.18 20.11.18 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

20. November 2018

DOI

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Creative Commons BY 4.0
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Eligibility Type 2 Diabetes Mellitus NCT00976495

Englisch

Eligibility Type 2 Diabetes Mellitus NCT00976495

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
type 2 diabetes and inadequate glycemic control, defined as a1c ≥ 6.6 and ≤ 9.5%
Beschreibung

Diabetes Mellitus, Non-Insulin-Dependent | Poor glycemic control | Hemoglobin A1c measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C0011860
UMLS CUI [2]
C0342299
UMLS CUI [3]
C0474680
stable dose of metformin and/or a sulfonylurea, for at least 4 weeks prior to the enrollment visit
Beschreibung

Metformin Dose Stable | Sulfonylurea Dose Stable

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0025598
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0205360
UMLS CUI [2,1]
C0038766
UMLS CUI [2,2]
C0178602
UMLS CUI [2,3]
C0205360
inadequate blood pressure (bp) control, defined as systolic bp (sbp) ≥ 130 and < 165 mmhg, and/or diastolic bp (dbp) ≥ 80 and < 105 mmhg
Beschreibung

Control of blood pressure Inadequate | Systolic Pressure | Diastolic blood pressure

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1753303
UMLS CUI [1,2]
C0205412
UMLS CUI [2]
C0871470
UMLS CUI [3]
C0428883
c-peptide ≥ 0.8 ng/ml
Beschreibung

C-peptide measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C0202100
estimated gfr by the modification of diet in renal disease (mdrd) formula > 60 ml/min/1.73m² and < 150 ml/min/1.73m²
Beschreibung

GFR estimation by MDRD

Datentyp

boolean

Alias
UMLS CUI [1]
C2170215
urine albumin:creatinine ratio (uacr) < 300 mg/g
Beschreibung

Urine albumin/creatinine ratio measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C0455271
bmi ≤ 45.0 kg/m2
Beschreibung

Body mass index

Datentyp

boolean

Alias
UMLS CUI [1]
C1305855
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
administration of diuretics or other medication approved for the treatment of hypertension (with the exception of either acei or arb), at any dose during the 12 weeks prior to the enrollment visit
Beschreibung

Diuretics | Antihypertensive Agents | Exception Angiotensin-Converting Enzyme Inhibitors | Exception Angiotensin II receptor antagonist

Datentyp

boolean

Alias
UMLS CUI [1]
C0012798
UMLS CUI [2]
C0003364
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0003015
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0521942
history of adverse reaction to radio-contrast dye
Beschreibung

Adverse reaction Contrast dye

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0559546
UMLS CUI [1,2]
C0742795
allergy or contraindication to use of thiazide diuretics
Beschreibung

Hypersensitivity Thiazide Diuretics | Medical contraindication Thiazide Diuretics

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0012802
UMLS CUI [2,1]
C1301624
UMLS CUI [2,2]
C0012802
aspartate aminotransferase (ast) > 3x upper limit of normal (uln)
Beschreibung

Aspartate aminotransferase increased

Datentyp

boolean

Alias
UMLS CUI [1]
C0151904
alanine aminotransferase (alt) > 3x uln
Beschreibung

Alanine aminotransferase increased

Datentyp

boolean

Alias
UMLS CUI [1]
C0151905
serum total bilirubin > 1.5x uln
Beschreibung

SERUM TOTAL BILIRUBIN ELEVATED

Datentyp

boolean

Alias
UMLS CUI [1]
C0595866
serum creatinine (scr) ≥ 1.50 mg/dl (133 μmol/l) for men; scr ≥ 1.40 mg/dl (124
Beschreibung

Creatinine measurement, serum | Gender

Datentyp

boolean

Alias
UMLS CUI [1]
C0201976
UMLS CUI [2]
C0079399
μmol/l) for women
Beschreibung

ID.15

Datentyp

boolean

currently unstable or serious cardiovascular, renal, hepatic, hematological, oncologic, endocrine, psychiatric, or rheumatic diseases
Beschreibung

