ID

38756

Beschreibung

A Study to Evaluate the Effect of Aleglitazar on Cardiac Energetics and Function in Patients With Type 2 Diabetes Mellitus and no History of Coronary Artery Disease; ODM derived from: https://clinicaltrials.gov/show/NCT01680978

Link

https://clinicaltrials.gov/show/NCT01680978

Stichworte

Versionen (1)
  1. 31.10.19 31.10.19 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

31. Oktober 2019

DOI

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Creative Commons BY 4.0
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Eligibility Diabetes Mellitus, Type 2 NCT01680978

Englisch

Eligibility Diabetes Mellitus, Type 2 NCT01680978

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
adult patients, 40 to 70 years of age (inclusive) at screening
Beschreibung

Adult | Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001675
UMLS CUI [2]
C0001779
patients with type 2 diabetes mellitus diagnosed at least 12 weeks before screening and either drug-naïve or treated with stable metformin monotherapy for at least 12 weeks prior to screening
Beschreibung

Non-Insulin-Dependent Diabetes Mellitus Disease length | Pharmaceutical Preparations Absent | Metformin Stable

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0011860
UMLS CUI [1,2]
C0872146
UMLS CUI [2,1]
C0013227
UMLS CUI [2,2]
C0332197
UMLS CUI [3,1]
C0025598
UMLS CUI [3,2]
C0205360
hba1c >/= 7 % and </= 9% at screening
Beschreibung

Hemoglobin A1c measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C0474680
absence of history of coronary artery disease
Beschreibung

Coronary Artery Disease Absent

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1956346
UMLS CUI [1,2]
C0332197
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
diagnosis or history of type 1 diabetes mellitus, diabetes resulting from pancreatic injury, or secondary forms of diabetes
Beschreibung

Diabetes Mellitus, Insulin-Dependent | Diabetes Mellitus Due to Injury of pancreas | Secondary diabetes mellitus

Datentyp

boolean

Alias
UMLS CUI [1]
C0011854
UMLS CUI [2,1]
C0011849
UMLS CUI [2,2]
C0678226
UMLS CUI [2,3]
C0273163
UMLS CUI [3]
C0271640
current treatment with fibrates, thiazolidinediones, or insulin
Beschreibung

Fibrates | Thiazolidinediones | Insulin

Datentyp

boolean

Alias
UMLS CUI [1]
C1449704
UMLS CUI [2]
C1257987
UMLS CUI [3]
C0021641
prior intolerance to thiazolidinediones and/or fibrates
Beschreibung

Intolerance to Thiazolidinediones | Intolerance to Fibrates

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1744706
UMLS CUI [1,2]
C1257987
UMLS CUI [2,1]
C1744706
UMLS CUI [2,2]
C1449704
clinically significant liver disease or impaired liver function
Beschreibung

Liver disease | Liver Dysfunction

Datentyp

boolean

Alias
UMLS CUI [1]
C0023895
UMLS CUI [2]
C0086565
know chronic diabetic complications (i.e. retinopathy, neuropathy, nephropathy)
Beschreibung

Complications of Diabetes Mellitus chronic | Retinal Disease | Neuropathy | Kidney Disease

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0342257
UMLS CUI [1,2]
C0205191
UMLS CUI [2]
C0035309
UMLS CUI [3]
C0442874
UMLS CUI [4]
C0022658
symptomatic congestive heart failure classified as nyha class ii-iv
Beschreibung

Symptomatic congestive heart failure New York Heart Association Classification

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0742758
UMLS CUI [1,2]
C1275491
diagnosed and/or treated malignancy within the past 5 years, except for treated basal cell skin cancer, in situ carcinoma of the cervix, or in situ prostate cancer
Beschreibung

Malignant Neoplasms | Cancer treatment | Exception Basal cell carcinoma Treated | Exception Carcinoma in situ of uterine cervix Treated | Exception Carcinoma in situ of prostate Treated

Datentyp

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2]
C0920425
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0007117
UMLS CUI [3,3]
C1522326
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0851140
UMLS CUI [4,3]
C1522326
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C0154088
UMLS CUI [5,3]
C1522326
contraindications to mri, or inability to tolerate mri scanning
Beschreibung

Medical contraindication MRI | MRI scan Receive Unable

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0024485
UMLS CUI [2,1]
C0024485
UMLS CUI [2,2]
C1514756
UMLS CUI [2,3]
C1299582
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Ähnliche Modelle

Eligibility Diabetes Mellitus, Type 2 NCT01680978

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Adult | Age
Item
adult patients, 40 to 70 years of age (inclusive) at screening
boolean
C0001675 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Non-Insulin-Dependent Diabetes Mellitus Disease length | Pharmaceutical Preparations Absent | Metformin Stable
Item
patients with type 2 diabetes mellitus diagnosed at least 12 weeks before screening and either drug-naïve or treated with stable metformin monotherapy for at least 12 weeks prior to screening
boolean
C0011860 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
C0013227 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0025598 (UMLS CUI [3,1])
C0205360 (UMLS CUI [3,2])
Hemoglobin A1c measurement
Item
hba1c >/= 7 % and </= 9% at screening
boolean
C0474680 (UMLS CUI [1])
Coronary Artery Disease Absent
Item
absence of history of coronary artery disease
boolean
C1956346 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Diabetes Mellitus, Insulin-Dependent | Diabetes Mellitus Due to Injury of pancreas | Secondary diabetes mellitus
Item
diagnosis or history of type 1 diabetes mellitus, diabetes resulting from pancreatic injury, or secondary forms of diabetes
boolean
C0011854 (UMLS CUI [1])
C0011849 (UMLS CUI [2,1])
C0678226 (UMLS CUI [2,2])
C0273163 (UMLS CUI [2,3])
C0271640 (UMLS CUI [3])
Fibrates | Thiazolidinediones | Insulin
Item
current treatment with fibrates, thiazolidinediones, or insulin
boolean
C1449704 (UMLS CUI [1])
C1257987 (UMLS CUI [2])
C0021641 (UMLS CUI [3])
Intolerance to Thiazolidinediones | Intolerance to Fibrates
Item
prior intolerance to thiazolidinediones and/or fibrates
boolean
C1744706 (UMLS CUI [1,1])
C1257987 (UMLS CUI [1,2])
C1744706 (UMLS CUI [2,1])
C1449704 (UMLS CUI [2,2])
Liver disease | Liver Dysfunction
Item
clinically significant liver disease or impaired liver function
boolean
C0023895 (UMLS CUI [1])
C0086565 (UMLS CUI [2])
Complications of Diabetes Mellitus chronic | Retinal Disease | Neuropathy | Kidney Disease
Item
know chronic diabetic complications (i.e. retinopathy, neuropathy, nephropathy)
boolean
C0342257 (UMLS CUI [1,1])
C0205191 (UMLS CUI [1,2])
C0035309 (UMLS CUI [2])
C0442874 (UMLS CUI [3])
C0022658 (UMLS CUI [4])
Symptomatic congestive heart failure New York Heart Association Classification
Item
symptomatic congestive heart failure classified as nyha class ii-iv
boolean
C0742758 (UMLS CUI [1,1])
C1275491 (UMLS CUI [1,2])
Malignant Neoplasms | Cancer treatment | Exception Basal cell carcinoma Treated | Exception Carcinoma in situ of uterine cervix Treated | Exception Carcinoma in situ of prostate Treated
Item
diagnosed and/or treated malignancy within the past 5 years, except for treated basal cell skin cancer, in situ carcinoma of the cervix, or in situ prostate cancer
boolean
C0006826 (UMLS CUI [1])
C0920425 (UMLS CUI [2])
C1705847 (UMLS CUI [3,1])
C0007117 (UMLS CUI [3,2])
C1522326 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C0851140 (UMLS CUI [4,2])
C1522326 (UMLS CUI [4,3])
C1705847 (UMLS CUI [5,1])
C0154088 (UMLS CUI [5,2])
C1522326 (UMLS CUI [5,3])
Medical contraindication MRI | MRI scan Receive Unable
Item
contraindications to mri, or inability to tolerate mri scanning
boolean
C1301624 (UMLS CUI [1,1])
C0024485 (UMLS CUI [1,2])
C0024485 (UMLS CUI [2,1])
C1514756 (UMLS CUI [2,2])
C1299582 (UMLS CUI [2,3])
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