Cardiovascular Diseases Unstable | Kidney Diseases Unstable | Liver diseases Unstable | Hematological Disease Unstable | Malignant disease Unstable | Endocrine System Diseases Unstable | Mental disorders Unstable | Rheumatism Unstable | Cardiovascular Diseases Serious | Kidney Diseases Serious | Liver diseases Serious | Hematological Disease Serious | Malignant disease Serious | Endocrine System Diseases Serious | Mental disorders Serious | Rheumatism Serious

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0007222
UMLS CUI [1,2]
C0443343
UMLS CUI [2,1]
C0022658
UMLS CUI [2,2]
C0443343
UMLS CUI [3,1]
C0023895
UMLS CUI [3,2]
C0443343
UMLS CUI [4,1]
C0018939
UMLS CUI [4,2]
C0443343
UMLS CUI [5,1]
C0442867
UMLS CUI [5,2]
C0443343
UMLS CUI [6,1]
C0014130
UMLS CUI [6,2]
C0443343
UMLS CUI [7,1]
C0004936
UMLS CUI [7,2]
C0443343
UMLS CUI [8,1]
C0035435
UMLS CUI [8,2]
C0443343
UMLS CUI [9,1]
C0007222
UMLS CUI [9,2]
C0205404
UMLS CUI [10,1]
C0022658
UMLS CUI [10,2]
C0205404
UMLS CUI [11,1]
C0023895
UMLS CUI [11,2]
C0205404
UMLS CUI [12,1]
C0018939
UMLS CUI [12,2]
C0205404
UMLS CUI [13,1]
C0442867
UMLS CUI [13,2]
C0205404
UMLS CUI [14,1]
C0014130
UMLS CUI [14,2]
C0205404
UMLS CUI [15,1]
C0004936
UMLS CUI [15,2]
C0205404
UMLS CUI [16,1]
C0035435
UMLS CUI [16,2]
C0205404
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Ähnliche Modelle

Eligibility Type 2 Diabetes Mellitus NCT00976495

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Diabetes Mellitus, Non-Insulin-Dependent | Poor glycemic control | Hemoglobin A1c measurement
Item
type 2 diabetes and inadequate glycemic control, defined as a1c ≥ 6.6 and ≤ 9.5%
boolean
C0011860 (UMLS CUI [1])
C0342299 (UMLS CUI [2])
C0474680 (UMLS CUI [3])
Metformin Dose Stable | Sulfonylurea Dose Stable
Item
stable dose of metformin and/or a sulfonylurea, for at least 4 weeks prior to the enrollment visit
boolean
C0025598 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
C0038766 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C0205360 (UMLS CUI [2,3])
Control of blood pressure Inadequate | Systolic Pressure | Diastolic blood pressure
Item
inadequate blood pressure (bp) control, defined as systolic bp (sbp) ≥ 130 and < 165 mmhg, and/or diastolic bp (dbp) ≥ 80 and < 105 mmhg
boolean
C1753303 (UMLS CUI [1,1])
C0205412 (UMLS CUI [1,2])
C0871470 (UMLS CUI [2])
C0428883 (UMLS CUI [3])
C-peptide measurement
Item
c-peptide ≥ 0.8 ng/ml
boolean
C0202100 (UMLS CUI [1])
GFR estimation by MDRD
Item
estimated gfr by the modification of diet in renal disease (mdrd) formula > 60 ml/min/1.73m² and < 150 ml/min/1.73m²
boolean
C2170215 (UMLS CUI [1])
Urine albumin/creatinine ratio measurement
Item
urine albumin:creatinine ratio (uacr) < 300 mg/g
boolean
C0455271 (UMLS CUI [1])
Body mass index
Item
bmi ≤ 45.0 kg/m2
boolean
C1305855 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Diuretics | Antihypertensive Agents | Exception Angiotensin-Converting Enzyme Inhibitors | Exception Angiotensin II receptor antagonist
Item
administration of diuretics or other medication approved for the treatment of hypertension (with the exception of either acei or arb), at any dose during the 12 weeks prior to the enrollment visit
boolean
C0012798 (UMLS CUI [1])
C0003364 (UMLS CUI [2])
C1705847 (UMLS CUI [3,1])
C0003015 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C0521942 (UMLS CUI [4,2])
Adverse reaction Contrast dye
Item
history of adverse reaction to radio-contrast dye
boolean
C0559546 (UMLS CUI [1,1])
C0742795 (UMLS CUI [1,2])
Hypersensitivity Thiazide Diuretics | Medical contraindication Thiazide Diuretics
Item
allergy or contraindication to use of thiazide diuretics
boolean
C0020517 (UMLS CUI [1,1])
C0012802 (UMLS CUI [1,2])
C1301624 (UMLS CUI [2,1])
C0012802 (UMLS CUI [2,2])
Aspartate aminotransferase increased
Item
aspartate aminotransferase (ast) > 3x upper limit of normal (uln)
boolean
C0151904 (UMLS CUI [1])
Alanine aminotransferase increased
Item
alanine aminotransferase (alt) > 3x uln
boolean
C0151905 (UMLS CUI [1])
SERUM TOTAL BILIRUBIN ELEVATED
Item
serum total bilirubin > 1.5x uln
boolean
C0595866 (UMLS CUI [1])
Creatinine measurement, serum | Gender
Item
serum creatinine (scr) ≥ 1.50 mg/dl (133 μmol/l) for men; scr ≥ 1.40 mg/dl (124
boolean
C0201976 (UMLS CUI [1])
C0079399 (UMLS CUI [2])
ID.15
Item
μmol/l) for women
boolean
Cardiovascular Diseases Unstable | Kidney Diseases Unstable | Liver diseases Unstable | Hematological Disease Unstable | Malignant disease Unstable | Endocrine System Diseases Unstable | Mental disorders Unstable | Rheumatism Unstable | Cardiovascular Diseases Serious | Kidney Diseases Serious | Liver diseases Serious | Hematological Disease Serious | Malignant disease Serious | Endocrine System Diseases Serious | Mental disorders Serious | Rheumatism Serious
Item
currently unstable or serious cardiovascular, renal, hepatic, hematological, oncologic, endocrine, psychiatric, or rheumatic diseases
boolean
C0007222 (UMLS CUI [1,1])
C0443343 (UMLS CUI [1,2])
C0022658 (UMLS CUI [2,1])
C0443343 (UMLS CUI [2,2])
C0023895 (UMLS CUI [3,1])
C0443343 (UMLS CUI [3,2])
C0018939 (UMLS CUI [4,1])
C0443343 (UMLS CUI [4,2])
C0442867 (UMLS CUI [5,1])
C0443343 (UMLS CUI [5,2])
C0014130 (UMLS CUI [6,1])
C0443343 (UMLS CUI [6,2])
C0004936 (UMLS CUI [7,1])
C0443343 (UMLS CUI [7,2])
C0035435 (UMLS CUI [8,1])
C0443343 (UMLS CUI [8,2])
C0007222 (UMLS CUI [9,1])
C0205404 (UMLS CUI [9,2])
C0022658 (UMLS CUI [10,1])
C0205404 (UMLS CUI [10,2])
C0023895 (UMLS CUI [11,1])
C0205404 (UMLS CUI [11,2])
C0018939 (UMLS CUI [12,1])
C0205404 (UMLS CUI [12,2])
C0442867 (UMLS CUI [13,1])
C0205404 (UMLS CUI [13,2])
C0014130 (UMLS CUI [14,1])
C0205404 (UMLS CUI [14,2])
C0004936 (UMLS CUI [15,1])
C0205404 (UMLS CUI [15,2])
C0035435 (UMLS CUI [16,1])
C0205404 (UMLS CUI [16,2])
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